Cognitive Function in Postmenopausal Women Treated with Raloxifene
Kristine Yaffe, M.D., Kathyrn Krueger, M.D., Somnath Sarkar, Ph.D., Deborah Grady, M.D., M.P.H., Elizabeth Barrett-Connor, M.D., David A. Cox, Ph.D., Thomas Nickelsen, M.D., for The Multiple Outcomes of Raloxifene Evaluation Investigators
Background In postmenopausal women, estrogen may have a beneficialeffect on cognition or reduce the risk of decline in cognitivefunction. Whether raloxifene, a selective estrogen-receptormodulator, might have similar actions is not known.
Methods As part of the Multiple Outcomes of Raloxifene Evaluationtrial, we studied 7478 postmenopausal women with osteoporosis(mean age, 66 years), who were enrolled at 178 sites in 25 countries.The women were randomly assigned to receive raloxifene (60 mgor 120 mg) or placebo daily for three years. We compared themean scores of the groups on six tests of cognitive function,which were administered at base line and at six months and one,two, and three years. Women were classified as having a declinein cognitive function if the change in their scores at threeyears was in the worst 10 percent.
Results The mean cognitive scores in the three groups of womenwere similar at base line. The scores improved slightly in allthree groups during the three-year study period, with no significantdifferences among the groups. The risk of decline in the cognitivefunction, as measured by four of the six tests, did not differsignificantly between the two raloxifene groups combined andthe placebo group, but there was a trend toward less declinein the combined raloxifene group on the two tests of verbalmemory (relative risk, 0.77) and attention (relative risk, 0.87).Newly reported or worsening hot flashes did not negatively influencetest scores or the effect of treatment on test performance.
Conclusions Raloxifene treatment for three years does not affectoverall cognitive scores in postmenopausal women with osteoporosis.(N Engl J Med 2001; 344:1207-13.)
Source Information
From the Departments of Psychiatry (K.Y.), Neurology (K.Y.), Medicine (D.G.), and Epidemiology (K.Y., D.G.), University of California at San Francisco, San Francisco; Lilly Research Laboratories, Eli Lilly, Indianapolis (K.K., S.S., D.A.C., T.N.); and the Department of Community and Family Medicine, University of California at San Diego, La Jolla (E.B.-C.).
Address reprint requests to Dr. Yaffe at the University of California at San Francisco, Box 111G, 4150 Clement St., San Francisco, CA 94121.
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