NEW YORK (Reuters Health) – In postmenopausal women with a high cardiovascular risk, raloxifene therapy reduces their chances of experiencing a cardiovascular event, according to a report in the February 20th issue of the Journal of the American Medical Association. However, in women without an elevated risk, raloxifene appears to offer no benefit in this regard.
While raloxifene, a selective estrogen receptor modulator, is known to improve cardiovascular risk factors, it was unclear whether the drug actually reduced the risk of cardiovascular events.
Dr. Elizabeth Barrett-Connor, from the University of California at San Diego in La Jolla, and colleagues evaluated the cardiovascular-related outcomes of 7705 postmenopausal women who participated in the Multiple Outcomes of Raloxifene Evaluation (MORE) trial. The study was funded by Eli Lilly & Co., the maker of raloxifene (Evista), and the investigators have served as consultants for or are employees of the company.
The women in the study, who all had osteoporosis, were randomized to 60 mg or 120 mg of raloxifene per day or placebo for 4 years. In the entire cohort, raloxifene therapy did not reduce the number of coronary or cerebrovascular events that occurred, the researchers note. However, in women at high risk for acute coronary events and in those with established heart disease, raloxifene therapy was associated with a significant reduction in the cardiovascular event risk.
Previous reports have noted an early increase in the cardiovascular event risk with hormone replacement therapy. In the current study, there was no evidence that raloxifene therapy produced this effect, the authors note.
Raloxifene had similar effects on the lipid profiles of high-risk women and the entire cohort, suggesting that its ability to reduce the event risk in high-risk women was probably due to some other mechanism, the investigators state.
While the results are encouraging, the authors stress that "before raloxifene is used for prevention of cardiovascular events, these findings require confirmation in trials with evaluation of cardiovascular outcomes as the primary objective."
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