These results are from a retrospective analysis of the Actonel HIP trialii and were presented today at the American Society for Bone and Mineral Research (ASBMR) 29th Annual Meeting.
“As physicians we want assurance that a therapy is effective at treating varying severities of disease. In this analysis risedronate effectively reduced fracture risk among patients with severe osteoporosis,” said Dr Michael McClung, primary investigator of the study and founding director of the Oregon Osteoporosis Centre in Portland, Oregon, USA.
A history of prior fracture is an important risk factor for future fracture. After a postmenopausal woman suffers a hip fracture her risk is approximately doubled for sustaining another fracture at the hip or elsewhere.iii Despite this, studies suggest that elderly adults with hip fractures rarely receive therapy for osteoporosis.iv In one study, only 13% of hip fracture patients received treatment in the year following the fracture.v
“It is troubling that so few patients who have had an osteoporosis-related hip fracture receive
appropriate care for osteoporosis” said Dr Steven Boonen, medical director of Leuven University Centre for Metabolic Bone Diseases, Belgium. “Therapies are available that can help reduce the risk of subsequent osteoporosis-related fractures. These high risk patients should be aggressively identified and managed to help prevent further fractures from occurring.”
About the Analysis
Patients were identified from the Actonel HIP trial who were between the ages of 70-79 years, had low bone mineral density (BMD, T-score ≤ -2.5), and had a history of at least one hip fracture prior to the study. The mean age of the patients was 75 years and the mean femoral neck and lumbar spine T-scores were -3.1 and -3.2, respectively. These patients were evaluated for combined incidence of clinical vertebral and nonvertebral fractures by a time-to-event analysis (Kaplan-Meier). All fractures were confirmed by x-ray.
The incidence of osteoporosis-related clinical fractures over three years among patients taking Actonel 5mg versus placebo was 13% (12 of 106 patients) and 28.4% (27 of 111 patients), respectively, corresponding to a 50% reduction (p=0.048) in fracture risk with Actonel.i The safety profile of Actonel was not measured in this retrospective analysis.
- Ends -
For further information please contact:
Georgina McVey Sebastian Stokes David Keown
Tel: 020 8392 8065 Tel: 020 8392 8022 The Alliance for Better Bone Health
gmcvey@rdcomms.com sstokes@rdcomms.com Tel: 01483 554447
NOTES TO EDITORS:
This study was sponsored by The Alliance for Better Bone Health
Osteoporosis
• Osteoporosis is a skeletal disease that increases bone fragility and susceptibility to fracture. Fracture is a devastating consequence of osteoporosis.
• A 50-year-old woman has around a 40% lifetime risk of suffering a fracture from osteoporosisvi - equivalent to the women’s lifetime risk for cardiovascular diseasevii
• Osteoporosis affects an estimated 75 million people in Europe, USA and Japanviii.
• Someone suffers an osteoporosis-related fracture about every 30 seconds in Europe aloneix
• In 2000, the estimated direct costs of osteoporosis-related fractures in Europe were €31.7 billion – this is expected to increase to €76.7 billion by 2050 based on the expected changes in the age profile of the European populationx
Impact of hip fractures in Europe
• Approximately one in five people who suffer a hip fracture will die within the following yearxi,xii
• The annual number of hip fractures will increase from 414,000 in 2000 to 972,000 in 2050xiii – equivalent to nearly two hip fractures every minute, 111 an hour or 2663 a day
• Hip-fracture patients occupy one fifth of all orthopaedic beds and account for nearly 90% of acute hospital costs of osteoporosis-related fracturesxiv
About The Alliance for Better Bone Health
The Alliance for Better Bone Health was formed by Procter & Gamble Pharmaceuticals and Aventis part of the sanofiaventis 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 [NYSE:PG]
Three billion times a day, P&G brands touch the lives of people around the world. The company has one of thestrongest portfolios of trusted, quality, leadership brands, including Pampers®, Tide®, Ariel®, Always®, Whisper®, Pantene®, Mach3®, Bounty®, Dawn®, Pringles®, Folgers®, Charmin®, Downy®, Lenor®, Iams®, Crest®, Oral-B®, Actonel®, Duracell®, Olay®, Head & Shoulders®, Wella, Gillette®, and Braun. The P&G community consists of over 135,000 employees working in over 80 countries worldwide. Please visit http://www.pg.com for the latest news and indepth information about P&G and its brands.
About sanofi-aventis
Sanofi-aventis is the world’s third-largest pharmaceutical company, ranking number one in Europe. Backed by a worldclass R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine, and vaccines. The sanofi-aventis Group is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Forward Looking Statements
For sanofi-aventis: This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates,” “plans” and similar expressions. Although sanofi-aventis’ management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in sanofi-aventis’ annual report on Form 20-F for the year ended December 31, 2006. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.
For P&G: All statements, other than statements of historical fact included in this release, are forward-looking statements, as that term is defined in the Private Securities Litigation Reform Act of 1995. Such statements are based on financial data, market assumptions and business plans available only as of the time the statements are made, which may become out of date or incomplete. We assume no obligation to update any forward-looking statement as a result of new information, future events or other factors. Forward-looking statements are inherently uncertain, and investors must recognize that events could differ significantly from our expectations. In addition to the risks and uncertainties noted in this release, there are certain factors that could cause actual results to differ materially from those anticipated by some of the statements made. These include: (1) the ability to achieve business plans, including with respect to lower income consumers and growing existing sales and volume profitably despite high levels of competitive activity, especially with respect to the product categories and geographical markets (including developing markets) in which the Company has chosen to focus; (2) the ability to successfully execute, manage and integrate key acquisitions and mergers, including (i) the Domination and Profit Transfer Agreement with Wella, and (ii) the Company’s merger with The Gillette Company, and to achieve the cost and growth synergies in accordance with the stated goals of these transactions; (3) the ability to manage and maintain key customer relationships; (4) the ability to maintain key manufacturing and supply sources (including sole supplier and plant manufacturing sources); (5) the ability to successfully manage regulatory, tax and legal matters (including product liability, patent, and intellectual property matters as well as those related to the integration of Gillette and its subsidiaries), and to resolve pending matters within current estimates; (6) the ability to successfully implement, achieve and sustain cost improvement plans in manufacturing and overhead areas, including the Company's outsourcing projects; (7) the ability to successfully manage currency (including currency issues in volatile countries), debt, interest rate and commodity cost exposures; (8) the ability to manage continued global political and/or economic uncertainty and disruptions, especially in the Company's significant geographical markets, as well as any political and/or economic uncertainty and disruptions due to terrorist activities; (9) the ability to successfully manage competitive factors, including prices, promotional incentives and trade terms for products; (10) the ability to obtain patents and respond to technological advances attained by competitors and patents granted to competitors; (11) the ability to successfully manage increases in the prices of raw materials used to make the Company's products; (12) the ability to stay close to consumers in an era of increased media fragmentation; and (13) the ability to stay on the leading edge of innovation and maintain a positive reputation on our brands. For additional information concerning factors that could cause actual results to materially differ from those projected herein, please refer to our most recent 10-K, 10-Q and 8-K reports.
Actonel is licensed for the treatment of women with established post-menopausal osteoporosis. Further
information on Actonel Once a Week 35mg is contained in the Summary of Product Characteristics, which is attached alongside this press release. A recommendation is made to consider the Summary of Product
Characteristics for side effects, precautions and contraindications prior to prescribing Actonel.
Informationabout adverse event reporting can be found at www.yellowcard.gov.uk. In theUKadverse events should be reportedto Procter&Gamble Pharmaceuticals on 01784 474900. InIrelandadverse events should be reported to sanofi-aventis on 01-4035 600 orDUBDrugSafety@emailph4.aventis.com.
REFERENCES
i McClung MR et al. The Effect of risedronate on risk of clinical fracture among patients with prior hip fracture. ASBMR. 2007. Honolulu. Abstract.
ii McClung MR et al. Effect of risedronate on the risk of hip fracture in elderly women. N Engl J Med 2001;344: 333-340.
iii Klotzbuecher, CM, et al. Patients with prior fractures have an increased risk of future fractures: a summary of the
literature and statistical synthesis. J of Bone Min Res 2000;15: 721-739.
iv Sheryl L.et al. Lack of diagnosis and treatment of osteoporosis in men and women after hip fracture.
Pharmacotherapy 2003;23(2): 190-198.
v Orwig DL, et al. Treatment of osteoporosis following a hip fracture: sending results of bone densitometry to primary care physicians does not increase use of pharmacologic therapy [abstr]. J Bone Miner Res 2001;15(suppl 1): SA323.
vi Melton LJ et al. Perspective. How many women have osteoporosis? J Bone Miner Res 1992; 7: 1005-1010
vii Kanis J A. Diagnosis of osteoporosis and assessment of fracture risk. Lancet 2002; 359: 1929-36
viii EFFO and NOF Who are candidates for prevention and treatment for osteoporosis? Osteoporos Int 1997;7:1.
ix International Osteoporosis Foundation. Osteoporosis in the European Community: a call to action. An audit of policy developments since 1998. International Osteoporosis Foundation 2001
x Kanis JA, Johnell O. Requirements for DXA for the management of osteoporosis in Europe. Osteoporosis Int 2005;16: 229-38
xi Leibson CL, Tosteson AN, Gabriel SE, et al. Mortality, disability, and nursing home use for persons with and without hip fracture: a population-based study. J Am Geriatr Soc 2002; 50: 1644-1650
xii Magaziner J, Simonsick EM, Kashner TM, et al. Predictors of functional recovery one year following hospital
discharge for hip fracture: a prospective study. J Gerontol 1990; 45: M101-M107
xiii European Commission Report on Osteoporosis in the European Community. Action for prevention. Luxembourg:
Office for Official Publications of the European Communities 1998
xiv World Health Organisation. Prevention and management of osteoporosis. WHO Technical Report Series 921.
Geneva: World Health Organisation 2003.
Date of preparation: September 2007
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