Servier Welcomes Revised NICE Guidance On Postmenopausal Osteoporosis But Urges NICE To Go Further

Servier Laboratories Ltd has welcomed the progress made by NICE to increase access to medicines such as strontium ranelate in its revised draft guidance for the primary and secondary prevention of osteoporosis in postmenopausal women but is disappointed that many women are still unable to access appropriate treatments across the UK. 1


NICE had originally recommended only one treatment (alendronate) for the estimated 2 million post-menopausal osteoporosis sufferers in England and Wales. 1,2 Unfortunately, this treatment is not appropriate for all women with osteoporosis leaving a large section of the patient population without any access to publicly-funded treatment for a disease which significantly affects their health and well-being.


Servier welcomes the fact that NICE has now acknowledged that bisphosphonates are not an appropriate treatment option for all patients and other treatment options, including Strontium Ranelate, are now recommended by NICE in its revised draft guidance. This will lead to greater treatment choices for the estimated 2 million post-menopausal osteoporosis suffers in England and Wales.


Servier also welcomes the acknowledgement by NICE in its draft guidance that caution should be exercised when considering the co-prescription of acid-suppressive medication and bisphosphonates due to the association of acid suppressant medication with increased fracture risk6,7,8,9. NICE had previously failed to address the increased risk of fractures associated with the use of acid suppressive medication, in particular proton pump inhibitors, which are commonly prescribed to treat side effects of bisphosphonates such as dyspepsia or heartburn. 10,11


However, Servier is disappointed that some patients will continue to be denied access to treatments. Under the revised guidance many patients who are unable to take bisphosphonates due to contra-indication or intolerance will continue to be left without access to therapy. Servier therefore calls on NICE to make alternative agents, including strontium ranelate, available to all patients who are unable to take alendronate without having to comply with more restrictive criteria.


Dr Alun Cooper, a GP with a Special Interest in osteoporosis (GPwSI) and Chair of the National Osteoporosis Society's Primary Care Forum said "Whilst I welcome the progress made by NICE in broadening the treatment options for most patients, they need to go further. It is vital that clinicians have a clear choice of treatments for all their patients as many patients do not tolerate bisphosphonates or are at risk of upper GI symptoms."















The NICE evaluation of osteoporosis initially started in 2001. 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 on 22 October 2007. The appeal decision was published on 13 December 2007.


- The World Health Organisation defines osteoporosis as a progressive skeletal disease characterized 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 pre-dominantly 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.


- Up to 20% of women who suffer a hip fracture die within the first year of a fracture. 3 Permanent disability occurs in more than 30% of hip fracture patients. 2 More than 50% of hip fracture patients are unable to return to full independence and 20% are unable to return home after a hip fracture. 4 The combined cost of social and hospital care for patients with a hip fracture amounts to more than ВЈ1.8 billion per year in the UK and is likely to increase to 2.1 billion by 2020. 5


- Servier Laboratories Limited is the UK subsidiary of The Servier Research Group, a leading French research based organisation, specialising in ethical pharmaceuticals. Servier UK offers a range of products in a number of medical areas: cardiovascular disease, especially hypertension and cardiac disease, diabetes and, more recently, osteoporosis. Servier develops truly innovative drugs and we invest in therapeutic areas where there is an unmet patient need.



References


1. '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' nice.uk


2. Van Staa T.P., Dennison E.M., Leufkens H.G., et al. Epidemiology of fractures in England and Wales. Bone 2001; 29 (6): 517-522


3. Cooper C, Atkinson E.J.,Jacobsen S.J., et al. Am J Epidemiology 1993; 137: 1001-1005


4. NOS nos.uk


5. National Osteoporosis Society. A proposal to improve health outcomes for people at risk of osteoporotic fractures through the Quality and Outcomes Framework. NOS Working Party on the GMS Contract. May 2005


6. Vestergaard, P., L. Rejnmark, L. Mosekilde. 2006 Proton Pump Inhibitors, Histamine H2 Receptor Antagonists, and Other Antacid Medications and the Risk of Fracture Calcified Tissue International Vol 79:76-83.


7. Yang Y-X, J.D. Lewis, S. Epstein, D.C. Metz. 2006, Long term proton pump inhibitor therapy and risk of hip fracture, JAMA, 296:2947-2953.


8. Yu E.W. C. Shinoff, T. Blackwell, K. Ensrud, T. Hillier, D.C. Bauer. Use of Acid-Suppressive Medications and Risk of Bone Loss and Fracture in Postmenopausal Women. J. Bone Min Res 2006; 79(2):76-83.


9. De Vries F, Cooper A, Logan R, Cockle S, van Staa T, Cooper C. 2007. Osteoporosis International 18 (Suppl 3): S261


10. Summary of Product Characteristics for alendronate, ibandronate (po) and risedronate


11. Roughead EE, McGeechan K, Sayer GP. 2004. Bisphosphonate use and subsequent prescription of acid suppressants. Br J Clin Pharm., 57(6), 813 816.


12. 'Alendronate, etidronate, risedronate and strontium ranelate for the primary prevention of osteoporotic fragility fractures in postmenopausal women' (FAD1) and 'Alendronate, etidronate, risedronate, strontium ranelate and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women' (FAD2) nice.uk


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