Phoenix, Ariz. (October 13, 2001) – New findings from clinical studies in 2,442 postmenopausal women offer evidence that Actonel® (risedronate sodium tablets) 5 mg reduced clinical vertebral (spinal) fractures as early as six months (p<0.01). Clinical vertebral fractures were reported as adverse events and all were confirmed radiographically. The data were presented today at the American Society for Bone and Mineral Research (ASBMR) 23rd Annual Meeting in Phoenix.
"It is important that we intervene as early as possible in patients at risk for fracture, and initiate fast and effective treatment, like Actonel, to stop the fracture cascade that often occurs,” said Nelson Watts, M.D., Professor of Medicine and Director of the Osteoporosis Center, University of Cincinnati. “We need to aggressively address the fact that one in five women who have experienced a vertebral fracture will fracture again within just one year."
Previous studies have shown Actonel therapy to quickly reduce vertebral (spinal) fracture risk in patients with postmenopausal osteoporosis (PMO) by up to 65 percent in just one year (p<0.001, absolute risk reduction 4 percent), and up to 74 percent in high-risk postmenopausal osteoporosis patients (at least two existing vertebral fractures, p<0.001, absolute risk reduction 7.1 percent).
The National Osteoporosis Foundation (NOF) estimates that 28 million Americans are threatened by osteoporosis – 10 million have the disease and another 18 million have low bone mass and are therefore at risk for osteoporosis. According to the NOF, every 20 seconds, someone in the United States will experience an osteoporotic fracture.
Findings from another study discussed at ASBMR meeting today suggest that bone turnover markers may be an alternative surrogate measure of response to anti-resorptive therapy. However, reduction in fracture risk remains the primary efficacy measure for osteoporosis therapies.
About Actonel ® (risedronate sodium tablets)
Actonel 5 mg is indicated for the prevention and treatment of postmenopausal osteoporosis (PMO) in women and glucocorticoid-induced osteoporosis (GIO) in men and women either initiating or continuing systemic glucocorticoid treatment (>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).
In clinical trials, the overall incidence of adverse events with Actonel was comparable to placebo. The most commonly reported adverse events regardless of causality were infection (primarily upper respiratory, placebo patients 29.7 percent vs. Actonel patients 29.9 percent), back pain (23.6 percent vs. 26.1 percent), and joint pain (21.1 percent vs. 23.7 percent).
Bisphosphonates may cause upper gastrointestinal disorders such as dysphagia (difficulty swallowing), esophagitis (irritation of the esophagus), and esophageal or gastric ulcers. 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.
About the Alliance for Better Bone Health
The Alliance for Better Bone Health was formed by Procter & Gamble and Aventis Pharma in May 1997 to develop and market Actonel collaboratively in Europe, the United States and Canada. The Alliance promotes bone health and disease awareness through numerous activities to support physicians and patients around the globe.
About Procter & Gamble Pharmaceuticals
Procter & Gamble Pharmaceuticals is a part of Procter & Gamble Health Care, a division of The Procter & Gamble Company (NYSE:PG) – a $40 billion global leader in the development, manufacturing and marketing of a broad range of consumer goods. In prescription drugs, P&G is focusing on musculoskeletal and cardiovascular health, as well as anti-infective therapies. Some of P&G’s leading prescription products include Actonel® (risedronate sodium tablets), Didronel® (etidronate disodium), Asacol® (mesalamine) and Macrobid® (nitrofurantoin monohydrate macrocrystals).
About Aventis Pharmaceuticals
Aventis Pharmaceuticals conducts the U.S. business of Aventis Pharma AG. With headquarters in Bridgewater, N.J., Aventis Pharmaceuticals focuses its activities on important therapeutic areas such as cardiology, oncology, anti-infectives, arthritis, allergy and respiratory, diabetes, and the central nervous system.
Aventis Pharma AG is the pharmaceutical company of Aventis S.A. (NYSE:AVE). Aventis Pharma is dedicated to treating and preventing human disease through the discovery, development, manufacture and sale of innovative pharmaceutical products aimed at fulfilling unmet medical needs. The corporate headquarters of Aventis Pharma is in Frankfurt, Germany. Aventis Pharma is comprised of Aventis Pharmaceuticals; Aventis Pasteur, a world leader in vaccines, headquartered in Lyon, France; and Aventis Behring, a world leader in therapeutic proteins, headquartered in King of Prussia, Pa.
Aventis S.A., a world leader in pharmaceuticals and agriculture, is headquartered in Strasbourg, France. The company employs approximately 92,500 people in more than 20 countries. Aventis was launched in December 1999 through the merger of Hoechst AG and Rhône-Poulenc S.A. Copies of this release or any recent release are also available at the U.S. Web site, or by calling 800/207-8049.
Please see full prescribing information for Actonel® (risedronate sodium tablets) for additional safety information. For a copy of the full prescribing information for Actonel please call 800/836-0658 or visit the Actonel Web site at http://www.actonel.com.
Statements in this news release other than historical information are forward-looking statements subject to risks and uncertainties. Actual results could differ materially depending on factors such as the availability of resources, the timing and effects of regulatory actions, the strength of competition, the outcome of litigation, and the effectiveness of patent protection. Additional information regarding risks and uncertainties is set forth in the current Annual Report on Form 20-F of Aventis on file with the Securities and Exchange Commission.