A topic in Clinical Evidence 1 summarizes the results of one large RCT including 7705 postmenopausal women aged 31-80 years. 60 mg/day and 120 mg/day of raloxifene reduced vertebral fractures compared with placebo after 36 months (6.6% with 60 mg/day vs 5.4% with 120 mg/day vs 10.1% with placebo). RR for 60 mg/day 0.7, 95% CI 0.5 to 0.8). The reduction in non-vertebral fracture was not significant (combined raloxifene 8.5% vs 9.3 placebo, RR 0.9, 95% CI 0.8 to 1.1). Raloxifene increased the risk of tromboembolic events (1.0% with raloxifene, 0.3% with placebo, RR 3.1, 95% CI 1.5 to 6.2).
In an RCT 2, 10 101 postmenopausal women (mean age 67.5 years) with CHD or multiple risk factors for CHD were randomly assigned to 60 mg of raloxifene daily or placebo. Median follow-up time was 5.6 years. Raloxifene had no significant effect on the risk of primary coronary events (533 vs. 553 events; hazard ratio [HR] 0.95; 95% confidence interval [CI] 0.84 to 1.07), and it reduced the risk of invasive breast cancer (40 vs. 70 events; HR 0.56; 95% CI 0.38 to 0.83; absolute risk reduction [ARR] 1.2 invasive breast cancers per 1 000 women treated for one year). There was no significant difference in the rates of death from any cause or total stroke according to group assignment, but raloxifene was associated with an increased risk of fatal stroke (59 vs. 39 events; HR 1.49; 95% CI 1.00 to 2.24; absolute risk increase 0.7 per 1 000 woman-years) and venous thromboembolism (103 vs. 71 events; HR 1.44; 95% CI 1.06 to 1.95; absolute risk increase 1.2 per 1 000 woman-years). Raloxifene reduced the risk of clinical vertebral fractures (64 vs. 97 events; HR 0.65; 95% CI 0.47 to 0.89; ARR 1.3 per 1 000).
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