Raloxifene and Risk for Cardiovascular Events and Breast Cancer

In this manufacturer-supported, international, double-blind trial, more than 10,000 postmenopausal women who had known coronary heart disease or were at increased risk for it were assigned to raloxifene (60 mg daily) or placebo. The participants’ mean age was 67.5 years, and median duration of follow-up was 5.6 years.

Raloxifene did not affect the risk for primary coronary events, but did significantly increase the risk for venous thromboembolism (hazard ratio, 1.44) and fatal stroke (HR, 1.49). In terms of benefits, raloxifene significantly reduced the risks for invasive breast cancer (HR, 0.56) and clinical vertebral fractures (HR, 0.65).