Trial Weighs Risks/Benefits of Raloxifene

Susan Farley
Published Online: Friday, September 1, 2006

New research shows that the osteoporosis drug raloxifene (Evista), now used to help prevent breast cancer, does not increase a woman's risk of coronary heart disease. For women already at a higher risk for coronary heart disease or for women who already have it, however, raloxifene increased the risk of fatal stroke and blood clots, according to new clinical trial data. The trial, Raloxifene Use for The Heart (RUTH), included data from more than 10,000 postmenopausal women with coronary heart disease or associated risk factors. Participants randomly received either 60 mg/day of raloxifene or placebo and were followed for about 5 years. Raloxifene had no significant effect on the women's coronary heart disease risk, but the women in this group had a 55% higher risk for fatal stroke and a 44% increased risk for blood clots. Whether the risk of stroke and blood clot outweighs the drug's benefits in preventing breast cancer remains an individual decision, according to the study authors. "In our study, there were almost an equal number of risks as there were benefits. It's a very individual decision," advises investigator Lori Mosca, MD, MPH, PhD. Study results were published in the July 13, 2006, issue of The New England Journal of Medicine.

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

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