Las Vegas – Vertebral fracture risk in men and women who take oral glucocorticoid treatment (> 7.5 mg/day prednisone or equivalent) for chronic diseases is significantly reduced with Actonel® (risedronate sodium tablets) 5 mg in just one year, according to data presented today at the 66th Annual Scientific Meeting of the American College of Gastroenterology in Las Vegas.
Patients on Actonel 5 mg daily while initiating or continuing glucocorticoid (a class of steroids) therapy experienced significant vertebral fracture reduction of 70 percent compared to placebo (p=0.01, absolute risk reduction 10.8 percent) within just one year. All patients received calcium supplementation and some received vitamin D. Vertebral fractures were confirmed radiographically, some were associated with symptoms.
The research results were presented by Stanley Wallach, M.D., Executive Director of the American College of Nutrition and Co-Director of the Hospital for Joint Diseases Osteoporosis Center at ArthroFitness, New York, N.Y., involving over 500 men and women, age 18 to 85, on chronic glucocorticoid therapy.
“The majority of patients on chronic glucocorticoid therapy do not receive treatment to prevent bone loss,” said Dr. Wallach. “Early intervention is important because glucocorticoid-induced bone loss can happen in as little as three months, which can quickly lead to fractures.”
It is estimated that up to 50 percent of patients on chronic glucocorticoid therapy (> 7.5 mg/day prednisone or equivalent) will experience osteoporotic fractures. Glucocorticoids are a primary therapy for many inflammatory and autoimmune diseases – including asthma and rheumatoid arthritis – as well as many allergic conditions.
Guidelines issued earlier this year by the ACR recommend bisphosphonates as first-line therapy for preventing GIO in men and postmenopausal women. This is in conjunction with calcium, vitamin D and lifestyle modifications for patients who are initiating glucocorticoid treatment expected to last at least 3 months. Actonel is the only drug approved by the U.S. Food and Drug Administration for both prevention and treatment of GIO.
About Actonel
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/day 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, 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.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.
Glucocorticoid-induced osteoporosis
Overview
Glucocorticoid steroids are used to treat a wide variety of allergic and inflammatory diseases and are prescribed by a wide variety of physicians, both specialists and generalists.
Glucocorticoid-induced osteoporosis (GIO) is a serious complication associated with long-term oral glucocorticoid use (>7.5 mg prednisone or equivalent).
In as little as three months, chronic use of steroids (>7.5 mg/day of prednisone or equivalent) can cause significant bone loss, which could eventually lead to fracture.
Prevalence
Approximately 50 percent of patients on chronic glucocorticoid treatment (>7.5 mg prednisone or equivalent) will fracture.
The majority of patients on long-term glucocorticoid therapy for chronic disease do not receive treatment to prevent bone loss.
At-Risk Populations
Patients on long-term or chronic oral glucocorticoids such as prednisone, prednisolone, methylprednisolone, betamethasone, dexamethasone and triamcinolone (>7.5 mg prednisone or equivalent) for chronic diseases (including asthma, chronic obstructive pulmonary disease (COPD), lupus, irritable bowel disease (IBD), and rheumatoid arthritis) are at risk.
Treatment and Prevention
Ideally, measures against GIO should begin prior to or at the start of glucocorticoid therapy.
The American College of Rheumatology recommends bisphosphonates as the first-line treatment for GIO in postmenopausal women and men initiating high doses of glucocorticoid therapy (>3 months duration), along with modification of lifestyle risk factors and calcium and vitamin D supplementation.
Actonel® (risedronate sodium tablets) 5 mg is the only therapy approved by the United States Food and Drug Administration (FDA) for both treatment and prevention of GIO. Specifically, Actonel is indicated for the treatment and prevention of GIO in men and women initiating or continuing oral glucocorticoid treatment (>7.5 mg/d prednisone or equivalent) for chronic diseases.
Actonel® (risedronate sodium tablets) demonstrated a 70 percent reduction in vertebral fractures in just 1 year (p=0.01, absolute risk reduction 10.8 percent). This is from a combined analysis of two one-year clinical studies in 518 patients initiating or on glucocorticoid therapy. All patients received 500 to 1,000 mg/d calcium. Vertebral fractures were confirmed radiographically; some were associated with symptoms.
Summary
Glucocorticoid therapy is essential for a large number of people who suffer from inflammatory and autoimmune diseases, but its benefits are often accompanied by serious adverse side effects, including increased risk of osteoporosis.
With careful evaluation, monitoring and treatment planning, the risk of significant bone loss and fracture risk from long-term or chronic glucocorticoid therapy can be minimized.