The number of spinal cord injuries among senior citizens (age 70 and above) has increased five times in the past 30 years, as compared with younger spinal cord injury patients, researchers at Thomas Jefferson University Hospital and Jefferson's Regional Spinal Cord Injury Center of the Delaware Valley recently reported.
As the population within the United States ages, it is estimated that 20 percent of its population will be older than age 65 by the year 2040, and will likely impact spine surgeons and spinal cord rehabilitation centers as these patients become a larger proportion of the spinal cord injury (SCI) population. The findings were just presented by Jefferson neurological surgeons at a meeting in Phoenix, Ariz. of the Joint Section on Disorders of the Spine and Peripheral Nerves of the American Association of Neurological Surgeons.
"Spinal cord injuries in older patients are becoming more prevalent," said James Harrop, M.D, Assistant Professor of Neurological and Orthopedic Surgery, Jefferson Medical College of Thomas Jefferson University, one of the study's primary investigators. "The mortality of these patients is much greater than younger patients and should be factored in when considering aggressive interventions and counseling families regarding prognosis." However, they also found that these patients have had an increase in survival over this period.
Admissions by geriatric SCI patients have increased five-fold and the percentage of geriatric patients within the SCI population has increased from 4.2 percent to 15.4 percent since 1980. In comparison to younger patients, geriatric patients are less likely to have severe neurological deficits but have higher rates of mortality. Researchers reviewed a database of 3,481 consecutive acute penetrating and blunt spinal cord and spine-injured patients treated at Jefferson Regional Spinal Cord Injury Center over a 28-year period (1978-2006).
Overall annual admissions for SCI at Jefferson's Spinal Cord Injury Center have increased 60 percent since the early 1980's, but geriatric SCI admissions have increased more than 580 percent during that same time period, the researchers found.
"This increase is likely a result of an aging population and propensity for these patients to have SCI with minor trauma," Dr. Harrop noted. "Falls continue to be the predominant mechanism for geriatric spinal cord injuries with 74 percent of geriatric injuries resulting from a fall in this series."
Geriatric patients also appear prone to traumatic spinal cord injuries due to:
(1) changes in bone quality with aging
(2) increasing prevalence of cervical spinal stenosis with older age
(3) an increased rate of motor vehicle accidents per mile driven
It is also believed that these older patients have an increased risk of mortality due to their concurrent medical illnesses, as well as their limited ability to overcome traumatic injuries, they said.
Mortality, both during hospitalization and the first year after injury, was much higher in the geriatric population-- approximately eight times higher, the study showed.
Mortality during hospitalization was 3.2 percent for adult patients less than age 70 and 27.7 percent for geriatric patients. Mortality one year after getting out of the hospital was 5.4 percent for the adult patients and 44.4 percent for the geriatric patients. In both cases of mortality (hospital and one-year), high-quadriplegic injuries were found to have the highest mortality and paraplegic injuries had the lowest mortality.
Contact: Jeff Baxt
Thomas Jefferson University
воскресенье, 23 октября 2011 г.
четверг, 20 октября 2011 г.
Patients Transitioned From Fosamax(R) To Denosumab Achieved Greater Gains In Bone Mineral Density Vs Those Continuing On Alendronate
Amgen (NASDAQ:AMGN) announced full data
results from a non-pivotal Phase 3 head-to-head, double-blind trial comparing bone
mineral density (BMD) gains in postmenopausal women with low bone mass who
transitioned from weekly oral alendronate (Fosamax®) to denosumab versus those who
continued alendronate therapy. In addition, patient preference data from another nonpivotal
head-to-head trial comparing denosumab to weekly oral alendronate were
announced today at the 2008 American Society of Bone and Mineral Research
(ASBMR) Annual Meeting in Montreal.
"Data from these trials highlight the potential for a new treatment option for the millions
of postmenopausal women worldwide with osteoporosis," said Roger M. Perlmutter,
M.D., Ph.D., executive vice president of Research and Development at Amgen. "In the
bisphosphonate transition study, it is particularly exciting to see significant bone density
gains in patients on denosumab who previously were treated with alendronate, as this
type of result has not been reported in any previous study transitioning patients from
one bisphosphonate to another. We believe these data coupled with data from a
separate Phase 3 head-to-head trial that reported patient preference for twice-yearly
subcutaneous injections versus a weekly oral therapy suggest denosumab offers the
promise to be a welcome new option for patients."
Effect of Denosumab versus Alendronate on Bone Mineral Density (BMD) and
Bone Turnover Markers (BTM) and Safety in Women Previously Treated with
Alendronate (Abstract # 646)
Data presented from the bisphosphonate transition study, also known as the STAND
(Study of Transitioning from AleNdronate to Denosumab) trial, demonstrated that subcutaneous injections of denosumab every six months achieved significantly greater
increases in BMD versus those achieved with alendronate at all sites measured. For the
primary endpoint, denosumab resulted in significant increases in BMD at the total hip
compared with alendronate (1.9 percent vs. 1.05 percent, p
Preference and Satisfaction with a 6-monthly Subcutaneous Injection Versus a
Weekly Tablet for Treatment of Low Bone Mass (Abstract # 434)
As part of the DECIDE (Determining Efficacy: Comparison of Initiating Denosumab vs.
AlEndronate) trial, patients were given a questionnaire after 12 months of treatment to
gauge preference on mode of administration as well as satisfaction with frequency of
dosing of twice-yearly subcutaneous injections versus weekly oral tablet. More than
three-quarters of patients in both study arms preferred subcutaneous injection over oral
pills (77 percent vs. 23 percent, p
results from a non-pivotal Phase 3 head-to-head, double-blind trial comparing bone
mineral density (BMD) gains in postmenopausal women with low bone mass who
transitioned from weekly oral alendronate (Fosamax®) to denosumab versus those who
continued alendronate therapy. In addition, patient preference data from another nonpivotal
head-to-head trial comparing denosumab to weekly oral alendronate were
announced today at the 2008 American Society of Bone and Mineral Research
(ASBMR) Annual Meeting in Montreal.
"Data from these trials highlight the potential for a new treatment option for the millions
of postmenopausal women worldwide with osteoporosis," said Roger M. Perlmutter,
M.D., Ph.D., executive vice president of Research and Development at Amgen. "In the
bisphosphonate transition study, it is particularly exciting to see significant bone density
gains in patients on denosumab who previously were treated with alendronate, as this
type of result has not been reported in any previous study transitioning patients from
one bisphosphonate to another. We believe these data coupled with data from a
separate Phase 3 head-to-head trial that reported patient preference for twice-yearly
subcutaneous injections versus a weekly oral therapy suggest denosumab offers the
promise to be a welcome new option for patients."
Effect of Denosumab versus Alendronate on Bone Mineral Density (BMD) and
Bone Turnover Markers (BTM) and Safety in Women Previously Treated with
Alendronate (Abstract # 646)
Data presented from the bisphosphonate transition study, also known as the STAND
(Study of Transitioning from AleNdronate to Denosumab) trial, demonstrated that subcutaneous injections of denosumab every six months achieved significantly greater
increases in BMD versus those achieved with alendronate at all sites measured. For the
primary endpoint, denosumab resulted in significant increases in BMD at the total hip
compared with alendronate (1.9 percent vs. 1.05 percent, p
Preference and Satisfaction with a 6-monthly Subcutaneous Injection Versus a
Weekly Tablet for Treatment of Low Bone Mass (Abstract # 434)
As part of the DECIDE (Determining Efficacy: Comparison of Initiating Denosumab vs.
AlEndronate) trial, patients were given a questionnaire after 12 months of treatment to
gauge preference on mode of administration as well as satisfaction with frequency of
dosing of twice-yearly subcutaneous injections versus weekly oral tablet. More than
three-quarters of patients in both study arms preferred subcutaneous injection over oral
pills (77 percent vs. 23 percent, p
понедельник, 17 октября 2011 г.
New Hip And Groin Disorders Guidelines From ACOEM Available
The American College of Occupational and Environmental Medicine (ACOEM) today published new medical treatment guidelines for providing care to workers with injuries and disorders of the hip and groin. The new guidelines, which represent the latest chapter in ACOEM's comprehensive publication Occupational Medicine Practice Guidelines, are available on line now via ACOEM's APG-I web application; a print version will be available in the fall of 2010, when the Third Edition hard-copy of Occupational Medicine Practice Guidelines is published.
More than 200 recommendations are featured in the new set of guidelines, focusing on diagnostic and other testing and treatments for hip and groin disorders. Conditions covered include acute, subacute, and chronic hip pain; hip osteoarthrosis; gluteus medius tendinosis and tears; trochanteric bursitis and greater trochanteric pain syndrome; femoroacetabular impingement, "hip impingement" and labral tears; osteonecrosis; hamstring and hip flexor strains; groin strains and adductor-related groin pain; lower abdominal strains; meralgia paresthetica; epididymo-orchitis; and hip fractures.
The new guidelines were developed by a multi-disciplinary panel that included specialists in occupational medicine, orthopedic surgery, and physical therapy. The guidelines follow ACOEM's enhanced methodology, highlighted by original systematic research and evidence-weighted recommendations.
"These new guidelines provide the most up-to-date, evidence-based approaches to care for occupational injuries available today, and will serve as a great help to occupational medicine community and all musculoskeletal injury providers," said Kurt Hegmann, MD, MPH, FACOEM, Editor in Chief of the Practice Guidelines.
An extensive volume of literature was used to develop the evidence-based recommendations in the new chapter. More than 1,500 references are featured, including 625 high- and moderate-quality randomized controlled trials or crossover trials.
Other highlights of the new chapter include:
- Discussion on the prevention of venous thromboembolic disease.
- Recommendations on hip arthroplasty and surgical recommendations for hip fracture.
- Recommendations for pre and post-operative rehabilitation, including hip arthroplasty and hip fractures.
- An appendix which covers anesthetic issues for hip surgery patients.
- An overview of each treatment option, indicating the existence or lack of evidence, and whether the option is costly, invasive, and has high/low risks or side effects.
- Algorithms for the different hip and groin disorders which offer quick and accurate guidance for cases with different progressions, circumstances, or outcomes.
ACOEM has announced that updates to ankle/foot, neck, knee and shoulder guidelines will follow electronic publication of the hip and groin chapter and will part of the Third Edition release later this year.
First published in 1997, Occupational Medicine Practice Guidelines has become the leading source in the United States for evidence-based guidelines used by occupational physicians and other health care professionals. ACOEM's guidelines are also used extensively by insurers, employers, attorneys, and other individuals and organizations involved in health and safety in the workplace.
To order an electronic version of the new chapter, or for more information about Occupational Medicine Practice Guidelines, visit acoem.
Source
American College of Occupational and Environmental Medicine
More than 200 recommendations are featured in the new set of guidelines, focusing on diagnostic and other testing and treatments for hip and groin disorders. Conditions covered include acute, subacute, and chronic hip pain; hip osteoarthrosis; gluteus medius tendinosis and tears; trochanteric bursitis and greater trochanteric pain syndrome; femoroacetabular impingement, "hip impingement" and labral tears; osteonecrosis; hamstring and hip flexor strains; groin strains and adductor-related groin pain; lower abdominal strains; meralgia paresthetica; epididymo-orchitis; and hip fractures.
The new guidelines were developed by a multi-disciplinary panel that included specialists in occupational medicine, orthopedic surgery, and physical therapy. The guidelines follow ACOEM's enhanced methodology, highlighted by original systematic research and evidence-weighted recommendations.
"These new guidelines provide the most up-to-date, evidence-based approaches to care for occupational injuries available today, and will serve as a great help to occupational medicine community and all musculoskeletal injury providers," said Kurt Hegmann, MD, MPH, FACOEM, Editor in Chief of the Practice Guidelines.
An extensive volume of literature was used to develop the evidence-based recommendations in the new chapter. More than 1,500 references are featured, including 625 high- and moderate-quality randomized controlled trials or crossover trials.
Other highlights of the new chapter include:
- Discussion on the prevention of venous thromboembolic disease.
- Recommendations on hip arthroplasty and surgical recommendations for hip fracture.
- Recommendations for pre and post-operative rehabilitation, including hip arthroplasty and hip fractures.
- An appendix which covers anesthetic issues for hip surgery patients.
- An overview of each treatment option, indicating the existence or lack of evidence, and whether the option is costly, invasive, and has high/low risks or side effects.
- Algorithms for the different hip and groin disorders which offer quick and accurate guidance for cases with different progressions, circumstances, or outcomes.
ACOEM has announced that updates to ankle/foot, neck, knee and shoulder guidelines will follow electronic publication of the hip and groin chapter and will part of the Third Edition release later this year.
First published in 1997, Occupational Medicine Practice Guidelines has become the leading source in the United States for evidence-based guidelines used by occupational physicians and other health care professionals. ACOEM's guidelines are also used extensively by insurers, employers, attorneys, and other individuals and organizations involved in health and safety in the workplace.
To order an electronic version of the new chapter, or for more information about Occupational Medicine Practice Guidelines, visit acoem.
Source
American College of Occupational and Environmental Medicine
пятница, 14 октября 2011 г.
A Novel In Vivo Method For Quantifying The Interfacial Biochemical Bond Strength Of Bone Implants
Since the breakthrough introduction of osseointegrated implants in the 1980s, great efforts have been made towards surface innovation of clinical implants.
So far, in vivo methods to determine biochemical bonds of the implants are as of yet essentially unexplored and remain challenging. In fact, it is extremely hard to exclusively measure interfacial biochemical bond in vivo.
To the best of our knowledge, the present study may be the first report of an in vivo method to identify an interfacial biochemical bond and quantify its bonding strength, which provide the key of knowledge for the better understanding on biochemical bonding in implant integration.
Proceedings of the Royal Society B: Biological Sciences
Proceedings B is the Royal Society's flagship biological research journal, dedicated to the rapid publication and broad dissemination of high-quality research papers, reviews and comment and reply papers. The scope of the journal is diverse and is especially strong in organismal biology.
rspb.royalsocietypublishing
So far, in vivo methods to determine biochemical bonds of the implants are as of yet essentially unexplored and remain challenging. In fact, it is extremely hard to exclusively measure interfacial biochemical bond in vivo.
To the best of our knowledge, the present study may be the first report of an in vivo method to identify an interfacial biochemical bond and quantify its bonding strength, which provide the key of knowledge for the better understanding on biochemical bonding in implant integration.
Proceedings of the Royal Society B: Biological Sciences
Proceedings B is the Royal Society's flagship biological research journal, dedicated to the rapid publication and broad dissemination of high-quality research papers, reviews and comment and reply papers. The scope of the journal is diverse and is especially strong in organismal biology.
rspb.royalsocietypublishing
вторник, 11 октября 2011 г.
Race For New Hips, Patient Treatment Preferences Play An Important Role In Racial Disparities
Study highlights impact of patient preferences on race disparity in surgeons' recommendations for joint replacement.
A recent study by researchers at the VA Center for Health Equity Research and Promotion in Pittsburgh, Pennsylvania, suggests that patient treatment preferences play an important role in racial disparities in total joint replacement utilization observed in the US. Different attitudes toward total joint replacement procedures held by African American and white patients explained racial disparities in whether orthopedic surgeons recommended the procedure to patients. These findings by Dr. Leslie Hausmann, from the VA, and her colleagues, are published online in the Journal of General Internal Medicine, published by Springer.
Osteoarthritis of the knee or hip is a leading cause of disability in the US. Total joint replacement is the most effective surgical option available to treat moderate to severe cases. Numerous studies have shown racial disparities in the utilization of the procedure. In particular, African-American patients are significantly less likely than white patients to undergo total joint replacement.
To explore potential reasons for this racial disparity, Dr. Hausmann and her team examined whether orthopaedic surgeons were less likely to recommend total joint replacement to African-American patients compared to white patients, and whether African-American patients were less likely to undergo the procedure within six months of study enrollment.
The researchers recruited patients from orthopedic surgery clinics in two large, tertiary care Veterans Affairs* hospitals in Pittsburgh and Cleveland. In total, 120 African-American and 337 white patients seeking treatment for knee or hip osteoarthritis were enrolled. Before their appointment with a surgeon, patients completed a survey asking them about their preferences for total joint replacement as a treatment option and their expectations regarding knee/hip pain management. The actual appointment was audio-taped and the patients were surveyed again after the visit to assess their impression of the exchange. The researchers also examined patients' medical records after the visit and again after six months.
They found that African-American patients were less likely to receive a recommendation for total joint replacement than white patients of similar age and disease severity. This racial difference disappeared when the researchers took patients' willingness to undergo the procedure into consideration, suggesting that race differences in total joint replacement recommendations were largely driven by patient treatment preferences. That is, African Americans showed a lower preference for the procedure than whites, and patients who had a lower preference for the procedure were less likely to receive a recommendation for it. Furthermore, patients who received a recommendation for joint replacement were much more likely to have undergone the procedure within six months compared to those who did not receive a recommendation for joint replacement. Of those patients who received a recommendation for joint replacement, 22% of African Americans had undergone the procedure within six months compared to 45% of whites.
The authors conclude: "These findings underscore the unique importance of patient preference in shaping decision-making about total joint replacement. Given the consistent race differences found in patient preferences for the procedure, coupled with the strong impact of patient preferences on its recommendation in the orthopedic setting, reducing disparities may require efforts to understand patient treatment preferences."
Source: Springer Science+Business Media
A recent study by researchers at the VA Center for Health Equity Research and Promotion in Pittsburgh, Pennsylvania, suggests that patient treatment preferences play an important role in racial disparities in total joint replacement utilization observed in the US. Different attitudes toward total joint replacement procedures held by African American and white patients explained racial disparities in whether orthopedic surgeons recommended the procedure to patients. These findings by Dr. Leslie Hausmann, from the VA, and her colleagues, are published online in the Journal of General Internal Medicine, published by Springer.
Osteoarthritis of the knee or hip is a leading cause of disability in the US. Total joint replacement is the most effective surgical option available to treat moderate to severe cases. Numerous studies have shown racial disparities in the utilization of the procedure. In particular, African-American patients are significantly less likely than white patients to undergo total joint replacement.
To explore potential reasons for this racial disparity, Dr. Hausmann and her team examined whether orthopaedic surgeons were less likely to recommend total joint replacement to African-American patients compared to white patients, and whether African-American patients were less likely to undergo the procedure within six months of study enrollment.
The researchers recruited patients from orthopedic surgery clinics in two large, tertiary care Veterans Affairs* hospitals in Pittsburgh and Cleveland. In total, 120 African-American and 337 white patients seeking treatment for knee or hip osteoarthritis were enrolled. Before their appointment with a surgeon, patients completed a survey asking them about their preferences for total joint replacement as a treatment option and their expectations regarding knee/hip pain management. The actual appointment was audio-taped and the patients were surveyed again after the visit to assess their impression of the exchange. The researchers also examined patients' medical records after the visit and again after six months.
They found that African-American patients were less likely to receive a recommendation for total joint replacement than white patients of similar age and disease severity. This racial difference disappeared when the researchers took patients' willingness to undergo the procedure into consideration, suggesting that race differences in total joint replacement recommendations were largely driven by patient treatment preferences. That is, African Americans showed a lower preference for the procedure than whites, and patients who had a lower preference for the procedure were less likely to receive a recommendation for it. Furthermore, patients who received a recommendation for joint replacement were much more likely to have undergone the procedure within six months compared to those who did not receive a recommendation for joint replacement. Of those patients who received a recommendation for joint replacement, 22% of African Americans had undergone the procedure within six months compared to 45% of whites.
The authors conclude: "These findings underscore the unique importance of patient preference in shaping decision-making about total joint replacement. Given the consistent race differences found in patient preferences for the procedure, coupled with the strong impact of patient preferences on its recommendation in the orthopedic setting, reducing disparities may require efforts to understand patient treatment preferences."
Source: Springer Science+Business Media
суббота, 8 октября 2011 г.
New Journal To Be Launched By SAGE: Geriatric Orthopaedic Surgery & Rehabilitation
Geriatric Orthopaedic Surgery & Rehabilitation is a new bimonthly journal being launched in September 2010 by SAGE, the world's leading independent academic and professional publisher.
Geriatric Orthopaedic Surgery & Rehabilitation will address a broad range of musculoskeletal disorders in the aging patient through peer-reviewed research reports and reviews, technical perspectives, case studies, and other evidence-based articles.
"The fastest growing portion of our population is the segment over 65 years old. Most older individuals will experience an orthopaedic problem as they age," said Stephen Kates, MD, the journal's founding Editor. Geriatric Orthopaedic Surgery & Rehabilitation will fill an important void in the medical literature and serve as home to scientific articles concerning older orthopaedic patients."
Contributors and readers will include orthopaedic surgeons, geriatricians, physiatrists, anesthesiologists, and other physicians specializing in care of the older adult.
"The projected incidence of musculoskeletal problems among the aging Baby Boomer population is staggering," said Ron Epstein, SAGE Director of STM Journals. "We anticipate that Geriatric Orthopaedic Surgery & Rehabilitation will prove a critical resource for the physicians and other health care providers who work with older patients with bone fractures, joint replacement, and related problems. Dr. Kates is one of the foremost clinicians and teachers in this field, and we are excited to work with him as the journal's Editor."
Geriatric Orthopaedic Surgery & Rehabilitation will be published bimonthly beginning in September 2010.
Source:
Jim Gilden
SAGE Publications
Geriatric Orthopaedic Surgery & Rehabilitation will address a broad range of musculoskeletal disorders in the aging patient through peer-reviewed research reports and reviews, technical perspectives, case studies, and other evidence-based articles.
"The fastest growing portion of our population is the segment over 65 years old. Most older individuals will experience an orthopaedic problem as they age," said Stephen Kates, MD, the journal's founding Editor. Geriatric Orthopaedic Surgery & Rehabilitation will fill an important void in the medical literature and serve as home to scientific articles concerning older orthopaedic patients."
Contributors and readers will include orthopaedic surgeons, geriatricians, physiatrists, anesthesiologists, and other physicians specializing in care of the older adult.
"The projected incidence of musculoskeletal problems among the aging Baby Boomer population is staggering," said Ron Epstein, SAGE Director of STM Journals. "We anticipate that Geriatric Orthopaedic Surgery & Rehabilitation will prove a critical resource for the physicians and other health care providers who work with older patients with bone fractures, joint replacement, and related problems. Dr. Kates is one of the foremost clinicians and teachers in this field, and we are excited to work with him as the journal's Editor."
Geriatric Orthopaedic Surgery & Rehabilitation will be published bimonthly beginning in September 2010.
Source:
Jim Gilden
SAGE Publications
среда, 5 октября 2011 г.
Court Of Appeal To Re-Evaluate NICE Osteoporosis Decision, UK
Servier Laboratories Limited has been granted permission by the Court of Appeal to challenge a High Court decision made at a Judicial Review in February this year, in which Servier was previously successful in its claim that the National Institute for Health and Clinical Excellence (NICE) had unlawfully failed to provide the economic model underlying its Guidance for the primary and secondary prevention of osteoporotic fractures in postmenopausal women. 1,2
The Court of Appeal will hear Servier's appeal against February's ruling on one legal point - misinterpretation of Servier's clinical data on the reduction of risk of hip fracture by its osteoporosis treatment, Protelos® (strontium ranelate).
Michael Sumpter, CEO of Servier Laboratories Ltd, commented; "We are delighted with today's decision granting Servier the right to appeal on the basis of the irrational consideration by NICE of data submitted by Servier during the appraisal process."
NICE refused to accept a post hoc analysis of a randomised controlled trial titled "The TReatment Of Peripheral OSteoporosis" ("TROPOS"), which was specifically requested by European Medicines Agency's (the "EMEA") scientific committee and clearly showed the efficacy of Protelos in teducing the risk of hip fracture. It was accepted as the basis for granting a licence for reduction of risk of hip fracture in post menopausal osteoporotic women by the European Commission on the recommendation of the EMEA.
Servier challenged NICE at Judicial Review because it believes the osteoporosis guidance unfairly and unnecessarily restricts access to Protelos for many patients who could benefit from it. Servier remains satisfied with the ruling by Mr Justice Holman on 19 February 2009 that NICE acted with procedural unfairness and, therefore, unlawfully by not releasing the economic model on which it based its decisions in the osteoporosis guidance. As a result of the February ruling, NICE has shared a copy of the economic model with the stakeholders who submitted evidence for the current NICE guidance. In addition, the current guidance is now being re-evaluated.
Professor Tim Spector, Consultant Rheumatologist at St Thomas' Hospital said; "Many of my patients are unable to tolerate the treatment recommended by NICE under the current guidance, but I have to wait for their disease to deteriorate before I can give them an alternative treatment. This leaves them unprotected from the risk of fracture for many years. While the previous court ruling means that the original NICE guidance is already under review, today's decision means there is a greater chance of the appropriate data being considered. This will hopefully result in new guidance that is simpler and more flexible, giving clinicians a real choice in prescribing for women with osteoporosis, who all have individual needs."
Osteoporosis is a severe disease that affects one in two women over the age of 50 and one in five men. Up to 20% of women who suffer a hip fracture die within the first year of a fracture.3 Half of those suffering an osteoporotic hip fracture can no longer live independently as a result of the injury. Following a hip fracture, 64% need a walking aid and half can no longer move about outside on their own.4
The appeal will be heard by the Court of Appeal in due course. The date will be confirmed by the Court.
About the Judicial Review
-- In January 2009, Servier challenged NICE on three grounds:
1. Lack of transparency around the economic model used to evaluate cost effectiveness
2. Misinterpretation of Servier's clinical data around hip fracture data
3. Unlawful discrimination on the basis of disability
-- On 19 February 2009, the High Court found in Servier's favour on ground one: Lack of transparency around the economic model used. The Judge ruled that the procedure by which the NICE guidance on treatments for primary and secondary prevention of osteoporosis was produced (Final Appraisal Determination dated 30 June 2008) was unlawful and the guidance must therefore be re-evaluated. The Judge ruled that the current guidance will not be quashed pending re-evaluation.
-- In light of February's decision NICE has been ordered to grant access to the economic model to stakeholders who will be given the opportunity to comment on the assumptions NICE made when developing the guidance. NICE will then be required under their legal duty of transparency to re-evaluate the guidance in light of the comments it receives.
-- The High Court did not find in Servier's favour on grounds two and three.
About the NICE guidance
-- The Final Appraisal Determinations (FADs) on the treatment of osteoporosis were published on 26 June 2007. An appeal hearing involving the National Osteoporosis Society, the Alliance for Better Bone Health and Servier Laboratories took place in October 2007. A decision upholding the appeal was published in December 2007 and the revised FADs were published by NICE in July 2008. Servier's second appeal took place in September 2008. Subsequently, technology appraisal guidance for both the primary and secondary prevention of osteoporotic fragility fractures in postmenopausal women was published in October 2008. The Judicial Review took place 20-22 January 2009. The decision by Mr Justice Holman was announced on 19 February 2009.
About Servier Laboratories Limited
-- Servier Laboratories Limited is the UK subsidiary of The Servier Research Group, a research-based pharmaceutical company specialising in innovative pharmaceuticals. Servier UK offers a range of products in a number of medical areas: cardiovascular disease, especially hypertension and cardiac disease, diabetes, osteoporosis and diseases of the central nervous system. Servier develops truly innovative drugs and invests in therapeutic areas where there is an unmet patient need.
About osteoporosis
-- The World Health Organisation defines osteoporosis as a progressive skeletal disease characterised by low bone mass and micro-architectural deterioration of bone tissue with a consequential increase in bone fragility and susceptibility to fracture. There is increased risk of fracture particularly of spine, hip, pelvis and forearm. It is predominantly a disease of post-menopausal women and risk of fracture increases with age. Fractures caused by osteoporosis affect one in two women and one in five men over the age of 50.
About Protelos
-- Protelos is a true innovation which was developed to improve quality of life for osteoporosis patients.5,6,7 Protelos is unlike other treatments and works by building bone to promote bone strength and reducing hip and spinal fractures.8,9,10 Unlike more traditional osteoporosis treatments the most common side effects of Protelos are mild and transient.11
References
1. Case number CO/2469/2008 between The Queen on the application of Servier Laboratories Ltd and the National Institute for Health and Clinical Excellence
2. National Institute for Health and Clinical Excellence (NICE). 'Alendronate, etidronate, risedronate and strontium ranelate for the primary prevention of osteoporotic fragility fractures in postmenopausal women' and 'Alendronate, etidronate, risedronate, strontium ranelate and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women'. Available from https://nice.uk (last accessed February 09)
3. Cooper C, et al. Am J Epidemiol 1993;137:1001-1005
4. Osnes EK, Lofthus CM, Meyer HE, et al. Osteoporos Int 2004;15:567 - 574
5. Jiang Y, Zhao JJ, Genant HK. Osteoporos Int 2006;17(suppl2):late breaking news
6. Arlot ME, et al. J Bone Miner Res 2008;23(2):215-222
7. Ammann P, et al. J Bone Miner Res 2004;19(12):2012-2020
8. Protelos SPC
9. Meunier PJ, et al. N Engl J Med 2004;350:459-468
10. Reginster JY, et al. Arthritis Rheum 2008;58(6):687-1695
11. Reginster JY, et al. J Clin Endocrinol Metab 2005;90(5):2816-2822
Source
Servier
The Court of Appeal will hear Servier's appeal against February's ruling on one legal point - misinterpretation of Servier's clinical data on the reduction of risk of hip fracture by its osteoporosis treatment, Protelos® (strontium ranelate).
Michael Sumpter, CEO of Servier Laboratories Ltd, commented; "We are delighted with today's decision granting Servier the right to appeal on the basis of the irrational consideration by NICE of data submitted by Servier during the appraisal process."
NICE refused to accept a post hoc analysis of a randomised controlled trial titled "The TReatment Of Peripheral OSteoporosis" ("TROPOS"), which was specifically requested by European Medicines Agency's (the "EMEA") scientific committee and clearly showed the efficacy of Protelos in teducing the risk of hip fracture. It was accepted as the basis for granting a licence for reduction of risk of hip fracture in post menopausal osteoporotic women by the European Commission on the recommendation of the EMEA.
Servier challenged NICE at Judicial Review because it believes the osteoporosis guidance unfairly and unnecessarily restricts access to Protelos for many patients who could benefit from it. Servier remains satisfied with the ruling by Mr Justice Holman on 19 February 2009 that NICE acted with procedural unfairness and, therefore, unlawfully by not releasing the economic model on which it based its decisions in the osteoporosis guidance. As a result of the February ruling, NICE has shared a copy of the economic model with the stakeholders who submitted evidence for the current NICE guidance. In addition, the current guidance is now being re-evaluated.
Professor Tim Spector, Consultant Rheumatologist at St Thomas' Hospital said; "Many of my patients are unable to tolerate the treatment recommended by NICE under the current guidance, but I have to wait for their disease to deteriorate before I can give them an alternative treatment. This leaves them unprotected from the risk of fracture for many years. While the previous court ruling means that the original NICE guidance is already under review, today's decision means there is a greater chance of the appropriate data being considered. This will hopefully result in new guidance that is simpler and more flexible, giving clinicians a real choice in prescribing for women with osteoporosis, who all have individual needs."
Osteoporosis is a severe disease that affects one in two women over the age of 50 and one in five men. Up to 20% of women who suffer a hip fracture die within the first year of a fracture.3 Half of those suffering an osteoporotic hip fracture can no longer live independently as a result of the injury. Following a hip fracture, 64% need a walking aid and half can no longer move about outside on their own.4
The appeal will be heard by the Court of Appeal in due course. The date will be confirmed by the Court.
About the Judicial Review
-- In January 2009, Servier challenged NICE on three grounds:
1. Lack of transparency around the economic model used to evaluate cost effectiveness
2. Misinterpretation of Servier's clinical data around hip fracture data
3. Unlawful discrimination on the basis of disability
-- On 19 February 2009, the High Court found in Servier's favour on ground one: Lack of transparency around the economic model used. The Judge ruled that the procedure by which the NICE guidance on treatments for primary and secondary prevention of osteoporosis was produced (Final Appraisal Determination dated 30 June 2008) was unlawful and the guidance must therefore be re-evaluated. The Judge ruled that the current guidance will not be quashed pending re-evaluation.
-- In light of February's decision NICE has been ordered to grant access to the economic model to stakeholders who will be given the opportunity to comment on the assumptions NICE made when developing the guidance. NICE will then be required under their legal duty of transparency to re-evaluate the guidance in light of the comments it receives.
-- The High Court did not find in Servier's favour on grounds two and three.
About the NICE guidance
-- The Final Appraisal Determinations (FADs) on the treatment of osteoporosis were published on 26 June 2007. An appeal hearing involving the National Osteoporosis Society, the Alliance for Better Bone Health and Servier Laboratories took place in October 2007. A decision upholding the appeal was published in December 2007 and the revised FADs were published by NICE in July 2008. Servier's second appeal took place in September 2008. Subsequently, technology appraisal guidance for both the primary and secondary prevention of osteoporotic fragility fractures in postmenopausal women was published in October 2008. The Judicial Review took place 20-22 January 2009. The decision by Mr Justice Holman was announced on 19 February 2009.
About Servier Laboratories Limited
-- Servier Laboratories Limited is the UK subsidiary of The Servier Research Group, a research-based pharmaceutical company specialising in innovative pharmaceuticals. Servier UK offers a range of products in a number of medical areas: cardiovascular disease, especially hypertension and cardiac disease, diabetes, osteoporosis and diseases of the central nervous system. Servier develops truly innovative drugs and invests in therapeutic areas where there is an unmet patient need.
About osteoporosis
-- The World Health Organisation defines osteoporosis as a progressive skeletal disease characterised by low bone mass and micro-architectural deterioration of bone tissue with a consequential increase in bone fragility and susceptibility to fracture. There is increased risk of fracture particularly of spine, hip, pelvis and forearm. It is predominantly a disease of post-menopausal women and risk of fracture increases with age. Fractures caused by osteoporosis affect one in two women and one in five men over the age of 50.
About Protelos
-- Protelos is a true innovation which was developed to improve quality of life for osteoporosis patients.5,6,7 Protelos is unlike other treatments and works by building bone to promote bone strength and reducing hip and spinal fractures.8,9,10 Unlike more traditional osteoporosis treatments the most common side effects of Protelos are mild and transient.11
References
1. Case number CO/2469/2008 between The Queen on the application of Servier Laboratories Ltd and the National Institute for Health and Clinical Excellence
2. National Institute for Health and Clinical Excellence (NICE). 'Alendronate, etidronate, risedronate and strontium ranelate for the primary prevention of osteoporotic fragility fractures in postmenopausal women' and 'Alendronate, etidronate, risedronate, strontium ranelate and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women'. Available from https://nice.uk (last accessed February 09)
3. Cooper C, et al. Am J Epidemiol 1993;137:1001-1005
4. Osnes EK, Lofthus CM, Meyer HE, et al. Osteoporos Int 2004;15:567 - 574
5. Jiang Y, Zhao JJ, Genant HK. Osteoporos Int 2006;17(suppl2):late breaking news
6. Arlot ME, et al. J Bone Miner Res 2008;23(2):215-222
7. Ammann P, et al. J Bone Miner Res 2004;19(12):2012-2020
8. Protelos SPC
9. Meunier PJ, et al. N Engl J Med 2004;350:459-468
10. Reginster JY, et al. Arthritis Rheum 2008;58(6):687-1695
11. Reginster JY, et al. J Clin Endocrinol Metab 2005;90(5):2816-2822
Source
Servier
воскресенье, 2 октября 2011 г.
Federal Funding Will Create Orthopedic Research Center At Rhode Island Hospital
The National Center for Research Resources, part of the National Institutes of Health, has awarded Rhode Island Hospital an $11.1 million grant to study the prevention and treatment of skeletal joint diseases. The 5-year grant will establish the Center of Biomedical Research Excellence (COBRE) for Skeletal Health and Repair at Rhode Island Hospital and create a multidisciplinary team of scientists with its academic partner, The Warren Alpert Medical School of Brown University.
The grant is one of the largest in the hospital's history and comes at a time of intense competition for federal funding for biomedical research. Basic science findings from the COBRE center may lead to improved preventive strategies or treatments for joint diseases such as osteoarthritis, which affects an estimated 21 million Americans and is one of the country's most common chronic illnesses.
"In this highly competitive research environment, we are honored that the NIH has again recognized Rhode Island Hospital as an institution with the talent, expertise and innovative spirit to conduct world-class, pioneering research in the area of orthopedics," said George Vecchione, interim president and CEO, Rhode Island Hospital.
This is the NIH's sixth COBRE grant to Rhode Island-based institutions, including the second at Rhode Island Hospital. These awards -- designed to strengthen institutional biomedical research capability and enhance research infrastructure -- have collectively brought in more than $60 million in federal research funding to the state since 2000.
"The creation of a multidisciplinary research center will enable investigators from across different disciplines -- including those with clinical, biological and engineering expertise -- to collaborate on cutting-edge research with the common goal of helping the millions of Americans who suffer from joint diseases or injury," said Michael Ehrlich, MD, surgeon-in-chief of orthopedics at Rhode Island Hospital and chairman of the Department of Orthopedics and rehabilitation at Alpert Medical School.
The new COBRE will focus on cartilage and joint health, disease mechanisms and repair strategies, according to center director and principal investigator Qian Chen, PhD, director of cell and molecular biology and head of orthopedic biology at Rhode Island Hospital. He is also a professor of medical science and the Michael G. Ehrlich Chair in Orthopedic Research at Alpert Medical School.
"The aging of the baby boom generation and soaring obesity rates mean we can expect to see a sharp increase in the number of patients with osteoarthritis and other joint diseases," said Chen. "That's why it's critical that we not only expand our search for new and better treatments for joint diseases, but that we also recruit and mentor the next generation of orthopedic researchers -- which our COBRE award allows us to do."
Chen will lead a multidisciplinary team that includes researchers from the departments of orthopedics, emergency medicine, pediatrics, medicine and bioengineering at Rhode Island Hospital and Brown University. Specific research projects will focus on how long bones are built up during skeletal development, how joint cartilage degenerates in adult joint diseases, and how to repair and rebuild healthy cartilage joint.
"This grant is proof positive that collaboration in science advances knowledge and improves lives," said Eli Y. Adashi, MD, dean of medicine and biological sciences at Brown. "Investigators from five distinct disciplines -- who work at both the bench and the bedside -- are joining forces to better understand arthritis and other common musculoskeletal diseases. This collaboration, this bridge between Brown and a major Lifespan partner, Rhode Island Hospital, will benefit the public by producing better methods of treatment and prevention."
The COBRE grant will primarily support these research projects, although some funds will go towards equipment, supplies and for renovating existing laboratories and research space at Rhode Island Hospital.
"This $11 million federal grant speaks volumes about the world-class talent at Rhode Island Hospital and Brown University," Governor Donald L. Carcieri said. "Not only will this grant enable Rhode Island Hospital and Brown University to develop cutting-edge biomedical research, it will also enhance the quality of life for those who suffer from chronic joint diseases. With these two institutions joining forces, I have every confidence that this grant will lead to great medical advances, breakthrough discoveries and important new preventative strategies."
"I am pleased that RIH is receiving this $11.1 million in federal aid to establish the Center for Biomedical Research Excellence for Skeletal Health and Repair here in Providence. This COBRE grant is a recognition of Rhode Island Hospital's groundbreaking achievements and dedicated staff," said Senator Jack Reed, a member of both the Health, Education, Labor and Pensions (HELP) Committee and the Appropriations subcommittee, which oversees federal spending of NIH programs. "This federal investment will allow Dr. Chen and his team to develop biomedical research that will help prevent and treat joint diseases such as osteoarthritis. Their work has the potential to improve the health and lives of millions of Americans who suffer from these common chronic illnesses."
"Rhode Island Hospital and Brown University continue to take the lead on innovative medical research aimed at helping to improve the quality of life for all Americans," said Congressman Patrick Kennedy. "This grant represents a substantial investment in not only treatment, but perhaps more importantly preventative medicine, to address common chronic illnesses that impact the lives of millions."
"I commend Rhode Island Hospital for securing this $11.1 million grant from NIH's National Center for Research Resources, especially at a time when financial resources are scarce and competition nationally is fierce," said Congressman Jim Langevin. "The research undertaken with this funding has the potential to help many Rhode Islanders and others across the nation who live with some of life's most painful and debilitating joint diseases. I look forward to learning more about this COBRE's development and growth in the coming years."
"This grant will improve lives, reaffirm the city's position as an emerging biotech center and strengthen our local economy," said Providence Mayor David N. Cicilline. "This is a win for everyone, from the world-class researchers at Brown University and Rhode Island Hospital to the community at large."
The COBRE program supports multidisciplinary centers, each concentrating on one general area of research. COBREs are a component of the Institutional Development Award (IDeA) program, which aims to increase the research capability of states with historically low success rates of obtaining NIH grants.
Each COBRE includes a principal investigator with established credentials relevant to the center's research theme; three to five individual research projects that share that theme and are supervised by a single junior investigator; and a development and mentoring plan that will prepare these investigators to secure competitive federal research funding.
"The NIH funding will provide core research facilities and essential mentoring that will enable clinicians to work side-by-side with basic research scientists, junior investigators with senior investigators, and biologists with bioengineers," said NCRR Deputy Director Louise Ramm, Ph.D. "This approach exemplifies translational research at its best and will spur discovery to more quickly bring cures and treatments to patients who need them."
Rhode Island Hospital received its first COBRE grant in 2002. That award led to the establishment of the state's first-ever Center for Cancer Research Development aimed at providing new investigators with the guidance, financial support and front line research technologies they need to make the breakthrough discoveries that will lead to improved methods for diagnosis and treatment of cancer.
Brown was among the first universities in the U.S. to establish a COBRE, receiving its first $11 million grant in 2000 to fund molecular genetics research. That grant built Rhode Island's first genomics facility and its first transgenic facility and contributed to more than 200 peer-reviewed journal articles, including work that identified new targets for cancer drugs and new insights into brain development and fertility. Brown received its second COBRE grant in 2005, an $11 million award for genomics-based cancer research that allows scientists to explore how cancer develops and spreads. The goal of much of the work is to map complex gene interactions and pinpoint genes that may be potential treatment targets.
About Rhode Island Hospital
Founded in 1863, Rhode Island Hospital (rhodeislandhospital/) is a private, not-for-profit hospital and is the largest teaching hospital of Brown Medical School. A major trauma center for southeastern New England, the hospital is dedicated to being on the cutting edge of medicine and research. Rhode Island Hospital ranks 13th among independent hospitals who receive funding from the National Institutes of Health, with research awards of more than $27 million annually. Many of its physicians are recognized as leaders in their respective fields of cancer, cardiology, diabetes, orthopedics and minimally invasive surgery. The hospital's pediatrics wing, Hasbro Children's Hospital, has pioneered numerous procedures and is at the forefront of fetal surgery, orthopedics and pediatric neurosurgery. Rhode Island Hospital is a founding member of the Lifespan health system.
About Brown University
Brown University is an internationally known Ivy League institution with a distinctive undergraduate academic curriculum, outstanding faculty, state-of-the-art research facilities, and a tradition of innovative and rigorous multidisciplinary study. Brown offers nearly 100 programs of study to its approximately 7,190 undergraduate, graduate, and medical students and has a firm commitment to academic excellence and diversity in its student population. The University adheres to a collaborative university-college model in which faculty are as committed to teaching as they are to research, embracing a curriculum that requires students to be architects of their education. In 2004, Brown publicly launched its Plan for Academic Enrichment, which is designed to strengthen educational opportunities and significantly increase the number of faculty, add more courses and research opportunities for undergraduates, improve support for graduate and medical education, and invest in libraries, information technology and new academic space. For more information, visit brown/.
Source: Jessica Collins Grimes
Lifespan
The grant is one of the largest in the hospital's history and comes at a time of intense competition for federal funding for biomedical research. Basic science findings from the COBRE center may lead to improved preventive strategies or treatments for joint diseases such as osteoarthritis, which affects an estimated 21 million Americans and is one of the country's most common chronic illnesses.
"In this highly competitive research environment, we are honored that the NIH has again recognized Rhode Island Hospital as an institution with the talent, expertise and innovative spirit to conduct world-class, pioneering research in the area of orthopedics," said George Vecchione, interim president and CEO, Rhode Island Hospital.
This is the NIH's sixth COBRE grant to Rhode Island-based institutions, including the second at Rhode Island Hospital. These awards -- designed to strengthen institutional biomedical research capability and enhance research infrastructure -- have collectively brought in more than $60 million in federal research funding to the state since 2000.
"The creation of a multidisciplinary research center will enable investigators from across different disciplines -- including those with clinical, biological and engineering expertise -- to collaborate on cutting-edge research with the common goal of helping the millions of Americans who suffer from joint diseases or injury," said Michael Ehrlich, MD, surgeon-in-chief of orthopedics at Rhode Island Hospital and chairman of the Department of Orthopedics and rehabilitation at Alpert Medical School.
The new COBRE will focus on cartilage and joint health, disease mechanisms and repair strategies, according to center director and principal investigator Qian Chen, PhD, director of cell and molecular biology and head of orthopedic biology at Rhode Island Hospital. He is also a professor of medical science and the Michael G. Ehrlich Chair in Orthopedic Research at Alpert Medical School.
"The aging of the baby boom generation and soaring obesity rates mean we can expect to see a sharp increase in the number of patients with osteoarthritis and other joint diseases," said Chen. "That's why it's critical that we not only expand our search for new and better treatments for joint diseases, but that we also recruit and mentor the next generation of orthopedic researchers -- which our COBRE award allows us to do."
Chen will lead a multidisciplinary team that includes researchers from the departments of orthopedics, emergency medicine, pediatrics, medicine and bioengineering at Rhode Island Hospital and Brown University. Specific research projects will focus on how long bones are built up during skeletal development, how joint cartilage degenerates in adult joint diseases, and how to repair and rebuild healthy cartilage joint.
"This grant is proof positive that collaboration in science advances knowledge and improves lives," said Eli Y. Adashi, MD, dean of medicine and biological sciences at Brown. "Investigators from five distinct disciplines -- who work at both the bench and the bedside -- are joining forces to better understand arthritis and other common musculoskeletal diseases. This collaboration, this bridge between Brown and a major Lifespan partner, Rhode Island Hospital, will benefit the public by producing better methods of treatment and prevention."
The COBRE grant will primarily support these research projects, although some funds will go towards equipment, supplies and for renovating existing laboratories and research space at Rhode Island Hospital.
"This $11 million federal grant speaks volumes about the world-class talent at Rhode Island Hospital and Brown University," Governor Donald L. Carcieri said. "Not only will this grant enable Rhode Island Hospital and Brown University to develop cutting-edge biomedical research, it will also enhance the quality of life for those who suffer from chronic joint diseases. With these two institutions joining forces, I have every confidence that this grant will lead to great medical advances, breakthrough discoveries and important new preventative strategies."
"I am pleased that RIH is receiving this $11.1 million in federal aid to establish the Center for Biomedical Research Excellence for Skeletal Health and Repair here in Providence. This COBRE grant is a recognition of Rhode Island Hospital's groundbreaking achievements and dedicated staff," said Senator Jack Reed, a member of both the Health, Education, Labor and Pensions (HELP) Committee and the Appropriations subcommittee, which oversees federal spending of NIH programs. "This federal investment will allow Dr. Chen and his team to develop biomedical research that will help prevent and treat joint diseases such as osteoarthritis. Their work has the potential to improve the health and lives of millions of Americans who suffer from these common chronic illnesses."
"Rhode Island Hospital and Brown University continue to take the lead on innovative medical research aimed at helping to improve the quality of life for all Americans," said Congressman Patrick Kennedy. "This grant represents a substantial investment in not only treatment, but perhaps more importantly preventative medicine, to address common chronic illnesses that impact the lives of millions."
"I commend Rhode Island Hospital for securing this $11.1 million grant from NIH's National Center for Research Resources, especially at a time when financial resources are scarce and competition nationally is fierce," said Congressman Jim Langevin. "The research undertaken with this funding has the potential to help many Rhode Islanders and others across the nation who live with some of life's most painful and debilitating joint diseases. I look forward to learning more about this COBRE's development and growth in the coming years."
"This grant will improve lives, reaffirm the city's position as an emerging biotech center and strengthen our local economy," said Providence Mayor David N. Cicilline. "This is a win for everyone, from the world-class researchers at Brown University and Rhode Island Hospital to the community at large."
The COBRE program supports multidisciplinary centers, each concentrating on one general area of research. COBREs are a component of the Institutional Development Award (IDeA) program, which aims to increase the research capability of states with historically low success rates of obtaining NIH grants.
Each COBRE includes a principal investigator with established credentials relevant to the center's research theme; three to five individual research projects that share that theme and are supervised by a single junior investigator; and a development and mentoring plan that will prepare these investigators to secure competitive federal research funding.
"The NIH funding will provide core research facilities and essential mentoring that will enable clinicians to work side-by-side with basic research scientists, junior investigators with senior investigators, and biologists with bioengineers," said NCRR Deputy Director Louise Ramm, Ph.D. "This approach exemplifies translational research at its best and will spur discovery to more quickly bring cures and treatments to patients who need them."
Rhode Island Hospital received its first COBRE grant in 2002. That award led to the establishment of the state's first-ever Center for Cancer Research Development aimed at providing new investigators with the guidance, financial support and front line research technologies they need to make the breakthrough discoveries that will lead to improved methods for diagnosis and treatment of cancer.
Brown was among the first universities in the U.S. to establish a COBRE, receiving its first $11 million grant in 2000 to fund molecular genetics research. That grant built Rhode Island's first genomics facility and its first transgenic facility and contributed to more than 200 peer-reviewed journal articles, including work that identified new targets for cancer drugs and new insights into brain development and fertility. Brown received its second COBRE grant in 2005, an $11 million award for genomics-based cancer research that allows scientists to explore how cancer develops and spreads. The goal of much of the work is to map complex gene interactions and pinpoint genes that may be potential treatment targets.
About Rhode Island Hospital
Founded in 1863, Rhode Island Hospital (rhodeislandhospital/) is a private, not-for-profit hospital and is the largest teaching hospital of Brown Medical School. A major trauma center for southeastern New England, the hospital is dedicated to being on the cutting edge of medicine and research. Rhode Island Hospital ranks 13th among independent hospitals who receive funding from the National Institutes of Health, with research awards of more than $27 million annually. Many of its physicians are recognized as leaders in their respective fields of cancer, cardiology, diabetes, orthopedics and minimally invasive surgery. The hospital's pediatrics wing, Hasbro Children's Hospital, has pioneered numerous procedures and is at the forefront of fetal surgery, orthopedics and pediatric neurosurgery. Rhode Island Hospital is a founding member of the Lifespan health system.
About Brown University
Brown University is an internationally known Ivy League institution with a distinctive undergraduate academic curriculum, outstanding faculty, state-of-the-art research facilities, and a tradition of innovative and rigorous multidisciplinary study. Brown offers nearly 100 programs of study to its approximately 7,190 undergraduate, graduate, and medical students and has a firm commitment to academic excellence and diversity in its student population. The University adheres to a collaborative university-college model in which faculty are as committed to teaching as they are to research, embracing a curriculum that requires students to be architects of their education. In 2004, Brown publicly launched its Plan for Academic Enrichment, which is designed to strengthen educational opportunities and significantly increase the number of faculty, add more courses and research opportunities for undergraduates, improve support for graduate and medical education, and invest in libraries, information technology and new academic space. For more information, visit brown/.
Source: Jessica Collins Grimes
Lifespan
четверг, 29 сентября 2011 г.
Goal To Extend Useful Life Of Arthritic Knees And Hips
An existing osteoporosis drug is the first ever found to prevent cartilage loss from osteoarthritis following injury to a joint, and may also regenerate some cartilage that has been lost to osteoarthritis, according to an early study presented at the annual meeting of the American Society for Bone and Mineral Research in Denver. While the study was in mice, the model closely mimics human osteoarthritis that develops following knee injuries, according to the study authors.
Cartilage can become damaged by many kinds of injury and by mechanical stresses that come with age. Over time, damaged cartilage deteriorates to cause osteoarthritis (OA), with its attendant joint inflammation and pain. Currently available drugs like steroids or non-steroidal anti-inflammatory agents (e.g. Advil, Aleve) reduce pain but do not address the loss of cartilage behind the osteoarthritis, which is projected to afflict more than 50 million Americans by 2020.
Cartilage forms the sponge-like, shock-absorbing layers that keep the impact of running and jumping and lifting from grinding bones against each other in joints. The cell type at the heart of osteoarthritis is the chondrocyte, the cartilage-producing cell responsible for maintaining the integrity of joint cartilage.
Outside of joints, chondrocytes undergo a normal maturation process that helps to form bone as part of fracture healing and bone growth in children. Disease processes and injury, however, cause chondrocytes in joint surface cartilage to become like those that help to heal bone elsewhere, but in a place where bone is not supposed to form. This mistaken maturation contributes to the gradual destruction of the joint seen in osteoarthritis.
Parathyroid hormone (PTH), known as teriparatide in drug form, has emerged as a major player in the maintenance and healing of bone, and the race is on to design new applications for it. Past studies have established that PTH prevents chondrocytes from undergoing maturation, and stimulates their proliferation, preserving larger pools of cartilage cells in the joint. Signaling molecules like PTH have their effect in the body by interacting with specifically shaped proteins on the cell surfaces called receptors. PTH docks into its receptors, like a ship coming into port, which changes the shape of the dock such that biochemical signals are sent.
The authors of the current study observed that chondrocytes within injured and degenerating cartilage have more PTH type 1 receptors on their surfaces. This makes them especially sensitive to the PTH signal that prevents harmful chondrocyte maturation into bone in the joint cartilage. Thus, PTH therapy should increase the cartilage supply exactly where cartilage loss is causing disease.
"Right now physicians have no way to bring back cartilage in patients who have lost it to osteoarthritis," said Randy Rosier, M.D., Ph.D., professor within the Department of Orthopaedics and Rehabilitation at the University of Rochester Medical Center. "Our current results, at least in mice, show that we can inhibit cartilage degeneration and improve the volume of cartilage in diseased joints. It's remarkable enough that this compound delays the loss of cartilage, but these results show it also may be able to restore, at least to some extent, cartilage in already degraded joint surfaces."
Researchers examined the impact of a daily dose of Forteo®/teriparatide, manufactured by Eli Lilly, and a generic version of teriparatide made by Sigma on the progress of OA following injury in study mice.
Experiments established a five-fold increase in PTH type 1 receptor expression in the articular cartilage of mice with injury-related osteoarthritis when compared to healthy cartilage. Injury triggers genetic mechanisms in an attempt to begin repairs, a repair response that may be responsible for the increase in PTH receptor in the joint. This in turn makes damaged cartilage particularly responsive to PTH.
In the current study, one group of mice with cartilage and ligament injuries was randomized to receive either saline as a control, Forteo® or generic PTH daily for 12 weeks. A second group of mice with joint injuries did not receive treatment until 8 weeks after injury. The delay was an attempt to determine the effect of treatment once the osteoarthritic process was already underway and some cartilage lost, a scenario that more closely mimics clinical reality. Patients do not visit their physician after an injury asking the doctor to prevent the onset of osteoarthritis 10 years in the future, Rosier said. They come in when an old injury and time have combined to degrade cartilage to the point where function is lost and pain felt.
Studies revealed that after 12 weeks of Forteo®- or generic PTH treatment, there was approximately 27 percent more joint cartilage compared to saline-treated mice. Strikingly, delayed teriparatide treatment was even more effective in improving the amount of cartilage, with up to 35 percent more cartilage in Forteo®- and PTH-treated groups than in the saline group, suggesting an ability to regenerate at least some of the lost cartilage.
With a new use patent application in place, the team will next seek to confirm the durability of the effect in further animal studies, and prepare to seek funding from the National Institutes of Health to begin pilot clinical studies of PTH treatment of osteoarthritis in humans, possibly in the later half of 2010.
Along with Rosier, the study was led by Erik Sampson, Todd O'Brien, Di Chen, Susan Bukata, J. Edward Puzas, Regis O'Keefe and Michael Zuscik within the Department of Orthopaedics and by Hani Awad in the Department of Biomedical Engineering at the University of Rochester Medical Center. The study was funded by the National Institutes of Health.
"These pre-clinical findings provide strong proof-of-concept support for the potential use of teriparatide to slow joint cartilage degeneration in OA patients, and perhaps even reverse it," Rosier said. "In the near future, we hope this serves as the foundation of new treatments that restore function to long injured joints, perhaps staving off joint replacement surgeries for some years."
Source:
Greg Williams
University of Rochester Medical Center
View drug information on Forteo.
Cartilage can become damaged by many kinds of injury and by mechanical stresses that come with age. Over time, damaged cartilage deteriorates to cause osteoarthritis (OA), with its attendant joint inflammation and pain. Currently available drugs like steroids or non-steroidal anti-inflammatory agents (e.g. Advil, Aleve) reduce pain but do not address the loss of cartilage behind the osteoarthritis, which is projected to afflict more than 50 million Americans by 2020.
Cartilage forms the sponge-like, shock-absorbing layers that keep the impact of running and jumping and lifting from grinding bones against each other in joints. The cell type at the heart of osteoarthritis is the chondrocyte, the cartilage-producing cell responsible for maintaining the integrity of joint cartilage.
Outside of joints, chondrocytes undergo a normal maturation process that helps to form bone as part of fracture healing and bone growth in children. Disease processes and injury, however, cause chondrocytes in joint surface cartilage to become like those that help to heal bone elsewhere, but in a place where bone is not supposed to form. This mistaken maturation contributes to the gradual destruction of the joint seen in osteoarthritis.
Parathyroid hormone (PTH), known as teriparatide in drug form, has emerged as a major player in the maintenance and healing of bone, and the race is on to design new applications for it. Past studies have established that PTH prevents chondrocytes from undergoing maturation, and stimulates their proliferation, preserving larger pools of cartilage cells in the joint. Signaling molecules like PTH have their effect in the body by interacting with specifically shaped proteins on the cell surfaces called receptors. PTH docks into its receptors, like a ship coming into port, which changes the shape of the dock such that biochemical signals are sent.
The authors of the current study observed that chondrocytes within injured and degenerating cartilage have more PTH type 1 receptors on their surfaces. This makes them especially sensitive to the PTH signal that prevents harmful chondrocyte maturation into bone in the joint cartilage. Thus, PTH therapy should increase the cartilage supply exactly where cartilage loss is causing disease.
"Right now physicians have no way to bring back cartilage in patients who have lost it to osteoarthritis," said Randy Rosier, M.D., Ph.D., professor within the Department of Orthopaedics and Rehabilitation at the University of Rochester Medical Center. "Our current results, at least in mice, show that we can inhibit cartilage degeneration and improve the volume of cartilage in diseased joints. It's remarkable enough that this compound delays the loss of cartilage, but these results show it also may be able to restore, at least to some extent, cartilage in already degraded joint surfaces."
Researchers examined the impact of a daily dose of Forteo®/teriparatide, manufactured by Eli Lilly, and a generic version of teriparatide made by Sigma on the progress of OA following injury in study mice.
Experiments established a five-fold increase in PTH type 1 receptor expression in the articular cartilage of mice with injury-related osteoarthritis when compared to healthy cartilage. Injury triggers genetic mechanisms in an attempt to begin repairs, a repair response that may be responsible for the increase in PTH receptor in the joint. This in turn makes damaged cartilage particularly responsive to PTH.
In the current study, one group of mice with cartilage and ligament injuries was randomized to receive either saline as a control, Forteo® or generic PTH daily for 12 weeks. A second group of mice with joint injuries did not receive treatment until 8 weeks after injury. The delay was an attempt to determine the effect of treatment once the osteoarthritic process was already underway and some cartilage lost, a scenario that more closely mimics clinical reality. Patients do not visit their physician after an injury asking the doctor to prevent the onset of osteoarthritis 10 years in the future, Rosier said. They come in when an old injury and time have combined to degrade cartilage to the point where function is lost and pain felt.
Studies revealed that after 12 weeks of Forteo®- or generic PTH treatment, there was approximately 27 percent more joint cartilage compared to saline-treated mice. Strikingly, delayed teriparatide treatment was even more effective in improving the amount of cartilage, with up to 35 percent more cartilage in Forteo®- and PTH-treated groups than in the saline group, suggesting an ability to regenerate at least some of the lost cartilage.
With a new use patent application in place, the team will next seek to confirm the durability of the effect in further animal studies, and prepare to seek funding from the National Institutes of Health to begin pilot clinical studies of PTH treatment of osteoarthritis in humans, possibly in the later half of 2010.
Along with Rosier, the study was led by Erik Sampson, Todd O'Brien, Di Chen, Susan Bukata, J. Edward Puzas, Regis O'Keefe and Michael Zuscik within the Department of Orthopaedics and by Hani Awad in the Department of Biomedical Engineering at the University of Rochester Medical Center. The study was funded by the National Institutes of Health.
"These pre-clinical findings provide strong proof-of-concept support for the potential use of teriparatide to slow joint cartilage degeneration in OA patients, and perhaps even reverse it," Rosier said. "In the near future, we hope this serves as the foundation of new treatments that restore function to long injured joints, perhaps staving off joint replacement surgeries for some years."
Source:
Greg Williams
University of Rochester Medical Center
View drug information on Forteo.
понедельник, 26 сентября 2011 г.
Laziness Increases Back Pain Risk
Officeworkers who rarely exercise are at increased risk of back injuries, according to UQ researchers working on a European Space Agency study.
The researchers participated in the Agency's Berlin Bed-Rest Study, monitoring 20 healthy, young men who spent 56 days lying in bed.
Lead researcher Dr Daniel Belavy said prolonged inactivity shrunk the deep muscles that protected the mens' backs.
He said that in some cases it took six months to recover but even then the muscles did not return to their normal size.
Dr Belavy said surface muscles closer to the skin, stomach and back became overactive, a condition which persisted for up to a year after returning to normal activity levels.
"If you sit around too much long-term, such as a desk job with no sport in your spare time, the muscles can slowly change in a bad way, giving you a bigger risk of hurting your back," Dr Belavy said.
He said short-term inactivity such as sitting at a desk for a couple of hours was not a major risk.
But a long-term habit of driving to work, working a desk job, going home watching TV and then going to bed would increase the chances of back problems.
Targeting inactivity could also be used in intervention and rehabilitation programs to decrease low back pain and future health care costs.
"I make sure my workspace is well set up so that I can sit with good posture and concentrate on sitting well," he said.
"This with regular attention to posture and regular 'earth-like' exercise such as walking and jogging can help to keep all the muscles fit and functioning."
UQ's Dr Julie Hides, Dr Stephen Wilson, and retired Associate Professor Carolyn Richardson also worked on the project.
The research has been published in Spine, an international journal for the study of the spine and also in the international Journal of Applied Physiology.
Dr Belavy gained his PhD under a joint study program between UQ's School of Information Technology and Electrical Engineering and the School of Health and Rehabilitation Sciences.
He has also been made the study coordinator of the upcoming 2nd Berlin Bed-Rest Study which starts in September.
Twenty-four subjects will spend 60 days in bed with their heads tilted six degrees down to simulate the body's fluid shift that occurs in microgravity of space.
The aim is to study muscle control changes and the effects of vibration exercise.
He will be based at the Centre of Muscle and Bone Research in the CharitГ© University Medicine Berlin.
University of Queensland, Brisbane, Australia
uq.au
The researchers participated in the Agency's Berlin Bed-Rest Study, monitoring 20 healthy, young men who spent 56 days lying in bed.
Lead researcher Dr Daniel Belavy said prolonged inactivity shrunk the deep muscles that protected the mens' backs.
He said that in some cases it took six months to recover but even then the muscles did not return to their normal size.
Dr Belavy said surface muscles closer to the skin, stomach and back became overactive, a condition which persisted for up to a year after returning to normal activity levels.
"If you sit around too much long-term, such as a desk job with no sport in your spare time, the muscles can slowly change in a bad way, giving you a bigger risk of hurting your back," Dr Belavy said.
He said short-term inactivity such as sitting at a desk for a couple of hours was not a major risk.
But a long-term habit of driving to work, working a desk job, going home watching TV and then going to bed would increase the chances of back problems.
Targeting inactivity could also be used in intervention and rehabilitation programs to decrease low back pain and future health care costs.
"I make sure my workspace is well set up so that I can sit with good posture and concentrate on sitting well," he said.
"This with regular attention to posture and regular 'earth-like' exercise such as walking and jogging can help to keep all the muscles fit and functioning."
UQ's Dr Julie Hides, Dr Stephen Wilson, and retired Associate Professor Carolyn Richardson also worked on the project.
The research has been published in Spine, an international journal for the study of the spine and also in the international Journal of Applied Physiology.
Dr Belavy gained his PhD under a joint study program between UQ's School of Information Technology and Electrical Engineering and the School of Health and Rehabilitation Sciences.
He has also been made the study coordinator of the upcoming 2nd Berlin Bed-Rest Study which starts in September.
Twenty-four subjects will spend 60 days in bed with their heads tilted six degrees down to simulate the body's fluid shift that occurs in microgravity of space.
The aim is to study muscle control changes and the effects of vibration exercise.
He will be based at the Centre of Muscle and Bone Research in the CharitГ© University Medicine Berlin.
University of Queensland, Brisbane, Australia
uq.au
пятница, 23 сентября 2011 г.
Recent Increase In Multiple Myeloma Survival Attributed To Novel Therapies
Multiple myeloma is one of the most common and devastating bone marrow cancers in the U.S., but survival rates have risen dramatically over the past decade. Recent analyses suggest that this trend may be attributed to new types of drugs and aggressive therapeutic interventions such as stem cell transplantation, according to the results of two studies prepublished online in Blood, the official journal of the American Society of Hematology.
Multiple myeloma (MM) is a neoplasm of plasma cells, a type of cell that resides in the bone marrow and produces antibody proteins. Survival rates for MM have traditionally been grim, with most patients dying within two to three years after diagnosis. However, within the last decade, a group of new therapies has been developed and approved for use in MM patients, including thalidomide (Thalidomid®), lenalidomide (Revlimid®), and bortezomib (Velcade®). Used alone or paired with traditional chemotherapy, these drugs have been shown to be highly effective in recently diagnosed and relapsed MM patients. Also, over the past decade high-dose chemotherapy and peripheral blood stem cell transplantation has been increasingly used for treatment of MM, especially in younger patients. Two recent studies analyzed outcomes in large populations of MM patients, comparing results with regard to diagnosis date, age, and gender.
Recent Major Improvement in Long-Term Survival of Younger Patients with Multiple Myeloma
In one study, a research team from the German Cancer Research Center and Weill Cornell Medical Center in New York analyzed trends in five- and 10-year survival of MM patients in the U.S. to understand how new therapies and innovative approaches have translated into better survival for patients. In this large epidemiologic study, 26,523 patients diagnosed with MM in the U.S. were studied from the 1990-1992 to 2002-2004 SEER (Surveillance, Epidemiology, and End Results) database.
The analyses found a definitive overall increase in the survival of MM patients over the past decade. In particular, five-year survival increased from 28.8 to 34.7 percent, and 10-year survival increased from 11.1 to 17.4 percent. Importantly, survival increased most dramatically in the youngest age group -- more than half (56.7 percent) of patients younger than 50 survived at least five years, and more than 40 percent (41.3 percent) survived at least 10 years. In real years, the average relative survival increased from four years after diagnosis in 1990-1992 to almost seven years after diagnosis in 2002-2004.
Patients age 50-59 also fared well, with approximately half (48.2 percent) surviving at least five years, and nearly a third (28.6 percent) surviving at least 10 years. However, only modest increases were seen in the age group 60-69, and virtually no improvement was seen in patients older than 70. Since about half of MM patients are diagnosed when they are 60 or older, the lack of improvement in the eldest groups is a critical finding of the research.
"The rise in survival among MM patients in this study may be attributed to improvements in stem cell protocols, supportive care, and therapies with better efficacy and lower toxicity," said Hermann Brenner, MD, of the Division of Clinical Epidemiology and Aging Research, German Cancer Research Center, and lead author of the study. "However, the improvements among older patients in our analysis remained much more modest, suggesting a need to better understand the natural history and treatment options for multiple myeloma in this population."
Improved Survival in Multiple Myeloma and the Impact of Novel Therapies
A second study conducted by researchers at the Mayo Clinic evaluated outcomes for a large group of MM patients by comparing survival among two date-specific analyses -- one from time of diagnosis and one from time of relapse -- to better understand trends in survival over time. "We wanted to understand if the new therapies available to these patients would translate directly into improved survival," said lead author Shaji Kumar, MD, of the Mayo Clinic.
The first analysis studied 387 patient records to compare disease relapses before and after December 31, 2000, based on the availability of thalidomide and subsequent clinical trials of bortezomib and lenalidomide. The second analysis was conducted over a 36-year period (1971-2006) with a larger group of 2,981 patients with newly diagnosed MM. These patients were divided by date of diagnosis (before or after January 1, 1997) to understand the significance of the novel advances in MM therapies.
Study results illustrated a dramatic improvement in survival among patients diagnosed in recent years, both from the time of diagnosis and from relapse after stem cell transplantation. Among the patients in the relapse group, the researchers noted a significant improvement in overall survival for patients relapsing after 2000, compared with those relapsing before 2000 (24 vs. 12 months). Patients relapsing before 2000 were less likely to receive a prompt transplant and more likely to have relapsed disease at the time of transplant and to have had more treatment regimens prior to transplant, compared with the group who relapsed after 2000, but the improvement seen in the recent times was independent of these differences.
In the larger group of newly diagnosed MM patients, diagnosis within the last decade translated into a 50 percent improvement in overall survival (45 vs. 30 months). Though the team divided the groups into six-year intervals to understand trends throughout the 36 years, they found no significant changes in survival until the most recent six-year period. When the team examined the relative impact of age and gender, they found that patients younger than 65 benefited the most from the recent improvements and that female patients fared slightly better.
"These results demonstrate a clear improvement in survival among myeloma patients in the last decade, and while supportive care may have contributed to this trend, we believe that the introduction of novel drugs played a major role," said Dr. Kumar. "This study also highlights the need to target the older patient population for innovative approaches to improve outcomes, considering these patients are more frail and more likely to have co-morbidities that may limit their treatment options. This progress reflects the effort of myeloma researchers worldwide, making myeloma a model for other cancers to follow."
The American Society of Hematology (hematology/) is the world's largest professional society concerned with the causes and treatment of blood disorders. Its mission is to further the understanding, diagnosis, treatment, and prevention of disorders affecting blood, bone marrow, and the immunologic, hemostatic, and vascular systems, by promoting research, clinical care, education, training, and advocacy in hematology.
Blood, the official journal of the American Society of Hematology, is the most cited peer-reviewed publication in the field. Blood is issued to Society members and other subscribers twice per month, available in print and online at bloodjournal/.
Source: Laura Stark
American Society of Hematology
View drug information on Revlimid; Velcade.
Multiple myeloma (MM) is a neoplasm of plasma cells, a type of cell that resides in the bone marrow and produces antibody proteins. Survival rates for MM have traditionally been grim, with most patients dying within two to three years after diagnosis. However, within the last decade, a group of new therapies has been developed and approved for use in MM patients, including thalidomide (Thalidomid®), lenalidomide (Revlimid®), and bortezomib (Velcade®). Used alone or paired with traditional chemotherapy, these drugs have been shown to be highly effective in recently diagnosed and relapsed MM patients. Also, over the past decade high-dose chemotherapy and peripheral blood stem cell transplantation has been increasingly used for treatment of MM, especially in younger patients. Two recent studies analyzed outcomes in large populations of MM patients, comparing results with regard to diagnosis date, age, and gender.
Recent Major Improvement in Long-Term Survival of Younger Patients with Multiple Myeloma
In one study, a research team from the German Cancer Research Center and Weill Cornell Medical Center in New York analyzed trends in five- and 10-year survival of MM patients in the U.S. to understand how new therapies and innovative approaches have translated into better survival for patients. In this large epidemiologic study, 26,523 patients diagnosed with MM in the U.S. were studied from the 1990-1992 to 2002-2004 SEER (Surveillance, Epidemiology, and End Results) database.
The analyses found a definitive overall increase in the survival of MM patients over the past decade. In particular, five-year survival increased from 28.8 to 34.7 percent, and 10-year survival increased from 11.1 to 17.4 percent. Importantly, survival increased most dramatically in the youngest age group -- more than half (56.7 percent) of patients younger than 50 survived at least five years, and more than 40 percent (41.3 percent) survived at least 10 years. In real years, the average relative survival increased from four years after diagnosis in 1990-1992 to almost seven years after diagnosis in 2002-2004.
Patients age 50-59 also fared well, with approximately half (48.2 percent) surviving at least five years, and nearly a third (28.6 percent) surviving at least 10 years. However, only modest increases were seen in the age group 60-69, and virtually no improvement was seen in patients older than 70. Since about half of MM patients are diagnosed when they are 60 or older, the lack of improvement in the eldest groups is a critical finding of the research.
"The rise in survival among MM patients in this study may be attributed to improvements in stem cell protocols, supportive care, and therapies with better efficacy and lower toxicity," said Hermann Brenner, MD, of the Division of Clinical Epidemiology and Aging Research, German Cancer Research Center, and lead author of the study. "However, the improvements among older patients in our analysis remained much more modest, suggesting a need to better understand the natural history and treatment options for multiple myeloma in this population."
Improved Survival in Multiple Myeloma and the Impact of Novel Therapies
A second study conducted by researchers at the Mayo Clinic evaluated outcomes for a large group of MM patients by comparing survival among two date-specific analyses -- one from time of diagnosis and one from time of relapse -- to better understand trends in survival over time. "We wanted to understand if the new therapies available to these patients would translate directly into improved survival," said lead author Shaji Kumar, MD, of the Mayo Clinic.
The first analysis studied 387 patient records to compare disease relapses before and after December 31, 2000, based on the availability of thalidomide and subsequent clinical trials of bortezomib and lenalidomide. The second analysis was conducted over a 36-year period (1971-2006) with a larger group of 2,981 patients with newly diagnosed MM. These patients were divided by date of diagnosis (before or after January 1, 1997) to understand the significance of the novel advances in MM therapies.
Study results illustrated a dramatic improvement in survival among patients diagnosed in recent years, both from the time of diagnosis and from relapse after stem cell transplantation. Among the patients in the relapse group, the researchers noted a significant improvement in overall survival for patients relapsing after 2000, compared with those relapsing before 2000 (24 vs. 12 months). Patients relapsing before 2000 were less likely to receive a prompt transplant and more likely to have relapsed disease at the time of transplant and to have had more treatment regimens prior to transplant, compared with the group who relapsed after 2000, but the improvement seen in the recent times was independent of these differences.
In the larger group of newly diagnosed MM patients, diagnosis within the last decade translated into a 50 percent improvement in overall survival (45 vs. 30 months). Though the team divided the groups into six-year intervals to understand trends throughout the 36 years, they found no significant changes in survival until the most recent six-year period. When the team examined the relative impact of age and gender, they found that patients younger than 65 benefited the most from the recent improvements and that female patients fared slightly better.
"These results demonstrate a clear improvement in survival among myeloma patients in the last decade, and while supportive care may have contributed to this trend, we believe that the introduction of novel drugs played a major role," said Dr. Kumar. "This study also highlights the need to target the older patient population for innovative approaches to improve outcomes, considering these patients are more frail and more likely to have co-morbidities that may limit their treatment options. This progress reflects the effort of myeloma researchers worldwide, making myeloma a model for other cancers to follow."
The American Society of Hematology (hematology/) is the world's largest professional society concerned with the causes and treatment of blood disorders. Its mission is to further the understanding, diagnosis, treatment, and prevention of disorders affecting blood, bone marrow, and the immunologic, hemostatic, and vascular systems, by promoting research, clinical care, education, training, and advocacy in hematology.
Blood, the official journal of the American Society of Hematology, is the most cited peer-reviewed publication in the field. Blood is issued to Society members and other subscribers twice per month, available in print and online at bloodjournal/.
Source: Laura Stark
American Society of Hematology
View drug information on Revlimid; Velcade.
вторник, 20 сентября 2011 г.
Congenital Abnormality Is The Focus Of University Of Hawaii At Manoa Research
Researchers at the University of Hawai'i at Manoa have developed innovative techniques that could have profound effects on congenital cervical vertebrae malformation research.
In the cover-featured research article of the November issue of Molecular Reproduction and Development, researchers looked into congenital cervical vertebrae malformation in humans that can cause neural problems and increase susceptibility to stillbirth in women. Research advancement on abnormal vertebrae development has been limited due to the lack of lab animals with taxonomic equivalency to humans (animal models), and restrictions on human subject research.
Leading the research effort was Dr. Jinzeng Yang, a molecular biologist in the College of Tropical Agriculture and Human Resources' Department of Human Nutrition, Food and Animal Sciences. Researchers from Yang's laboratory have developed a new mouse model that reveals how patterning and developmental proteins can influence cervical vertebrae formation.
The mouse model uses a gene suppression technique that induces skeletal formation. The mice and their offspring appear normal but have striking cervical vertebrae formation. Yang's new gene suppression technique offers benefits, in this case, over the mouse model generated by complete gene removal (knockout mice), which cause mice to die shortly after birth.
Yang's laboratory has been studying myostatin, a protein playing a dominant role in reducing muscle mass. By genetically blocking the function of myostatin by its partial DNA sequences, mice were developed with 40 percent more muscle mass. Yang's graduate student Zicong Li, the first author of the publication, hypothesized that this gene suppression strategy would also work to stimulate skeletal development by inhibiting growth differentiation factor 11 (GDF11), a similar protein to myostatin, and produce live animals. Previously, the mice with complete removal of the GDF11 gene or knockout mice died shortly after birth. In collaboration with Dr. Stefan Moisyadi's laboratory in the UH Institute of Biogenesis Research, they generated the transgenic mice by using a new single plasmid system of piggyBac transgene delivery, which offers greater transposition rates and precision.
The original research article is titled, "Transgenic Over-Expression of Growth Differentiation Factor 11 Propeptide in Skeleton Results in Transformation of the Seventh Cervical Vertebra into a Thoracic Vertebra."
Work was supported by grants from the U.S. Department of Agriculture and the National Institutes of Health.
Source:
Jinzeng Yang
University of Hawaii at Manoa
In the cover-featured research article of the November issue of Molecular Reproduction and Development, researchers looked into congenital cervical vertebrae malformation in humans that can cause neural problems and increase susceptibility to stillbirth in women. Research advancement on abnormal vertebrae development has been limited due to the lack of lab animals with taxonomic equivalency to humans (animal models), and restrictions on human subject research.
Leading the research effort was Dr. Jinzeng Yang, a molecular biologist in the College of Tropical Agriculture and Human Resources' Department of Human Nutrition, Food and Animal Sciences. Researchers from Yang's laboratory have developed a new mouse model that reveals how patterning and developmental proteins can influence cervical vertebrae formation.
The mouse model uses a gene suppression technique that induces skeletal formation. The mice and their offspring appear normal but have striking cervical vertebrae formation. Yang's new gene suppression technique offers benefits, in this case, over the mouse model generated by complete gene removal (knockout mice), which cause mice to die shortly after birth.
Yang's laboratory has been studying myostatin, a protein playing a dominant role in reducing muscle mass. By genetically blocking the function of myostatin by its partial DNA sequences, mice were developed with 40 percent more muscle mass. Yang's graduate student Zicong Li, the first author of the publication, hypothesized that this gene suppression strategy would also work to stimulate skeletal development by inhibiting growth differentiation factor 11 (GDF11), a similar protein to myostatin, and produce live animals. Previously, the mice with complete removal of the GDF11 gene or knockout mice died shortly after birth. In collaboration with Dr. Stefan Moisyadi's laboratory in the UH Institute of Biogenesis Research, they generated the transgenic mice by using a new single plasmid system of piggyBac transgene delivery, which offers greater transposition rates and precision.
The original research article is titled, "Transgenic Over-Expression of Growth Differentiation Factor 11 Propeptide in Skeleton Results in Transformation of the Seventh Cervical Vertebra into a Thoracic Vertebra."
Work was supported by grants from the U.S. Department of Agriculture and the National Institutes of Health.
Source:
Jinzeng Yang
University of Hawaii at Manoa
суббота, 17 сентября 2011 г.
FDA Orders Postmarket Surveillance Of Certain TMJ Implants
Today the U.S. Food and Drug Administration ordered three manufacturers of temporomandibular joint (TMJ) implants to conduct postmarket surveillance studies to determine the length of time before the implants are removed or replaced due to pain or other reasons.
The TMJ connects the lower jaw (mandible) to the temporal bone in the skull. A person may have an implant to replace the socket in the temporal bone or the rounded edge of the lower jaw that glides in the temporal bone socket because of an injury, arthritis, physical abnormality, or lost mobility.
The three manufacturers, TMJ Solutions, TMJ Medical, and Biomet Microfixation, make all of the currently approved TMJ devices marketed in the United States. The companies will have 30 days to submit a study plan which will need to be approved by the agency before any postmarket studies can begin.
TMJ implants also can be used to treat temporomandibular disorder (TMD) that has not responded to more conservative treatments such as limiting jaw movement, soft diet, jaw splint or adjustments, medicine to reduce pain, or physical therapy.
The FDA analyzed TMJ implant-related adverse event reports submitted between April 30, 2004 and Aug. 17, 2010. The analysis described a substantial number of patients who had implants replaced within three years or less after implantation because of extreme pain. This is considerably shorter than the expected minimum five-year life span of the device, based on premarket mechanical testing.
The FDA is not recommending any changes on use of the implants. The agency may revise its recommendations or issue other recommendations after reviewing additional clinical data from the studies. Patients who have or are considering a TMJ implant should consult with their health care professional.
TMJ implant manufacturers were required to collect postmarket data on their implants as part of the approval process. However, the data collected did not adequately address the timing or reasons for replacement, and the studies lost contact over the years with many of the enrolled patients.
The TMJ implant postmarket surveillance studies must address the following:
- Time between initial implant and removal/replacement
- Association between patient diagnosis and the timeframe between implant and removal/replacement
- For replacement implants, the time between implant and subsequent removal/replacement
- Reasons for removal/replacement of the implant
- Associations between patient demographic and clinical data and the need or removal/replacement
- Assessment of devices that have been removed from patients
As part of its review, the FDA will consider whether labeling changes, additional preclinical and clinical testing requirements, or other regulatory actions are necessary for these devices.
Source:
U.S. Food and Drug Administration
The TMJ connects the lower jaw (mandible) to the temporal bone in the skull. A person may have an implant to replace the socket in the temporal bone or the rounded edge of the lower jaw that glides in the temporal bone socket because of an injury, arthritis, physical abnormality, or lost mobility.
The three manufacturers, TMJ Solutions, TMJ Medical, and Biomet Microfixation, make all of the currently approved TMJ devices marketed in the United States. The companies will have 30 days to submit a study plan which will need to be approved by the agency before any postmarket studies can begin.
TMJ implants also can be used to treat temporomandibular disorder (TMD) that has not responded to more conservative treatments such as limiting jaw movement, soft diet, jaw splint or adjustments, medicine to reduce pain, or physical therapy.
The FDA analyzed TMJ implant-related adverse event reports submitted between April 30, 2004 and Aug. 17, 2010. The analysis described a substantial number of patients who had implants replaced within three years or less after implantation because of extreme pain. This is considerably shorter than the expected minimum five-year life span of the device, based on premarket mechanical testing.
The FDA is not recommending any changes on use of the implants. The agency may revise its recommendations or issue other recommendations after reviewing additional clinical data from the studies. Patients who have or are considering a TMJ implant should consult with their health care professional.
TMJ implant manufacturers were required to collect postmarket data on their implants as part of the approval process. However, the data collected did not adequately address the timing or reasons for replacement, and the studies lost contact over the years with many of the enrolled patients.
The TMJ implant postmarket surveillance studies must address the following:
- Time between initial implant and removal/replacement
- Association between patient diagnosis and the timeframe between implant and removal/replacement
- For replacement implants, the time between implant and subsequent removal/replacement
- Reasons for removal/replacement of the implant
- Associations between patient demographic and clinical data and the need or removal/replacement
- Assessment of devices that have been removed from patients
As part of its review, the FDA will consider whether labeling changes, additional preclinical and clinical testing requirements, or other regulatory actions are necessary for these devices.
Source:
U.S. Food and Drug Administration
среда, 14 сентября 2011 г.
Osteoporosis Prevalance In Older Australian Men Severely Underestimated
Despite a high prevalence of osteoporosis in elderly Australian men, awareness, diagnosis and treatment of the condition remain low, according to a study published in the Medical Journal of Australia.
Ms Kerrin Bleicher, a physiotherapist and PhD Student at the University of Sydney, and co-authors conducted a study to determine the proportion of older Australian men who meet the Pharmaceutical Benefits Scheme (PBS) criteria for osteoporosis treatment and are receiving effective treatment.
Of the 1705 men aged over 70 years who participated in the study, 25 per cent met one or more of the PBS criteria for osteoporosis treatment. Ninety per cent of the men who met the PBS criteria were unaware they had osteoporosis.
Ms Bleicher said that this lack of awareness may have resulted in substantial underestimation of osteoporosis prevalence in men in a recent report by the Australian Institute of Health and Welfare that relied on self-report of osteoporosis.
"Identifying men who will benefit from osteoporosis treatment and increasing the proportion of eligible men receiving appropriate treatment is a public health issue," Ms Bleicher said.
"Both non-pharmacological treatments and pharmacological treatments need to be implemented to reduce fracture rates.
"Currently it is projected that, because of the ageing population, hip fractures may double by 2026, and increase fourfold by 2051.
"An important step forward is to build public and general medical awareness that osteoporosis is common in older men and that minimal trauma fractures and vertebral deformities are indicators of increased risk of future fractures.
"Obtaining information about previous fractures, identifying vertebral deformities, and testing bone density, where appropriate, can identify men at higher risk of fracture who may benefit from interventions."
The Medical Journal of Australia is a publication of the Australian Medical Association.
The statements or opinions that are expressed in the MJA reflect the views of the authors and do not represent the official policy of the AMA unless that is so stated.
Source:
Medical Journal of Australia
Ms Kerrin Bleicher, a physiotherapist and PhD Student at the University of Sydney, and co-authors conducted a study to determine the proportion of older Australian men who meet the Pharmaceutical Benefits Scheme (PBS) criteria for osteoporosis treatment and are receiving effective treatment.
Of the 1705 men aged over 70 years who participated in the study, 25 per cent met one or more of the PBS criteria for osteoporosis treatment. Ninety per cent of the men who met the PBS criteria were unaware they had osteoporosis.
Ms Bleicher said that this lack of awareness may have resulted in substantial underestimation of osteoporosis prevalence in men in a recent report by the Australian Institute of Health and Welfare that relied on self-report of osteoporosis.
"Identifying men who will benefit from osteoporosis treatment and increasing the proportion of eligible men receiving appropriate treatment is a public health issue," Ms Bleicher said.
"Both non-pharmacological treatments and pharmacological treatments need to be implemented to reduce fracture rates.
"Currently it is projected that, because of the ageing population, hip fractures may double by 2026, and increase fourfold by 2051.
"An important step forward is to build public and general medical awareness that osteoporosis is common in older men and that minimal trauma fractures and vertebral deformities are indicators of increased risk of future fractures.
"Obtaining information about previous fractures, identifying vertebral deformities, and testing bone density, where appropriate, can identify men at higher risk of fracture who may benefit from interventions."
The Medical Journal of Australia is a publication of the Australian Medical Association.
The statements or opinions that are expressed in the MJA reflect the views of the authors and do not represent the official policy of the AMA unless that is so stated.
Source:
Medical Journal of Australia
воскресенье, 11 сентября 2011 г.
Orthopedic Oncologist Shares New Limb Sparing Surgical Techniques
James C. Wittig, M.D., chief of the division of skin and sarcoma cancer at the John Theurer Cancer Center at Hackensack University Medical Center presented eleven different educational videos on innovative approaches to orthopedic oncology at the American Academy of Orthopaedic Surgeons Conference. Dr. Wittig is known for inventing some of the most-used best practices in limb-sparing surgery. In 2009, he and his colleagues began filming their surgeries so that other surgeons across the globe could use their radically innovative techniques.
"We have spent years developing some of the best practices in limb-sparing surgery, and sharing this knowledge is going to benefit patients worldwide," said Dr. Wittig. "Conference attendees represent some of the finest minds in orthopedics today, so to be chosen to lead such a great number of presentations is an honor and speaks to the importance of limb sparing surgery and its significance to the field."
The videos range in content from radical resection and reconstruction of a distal femur tumor to a radical sacrectomy and reconstruction for a high-grade primary sarcoma of the sacrum. All of the educational videos describe various orthopedic oncology procedures pertaining to radical limb sparing surgery and reconstruction for bone and soft tissue tumors in different locations, representing state-of-the-art approaches to these surgeries.
"The physicians and staff of the John Theurer Cancer Center are focused on delivering extraordinary care," said Andrew Pecora M.D., F.A.C.P., C.P.E., chief innovations officer and professor and vice president of cancer services, John Theurer Cancer Center. "The multimedia presentations by Dr. Wittig and his team exemplify this approach from both a patient care and an educational perspective"
The conference was held in San Diego, California from February 15-19 featuring international experts in orthopedics as well as a keynote address from one of the greatest football coaches of all-time Lou Holtz. Limb sparing surgery and innovative approaches to orthopedic oncology have increasingly assumed a more prominent role within both cancer and orthopedic care. The work by Dr. Wittig and colleagues points to increasing options for patients with tumors in difficult locations of the body and how new approaches are improving patient care.
Titles and short descriptions of the video presentations Dr. Witting and colleagues present are listed below:
Osteosarcoma of Distal Femur: Radical Resection & Reconstruction with Distal Femur Tumor Prosthesis
Authors: James C. Wittig, Camilo E. Villalobos, Brett Hayden, Andrew Silverman, Benjamin Lerner, Martin M Malawer
This video describes limb-sparing resection of an Osteosarcoma involving the distal femur and knee joint. A modular segmental distal femur tumor prosthesis is utilized to reconstruct the knee joint. Emphasis is placed on meticulous neurovascular dissection and multiple muscle transfers to optimize function and minimize complications. The procedure described is a safe, reliable technique for limb sparing surgery for sarcomas of the distal femur.
Limb-Sparing Total Scapula & Proximal Humerus (Tikhoff-Linberg) Resection and Reconstruction
Authors: James C. Wittig, Camilo E. Villalobos, Brett Hayden, Andrew Silverman, Benjamin Lerner, Martin M Malawer
This video depicts a 60 year old male patient who was presented with a fungating squamous cell carcinoma involving the shoulder girdle. The radiologic studies demonstrated an extensive loss of soft tissue overlying the scapula, proximal humerus and distal clavicle. The patient underwent a limb sparing radical resection of the left scapula as well the proximal humerus including the deltoid, rotator cuff muscles, portions of the trapezius and the clavicle. A modular proximal humerus tumor prosthesis was used for reconstruction. It was stabilized to the clavicle and second rib with heavy Dacron tapes. Multiple muscle rotation flaps were used for coverage and to stabilize the prosthesis
Intraarticular Proximal Humerus Resection and Prosthetic Reconstruction for a Pathologic Fracture
Authors: James C. Wittig, Andrew Silverman. Camilo E.Villalobos, Brett Hayden, Benjamin Lerner
This is a patient with a pathologic fracture of his right humerus due to metastatic renal cell carcinoma. Dr. Wittig and his team performed an intraarticular resection of the right proximal humerus. A modular proximal humerus tumor prosthesis was utilized for reconstruction. Static and dynamic methods were utilized for stabilizing the prosthesis. Reconstruction of the glenohumeral ligaments with gore-tex aortic graft was performed to provide multidirectional stability. Multiple muscle transfers and rotational flaps were performed for dynamic stabilization as well as to power the shoulder girdle and cover the entire prosthesis with soft tissue. The goal of the reconstruction is to stabilize the shoulder girdle for optimal hand and elbow function without compromising rotation. Our patients have been pain-free and have shown good elbow and hand function.
Primary MFH of Proximal Tibia: Limb-Sparing Resection with Prosthetic and Soft Tissue Reconstruction
Authors: James C. Wittig, Camilo E. Villalobos, Brett Hayden, Andrew Silverman, Benjamin Lerner, Martin M Malawer
A limb-sparing resection of the proximal tibia is performed for a patient with a primary Malignant Fibrous Histiocytoma (MFH) of bone. A modular segmental proximal tibia endoprosthesis is used to reconstruct the bony defect and knee joint. Emphasis is placed on neurovascular dissection and reconstruction of the extensor mechanism with a medial gastrocnemius muscle flap.
Radical Resection of the Distal Humerus and Reconstruction with a Distal Humerus Tumor Prosthesis
Authors: James C. Wittig, Andrew Silverman, Brett Hayden, Camilo E. Villalobos, Benjamin Lerner
The distal humerus is a relatively rare site for developing a tumor. Limb sparing resection and reconstruction is challenging due to the close proximity of several critical neurovascular structures as well as the paucity of surrounding soft tissues. The video describes an anterior approach for resecting tumors involving the distal humerus and reconstruction with an endoprosthetic replacement. Limb-sparing resection for tumors involving the distal humerus through an anterior approach and reconstruction with a modular distal humerus tumor prosthesis and multiple muscle transfers is a safe and reliable method for treating tumors in this location.
Chondrosarcoma of the Proximal Femur: Limb-Sparing Resection and Prosthetic Reconstruction
Authors: James C. Wittig, Andrew Silverman, Camilo E. Villalobos, Brett Hayden, Benjamin Lerner
A limb-sparing resection of a Proximal Femur is performed for an 81 year old male patient with a Chondrosarcoma of the right proximal femur. Modular segmental proximal femur tumor prosthesis is utilized to reconstruct the proximal femur. Emphasis is placed on preservation of neurovascular structures and employment of major muscle rotations to optimize post-operative hip function and minimize infection. Proximal femur resection with endoprosthetic reconstruction is a complex surgical procedure. Preservation of the acetabulum and joint capsule, capsulorraphy, and reconstruction of the abductor mechanism are major determinants of joint stability. This reconstruction can also be used for a variety of nononcologic indications, as for major total hip revision surgeries and persistent infection.
Intermuscular Liposarcoma of the Posterior Thigh: Radical Resection and Sciatic Nerve Preservation
Authors: James C. Wittig, Brett Hayden, Andrew Silverman, Benjamin Lerner, Camilo E. Villalobos
This video demonstrates radical resection of an intermuscular myxoid liposarcoma of the posterior thigh in a 39 year old patient. The surgical procedure included radical resection of the intermuscular tumor as well as the use of multiple muscle rotation flaps for soft tissue closure. Strong emphasis in this video is placed on sciatic nerve dissection, mobilization, and preservation prior to tumor removal. This reconstruction technique is a safe and reliable method for treatment of soft tissue tumors in this location.
Radical Sacrectomy and Reconstruction for a High Grade Primary Sarcoma of the Sacrum
Authors: James C. Wittig, Benjamin Lerner, Andrew Silverman, Brett Hayden, Camilo E. Villalobos, Sheeraz Qureshi
This video details a radical subtotal sacrectomy and reconstruction for a high grade primary sarcoma. Sarcomas of the sacrum are extremely rare. Resection of sacral tumors is complex and risky, often requiring resection of multiple sacral nerve roots. These surgeries are associated with multiple complications. The patient, a 43 year old woman, presented with a sarcoma arising from the right side of her sacrum. The tumor had a large soft tissue component. Resection and reconstruction was undertaken through three separate approaches. This video details the steps of this complex surgical procedure.
Spinopelvic Fusion and Gluteus Maximus Muscle Rotation Following Radical Sacral Tumor Removal
Authors: James C. Wittig, Benjamin Lerner, Andrew Silverman, Brett Hayden, Camilo E. Villalobos, Sheeraz Qureshi
This video details a radical subtotal sacrectomy and reconstruction for a high grade primary sarcoma. Sarcomas of the sacrum are extremely rare. Resection of sacral tumors is risky, often requiring resection of multiple sacral nerve roots. These surgeries are associated with multiple complications. The patient, a 43 year old woman, presented with a sarcoma arising from the right side of her sacrum. The tumor had a large soft tissue component. Resection and reconstruction was undertaken through three separate approaches. The spine was fused to the iliac wings and the entire defect was covered with bilateral glutes maximus rotational flaps.
Revision Arthroplasty with a Total Femur Replacement for Multiply Failed Total Hip and Total Knee Replacement
Authors: Calin Moucha, Richard Greendyk, Benjamin Lerner, Andrew Silverman, Brett Hayden, Camilo E. Villalobos and James C. Wittig
The number of revision total knee replacement (TKR) surgeries done worldwide is increasing at a rapid pace. On rare occasions the failed TKR needs to be revised during the same surgery as an ipsilateral failed total hip replacement. In these instances the femoral bone stock is usually highly deficient and a total femoral replacement may be required. This video demonstrates a surgical technique that utilizes a total femoral replacement prosthesis for revision arthroplasty. After an extensive negative infection work-up a decision was made to undergo the procedure described. The video highlights the extensile exposure, resection of the femur, removal of a stemmed, well-fixed tibial component, and reconstruction using a total femoral prosthesis.
Massive Reconstruction of Femur with a Total Femur Replacement for Failed Arthroplasties
Authors: Calin Moucha, Richard Greendyk, Benjamin Lerner, Andrew, Brett Hayden, Camilo E. Villalobos and James C. Wittig
The number of patients who require revision surgery for a failed total hip arthroplasty is increasing at a rapid rate. While multiple reconstructive options are available in the majority of cases, on rare occasions the femoral bone stock is so deficient that standard revision implants cannot be securely fixed in the remaining bone. This video demonstrates a surgical technique that utilizes a total femoral replacement prosthesis for revision arthroplasty of a highly deficient femur. The type of implant and surgical technique used in this case should be included in the revision surgeons armamentarium for treating patients with these increasingly more common, difficult cases.
Source:
Amy Leahing
John Theurer Cancer Center
"We have spent years developing some of the best practices in limb-sparing surgery, and sharing this knowledge is going to benefit patients worldwide," said Dr. Wittig. "Conference attendees represent some of the finest minds in orthopedics today, so to be chosen to lead such a great number of presentations is an honor and speaks to the importance of limb sparing surgery and its significance to the field."
The videos range in content from radical resection and reconstruction of a distal femur tumor to a radical sacrectomy and reconstruction for a high-grade primary sarcoma of the sacrum. All of the educational videos describe various orthopedic oncology procedures pertaining to radical limb sparing surgery and reconstruction for bone and soft tissue tumors in different locations, representing state-of-the-art approaches to these surgeries.
"The physicians and staff of the John Theurer Cancer Center are focused on delivering extraordinary care," said Andrew Pecora M.D., F.A.C.P., C.P.E., chief innovations officer and professor and vice president of cancer services, John Theurer Cancer Center. "The multimedia presentations by Dr. Wittig and his team exemplify this approach from both a patient care and an educational perspective"
The conference was held in San Diego, California from February 15-19 featuring international experts in orthopedics as well as a keynote address from one of the greatest football coaches of all-time Lou Holtz. Limb sparing surgery and innovative approaches to orthopedic oncology have increasingly assumed a more prominent role within both cancer and orthopedic care. The work by Dr. Wittig and colleagues points to increasing options for patients with tumors in difficult locations of the body and how new approaches are improving patient care.
Titles and short descriptions of the video presentations Dr. Witting and colleagues present are listed below:
Osteosarcoma of Distal Femur: Radical Resection & Reconstruction with Distal Femur Tumor Prosthesis
Authors: James C. Wittig, Camilo E. Villalobos, Brett Hayden, Andrew Silverman, Benjamin Lerner, Martin M Malawer
This video describes limb-sparing resection of an Osteosarcoma involving the distal femur and knee joint. A modular segmental distal femur tumor prosthesis is utilized to reconstruct the knee joint. Emphasis is placed on meticulous neurovascular dissection and multiple muscle transfers to optimize function and minimize complications. The procedure described is a safe, reliable technique for limb sparing surgery for sarcomas of the distal femur.
Limb-Sparing Total Scapula & Proximal Humerus (Tikhoff-Linberg) Resection and Reconstruction
Authors: James C. Wittig, Camilo E. Villalobos, Brett Hayden, Andrew Silverman, Benjamin Lerner, Martin M Malawer
This video depicts a 60 year old male patient who was presented with a fungating squamous cell carcinoma involving the shoulder girdle. The radiologic studies demonstrated an extensive loss of soft tissue overlying the scapula, proximal humerus and distal clavicle. The patient underwent a limb sparing radical resection of the left scapula as well the proximal humerus including the deltoid, rotator cuff muscles, portions of the trapezius and the clavicle. A modular proximal humerus tumor prosthesis was used for reconstruction. It was stabilized to the clavicle and second rib with heavy Dacron tapes. Multiple muscle rotation flaps were used for coverage and to stabilize the prosthesis
Intraarticular Proximal Humerus Resection and Prosthetic Reconstruction for a Pathologic Fracture
Authors: James C. Wittig, Andrew Silverman. Camilo E.Villalobos, Brett Hayden, Benjamin Lerner
This is a patient with a pathologic fracture of his right humerus due to metastatic renal cell carcinoma. Dr. Wittig and his team performed an intraarticular resection of the right proximal humerus. A modular proximal humerus tumor prosthesis was utilized for reconstruction. Static and dynamic methods were utilized for stabilizing the prosthesis. Reconstruction of the glenohumeral ligaments with gore-tex aortic graft was performed to provide multidirectional stability. Multiple muscle transfers and rotational flaps were performed for dynamic stabilization as well as to power the shoulder girdle and cover the entire prosthesis with soft tissue. The goal of the reconstruction is to stabilize the shoulder girdle for optimal hand and elbow function without compromising rotation. Our patients have been pain-free and have shown good elbow and hand function.
Primary MFH of Proximal Tibia: Limb-Sparing Resection with Prosthetic and Soft Tissue Reconstruction
Authors: James C. Wittig, Camilo E. Villalobos, Brett Hayden, Andrew Silverman, Benjamin Lerner, Martin M Malawer
A limb-sparing resection of the proximal tibia is performed for a patient with a primary Malignant Fibrous Histiocytoma (MFH) of bone. A modular segmental proximal tibia endoprosthesis is used to reconstruct the bony defect and knee joint. Emphasis is placed on neurovascular dissection and reconstruction of the extensor mechanism with a medial gastrocnemius muscle flap.
Radical Resection of the Distal Humerus and Reconstruction with a Distal Humerus Tumor Prosthesis
Authors: James C. Wittig, Andrew Silverman, Brett Hayden, Camilo E. Villalobos, Benjamin Lerner
The distal humerus is a relatively rare site for developing a tumor. Limb sparing resection and reconstruction is challenging due to the close proximity of several critical neurovascular structures as well as the paucity of surrounding soft tissues. The video describes an anterior approach for resecting tumors involving the distal humerus and reconstruction with an endoprosthetic replacement. Limb-sparing resection for tumors involving the distal humerus through an anterior approach and reconstruction with a modular distal humerus tumor prosthesis and multiple muscle transfers is a safe and reliable method for treating tumors in this location.
Chondrosarcoma of the Proximal Femur: Limb-Sparing Resection and Prosthetic Reconstruction
Authors: James C. Wittig, Andrew Silverman, Camilo E. Villalobos, Brett Hayden, Benjamin Lerner
A limb-sparing resection of a Proximal Femur is performed for an 81 year old male patient with a Chondrosarcoma of the right proximal femur. Modular segmental proximal femur tumor prosthesis is utilized to reconstruct the proximal femur. Emphasis is placed on preservation of neurovascular structures and employment of major muscle rotations to optimize post-operative hip function and minimize infection. Proximal femur resection with endoprosthetic reconstruction is a complex surgical procedure. Preservation of the acetabulum and joint capsule, capsulorraphy, and reconstruction of the abductor mechanism are major determinants of joint stability. This reconstruction can also be used for a variety of nononcologic indications, as for major total hip revision surgeries and persistent infection.
Intermuscular Liposarcoma of the Posterior Thigh: Radical Resection and Sciatic Nerve Preservation
Authors: James C. Wittig, Brett Hayden, Andrew Silverman, Benjamin Lerner, Camilo E. Villalobos
This video demonstrates radical resection of an intermuscular myxoid liposarcoma of the posterior thigh in a 39 year old patient. The surgical procedure included radical resection of the intermuscular tumor as well as the use of multiple muscle rotation flaps for soft tissue closure. Strong emphasis in this video is placed on sciatic nerve dissection, mobilization, and preservation prior to tumor removal. This reconstruction technique is a safe and reliable method for treatment of soft tissue tumors in this location.
Radical Sacrectomy and Reconstruction for a High Grade Primary Sarcoma of the Sacrum
Authors: James C. Wittig, Benjamin Lerner, Andrew Silverman, Brett Hayden, Camilo E. Villalobos, Sheeraz Qureshi
This video details a radical subtotal sacrectomy and reconstruction for a high grade primary sarcoma. Sarcomas of the sacrum are extremely rare. Resection of sacral tumors is complex and risky, often requiring resection of multiple sacral nerve roots. These surgeries are associated with multiple complications. The patient, a 43 year old woman, presented with a sarcoma arising from the right side of her sacrum. The tumor had a large soft tissue component. Resection and reconstruction was undertaken through three separate approaches. This video details the steps of this complex surgical procedure.
Spinopelvic Fusion and Gluteus Maximus Muscle Rotation Following Radical Sacral Tumor Removal
Authors: James C. Wittig, Benjamin Lerner, Andrew Silverman, Brett Hayden, Camilo E. Villalobos, Sheeraz Qureshi
This video details a radical subtotal sacrectomy and reconstruction for a high grade primary sarcoma. Sarcomas of the sacrum are extremely rare. Resection of sacral tumors is risky, often requiring resection of multiple sacral nerve roots. These surgeries are associated with multiple complications. The patient, a 43 year old woman, presented with a sarcoma arising from the right side of her sacrum. The tumor had a large soft tissue component. Resection and reconstruction was undertaken through three separate approaches. The spine was fused to the iliac wings and the entire defect was covered with bilateral glutes maximus rotational flaps.
Revision Arthroplasty with a Total Femur Replacement for Multiply Failed Total Hip and Total Knee Replacement
Authors: Calin Moucha, Richard Greendyk, Benjamin Lerner, Andrew Silverman, Brett Hayden, Camilo E. Villalobos and James C. Wittig
The number of revision total knee replacement (TKR) surgeries done worldwide is increasing at a rapid pace. On rare occasions the failed TKR needs to be revised during the same surgery as an ipsilateral failed total hip replacement. In these instances the femoral bone stock is usually highly deficient and a total femoral replacement may be required. This video demonstrates a surgical technique that utilizes a total femoral replacement prosthesis for revision arthroplasty. After an extensive negative infection work-up a decision was made to undergo the procedure described. The video highlights the extensile exposure, resection of the femur, removal of a stemmed, well-fixed tibial component, and reconstruction using a total femoral prosthesis.
Massive Reconstruction of Femur with a Total Femur Replacement for Failed Arthroplasties
Authors: Calin Moucha, Richard Greendyk, Benjamin Lerner, Andrew, Brett Hayden, Camilo E. Villalobos and James C. Wittig
The number of patients who require revision surgery for a failed total hip arthroplasty is increasing at a rapid rate. While multiple reconstructive options are available in the majority of cases, on rare occasions the femoral bone stock is so deficient that standard revision implants cannot be securely fixed in the remaining bone. This video demonstrates a surgical technique that utilizes a total femoral replacement prosthesis for revision arthroplasty of a highly deficient femur. The type of implant and surgical technique used in this case should be included in the revision surgeons armamentarium for treating patients with these increasingly more common, difficult cases.
Source:
Amy Leahing
John Theurer Cancer Center
четверг, 8 сентября 2011 г.
Wyeth Presents Data From Five-Year Vertebral Fracture Prevention Study With Bazedoxifene
Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announces findings from a placebo-controlled Phase 3 study of bazedoxifene 20 mg extended to five years, which indicated a significant reduction versus placebo in new vertebral fractures in postmenopausal women with osteoporosis. These and other data were presented at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting in Denver, Colo. Bazedoxifene, a selective estrogen receptor modulator (SERM), is under clinical investigation for the prevention and treatment of postmenopausal osteoporosis.
"These new data are important in that they suggest the reduction in vertebral fracture risk with bazedoxifene seen at five years is comparable to that seen at three years," says Stuart Silverman, M.D., Clinical Professor of Medicine at the University of California, Los Angeles and Cedars-Sinai Medical Center, and the study's lead investigator.
About Study 301
The results being presented are from a two-year extension of a three-year Phase 3 trial, which enrolled 7,492 generally healthy postmenopausal women aged 55 to 85 years with osteoporosis. The primary endpoint of the three-year Phase 3 study was the incidence of new vertebral fractures. Eligible subjects were randomized to daily treatment with bazedoxifene 20 mg or 40 mg, raloxifene (RLX) 60 mg, or placebo. At the conclusion of the pivotal three-year study, a total of 4,216 subjects were enrolled in the extension to five years. Patients receiving bazedoxifene 20 mg continued on that dosage, while the RLX 60 mg treatment arm was discontinued (as prespecified in the protocol) after the three-year database was finalized, and subjects receiving bazedoxifene 40 mg were transitioned to bazedoxifene 20 mg after all subjects completed four years of treatment. At five years, the study showed that the incidence of new vertebral fractures was significantly reduced in the bazedoxifene 20 mg group (4.5%) and in the group transitioned from bazedoxifene 40 mg to 20 mg (3.9%) compared with placebo (6.8%). This corresponds to relative risk reductions of 35% (P=0.014) and 40% (P=0.005), respectively. The incidence of venous thromboembolic events in this Phase 3 clinical trial was higher in bazedoxifene-treated subjects when compared with placebo. This finding is consistent with what was seen at three years.
Additional New Bazedoxifene Data Presented at ASBMR
Assessment of the Effect of Bazedoxifene on Non-Vertebral Fracture Risk (McCloskey EV, et al)
Data were also presented from a post-hoc analysis performed using the Fracture Risk Assessment Tool (FRAX(R)), which was developed by the World Health Organization to calculate a woman's 10-year risk of experiencing an osteoporotic fracture. This post-hoc analysis indicated that the higher a woman's risk of a fracture, the greater the reduction in non-vertebral fractures when receiving bazedoxifene therapy based on her FRAX score.
Safety and Tolerability of Bazedoxifene in Postmenopausal Women with Osteoporosis: Results of a 5-Year, Randomized, Placebo-controlled Phase 3 Trial (de Villiers TJ, et al)
Bazedoxifene five-year safety and tolerability data in postmenopausal women with osteoporosis were also presented. The incidence of adverse events (AEs), serious AEs and discontinuations due to AEs was similar to that seen in the placebo group. The incidence of cardiac or cerebrovascular events, including myocardial infarction and stroke, in the bazedoxifene treatment groups was similar to that seen in the placebo group. Subjects treated with bazedoxifene had a higher incidence of deep venous thrombosis, hot flushes and leg cramps compared with placebo-treated subjects. The effect of bazedoxifene on the breast and endometrium was comparable to placebo.
Cost-effectiveness of Bazedoxifene in the US Incorporating the FRAX(R) Algorithm (Strom, et al)
Data from an analysis performed using a Marcov cohort model and published U.S. cost and epidemiological data evaluated the potential cost-effectiveness and intervention thresholds of bazedoxifene treatment (20 mg and 40 mg doses combined) compared to placebo. Cost-effective scenarios were projected for women with strong risk factors and with a T-score above the threshold for osteoporosis. When effect was modeled for non-vertebral fractures, the data suggested that potential cost effectiveness improved further in women from the age of 60 years with prior fracture and at the threshold of osteoporosis (T-score=-2.5 SD).
About Bazedoxifene
Wyeth is pursuing regulatory approval of bazedoxifene for the prevention and treatment of postmenopausal osteoporosis in the United States and other countries worldwide. In April 2009, the European Commission granted marketing authorization for CONBRIZA(TM) (bazedoxifene) for the treatment of postmenopausal osteoporosis in women at increased risk of fracture. Wyeth intends to introduce CONBRIZA in certain European markets following receipt of necessary reimbursement authorizations in those markets.
Bazedoxifene paired with conjugated estrogens (BZA/CE) is also being studied by Wyeth for the treatment of moderate-to-severe menopausal vasomotor symptoms such as hot flushes, night sweats and vulvar and vaginal atrophy, and for the prevention of postmenopausal osteoporosis.
About Osteoporosis
Osteoporosis affects an estimated 75 million people in the United States, Europe and Japan. In the United States, the condition is a major public health threat for an estimated 44 million Americans, or 55 percent of the people 50 years of age and older. Osteoporosis is characterized by low bone mass and structural deterioration of bone tissue, leading to bone fragility and an increased risk of fractures. Up to 20 percent of a woman's expected lifetime bone loss can occur in the years immediately following menopause. The treatment of postmenopausal osteoporosis could lead to significant improvement in the overall health for millions of women worldwide as well as reduce costs associated with postmenopausal osteoporosis-related fractures.
About Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products.
Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products, nutritionals and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
The statements in this press release that are not historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In particular, clinical trial data are subject to differing interpretations, and the views of regulatory agencies, medical and scientific experts and others may differ from ours. In addition, there can be no assurance that bazedoxifene will be commercially successful in the markets where approved or that bazedoxifene will be approved in the future in other formulations or indications and/or in other countries, including the United States. Other risks and uncertainties that could cause actual results to differ materially from those expressed or implied by forward looking statements include, among others, risks related to our proposed merger with Pfizer, including satisfaction of the conditions of the proposed merger on the proposed timeframe or at all, contractual restrictions on the conduct of our business included in the merger agreement, and the potential for loss of key personnel, disruption in key business activities or any impact on our relationships with third parties as a result of the announcement of the proposed merger; the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products and pipeline products; government cost-containment initiatives; restrictions on third-party payments for our products; substantial competition in our industry, including from branded and generic products; emerging data on our products and pipeline products; the importance of strong performance from our principal products and our anticipated new product introductions; the highly regulated nature of our business; product liability, intellectual property and other litigation risks and environmental liabilities; the outcome of government investigations; uncertainty regarding our intellectual property rights and those of others; difficulties associated with, and regulatory compliance with respect to, manufacturing of our products; risks associated with our strategic relationships; global economic conditions; interest and currency exchange rate fluctuations and volatility in the credit and financial markets; changes in generally accepted accounting principles; trade buying patterns; the impact of legislation and regulatory compliance; risks and uncertainties associated with global operations and sales; and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption "Item 1A, Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2008, which was filed with the Securities and Exchange Commission on February 27, 2009. The forward-looking statements in this press release are qualified by these risk factors. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
Source: Wyeth Pharmaceuticals
"These new data are important in that they suggest the reduction in vertebral fracture risk with bazedoxifene seen at five years is comparable to that seen at three years," says Stuart Silverman, M.D., Clinical Professor of Medicine at the University of California, Los Angeles and Cedars-Sinai Medical Center, and the study's lead investigator.
About Study 301
The results being presented are from a two-year extension of a three-year Phase 3 trial, which enrolled 7,492 generally healthy postmenopausal women aged 55 to 85 years with osteoporosis. The primary endpoint of the three-year Phase 3 study was the incidence of new vertebral fractures. Eligible subjects were randomized to daily treatment with bazedoxifene 20 mg or 40 mg, raloxifene (RLX) 60 mg, or placebo. At the conclusion of the pivotal three-year study, a total of 4,216 subjects were enrolled in the extension to five years. Patients receiving bazedoxifene 20 mg continued on that dosage, while the RLX 60 mg treatment arm was discontinued (as prespecified in the protocol) after the three-year database was finalized, and subjects receiving bazedoxifene 40 mg were transitioned to bazedoxifene 20 mg after all subjects completed four years of treatment. At five years, the study showed that the incidence of new vertebral fractures was significantly reduced in the bazedoxifene 20 mg group (4.5%) and in the group transitioned from bazedoxifene 40 mg to 20 mg (3.9%) compared with placebo (6.8%). This corresponds to relative risk reductions of 35% (P=0.014) and 40% (P=0.005), respectively. The incidence of venous thromboembolic events in this Phase 3 clinical trial was higher in bazedoxifene-treated subjects when compared with placebo. This finding is consistent with what was seen at three years.
Additional New Bazedoxifene Data Presented at ASBMR
Assessment of the Effect of Bazedoxifene on Non-Vertebral Fracture Risk (McCloskey EV, et al)
Data were also presented from a post-hoc analysis performed using the Fracture Risk Assessment Tool (FRAX(R)), which was developed by the World Health Organization to calculate a woman's 10-year risk of experiencing an osteoporotic fracture. This post-hoc analysis indicated that the higher a woman's risk of a fracture, the greater the reduction in non-vertebral fractures when receiving bazedoxifene therapy based on her FRAX score.
Safety and Tolerability of Bazedoxifene in Postmenopausal Women with Osteoporosis: Results of a 5-Year, Randomized, Placebo-controlled Phase 3 Trial (de Villiers TJ, et al)
Bazedoxifene five-year safety and tolerability data in postmenopausal women with osteoporosis were also presented. The incidence of adverse events (AEs), serious AEs and discontinuations due to AEs was similar to that seen in the placebo group. The incidence of cardiac or cerebrovascular events, including myocardial infarction and stroke, in the bazedoxifene treatment groups was similar to that seen in the placebo group. Subjects treated with bazedoxifene had a higher incidence of deep venous thrombosis, hot flushes and leg cramps compared with placebo-treated subjects. The effect of bazedoxifene on the breast and endometrium was comparable to placebo.
Cost-effectiveness of Bazedoxifene in the US Incorporating the FRAX(R) Algorithm (Strom, et al)
Data from an analysis performed using a Marcov cohort model and published U.S. cost and epidemiological data evaluated the potential cost-effectiveness and intervention thresholds of bazedoxifene treatment (20 mg and 40 mg doses combined) compared to placebo. Cost-effective scenarios were projected for women with strong risk factors and with a T-score above the threshold for osteoporosis. When effect was modeled for non-vertebral fractures, the data suggested that potential cost effectiveness improved further in women from the age of 60 years with prior fracture and at the threshold of osteoporosis (T-score=-2.5 SD).
About Bazedoxifene
Wyeth is pursuing regulatory approval of bazedoxifene for the prevention and treatment of postmenopausal osteoporosis in the United States and other countries worldwide. In April 2009, the European Commission granted marketing authorization for CONBRIZA(TM) (bazedoxifene) for the treatment of postmenopausal osteoporosis in women at increased risk of fracture. Wyeth intends to introduce CONBRIZA in certain European markets following receipt of necessary reimbursement authorizations in those markets.
Bazedoxifene paired with conjugated estrogens (BZA/CE) is also being studied by Wyeth for the treatment of moderate-to-severe menopausal vasomotor symptoms such as hot flushes, night sweats and vulvar and vaginal atrophy, and for the prevention of postmenopausal osteoporosis.
About Osteoporosis
Osteoporosis affects an estimated 75 million people in the United States, Europe and Japan. In the United States, the condition is a major public health threat for an estimated 44 million Americans, or 55 percent of the people 50 years of age and older. Osteoporosis is characterized by low bone mass and structural deterioration of bone tissue, leading to bone fragility and an increased risk of fractures. Up to 20 percent of a woman's expected lifetime bone loss can occur in the years immediately following menopause. The treatment of postmenopausal osteoporosis could lead to significant improvement in the overall health for millions of women worldwide as well as reduce costs associated with postmenopausal osteoporosis-related fractures.
About Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products.
Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products, nutritionals and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
The statements in this press release that are not historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In particular, clinical trial data are subject to differing interpretations, and the views of regulatory agencies, medical and scientific experts and others may differ from ours. In addition, there can be no assurance that bazedoxifene will be commercially successful in the markets where approved or that bazedoxifene will be approved in the future in other formulations or indications and/or in other countries, including the United States. Other risks and uncertainties that could cause actual results to differ materially from those expressed or implied by forward looking statements include, among others, risks related to our proposed merger with Pfizer, including satisfaction of the conditions of the proposed merger on the proposed timeframe or at all, contractual restrictions on the conduct of our business included in the merger agreement, and the potential for loss of key personnel, disruption in key business activities or any impact on our relationships with third parties as a result of the announcement of the proposed merger; the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products and pipeline products; government cost-containment initiatives; restrictions on third-party payments for our products; substantial competition in our industry, including from branded and generic products; emerging data on our products and pipeline products; the importance of strong performance from our principal products and our anticipated new product introductions; the highly regulated nature of our business; product liability, intellectual property and other litigation risks and environmental liabilities; the outcome of government investigations; uncertainty regarding our intellectual property rights and those of others; difficulties associated with, and regulatory compliance with respect to, manufacturing of our products; risks associated with our strategic relationships; global economic conditions; interest and currency exchange rate fluctuations and volatility in the credit and financial markets; changes in generally accepted accounting principles; trade buying patterns; the impact of legislation and regulatory compliance; risks and uncertainties associated with global operations and sales; and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption "Item 1A, Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2008, which was filed with the Securities and Exchange Commission on February 27, 2009. The forward-looking statements in this press release are qualified by these risk factors. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
Source: Wyeth Pharmaceuticals
понедельник, 5 сентября 2011 г.
Increasing Dose Intensity Of Chemotherapy In Osteosarcoma Offers No Benefit Study Finds
A dose-intensive regimen of the chemotherapy drugs cisplatin and doxorubicin offered no clinical benefit over standard doses of the chemotherapy drugs in patients with a bone cancer called osteosarcoma, according to results from a randomized trial in the January 17 issue of the Journal of the National Cancer Institute. Although the dose-intensive regimen killed tumor cells better than the standard regimen after surgery, survival rates were similar in both groups.
Some studies in cancers such as non-Hodgkin lymphoma and breast cancer have suggested that increasing the intensity of a chemotherapy regimen--that is, decreasing the number of days between chemotherapy treatments--may improve survival. Because chemotherapy drugs can be very toxic, doctors often have to add additional medications to such dose-intense regimens so the patient can tolerate them. For example, some chemotherapy drugs cause a patient's white blood cell count to drop, so doctors also give patients a drug called granulocyte colony-stimulating factor (G-CSF) to increase their production of white blood cells.
In the new study, Ian J. Lewis, M.D., of St. James University Hospital in Leeds, England, with colleagues at the Medical Research Council Clinical Trials Unit in London and the European Osteosarcoma Intergroup, tested whether a dose-intensive regimen consisting of standard drugs used to treat osteosarcoma would improve survival when given before surgery to remove the tumor. A total of 497 patients age 40 or younger with high-grade osteosarcoma that had not spread elsewhere in the body were randomly assigned to receive six cisplatinвЂ"doxorubicin treatments at 3-week intervals (standard regimen) or to receive the treatments at 2-week intervals (dose-intense regimen). The patients receiving the dose-intense regimen also received injections of G-CSF to help them better tolerate the chemotherapy.
The researchers observed favorable tumor responses--measured by tumor cell death--in 36 percent of patients receiving the standard treatment and in 50 percent of those receiving the dose-intense regimen. However, after an average of about 5 years, overall survival and progression-free survival were similar in both groups; for example, overall survival was 55 percent in the conventional-treatment group and 58 percent in the dose-intense group. Those who received the dose-intense regimen had a lower risk of leukopenia (low white cell count) and neutropenia (low neutrophil count) but a higher risk of thrombocytopenia (platelet deficiency) and mucositis (inflamed mucus membranes).
"[The dose-intense regimen] resulted in more tumors having good histologic response to preoperative chemotherapy, but this did not translate into a demonstratable patient benefit in overall survival or progression-free survival over [the conventional regimen]," the authors write. "This emphasis placed on histologic response as the key treatment-related predictive factor is thereby challenged."
Indeed, writes editorialist Stephen L. George, Ph.D., of Duke University Medical Center, "promising early results measured by response rates often do not translate into long-term benefits such as longer progression-free survival or overall survival." Part of the reason for this, he writes, is that large increases in response rates are needed to translate into measurable differences in survival. George reviews the conditions under which response rate is a useful endpoint, and notes that this osteosarcoma clinical trial doesn't meet those circumstances. "It is clear that response rate as an endpoint is most useful in early phase clinical trials, in which interest focuses more on assessing activity than proving clinical benefit, and as an important but secondary outcome in more definitive trials," he writes.
Contact:
* Article: Medical Research Council Press Office
* Editorial: Chris Difrancesco, News Office, Duke University Medical Center
Citation:
* Article: Lewis IJ, Nooij M, Whelan J, Sydes MR, Grimer R, Hogendorn PCW, et al. Improvement in Histologic Response, But Not Survival, in Osteosarcoma Patients Treated With Intensified Chemotherapy: A Randomized Phase III Trial of the European Osteosarcoma Intergroup (MRC BO06, EORTC 80931, ISRCTN86294690 ). J Natl Cancer Inst 2006; 99:112-129.
* Editorial: George SL. Response rate as an endpoint in clinical trials. J Natl Cancer Inst 2006; 99:98-99.
Note: The Journal of the National Cancer Institute is published by Oxford University Press and is not affiliated with the National Cancer Institute. Attribution to the Journal of the National Cancer Institute is requested in all news coverage. Visit the Journal online at jnci.oxfordjournals/.
Contact: Andrea Widener
Journal of the National Cancer Institute
Some studies in cancers such as non-Hodgkin lymphoma and breast cancer have suggested that increasing the intensity of a chemotherapy regimen--that is, decreasing the number of days between chemotherapy treatments--may improve survival. Because chemotherapy drugs can be very toxic, doctors often have to add additional medications to such dose-intense regimens so the patient can tolerate them. For example, some chemotherapy drugs cause a patient's white blood cell count to drop, so doctors also give patients a drug called granulocyte colony-stimulating factor (G-CSF) to increase their production of white blood cells.
In the new study, Ian J. Lewis, M.D., of St. James University Hospital in Leeds, England, with colleagues at the Medical Research Council Clinical Trials Unit in London and the European Osteosarcoma Intergroup, tested whether a dose-intensive regimen consisting of standard drugs used to treat osteosarcoma would improve survival when given before surgery to remove the tumor. A total of 497 patients age 40 or younger with high-grade osteosarcoma that had not spread elsewhere in the body were randomly assigned to receive six cisplatinвЂ"doxorubicin treatments at 3-week intervals (standard regimen) or to receive the treatments at 2-week intervals (dose-intense regimen). The patients receiving the dose-intense regimen also received injections of G-CSF to help them better tolerate the chemotherapy.
The researchers observed favorable tumor responses--measured by tumor cell death--in 36 percent of patients receiving the standard treatment and in 50 percent of those receiving the dose-intense regimen. However, after an average of about 5 years, overall survival and progression-free survival were similar in both groups; for example, overall survival was 55 percent in the conventional-treatment group and 58 percent in the dose-intense group. Those who received the dose-intense regimen had a lower risk of leukopenia (low white cell count) and neutropenia (low neutrophil count) but a higher risk of thrombocytopenia (platelet deficiency) and mucositis (inflamed mucus membranes).
"[The dose-intense regimen] resulted in more tumors having good histologic response to preoperative chemotherapy, but this did not translate into a demonstratable patient benefit in overall survival or progression-free survival over [the conventional regimen]," the authors write. "This emphasis placed on histologic response as the key treatment-related predictive factor is thereby challenged."
Indeed, writes editorialist Stephen L. George, Ph.D., of Duke University Medical Center, "promising early results measured by response rates often do not translate into long-term benefits such as longer progression-free survival or overall survival." Part of the reason for this, he writes, is that large increases in response rates are needed to translate into measurable differences in survival. George reviews the conditions under which response rate is a useful endpoint, and notes that this osteosarcoma clinical trial doesn't meet those circumstances. "It is clear that response rate as an endpoint is most useful in early phase clinical trials, in which interest focuses more on assessing activity than proving clinical benefit, and as an important but secondary outcome in more definitive trials," he writes.
Contact:
* Article: Medical Research Council Press Office
* Editorial: Chris Difrancesco, News Office, Duke University Medical Center
Citation:
* Article: Lewis IJ, Nooij M, Whelan J, Sydes MR, Grimer R, Hogendorn PCW, et al. Improvement in Histologic Response, But Not Survival, in Osteosarcoma Patients Treated With Intensified Chemotherapy: A Randomized Phase III Trial of the European Osteosarcoma Intergroup (MRC BO06, EORTC 80931, ISRCTN86294690 ). J Natl Cancer Inst 2006; 99:112-129.
* Editorial: George SL. Response rate as an endpoint in clinical trials. J Natl Cancer Inst 2006; 99:98-99.
Note: The Journal of the National Cancer Institute is published by Oxford University Press and is not affiliated with the National Cancer Institute. Attribution to the Journal of the National Cancer Institute is requested in all news coverage. Visit the Journal online at jnci.oxfordjournals/.
Contact: Andrea Widener
Journal of the National Cancer Institute
пятница, 2 сентября 2011 г.
Vitamin D Supplements Associated With Reduced Fracture Risk In Older Adults
Oral vitamin D supplements at a dose of at least 400 international units per day are associated with a reduced risk of bone fractures in older adults, according to results of a meta-analysis published in the March 23 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.
"The anti-fracture benefits of vitamin D have been questioned by several recent trials, leading to uncertainty among patients and physicians regarding recommendations for vitamin D supplementation," the authors write as background information in the article. "Factors that may obscure a benefit of vitamin D are low adherence to treatment, low dose of vitamin D or the use of less potent ergocalciferol (vitamin D2)."
Heike A. Bischoff-Ferrari, Dr.P.H., of the University of Zurich, University Hospital, Zurich, Switzerland, and colleagues performed a meta-analysis on 12 previously published clinical trials of oral vitamin D supplements among adults age 65 or older. These double-blind randomized controlled trials involved 42,279 participants (average age 78) and looked at non-vertebral (non-spinal) fractures, including eight trials of 40,886 participants specifically studying hip fractures.
When the results of the trials were pooled, vitamin D supplements decreased the risk of non-vertebral fractures by 14 percent and of hip fractures by 9 percent. The authors then pooled the results of only the nine trials in which participants received doses of more than 400 international units per day. At this dosage, vitamin D supplements reduced non-vertebral fractures by 20 percent and hip fractures by 18 percent. Doses of 400 international units per day or lower did not reduce the risk of either fracture type. A greater reduction in risk was also seen among trial participants whose blood levels of 25-hydroxyvitamin D (a commonly used measure of blood vitamin D levels) achieved a greater increase.
Among individuals taking high doses of vitamin D, additional calcium did not appear to have any further protective effect against fractures. "Physiologically, the calcium-sparing effect of vitamin D may explain why we did not see an additional benefit of calcium supplementation at a higher dose of vitamin D," the authors write.
"The greater fracture reduction with a higher received dose or higher achieved 25-hydroxyvitamin D levels for both any non-vertebral fractures and hip fractures suggests that higher doses of vitamin D should be explored in future research to optimize anti-fracture efficacy," they conclude. "Also, it is possible that greater benefits may be achieved with earlier initiation of vitamin D supplementation and longer duration of use. Our results do not support use of low-dose vitamin D with or without calcium in the prevention of fractures among older individuals."
Arch Intern Med. 2009;169[6]:551-561.
archinte.ama-assn
"The anti-fracture benefits of vitamin D have been questioned by several recent trials, leading to uncertainty among patients and physicians regarding recommendations for vitamin D supplementation," the authors write as background information in the article. "Factors that may obscure a benefit of vitamin D are low adherence to treatment, low dose of vitamin D or the use of less potent ergocalciferol (vitamin D2)."
Heike A. Bischoff-Ferrari, Dr.P.H., of the University of Zurich, University Hospital, Zurich, Switzerland, and colleagues performed a meta-analysis on 12 previously published clinical trials of oral vitamin D supplements among adults age 65 or older. These double-blind randomized controlled trials involved 42,279 participants (average age 78) and looked at non-vertebral (non-spinal) fractures, including eight trials of 40,886 participants specifically studying hip fractures.
When the results of the trials were pooled, vitamin D supplements decreased the risk of non-vertebral fractures by 14 percent and of hip fractures by 9 percent. The authors then pooled the results of only the nine trials in which participants received doses of more than 400 international units per day. At this dosage, vitamin D supplements reduced non-vertebral fractures by 20 percent and hip fractures by 18 percent. Doses of 400 international units per day or lower did not reduce the risk of either fracture type. A greater reduction in risk was also seen among trial participants whose blood levels of 25-hydroxyvitamin D (a commonly used measure of blood vitamin D levels) achieved a greater increase.
Among individuals taking high doses of vitamin D, additional calcium did not appear to have any further protective effect against fractures. "Physiologically, the calcium-sparing effect of vitamin D may explain why we did not see an additional benefit of calcium supplementation at a higher dose of vitamin D," the authors write.
"The greater fracture reduction with a higher received dose or higher achieved 25-hydroxyvitamin D levels for both any non-vertebral fractures and hip fractures suggests that higher doses of vitamin D should be explored in future research to optimize anti-fracture efficacy," they conclude. "Also, it is possible that greater benefits may be achieved with earlier initiation of vitamin D supplementation and longer duration of use. Our results do not support use of low-dose vitamin D with or without calcium in the prevention of fractures among older individuals."
Arch Intern Med. 2009;169[6]:551-561.
archinte.ama-assn
вторник, 30 августа 2011 г.
Avoid Spring Cleaning Orthopaedic Injuries
As the weather becomes warmer, people start preparing their homes and yards for the spring and summer seasons. Projects such as yard work, cleaning and painting become priorities on the to-do list. However, thousands of orthopaedic injuries occur each year as a result of mishaps around the house. That is why the American Academy of Orthopaedic Surgeons urges people to take the proper safety precautions to reduce the number of spring cleaning-related accidents.
More than 530,000 ladder injuries, nearly 72,000 garden tool-related injuries and approximately 239,000 lawn mowing injuries were treated in hospital emergency rooms, doctors' offices and clinics in 2005, according to the U.S. Consumer Product Safety Commission.
"Many spring cleaning injuries occur when people rush or do not follow the proper safety precautions," explained Stephen Hurst, MD, orthopaedic surgeon and Fellow of the Academy. "Because most injuries are preventable, it is important to use the appropriate equipment for each project and take your time to minimize spring cleaning-related accidents."
Because orthopaedic surgeons not only treat, but try to prevent injuries of the bones, joints and muscles, the AAOS recommends the following guidelines for spring cleaning projects.
Proper techniques for lifting, carrying and bending should be part of any spring cleaning project:
-- Separate your feet, shoulder-width apart, keep your back upright and bend at the knees while tightening the stomach muscles.
-- Lift with your leg muscles as you stand up; don't try to lift any object by yourself if it is too heavy or an awkward shape.
-- Use a step stool instead of furniture - such as a couch or dining room chair - when dusting hard to reach areas.
-- Ladders used for chores - such as washing windows, painting, cleaning gutters and trimming trees - should be placed on a firm, level surface. Never place a ladder on ground or flooring that is uneven, soft or wet.
-- Over-reaching or leaning too far to one side when working on a ladder can also make you lose your balance and fall. Your bellybutton should not go beyond the sides of the ladder.
-- When gardening, avoid prolonged repetitive motions during activities such as digging, planting trimming and pruning. It is also important to wear gloves to reduce blistering and protect the skin.
-- Read product labels for proper use and wear protective clothing and gloves when using chemicals for gardening or cleaning. Store all chemicals - at the appropriate temperature, which is usually indicated on the package - in a place that is out of reach of both children and pets.
-- Take frequent breaks and replenish fluids to prevent dehydration. If you experience chest pain, shortness of breath or other signs of a heart attack, seek emergency care, such as by calling 9-1-1.
-- More information about the AAOS
-- For additional spring cleaning related injury prevention tips
www6.aaos
More than 530,000 ladder injuries, nearly 72,000 garden tool-related injuries and approximately 239,000 lawn mowing injuries were treated in hospital emergency rooms, doctors' offices and clinics in 2005, according to the U.S. Consumer Product Safety Commission.
"Many spring cleaning injuries occur when people rush or do not follow the proper safety precautions," explained Stephen Hurst, MD, orthopaedic surgeon and Fellow of the Academy. "Because most injuries are preventable, it is important to use the appropriate equipment for each project and take your time to minimize spring cleaning-related accidents."
Because orthopaedic surgeons not only treat, but try to prevent injuries of the bones, joints and muscles, the AAOS recommends the following guidelines for spring cleaning projects.
Proper techniques for lifting, carrying and bending should be part of any spring cleaning project:
-- Separate your feet, shoulder-width apart, keep your back upright and bend at the knees while tightening the stomach muscles.
-- Lift with your leg muscles as you stand up; don't try to lift any object by yourself if it is too heavy or an awkward shape.
-- Use a step stool instead of furniture - such as a couch or dining room chair - when dusting hard to reach areas.
-- Ladders used for chores - such as washing windows, painting, cleaning gutters and trimming trees - should be placed on a firm, level surface. Never place a ladder on ground or flooring that is uneven, soft or wet.
-- Over-reaching or leaning too far to one side when working on a ladder can also make you lose your balance and fall. Your bellybutton should not go beyond the sides of the ladder.
-- When gardening, avoid prolonged repetitive motions during activities such as digging, planting trimming and pruning. It is also important to wear gloves to reduce blistering and protect the skin.
-- Read product labels for proper use and wear protective clothing and gloves when using chemicals for gardening or cleaning. Store all chemicals - at the appropriate temperature, which is usually indicated on the package - in a place that is out of reach of both children and pets.
-- Take frequent breaks and replenish fluids to prevent dehydration. If you experience chest pain, shortness of breath or other signs of a heart attack, seek emergency care, such as by calling 9-1-1.
-- More information about the AAOS
-- For additional spring cleaning related injury prevention tips
www6.aaos
суббота, 27 августа 2011 г.
Aclasta Receives European Approval As First Once Yearly Treatment For Postmenopausal Osteoporosis
Aclasta (zoledronic acid 5 mg) has received European Union approval as the first once yearly treatment for women with postmenopausal osteoporosis.
The announcement closely follows the recent approval in the US, where the Food and Drug Administration (FDA) approved Aclasta under the brand name Reclast in August 2007. The European Commission decision applies to all 27 member states, Norway and Iceland.
"We are very pleased to receive EU approval, especially as it comes so soon after a similar decision in the US," said James Shannon, MD, Global Head of Development at Novartis Pharma AG. "This demonstrates widespread confidence in Aclasta, which provides physicians and patients with a completely new way to manage osteoporosis. The unique once yearly dosing of this medicine has the potential for significant compliance benefits and improved quality of life for women with osteoporosis."
Unlike oral bisphosphonate therapies taken daily, weekly or monthly, Aclasta is given as a once-yearly 15-minute intravenous (IV) infusion. This means with a single treatment, a patient can receive a full year's protection against the effects of osteoporosis. Data show that more than 70% of patients prefer a once-yearly infusion of Aclasta to a weekly tablet[4,5].
Osteoporosis is a long-term bone disease that causes bones to break more easily. The need for more effective treatments is based on estimates that about 200 million people worldwide suffer from this disease[6] and that one of two women over age 50 will suffer an osteoporotic fracture in their lifetime[3].
Aclasta is the only treatment approved in the EU and US to reduce the risk of fractures in areas of the body typically affected by osteoporosis, including the hip, spine and non-spine (e.g. wrist and rib)[1].
"Aclasta is highly effective at reducing fractures and can be given once-yearly which is a significant benefit to patients and clinicians," said Steven Boonen, Professor of Medicine at the Centre for Metabolic Bone Diseases & Division of Geriatric Medicine at the Leuven University in Belgium. "The convenience of a once-yearly dose should improve compliance and bone protection among patients while reducing fracture-related hospitalization and healthcare costs."
Results of the first-ever clinical study in patients with osteoporosis who had suffered a hip fracture, published in September in the The New England Journal of Medicine, show a once-yearly infusion of Aclasta reduced the risk of any type of subsequent osteoporotic fracture by 35% compared to patients treated with placebo. The Recurrent Fracture Trial involving more than 2,100 men and women also found the risk of death was significantly reduced by 28% in the Aclasta patient group compared to the placebo group (101 vs. 141 deaths)[2].
The regulatory approvals were based on efficacy and safety data from another study, the three-year Pivotal Fracture Trial involving more than 7,700 women. In this study, Aclasta was shown to increase bone strength and reduce the risk of spine fractures by 70% and hip fractures by 41%. The reduction in spine fractures was sustained over three years, and bone mineral density increased significantly in the spine by 6.7% and in the hip by 6% in women on Aclasta compared to placebo[1].
Osteoporotic fracture risk is often under-diagnosed and under-treated, resulting in sub-optimal outcomes and costs to healthcare systems[7]. Fractures can lead to reduced quality of life and loss of independence; someone with osteoporosis may also become partially disabled or immobilized, thereby requiring long-term care.
In women over age 45, osteoporosis accounts for more days spent in hospital than many other diseases, including diabetes, myocardial infarction (or heart attack) and breast cancer[8]. In 2000, the total direct costs related to osteoporotic fractures were estimated at 31.7 billion; these are forecast to increase to 76.7 billion in 2050 based on the expected changes in the demography of Europe[9].
Aclasta is now approved in more than 30 countries for the treatment of post-menopausal osteoporosis and in more than 60 countries including the US, Canada and the EU for the treatment of Paget's disease, the second most common metabolic bone disorder. Additional studies are ongoing to examine treatment of corticosteroid-induced osteoporosis, male osteoporosis, and prevention of bone loss in osteopenic patients.
The active ingredient in Aclasta is zoledronic acid, which is also available in a different dosage under the brand name Zometa (zoledronic acid 4 mg) Injection for use in certain oncology indications.
Aclasta was found to be generally safe and well tolerated in clinical trials. The most common adverse events associated with Aclasta were transient post-dose symptoms such as fever and muscle pain. Most of these symptoms occurred within the first three days following Aclasta administration and resolved within three days. The incidence of post-dose symptoms can be reduced with the administration of paracetamol or ibuprofen shortly following Aclasta infusion.
In the Pivotal Fracture Trial an increased number of cases of atrial fibrillation serious adverse events were observed in women given Aclasta compared to those on placebo (1.3% vs. 0.6% respectively). However, this finding has not been observed in other clinical studies or in post-marketing experience with over 1.5 million patients treated with zoledronic acid for oncology indications. In the Recurrent Fracture Trial, atrial fibrillation serious adverse events occurred in 1.1% of Aclasta-treated patients compared to 1.3% of placebo-treated patients. No spontaneous reports of osteonecrosis of the jaw (ONJ) - a rare occurrence in the osteoporosis population treated with bisphosphonates were seen in either the Pivotal Fracture Trial or Recurrent Fracture Trial.
Disclaimer
The foregoing press release contains forward-looking statements that can be identified by the use of forward-looking terminology such as "can", "potential", "expected", "will", "should", similar expressions or express or implied discussions regarding potential future regulatory submissions or approvals with respect to, or future sales of, of Aclasta, Reclast or Zometa. Such forward-looking statements reflect the current views of Novartis and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Aclasta,Reclast or Zometa will be approved for any additional indications in the EU, US or any additional markets or that Aclasta, Reclast or Zometa will reach any particular level of sales. In particular, management's expectations regarding Aclasta, Reclast and Zometa could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including unexpected additional analysis of existing clinical data, and unexpected new clinical data; competition in general; government, industry, and general public pricing pressures; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; as well as the additional factors discussed in Novartis AG's Form 20-F filed with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Novartis is providing this information as of this date and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
About Novartis
Novartis AG (NYSE: NVS) is a world leader in offering medicines to protect health, cure disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. Novartis is the only company with leadership positions in these areas. In 2006, the Group's businesses achieved net sales of USD 37.0 billion and net income of USD 7.2 billion. Approximately USD 5.4 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ more than 100,000 associates and operate in over 140 countries around the world. For more information, please visit novartis.
References
[1] Black D, Delmas S, Eastell R et al for the HORIZON Pivotal Fracture Trial. Once-Yearly Zoledronic Acid for Treatment of Postmenopausal Osteoporosis. NEJM 2007; 356(18): 1809-22.
[2] Lyles KW, Colon-Emeric CS, Magaziner JS et al for the HORIZON Recurrent Fracture Trial. Zoledronic Acid and Clinical Fractures and Mortality after Hip Fracture. NEJM 2007;357:10.1056/NEJMoa074941, published online Sept 17 2007.
[3] National Institutes of Health Osteoporosis and Related Bone Diseases National Resource Center. Osteoporosis Overview. Department of Health and Human Services.
[4] Saag K, Lindsay R, Kriegman A et al. A single zoledronic acid 5mg infusion is preferred over weekly 70 mg oral alendronate in a clinical trial of postmenopausal women with osteoporosis/osteopenia. Osteo Int 2006; 17(1):S1-124.
[5] Omizo M, McClung M, Minkoff J et al. A single infusion is preferred to oral weekly treatment in post-menopausal women with low bone mineral density previously treated with alendronate. Presented at 28th Annual meeting of the American Society for Bone and Mineral Research (ASBMR), 15-19 September 2006, Philadelphia, USA. Forthcoming 2007.
[6] Cooper C. Epidemiology of osteoporosis. Osteoporosis Int 1999;9 (Suppl2):S2-8 Available at iofbonehealth/health-professionals/about osteoporosis/epidemiology.html. Accessed on September 1, 2007.
[7] Siris E, Miller P, Barrett-Connor E et al. Identification and fracture outcomes of undiagnosed low bone mineral density in postmenopausal women: results from the National Osteoporosis Risk Assessment. JAMA 2001; 286:2815-22.
[8] Kanis JA, Delmas P, Burckhardt P et al. Guidelines for diagnosis and management of osteoporosis. The European Foundation for Osteoporosis and Bone Disease. Osteoporos Int 1997; 7:390-406
[9] Kanis JA and Johnell O. Requirements for DXA for the management of osteoporosis in Europe. Osteoporos Int 2005; 16:229.
View drug information on Reclast; Zometa.
The announcement closely follows the recent approval in the US, where the Food and Drug Administration (FDA) approved Aclasta under the brand name Reclast in August 2007. The European Commission decision applies to all 27 member states, Norway and Iceland.
"We are very pleased to receive EU approval, especially as it comes so soon after a similar decision in the US," said James Shannon, MD, Global Head of Development at Novartis Pharma AG. "This demonstrates widespread confidence in Aclasta, which provides physicians and patients with a completely new way to manage osteoporosis. The unique once yearly dosing of this medicine has the potential for significant compliance benefits and improved quality of life for women with osteoporosis."
Unlike oral bisphosphonate therapies taken daily, weekly or monthly, Aclasta is given as a once-yearly 15-minute intravenous (IV) infusion. This means with a single treatment, a patient can receive a full year's protection against the effects of osteoporosis. Data show that more than 70% of patients prefer a once-yearly infusion of Aclasta to a weekly tablet[4,5].
Osteoporosis is a long-term bone disease that causes bones to break more easily. The need for more effective treatments is based on estimates that about 200 million people worldwide suffer from this disease[6] and that one of two women over age 50 will suffer an osteoporotic fracture in their lifetime[3].
Aclasta is the only treatment approved in the EU and US to reduce the risk of fractures in areas of the body typically affected by osteoporosis, including the hip, spine and non-spine (e.g. wrist and rib)[1].
"Aclasta is highly effective at reducing fractures and can be given once-yearly which is a significant benefit to patients and clinicians," said Steven Boonen, Professor of Medicine at the Centre for Metabolic Bone Diseases & Division of Geriatric Medicine at the Leuven University in Belgium. "The convenience of a once-yearly dose should improve compliance and bone protection among patients while reducing fracture-related hospitalization and healthcare costs."
Results of the first-ever clinical study in patients with osteoporosis who had suffered a hip fracture, published in September in the The New England Journal of Medicine, show a once-yearly infusion of Aclasta reduced the risk of any type of subsequent osteoporotic fracture by 35% compared to patients treated with placebo. The Recurrent Fracture Trial involving more than 2,100 men and women also found the risk of death was significantly reduced by 28% in the Aclasta patient group compared to the placebo group (101 vs. 141 deaths)[2].
The regulatory approvals were based on efficacy and safety data from another study, the three-year Pivotal Fracture Trial involving more than 7,700 women. In this study, Aclasta was shown to increase bone strength and reduce the risk of spine fractures by 70% and hip fractures by 41%. The reduction in spine fractures was sustained over three years, and bone mineral density increased significantly in the spine by 6.7% and in the hip by 6% in women on Aclasta compared to placebo[1].
Osteoporotic fracture risk is often under-diagnosed and under-treated, resulting in sub-optimal outcomes and costs to healthcare systems[7]. Fractures can lead to reduced quality of life and loss of independence; someone with osteoporosis may also become partially disabled or immobilized, thereby requiring long-term care.
In women over age 45, osteoporosis accounts for more days spent in hospital than many other diseases, including diabetes, myocardial infarction (or heart attack) and breast cancer[8]. In 2000, the total direct costs related to osteoporotic fractures were estimated at 31.7 billion; these are forecast to increase to 76.7 billion in 2050 based on the expected changes in the demography of Europe[9].
Aclasta is now approved in more than 30 countries for the treatment of post-menopausal osteoporosis and in more than 60 countries including the US, Canada and the EU for the treatment of Paget's disease, the second most common metabolic bone disorder. Additional studies are ongoing to examine treatment of corticosteroid-induced osteoporosis, male osteoporosis, and prevention of bone loss in osteopenic patients.
The active ingredient in Aclasta is zoledronic acid, which is also available in a different dosage under the brand name Zometa (zoledronic acid 4 mg) Injection for use in certain oncology indications.
Aclasta was found to be generally safe and well tolerated in clinical trials. The most common adverse events associated with Aclasta were transient post-dose symptoms such as fever and muscle pain. Most of these symptoms occurred within the first three days following Aclasta administration and resolved within three days. The incidence of post-dose symptoms can be reduced with the administration of paracetamol or ibuprofen shortly following Aclasta infusion.
In the Pivotal Fracture Trial an increased number of cases of atrial fibrillation serious adverse events were observed in women given Aclasta compared to those on placebo (1.3% vs. 0.6% respectively). However, this finding has not been observed in other clinical studies or in post-marketing experience with over 1.5 million patients treated with zoledronic acid for oncology indications. In the Recurrent Fracture Trial, atrial fibrillation serious adverse events occurred in 1.1% of Aclasta-treated patients compared to 1.3% of placebo-treated patients. No spontaneous reports of osteonecrosis of the jaw (ONJ) - a rare occurrence in the osteoporosis population treated with bisphosphonates were seen in either the Pivotal Fracture Trial or Recurrent Fracture Trial.
Disclaimer
The foregoing press release contains forward-looking statements that can be identified by the use of forward-looking terminology such as "can", "potential", "expected", "will", "should", similar expressions or express or implied discussions regarding potential future regulatory submissions or approvals with respect to, or future sales of, of Aclasta, Reclast or Zometa. Such forward-looking statements reflect the current views of Novartis and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Aclasta,Reclast or Zometa will be approved for any additional indications in the EU, US or any additional markets or that Aclasta, Reclast or Zometa will reach any particular level of sales. In particular, management's expectations regarding Aclasta, Reclast and Zometa could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including unexpected additional analysis of existing clinical data, and unexpected new clinical data; competition in general; government, industry, and general public pricing pressures; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; as well as the additional factors discussed in Novartis AG's Form 20-F filed with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Novartis is providing this information as of this date and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
About Novartis
Novartis AG (NYSE: NVS) is a world leader in offering medicines to protect health, cure disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. Novartis is the only company with leadership positions in these areas. In 2006, the Group's businesses achieved net sales of USD 37.0 billion and net income of USD 7.2 billion. Approximately USD 5.4 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ more than 100,000 associates and operate in over 140 countries around the world. For more information, please visit novartis.
References
[1] Black D, Delmas S, Eastell R et al for the HORIZON Pivotal Fracture Trial. Once-Yearly Zoledronic Acid for Treatment of Postmenopausal Osteoporosis. NEJM 2007; 356(18): 1809-22.
[2] Lyles KW, Colon-Emeric CS, Magaziner JS et al for the HORIZON Recurrent Fracture Trial. Zoledronic Acid and Clinical Fractures and Mortality after Hip Fracture. NEJM 2007;357:10.1056/NEJMoa074941, published online Sept 17 2007.
[3] National Institutes of Health Osteoporosis and Related Bone Diseases National Resource Center. Osteoporosis Overview. Department of Health and Human Services.
[4] Saag K, Lindsay R, Kriegman A et al. A single zoledronic acid 5mg infusion is preferred over weekly 70 mg oral alendronate in a clinical trial of postmenopausal women with osteoporosis/osteopenia. Osteo Int 2006; 17(1):S1-124.
[5] Omizo M, McClung M, Minkoff J et al. A single infusion is preferred to oral weekly treatment in post-menopausal women with low bone mineral density previously treated with alendronate. Presented at 28th Annual meeting of the American Society for Bone and Mineral Research (ASBMR), 15-19 September 2006, Philadelphia, USA. Forthcoming 2007.
[6] Cooper C. Epidemiology of osteoporosis. Osteoporosis Int 1999;9 (Suppl2):S2-8 Available at iofbonehealth/health-professionals/about osteoporosis/epidemiology.html. Accessed on September 1, 2007.
[7] Siris E, Miller P, Barrett-Connor E et al. Identification and fracture outcomes of undiagnosed low bone mineral density in postmenopausal women: results from the National Osteoporosis Risk Assessment. JAMA 2001; 286:2815-22.
[8] Kanis JA, Delmas P, Burckhardt P et al. Guidelines for diagnosis and management of osteoporosis. The European Foundation for Osteoporosis and Bone Disease. Osteoporos Int 1997; 7:390-406
[9] Kanis JA and Johnell O. Requirements for DXA for the management of osteoporosis in Europe. Osteoporos Int 2005; 16:229.
View drug information on Reclast; Zometa.
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