The guidelines state that for patients at risk for, or already experiencing GIO, a bisphosphonate is the recommended first-line treatment along with modification of lifestyle risk factors for osteoporosis. Actonel? (risedronate sodium tablets) 5mg is the only drug in the U.S. approved by the FDA for both prevention and treatment of GIO in men and women.
According to the ACR, more than 30 million Americans may be affected by diseases that are treated with glucocorticoid therapy (e.g. prednisone). Glucocorticoids are the primary therapy for many inflammatory and autoimmune diseases -- including asthma and rheumatoid arthritis - as well as many allergic conditions. In as little as 3 months, chronic steroids (>7.5 mg/d of prednisone or equivalent) can cause significant bone loss.
It is estimated that up to 50 percent of patients on chronic glucocorticoid therapy will experience osteoporotic fractures. Unfortunately, the majority of these patients do not receive treatment to prevent GIO.
Actonel® (risedronate sodium tablets) 5mg is the only therapy proven to reduce vertebral fracture incidence in GIO patients on chronic glucocorticoid treatment in just one year. A combined analysis of 2 clinical studies demonstrated that Actonel 5mg reduced the incidence of vertebral fracture by 70 percent in one year (19% of the 111 patients in the placebo group fractured compared to only 5% of the 111 patients in the Actonel 5mg group).
According to the new ACR guidelines, treatment with a bisphosphonate is recommended to prevent bone loss in all men and postmenopausal women in whom long-term glucocorticoid treatment at medium to high doses is being initiated or continued. The guidelines also recommend calcium and vitamin D supplementation in conjunction with bisphosphonate therapy.
Actonel 5 mg is indicated for the treatment and prevention of postmenopausal osteoporosis in women and GIO in men and women who are either initiating or continuing systemic glucocorticoid treatment (>7.5 mg/d prednisone or equivalent) for chronic diseases.
Actonel® (risedronate sodium tablets) should not be used in patients with low blood calcium, known allergy to Actonel, or an inability to stand or sit upright for at least 30 minutes. Low blood calcium 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 kidney disease.
Bisphosphonates may cause upper gastrointestinal disorders such as dysphagia (difficulty swallowing), esophagitis (irritation of the esophagus), and esophageal or gastric ulcers. Patients should take Actonel with a full glass of plain water (6-8 oz.) to facilitate delivery to the stomach, and should not lie down for 30 minutes after taking the drug.
In clinical trials, Actonel was generally well tolerated. Most side effects were mild to moderate and did not require patients to stop taking Actonel. Overall, side effects regardless of causality, were comparable to placebo and included infection (primarily upper respiratory, placebo patients, 29.7% vs. Actonel patients 29.9%), back pain (23.6% vs. 26.1%), and joint pain (21.1% vs. 23.7%).
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 risedronate (Actonel®/Optinate®) collaboratively in the United States, Canada and Europe. The Alliance promotes bone health and disease awareness through numerous activities to support physicians and patients around the globe, such as patient outreach programs on the latest advances in osteoporosis. In addition, the Alliance conducts clinical trials to better identify at-risk patients and supports patient compliance by showing the impact treatment can have on the health of their bones.
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), 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 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.
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.