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| |  ACR MEETING: Actonel Builds Bone Mass, Reduces Vertebral Fractures SAN DIEGO, CA -- Nov. 11, 1998 -- Data from two new studies show that Actonel (risedronate) reduced the incidence of vertebral fractures by up to 70 percent, built and prevented the loss of bone mass and showed gastrointestinal tolerability similar to placebo in men and women taking chronic corticosteroid therapy. The studies were presented separately and in a pooled analysis at the annual meeting of the American College of Rheumatology (ACR). Procter & Gamble’s and Hoechst Marion Roussel’s Actonel is a novel, pyridinyl bisphosphonate in the final stages of development for the prevention and treatment of corticosteroid-induced osteoporosis (CIO) and post-menopausal osteoporosis (PMO). Corticosteroids are widely used to treat chronic, non-infectious inflammatory diseases such as rheumatoid arthritis, Crohn's disease and lupus. More than 30 million Americans are estimated to suffer from these conditions. In higher doses (more than 7.5 mg of prednisone, or its equivalent), corticosteroids can decrease painful inflammation -- but they also can damage bones, causing corticosteroid-induced osteoporosis (CIO). In fact, more than 40 percent of patients treated with long-term corticosteroid therapy will develop fractures. This underscores the importance of building and maintaining bone mass, which is critical in minimising the damaging effects of corticosteroids on bone. Bone loss as a result of corticosteroid therapy occurs most rapidly during the first six months of therapy and continues for the duration of the corticosteroid therapy. Patients taking more than 7.5 milligrams of prednisone, a common corticosteroid, face double the risk of experiencing a hip fracture and are five times more likely to experience a vertebral fracture than people not taking corticosteroids. Hip fractures are associated with a 30 percent increase in mortality. "Men and women with CIO have more than double the risk of experiencing bone loss and fractures than people with post-menopausal osteoporosis," said David Reid, M.D., reader in rheumatology, department of medicine and therapeutics, University of Aberdeen, who presented the results from the pooled analysis at the meeting. "These new data give us hope that there may be an important new medication that can help men and women taking corticosteroids reduce the risk of vertebral fractures associated with CIO." In the new studies, a total of 518 patients were enrolled in two double-blind, randomised, multicentre, placebo-controlled trials. One study involved 228 patients in the United States who, at baseline, had newly initiated corticosteroid therapy and had been taking corticosteroids for three months or less. In this study, patients received Actonel or placebo daily, in addition to 500 milligrams (mg) of calcium per day. This study showed that calcium alone was not effective in preventing the rapid and significant bone loss, which occurred in patients initiating corticosteroid therapy. The other study, conducted in Europe, included 290 patients who had been taking corticosteroids for six months or more at baseline. In this study, patients received Actonel or a placebo daily, in addition to 1,000 mg of calcium and 400 I.U. of vitamin D per day. This study showed that calcium and vitamin D taken together were not effective in significantly increasing bone mass in patients on chronic corticosteroid therapy. Patients in this study had low bone mass at baseline and an increased risk of fracture. Combined results from the studies demonstrate that patients taking 5 mg of Actonel maintained or increased bone mineral density and that Actonel 5 mg significantly reduced the incidence of vertebral fractures by 70 percent versus the control group at 12 months. "These studies suggest that taking just calcium or calcium with vitamin D may not be enough to significantly increase bone mass," said Stanley Cohen, M.D., clinical associate professor at Southwestern Medical School in Dallas, who also presented the study results at the meeting. "Patients on chronic corticosteroid therapy should consider that over-the-counter dietary supplements, when taken alone, might not be enough to protect them from bone loss resulting from chronic corticosteroid therapy." In the new studies, Actonel was generally well tolerated. There was no significant difference in gastrointestinal side effects between the Actonel-treated patients and patients in the placebo groups. The majority of adverse experiences reported with Actonel in these trials were mild or moderate and did not require discontinuation of therapy. The most commonly reported adverse events, from data pooled from these two studies, were the following: back pain, arthralgia, infection, nausea, headache, peripheral edema, diarrhea and abdominal pain. These adverse events were also seen in the placebo group.
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