Clinical trials report
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Effects of Raloxifene on Cardiovascular Events and Breast Cancer in Postmenopausal Women Barrett-Connor E, Mosca L, Collins P, et al.: Effects of raloxifene on cardiovascular events and breast cancer in postmenopausal women. N Engl J Med 2006, 355:125–137. Rating: ••Of outstanding importance Introduction: The effect of raloxifene, a selective estrogenreceptor modulator (SERM), on coronary heart disease (CHD), stroke, and breast cancer, as well as its overall balance of benefits and risks in postmenopausal women, had not been established. Aims: The Raloxifene Use for the Heart (RUTH) trial was designed to determine the effect of raloxifene on clinical CHD events in postmenopausal women who were at elevated risk of CHD. Raloxifene is a SERM with estrogenagonist effects in some tissues and antagonist effects in others. Despite known favorable effects on selected biomarkers for CHD, the influence of raloxifene on clinical cardiovascular disease (CVD) events and its overall benefit-to-risk profile were unknown. Methods: The RUTH trial was a randomized placebocontrolled trial including 10,101 postmenopausal women aged 55 years or older (mean age, 67.5 years) who had known CHD or multiple coronary risk factors. Exclusion criteria included recent myocardial infarction or coronary revascularization, history of venous thromboembolism, class III or IV heart failure, cancer, chronic liver or renal disease, life expectancy less than 5 years, or recent or current use of estrogen or SERMs. Participants were randomly assigned to oral raloxifene (60 mg/d) or to placebo and were followed for a median of 5.6 years. The primary trial outcomes were coronary events (myocardial infarction, fatal CHD, or hospitalization for acute coronary syndrome) and invasive breast cancer. Other clinical outcomes included stroke, venous thromboembolism, clinical fractures, death from CVD, and death from other causes. Results: Adherence to treatment (defined as taking at least 70% of the assigned study pills) was 71% in the placebo group and 70% in the raloxifene group. The study was completed by 79% to 80% of participants. Raloxifene had no significant effect on the risk of the primary CHD outcome, compared with placebo (hazard ratio [HR],
0.95; 95% CI, 0.84 to 1.07). Invasive breast cancer was reduced by 44% (HR, 0.56; 95% CI, 0.38 to 0.83), primarily due to a reduction in estrogen-receptor–positive tumors. Although raloxifene did not affect the risk of total stroke, it increased the risk of fatal stroke (HR, 1.49; 95% CI, 1.00 to 2.24). The risk of venous thromboembolism was also increased in the active treatment group (HR, 1.44; 95% CI, 1.06 to 1.95). Raloxifene reduced the risk of clinical vertebral fractures (HR, 0.65; 95% CI, 0.47 to 0.89). Mortality rates due to CVD or all causes were not altered by raloxifene. In terms of absolute rates per 10,000 women per year, raloxifene caused seven more fatal strokes and 12 more venous thromboembolic events but prevented 12 cases of breast cancer and 13 clinical vertebral fractures. Side effects included
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