ORLANDO — The Framingham stroke risk score can predict a high-risk postmenopausal woman's likelihood of a future cerebrovascular event with raloxifene use.
Investigators in 26 countries enrolled 10,101 women at risk for a major coronary event in the Raloxifene for the Heart Study (RUTH). A total of 5,031 women had documented coronary heart disease and the remaining 5,070 had multiple coronary heart disease risk factors. Although overall stroke risk was not significantly different between women randomized to raloxifene versus placebo, a higher number of fatal stroke events occurred in the treatment group, 59, compared with 39 in the placebo group during a mean of 5.6 years follow-up.
To see how this increased risk associated with raloxifene (hazard ratio, 1.49; absolute risk increase, 0.7 per 1,000 woman-years) would apply to women stratified by baseline Framingham stroke scale score, David Cox, Ph.D., and colleague retrospectively calculated 10-year cumulative risk. They presented findings at the annual meeting of the North American Menopause Society. Eli Lilly & Co. supported the study, and Dr. Cox is a clinical research scientist for the company.
As expected, risks congregated in the third- and fourth-highest quartiles of Framingham score risk. However, there were no significant differences between treatment groups in either all strokes or nonfatal strokes, regardless of baseline Framingham score. Regarding fatal stroke, Dr. Cox said, “after 2 years, you start to see a split between placebo and raloxifene for risk of fatal stroke by Framingham stroke risk score in RUTH.” Specifically, women who scored a 13 or greater on the Framingham tool at baseline were at increased risk of stroke death.