EGHAM, England, July 8 /PRNewswire/ -- Procter & Gamble Pharmaceuticals (P&GP) welcome the new Final Appraisal Determination (FAD) Guidance for the primary and secondary prevention of osteoporosis from NICE.

The revised NICE FAD recommends risedronate - alongside etidronate - as the first alternative treatment option to generic alendronate for postmenopausal women who are unable to comply with the special administration instructions, have a contraindication to, or are intolerant of alendronate (and also meet certain criteria such as BMD T- scores (a measurement of Bone Mineral Density), age and independent risk factors for fracture)(i,ii).

Suggested Treatment Flow(i,ii) First treatment Primary and Secondary Prevention option Generic alendronate* (T-score (less than or equal to)2.5SD) First alternative Risedronate* or etidronate* Second alternative Strontium ranelate* or raloxifene** Third alternative Teriparatide**

* Dependent on age, T score, independent clinical risk factor for fracture, and indicators of low BMD

** Recommended for secondary prevention only

Recommended treatment options are not only based on the clinical efficacy of the therapies but also the acquisition cost of the available osteoporosis medicines and form a clear stepwise process. There are still some complexities within the guidance regarding thresholds for age and level of condition (i,ii). The Guidance is still in draft form until finalised guidance is issued later this year.

"For some patients, alendronate is not a suitable treatment and it is essential that these individuals have access to other treatments." Professor Juliet Compston, Professor of Bone Medicine, University of Cambridge

What the revised NICE FAD Guidance says

Previous draft NICE FAD guidance had only recommended alendronate as a treatment option for postmenopausal osteoporosis patients. However this decision was met with opposition from patient groups such as the National Osteoporosis Society (NOS) (please see section notes to the editors). The revised position of the NICE FADs recommend risedronate, alongside etidronate, as the first alternative treatment option following generic alendronate(i,ii). Strontium ranelate has been recommended as a second alternative therapy only where patients are not able to comply with special instructions for the administration of either alendronate and risedronate or etidronate, or who have a contraindication to or are intolerant of alendronate and risedronate or etidronate(i,ii).

"It remains vitally important that my patients have a choice of therapy as many will get upper gastrointestinal problems with generic alendronate. I am pleased that NICE now supports my prescribing of risedronate where I feel it is the best alternative to alendronate." Dr Pam Brown, The Grove Medical Centre, Swansea

Why is the revised NICE FAD Guidance important?

The revised position of the NICE FAD Guidance is particularly important for post-menopausal osteoporosis patients as NICE recognise that one third of participants in post-marketing studies of alendronate reported the occurrence of adverse gastrointestinal events(i,ii). Osteoporosis care should now better meet the needs of individual patients as treatment options have been recognised by NICE for patients who cannot take generic alendronate.

"There are significant differences between bisphosphonates, many patients cannot tolerate alendronate and need to be able to receive an alternative treatment like risedronate." Dr Alun Cooper, GPwSI, Bridge Medical Centre, Crawley

There is a wealth of evidence supporting the efficacy of bisphosphonates as the leading treatment class in the management of osteoporosis. However, not all bisphosphonates have the same tolerability profiles, mode of administration and efficacy at key osteoporotic sites(iii,iv,v). Managing osteoporosis involves a balance between choosing a treatment that best protects the individual from fracture, has an adequate tolerability profile, and makes best use of NHS resources.

Final Guidance is expected from NICE later this year and without further appeal must be implemented by all healthcare professionals within 3 months of publication.

Notes to editors - Approximately 80% of patients who could not tolerate alendronate were able to tolerate risedronate(vi). There are limited data available on switching patients between bisphosphonates. In a randomised, double-blind study of 66 patients that had previously discontinued treatment with 10mg/day alendronate due to upper gastrointestinal adverse events, when switched to risedronate (5mg daily) patients showed a similar incidence of upper GI events to placebo at 3 months(vi). Oral bisphosphonates have been associated with upper gastrointestinal disorders. Therefore, risedronate should be used with caution in patients with stricture, achalasia, those with active/recent history of upper gastrointestinal problems and patients who are unable to follow the dosing instructions(iv). - Nine multicenter, randomized, double blind, placebo controlled studies of risedronate were pooled and evaluated to determine the frequency of upper gastrointestinal (GI) tract adverse events associated with risedronate, especially among high risk patients (those on NSAIDS, PPIs and H2As). The results of this extensive evaluation indicate that among these high risk patients the incidence of upper gastrointestinal adverse events with those on risedronate was similar to that in control patients(vii). - In June 2007 the previous version of the NICE FADs were published. Despite the length and depth of the consultation NICE failed to incorporate many of the recommendations which their stakeholders had made. The two documents recommended only one of the entire range of treatments that are available for osteoporosis - generic alendronate. In October 2007 independent appeals were made by the National Osteoporosis Society, the Alliance for Better Bone Health (Procter & Gamble Pharmaceuticals and sanofi aventis), and Servier as no alternative treatments were provided for women with osteoporosis who could not tolerate or for whom alendronate was contraindicated. This appeal was successful. Furthermore the NOS presented a petition to Downing Street demanding treatment options for postmenopausal patients with osteoporosis. - There has been a huge demographic shift in the UK over the past twenty years, so the population is growing older. Consequently, osteoporosis related disability is now highly significant, particularly in terms of patient quality of life, morbidity/mortality costs and the overall socio-economic burden: - Three million people are at risk of osteoporosis in the United Kingdom(viii). - It is estimated that treating osteoporotic fractures in postmenopausal women costs the NHS and government GBP1.7 billion a year, the equivalent of GBP5 million a day(viii).

About The Alliance for Better Bone Health

The Alliance for Better Bone Health was formed by Procter & Gamble Pharmaceuticals and Aventis part of the sanofi-aventis Group, in May 1997 to promote bone health and disease awareness through numerous activities to support physicians and patients around the globe.

About Procter & Gamble Pharmaceuticals (NYSE:PG)

Procter & Gamble Pharmaceuticals has a rich heritage in health care that extends back more than 150 years. Then and now, P&G is driven by our mission to improve the lives of people around the world every day. P&G's health care products include prescription medicines, over-the-counter medications and oral care products. P&G began developing and marketing prescription products in the late-1960s.

Three billion times a day, P&G brands touch the lives of people around the world. The company has one of the strongest portfolios of trusted, quality, leadership brands, including Actonel(R), Asacol(R), Crest(R), Didronel PMO(R), Fibresure(R), Intrinsa(R), Metamucil(R), Oral-B(R), Pepto-bismol(R), Thermacare(R), Vicks(R), Pampers(R), Ariel(R), Always(R), Pantene(R), Herbal Essences(R), Mach3(R), Fairy(R), Ace(R), Lenor(R), M. Propre(R), Tampax(R), Tempo(R), Dash(R), Pringles(R), Iams(R), Eukanuba(R), Duracell(R), Olay(R), Head & Shoulders(R), Wella, Gillette(R), and Braun. The P&G community consists of 138,000 employees working in over 80 countries worldwide. Please visit for the latest news and in-depth information about P&G and its brands. For more information about P&G Pharmaceuticals, please visit

About sanofi-aventis

Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Forward Looking Statements

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(i) National Institute for Health and Clinical Excellence, Alendronate, etidronate, risedronate, raloxifene, and strontium ranelate for the primary prevention of osteoporotic fragility fractures in postmenopausal women. Final Appraisal Determination, July 2008

(ii) National Institute for Health and Clinical Excellence, Alendronate, etidronate, risedronate, raloxifene, and strontium ranelate for the secondary prevention of osteoporotic fragility fractures in postmenopausal women. Final Appraisal Determination, July 2008

(iii) Alendronate SmPC, Available online at Electronic Medicines Compendium, July 2008

(iv) Risedronate SmPC, Available online at Electronic Medicines Compendium, July 2008

(v) Etidronate (Didronel PMO) SmPC, Available online at Electronic Medicines Compendium, July 2008

(vi) Adachi JD, et al. Aging Clin Exp Res 2001; 13: 347-354

(vii) Taggart H, et al. Mayo Clin Proc. 2002; 77: 262-270

(viii) National Osteoporosis Society, Annual Report 2007

Media Contacts: Sebastian Stokes, Account Manager, Red Door Communications, , +44(0)208-392-6922 ; Liz Adams, Account Director, Red Door Communications, , +44(0)208-392-8092. Jane Quigley, External Relations, Procter & Gamble Pharmaceuticals.