Level 1: Likely reliable evidence

Raloxifene (Evista) reduced the risk of breast cancer and vertebral fracture but increased the risk of fatal stroke and venous thromboembolism, based on the results of the Raloxifene Use for the Heart (RUTH) trial with 10,101 postmenopausal women older than 55 years who had coronary heart disease (CHD) or multiple risk factors for CHD (N Engl J Med. 2006;355:125-137).

Participants were randomized to raloxifene 60 mg vs. placebo once daily for a median of 5.6 years. A total of 913 (9%) women dropped out before the study was completed and 1,149 (11%) died during the study.

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For many outcomes, there were no significant differences when comparing raloxifene with placebo: primary coronary events (533 vs. 553, or 2.06% vs. 2.16% per year), total stroke (249 vs. 224 events, or 0.95% vs. 0.86% per year), total death (554 vs. 595 deaths, or 2.07% vs. 2.25% per year), cardiovascular death, and clinical nonvertebral fractures. Raloxifene reduced the risk of invasive breast cancer (40 vs. 70 cases, or 0.15% vs. 0.27% per year, NNT 833 per year) and clinical vertebral fractures (64 vs. 97, or 0.24% vs. 0.37% per year, NNT 769 per year). But raloxifene increased the risk for fatal strokes (59 vs. 39, NNH 1,428 per year), venous thromboembolism events (103 vs. 71, NNH 833 per year), hot flushes (8% vs. 4.8%, NNH 31), leg cramps (9.7% vs. 6.7%, NNH 33), peripheral edema (14.4% vs. 12.1%, NNH 43), and gallbladder disease (5.6% vs. 4.5%, NNH 91).