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Previous Volume 355:125-137 July 13, 2006 Number 2 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Editorial by Stefanick, M. L. Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

ABSTRACT

Background The effect of raloxifene, a selective estrogen-receptor modulator, on coronary heart disease (CHD) and breast cancer is not established.

Methods We randomly assigned 10,101 postmenopausal women (mean age, 67.5 years) with CHD or multiple risk factors for CHD to 60 mg of raloxifene daily or placebo and followed them for a median of 5.6 years. The two primary outcomes were coronary events (i.e., death from coronary causes, myocardial infarction, or hospitalization for an acute coronary syndrome) and invasive breast cancer.

Results As compared with placebo, raloxifene had no significant effect on the risk of primary coronary events (533 vs. 553 events; hazard ratio, 0.95; 95 percent confidence interval, 0.84 to 1.07), and it reduced the risk of invasive breast cancer (40 vs. 70 events; hazard ratio, 0.56; 95 percent confidence interval, 0.38 to 0.83; absolute risk reduction, 1.2 invasive breast cancers per 1000 women treated for one year); the benefit was primarily due to a reduced risk of estrogen-receptor–positive invasive breast cancers. 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; hazard ratio, 1.49; 95 percent confidence interval, 1.00 to 2.24; absolute risk increase, 0.7 per 1000 woman-years) and venous thromboembolism (103 vs. 71 events; hazard ratio, 1.44; 95 percent confidence interval, 1.06 to 1.95; absolute risk increase, 1.2 per 1000 woman-years). Raloxifene reduced the risk of clinical vertebral fractures (64 vs. 97 events; hazard ratio, 0.65; 95 percent confidence interval, 0.47 to 0.89; absolute risk reduction, 1.3 per 1000).

Conclusions Raloxifene did not significantly affect the risk of CHD. The benefits of raloxifene in reducing the risks of invasive breast cancer and vertebral fracture should be weighed against the increased risks of venous thromboembolism and fatal stroke. (ClinicalTrials.gov number, NCT00190593.)

Source Information

From the Department of Family and Preventive Medicine, University of California, San Diego, La Jolla (E.B.-C.); the Department of Medicine, Columbia University College of Physicians and Surgeons, New York (L.M.); the Department of Cardiac Medicine, Royal Brompton Hospital and National Heart and Lung Institute, Imperial College London, London (P.C.); Lilly Research Laboratories, Eli Lilly, Indianapolis (M.J.G., M.A.M.); the Departments of Epidemiology and Biostatistics and Medicine, University of California, San Francisco, and the San Francisco Veterans Affairs Medical Center, San Francisco (D.G.); the Department of Epidemiology and Health Promotion, School of Public Health, Brussels Free University, Brussels (M.K.); and Emory University School of Medicine, Atlanta (N.K.W.).

Address reprint requests to Dr. Barrett-Connor at the Department of Family and Preventive Medicine, University of California, San Diego, 9500 Gilman Dr., La Jolla, CA 92093-0607, or at ebarrettconnor{at}ucsd.edu.

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