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| |  ACG: Actonel (Risedronate) Greatly Reduces Vertebral Fracture Risk in Patients on Chronic Steroid Therapy LAS VEGAS, NV -- October 24, 2001 -- Vertebral fracture risk in men and women who take oral glucocorticoid treatment (greater than or equal to 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 (ACG) 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, and 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, New York, 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 (greater than or equal to 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 American College of Rheumatology recommend bisphosphonates as first-line therapy for preventing glucocorticoid-induced osteoporosis (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 three months. Actonel is the only drug approved by the U.S. Food and Drug Administration for both prevention and treatment of GIO. 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 (greater than or equal to 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 versus Actonel patients 29.9 percent), back pain (23.6 percent versus 26.1 percent), and joint pain (21.1 percent versus 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. SOURCE: Aventis Pharmaceuticals Related Link: Aventis Pharmaceuticals.
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