In the study, patients taking Actonel 35 mg once a week experienced a significant 3.9 percent increase in lumbar spine BMD at 12 months versus baseline, comparable to the 4.0 percent increase achieved with the 5 mg daily dose. Total hip, femoral neck and trochanteric BMD also increased significantly at 12 months versus baseline with both dosages, with differences in BMD increases of less than 0.5 percent between the daily and once-a-week treatments. In addition, the adverse event profile of risedronate 35 mg once a week was comparable to the 5 mg daily dose.
The study included postmenopausal women at least 50 years old with osteoporosis (defined as low lumbar spine BMD, or t-score <-2.0 with at least one prior vertebral fracture). All women received calcium supplementation, and some received vitamin D if baseline levels were low.
“These data suggest that once a week use of 35 mg risedronate may be an alternative to daily dosing,” said Robert Lindsay, M.D., Ph.D., Helen Hayes Hospital, principal investigator of the study. “I expect that once a week dosing will be an important option for some patients and physicians.”
According to the National Osteoporosis Foundation, 10 million people suffer from osteoporosis in the United States; 18 million more have low bone mass, placing them at risk for osteoporosis. Postmenopausal osteoporosis, caused by estrogen deficiency that typically occurs at menopause, is the most common form of osteoporosis.
About Actonel ® (risedronate sodium tablets)
Actonel 5 mg is indicated for the prevention and treatment of postmenopausal osteoporosis 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. Actonel 30 mg is approved as a daily dosage for the treatment of Paget's disease of bone.
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.