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Procter & Gamble Pharmaceuticals, Inc. Risedronate Reduced Risk of Fracture


9/17/2007 8:22:53 AM

HONOLULU, Sept. 17 /PRNewswire-FirstCall/ -- In a new analysis reported at the American Society for Bone and Mineral Research (ASBMR) 29th Annual Meeting, risedronate 5 mg decreased clinical fracture risk by 50% over three years relative to placebo in a group of postmenopausal women with osteoporosis who had suffered a previous hip fracture. This retrospective analysis of the risedronate HIP trial(1) evaluated the combined incidence of vertebral and nonvertebral clinical fractures among this high risk group of patients.

"As physicians we want assurance that a therapy is effective at treating varying severities of disease," said Michael McClung, M.D., Founding Director of the Oregon Osteoporosis Center in Portland and a primary investigator of the study. "In this analysis risedronate effectively reduced fracture risk among patients with severe osteoporosis."

According to the National Osteoporosis Foundation, a history of prior fracture is an important risk factor for future fracture. After a postmenopausal woman suffers a hip fracture, her risk approximately doubles for sustaining another fracture.

"These at-risk patients need to be identified and considered for therapy that can help prevent another fracture from occurring," said Dr. McClung.

About the Analysis

In the HIP trial(1), there were 339 postmenopausal women between ages 70-79 years with low bone mineral density (BMD) and a history of at least one hip fracture prior to the study. These patients were treated with either placebo (PLC) or risedronate (RIS) 2.5 mg or 5 mg daily. Over the 3 year period, the clinical fracture incidences were 28.4%, 14.9% and 13% for the PLC, RIS 2.5 mg and RIS 5 mg groups, respectively. This corresponds to a 50% reduction in clinical fracture risk relative to placebo for both the 2.5 mg and 5 mg treatment groups (p=0.031 and p=0.048, respectively).

The incidence of osteoporosis-related clinical fracture, defined by the occurrence of radiographically confirmed clinical vertebral fracture or radiographically confirmed non-traumatic non-vertebral fracture was calculated using Kaplan-Meier survival estimates over a 3 year period and was compared between placebo- and risedronate-treated patients. Treatments were compared using log rank test, and the risk ratio and its 95% confidence interval were obtained using a Cox regression model stratified for study. Subjects' mean age was 75 years, and their mean femoral neck (FN) and lumbar spine (LS) T-scores were -3.1 and -3.2 SD, respectively. Baseline characteristics were well balanced between the 3 treatment groups.

This study was sponsored by The Alliance for Better Bone Health.

About The Alliance for Better Bone Health

The Alliance for Better Bone Health was formed in May 1997 to promote bone health and disease awareness through numerous activities to support physicians and patients around the globe. It is a collaboration between Procter & Gamble Pharmaceuticals and sanofi-aventis U.S.

About Procter & Gamble

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 Pampers(R), Tide(R), Ariel(R), Always(R), Whisper(R), Pantene(R), Mach3(R), Bounty(R), Dawn(R), Gain(R), Pringles(R), Folgers(R), Charmin(R), Downy(R), Lenor(R), Iams(R), Crest(R), Oral-B(R), Actonel(R), Duracell(R), Olay(R), Head & Shoulders(R), Wella(R), Gillette(R), and Braun(R). The P&G community consists of 138,000 employees working in over 80 countries worldwide. Please visit http://www.pg.com for the latest news and in-depth information about P&G and its brands.

About sanofi-aventis

Sanofi-aventis is one of the world leaders in the pharmaceutical industry, ranking number one in Europe. Backed by a world-class 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. Sanofi-aventis is listed in Paris and in New York .

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.

(1) McClung MR, Geusens P, Miller PD, et al. Effect of risedronate on the risk of hip fracture in elderly women. N Engl J Med 2001;344:333-340

The Alliance for Better Bone Health

CONTACT: Paula Koenigs of Procter & Gamble Pharmaceuticals,+1-513-622-3923, on-site, +1-513-293-9724, koenigs.pm@pg.com; Terri Pedoneof sanofi-aventis U.S., +1-908-981-6562, terri.pedone@sanofi-aventis.com;or Angela Collom of Dorland Global Public Relations, +1-215-928-2188,acollom@dorland.com, for The Alliance for Better Bone Health

Web site: http://www.pg.com/



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