New Data Support Long-term Safety Profile of Osteoporosis Drug

Susan Farley
Published Online: Thursday, December 1, 2005

Eight years of trial data for Evista (raloxifene HCl), a selective estrogen receptor modulator used in the prevention and treatment of osteoporosis, supported the drug's long-term safety profile. Data were compiled from 2 clinical trials, the Multiple Outcomes of Raloxifen Evaluation (MORE), which measured fracture risk reduction, and the Continuing Outcomes Relevant to Evista (CORE), which measured breast cancer risk reduction. MORE was a 4-year, double-blind, placebo-controlled study, including 7705 postmenopausal women with osteoporosis. CORE, a 4-year, placebo-controlled follow-up trial to MORE, included 4011 postmenopausal women with osteoporosis. Both studies included patients' reports of adverse events. Results showed that, when compared with placebo, Evista did not increase risk for the following side effects: myocardial infarction; stroke; endometrial hyperplasia; postmenopausal bleeding; and uterine and ovarian cancer. In the CORE trial, however, researchers found that Evista increased the risk for developing venous thromboembolism—1.7%, compared with 1% in the placebo group. Therefore, Evista is not recommended for women with a history of deep vein thrombosis, pulmonary embolism, or retinal vein thrombosis. Silvano Martino, CORE's lead investigator, stated, "The results of these studies...[provide] physicians and patients with information they need to weigh the risks and benefits of treatment and to decide if Evista is right for [them]."

Ms. Farley is a freelance medical writer based in Wakefield, RI.

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