New Data Support Long-term Safety Profile of Osteoporosis Drug

Eight years of trial data for Evista (raloxifene HCl), a selectiveestrogen receptor modulator used in the prevention andtreatment of osteoporosis, supported the drug's long-term safetyprofile. Data were compiled from 2 clinical trials, the MultipleOutcomes of Raloxifen Evaluation (MORE), which measuredfracture risk reduction, and the Continuing OutcomesRelevant to Evista (CORE), which measured breast cancer riskreduction. MORE was a 4-year, double-blind, placebo-controlledstudy, including 7705 postmenopausal women withosteoporosis. CORE, a 4-year, placebo-controlled follow-up trialto MORE, included 4011 postmenopausal women withosteoporosis. Both studies included patients' reports of adverseevents. Results showed that, when compared with placebo,Evista did not increase risk for the following side effects:myocardial infarction; stroke; endometrial hyperplasia; postmenopausalbleeding; and uterine and ovarian cancer. In theCORE trial, however, researchers found that Evista increasedthe risk for developing venous thromboembolism—1.7%,compared with 1% in the placebo group. Therefore, Evista isnot recommended for women with a history of deep veinthrombosis, pulmonary embolism, or retinal vein thrombosis.Silvano Martino, CORE's lead investigator, stated, "The resultsof these studies...[provide] physicians and patients with informationthey need to weigh the risks and benefits of treatmentand to decide if Evista is right for [them]."

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