San Francisco, Calif. (June 19, 2002) - A new analysis shows Actonel® (risedronate sodium tablets) reduced the risk of nonvertebral osteoporotic fractures by 74 percent within one year in postmenopausal women with osteoporosis. A significant reduction in the risk of nonvertebral fractures was observed as soon as six months. The effect of Actonel on nonvertebral fracture risk was based on a combined endpoint of the following sites: wrist, humerus, hip, pelvis, leg, and clavicle. The data were presented this week at the 84th Annual Meeting of The Endocrine Society in San Francisco.
"The ultimate goal of osteoporosis therapy is to prevent fractures," said J. T. Harrington, M.D., Associate Professor, Department of Medicine, University of Wisconsin Medical School, Madison, WI who was a lead investigator and presented the results today in a plenary session. "These study findings, combined with the consistent 1 year vertebral fracture reductions from previously published Actonel clinical trials, provide support for the rapid fracture benefits that Actonel provides across the skeleton."
The combined analysis included 1172 postmenopausal women with a lumbar spine T-score < -2.5 which is the World Health Organization (WHO) definition of osteoporosis. All patients received 1000 mg/d calcium in addition to either placebo or Actonel 5 mg daily. Nonvertebral fractures were collected as adverse events in three-month intervals and confirmed via x-ray. There was a statistically significant reduction in the risk of nonvertebral fractures as early as six months with a 74 percent reduction at one year (p=0.001, absolute risk reduction 3.3 percent).
According to the World Health Organization (WHO), osteoporosis is a significant and growing public health problem. The National Osteoporosis Foundation estimates that, in the United States, approximately 40 percent of women over 50 will experience a fracture due to osteoporosis in their lifetimes. Postmenopausal osteoporosis, is the most common form of osteoporosis.
About Actonel ® (risedronate sodium tablets)
Actonel is co-developed and co-marketed by Procter & Gamble Pharmaceuticals and Aventis Pharmaceuticals. 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 (? 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).
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 in the areas of endocrinology, cardiovascular and musculoskeletal diseases, 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. prescription drug business of Aventis. With headquarters in Bridgewater, N.J., Aventis Pharmaceuticals focuses its activities on important therapeutic areas such as cardiology, oncology, anti-infectives, arthritis, osteoporosis, allergy and respiratory, diabetes, and the central nervous system.
Aventis (NYSE: AVE) is dedicated to improving life by treating and preventing human disease through the discovery and development of innovative pharmaceutical products. Aventis focuses on prescription drugs for important therapeutic areas such as oncology, cardiology, diabetes and respiratory disorders as well as on human vaccines. In 2001, Aventis generated sales of € 17.7 billion ($15.9 billion), invested approx. € 3 billion ($2.7 billion) in research and development and employed approx. 75,000 people in its core business. Aventis corporate headquarters are in Strasbourg, France. For more information, please visit: www.aventis.com.
Please see full prescribing information for Actonel by visiting www.actonel.com. Copies of this release are available on the Procter & Gamble Pharmaceuticals Web site at http://www.
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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.
Contacts: Mary Johnson
Procter & Gamble