Raloxifene Halves Cerebrovascular Risk in Postmenopausal Women

Laurie Barclay, MD

November 20, 2002

Nov. 20, 2002 — Results of the Multiple Outcomes of Raloxifene Evaluation (MORE) trial presented at the American Heart Association 75th Scientific Sessions held in Chicago, Illinois, suggest that raloxifene (Evista) reduces the risk of stroke or transient ischemic attack (TIA) in postmenopausal women by 48% over four years. Although earlier reports from this trial addressed osteoporosis risk and heart disease risk, these findings support the specific benefit of this medication in protecting against cerebrovascular disease.

"These data are particularly interesting in light of recent findings from the Women's Health Initiative (WHI) trial examining hormone therapy," presenter Elizabeth Barrett-Connor, from the University of California, San Diego, says in a news release. "While raloxifene and hormone therapy are both prescribed for osteoporosis, the WHI data showed that combined estrogen-progestin hormone therapy (Prempro) actually increased the risk of stroke [by 41%]."

Of 7,705 women enrolled in this randomized controlled trial, 1,035 were at increased cardiovascular risk due to established coronary heart disease or to multiple cardiovascular risk factors. The rate of stroke or TIA in the high-risk group was 3.5-fold higher than in the total cohort.

In high-risk women, raloxifene 60 mg or 120 mg daily was associated with a significant 48% reduction in risk of any stroke or TIA through four years, with less risk than placebo for each year. Risk reductions with raloxifene were significant for any stroke (relative risk [RR], 0.38; 95% confidence interval [CI], 0.18-0.79) and for nonfatal stroke (RR, 0.32; 95% CI, 0.14-0.76), but not for fatal stroke or TIA individually. Compared with placebo, raloxifene did not significantly affect systolic or diastolic blood pressure.

"Contrary to what has recently been shown for hormone therapy, these data demonstrate a trend that the longer the treatment therapy with Evista, the better the treatment effect appears to be," says Cheryl Keech from Eli Lilly and Company. "We are encouraged by these evidence-based findings for Evista and are eager to find out more about the effects of Evista on heart disease from the Raloxifene Use for the Heart (RUTH) Study."

AHA 75th Scientific Sessions: Abstract 3555. Presented Nov. 17, 2002.

Reviewed by Gary D. Vogin, MD