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Submitted on January 8, 2002
From the Department of Internal Medicine/Cardiology (D.M.H.), Wake Forest University School of Medicine, Winston-Salem, NC; the Department of Epidemiology and Biostatistics (E.V., F.L., J.F., F.H.), University of California-San Francisco, San Francisco; the Departments of Pharmacology and Medicine/Cardiology (D.H.), University of Minnesota Health Center, Minneapolis; the Department of Medicine (V.B.), University of Alabama at Birmingham, Birmingham; the Department of Preventive Medicine (H.G.S.), University of Iowa College of Medicine, Iowa City; the Preventive Cardiology Center (R.S.B.), Johns Hopkins Hospital, Baltimore, Md; and Wyeth-Ayerst Research (R.L.), Radnor, Pa. * To whom correspondence should be addressed. E-mail: dherring{at}wfubmc.edu.
BackgroundAlthough effects of statins on cardiovascular outcomes are well established in men, fewer data exist for women. Furthermore, the effects of statins plus hormone replacement therapy (HRT) on cardiovascular outcomes are uncertain. Methods and ResultsWe examined statin use, cardiovascular events, and total mortality in the Heart and Estrogen/progestin Replacement Study (HERS), a randomized clinical trial of estrogen plus progestin versus placebo in postmenopausal women with heart disease (n=2763). A nonrandomized comparison of statin users and nonusers revealed lower rates of the primary outcome, nonfatal myocardial infarction or coronary heart disease death (relative hazard [RH]=0.79, 95% confidence intervals [CI] 0.63 to 0.99, P=0.04), and total mortality (RH=0.67, 95% CI 0.51 to 0.87, P=0.003). Rates of venous thromboembolic events were also lower among statin users (RH=0.45, 95% CI 0.23 to 0.88, P=0.02). HRT resulted in a significant increase in early risk for primary events in women who did not use statins (RH=1.75, 95% CI 1.02 to 3.03, P=0.04) but not in statin users (RH=1.34, 95% CI 0.63 to 2.86, P=0.45). Adjustment for postrandomization statin use showed no effect of HRT on risk for the primary outcome (RH=0.96, 95% CI 0.77 to 1.29; P=0.72). ConclusionsIn HERS, statin use was associated with lower rates of cardiovascular events, venous thromboembolic events, and total mortality. These data provide strong support for statin use in eligible women with coronary disease.
Revised on April 12, 2002
Accepted on April 12, 2002
Statin Therapy, Cardiovascular Events, and Total Mortality in the Heart and Estrogen/Progestin Replacement Study (HERS)
David M. Herrington MD, MHS*,
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