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The Alliance For Better Bone Health Release: Actonel Provides Vertebral Fracture Risk Reduction In Women With Postmenopausal Osteoporosis At Risk For Upper GI Side Effects


10/19/2005 5:11:52 PM

SAN ANTONIO, Oct. 18 /PRNewswire/ -- Actonel(R) (risedronate sodium tablets) reduces the risk of vertebral fracture up to 62 percent at one year in women with postmenopausal osteoporosis who are at risk for upper gastrointestinal (GI) side effects, according to new analyses presented today at the American College of Rheumatology (ACR) annual meeting.

"These data are further evidence that Actonel provides fracture risk reduction across a broad range of postmenopausal women with osteoporosis, even those prone to experiencing GI side effects," said Dr. Karen Hansen, Assistant Professor of Medicine, Rheumatology Division, University of Wisconsin Department of Medicine and Chief of Rheumatology, VA Hospital, Madison, WI. "Importantly, the study also shows that women who take medications which reduce stomach acid receive the same benefit as the overall Actonel-treated population."

Actonel is the only osteoporosis therapy proven to reduce the risk of vertebral fracture in just one year in postmenopausal women with osteoporosis. Additionally, Actonel is the only marketed bisphosphonate with upper GI events comparable to placebo in clinical trials that did not exclude patients at risk for GI side effects.

About the Analyses

Data for the analyses were obtained from subgroups of patients who participated in the treatment and placebo arms of the Actonel fracture clinical trials (VERT-NA, VERT-MN and HIP). In order to represent a real world population, the Actonel fracture clinical trials included patients at risk of upper GI side effects (those with past or active GI disease, taking H2 blockers, proton pump inhibitors (PPIs), non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin).

Fracture rates between those on Actonel and placebo were compared for three subgroups: patients with preexisting GI disease (n = 1,736), patients who reported using H2-blockers and/or PPIs (n =1,258) and patients who reported taking NSAIDs (n = 2,870). All subgroups were well matched across baseline demographics including age (74 years), femoral neck T-score (-2.5), lumbar spine T-score (-2.5) and pre-existing vertebral fractures (58 percent).

In the group of Actonel-treated women with pre-existing GI disease the one-year reduction in new vertebral fractures was 62 percent (p<0.001), in the PPIs/H2-blockers subgroup it was 61 percent (p=0.002), and in the NSAID subgroup it was 59 percent (p<0.001). These reductions were comparable to the risk reduction observed in the overall study population (65 percent VERT-NA, 61 percent VERT-NM, and 55 percent HIP).

About Osteoporosis

Osteoporosis is a disease characterized by reduced bone strength predisposing a person to an increased risk of fracture. According to the National Osteoporosis Foundation (NOF), 8 million women in the U.S. have osteoporosis, and 1.2 million osteoporotic fractures occur annually. The NOF estimates that every 20 seconds an osteoporosis-related fracture occurs. Risk factors for osteoporosis in postmenopausal women include age, personal history or family history of fracture, low bone mineral density, cigarette use, and race.

Studies show that among postmenopausal women with osteoporosis who experience a spinal fracture, one out of five will suffer their next spinal fracture within just one year, potentially leading to a fracture cascade. Fractures can progress quickly if osteoporosis is left untreated. The NOF, National Institutes of Health, and American Association of Clinical Endocrinologists agree that fracture risk reduction is the efficacy endpoint by which osteoporosis therapies should be evaluated.

Preventive measures, such as not smoking, maintaining a balanced diet supplemented with calcium and vitamin D, if needed, and engaging in weight- bearing exercise, like walking, can reduce an individual's chances of developing osteoporosis. However, in some women, these preventive measures may not be enough, and prescription medications such as Actonel may be beneficial.

About Actonel(R) (risedronate sodium tablets)

Actonel is developed by Procter & Gamble Pharmaceuticals and co-marketed by Procter & Gamble Pharmaceuticals and Aventis, part of the sanofi-aventis Group. Actonel 35 mg Once-a-Week and Actonel 5 mg daily are indicated for the prevention and treatment of osteoporosis in postmenopausal women. Actonel 5 mg daily is also indicated for the prevention and treatment of glucocorticoid-induced osteoporosis (GIO) in men and women either initiating or continuing systemic glucocorticoid treatment (greater than or equal to 7.5 mg/d prednisone or equivalent) for chronic diseases.

In clinical trials, Actonel was generally well tolerated. Actonel is contraindicated in patients with hypocalcemia, known hypersensitivity to any component of this product, or inability to stand or sit upright for at least 30 minutes. Hypocalcemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Actonel therapy. Actonel is not recommended for use in patients with severe renal impairment (creatinine clearance < 30 mL/min).

Bisphosphonates may cause upper gastrointestinal disorders such as dysphagia, esophagitis and esophageal or gastric ulcer. Patients should pay particular attention to the dosing instructions, as failure to take the drug according to instructions may compromise clinical benefits and may increase the risk of adverse events.

In clinical trials, the overall incidence of adverse events with Actonel 5 mg daily was comparable to placebo. The most commonly reported adverse events regardless of causality were infection (primarily upper respiratory, placebo 29.7 percent vs. Actonel 5 mg 29.9 percent), back pain (23.6 percent vs. 26.1 percent), and arthralgia (21.1 percent vs. 23.7 percent).

In a one-year clinical trial comparing Actonel 35 mg Once-a-Week and Actonel 5 mg daily, the overall incidence of adverse events with the two dosing regimens was similar. The most commonly reported adverse events regardless of causality were infection (Actonel 35 mg 20.6 percent vs. Actonel 5 mg 19.0 percent), arthralgia (14.2 percent vs. 11.5 percent) and constipation (12.2 percent vs. 12.5 percent). Please visit http://www.actonel.com/ for full prescribing information for Actonel.

About The Alliance for Better Bone Health

The Alliance for Better Bone Health was formed by Procter & Gamble 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 P&G

Two 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), Bounty(R), Pringles(R), Folgers(R), Charmin(R), Downy(R), Lenor(R), Iams(R), Crest(R), Actonel(R), Olay(R) and Clairol Nice 'n Easy(R), Head & Shoulders(R), and Wella. The P&G community consists of almost 110,000 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.

Aventis is part of the sanofi-aventis Group. About sanofi-aventis

The sanofi-aventis Group is the world's 3rd largest pharmaceutical company, ranking number 1 in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular disease, thrombosis, oncology, diabetes, central nervous system, internal medicine, vaccines. The sanofi-aventis Group is listed in Paris (EURONEXT : SAN) and in New York . Copies of this release are available on the Procter & Gamble Pharmaceuticals Web site at http://www.pgpharma.com/, on the Aventis Pharmaceuticals U.S. Web site at http://www.aventis-us.com/, or by calling (800) 207-8049.

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. 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) successfully executing, managing and integrating key acquisitions (including the Domination and Profit Transfer Agreement with Wella); (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 matters), 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 success of the company's outsourcing projects; (7) the ability to successfully manage currency (including currency issues in volatile countries), interest rate and certain commodity cost exposures; (8) the ability to manage the 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 increases in the prices of raw materials used to make the company's products; (10) the ability to stay close to consumers in an era of increased media fragmentation; and (11) the ability to stay on the leading edge of innovation. 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.

For sanofi-aventis and Aventis: This press release may contain forward- looking statements as defined in the Private Securities Litigation Reform Act of 1995. 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 and expectations with respect to future operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words "expect," "anticipates," "believes," "intends," "estimates" and similar expressions. Although management of sanofi-aventis and Aventis believe 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 and Aventis, including those listed under "Forward-Looking Statements" and "Risk Factors" in their respective annual reports on Form 20-F for the year ended December 31, 2003. Other than as required by applicable law, neither sanofi-aventis nor Aventis undertakes any obligation to update or revise any forward-looking information or statements.

The Alliance for Better Bone Health

CONTACT: Suzette Middleton of P&G Pharmaceuticals, +1-513-622-2093, ormiddleton.sj@pg.com; or Terri Pedone of Aventis, +1-908-243-6578, orterri.pedone@aventis.com


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