The Effect of Pravastatin on Coronary Events after Myocardial Infarction in Patients with Average Cholesterol Levels
Frank M. Sacks, M.D., Marc A. Pfeffer, M.D., Ph.D., Lemuel A. Moye, M.D., Ph.D., Jean L. Rouleau, M.D., John D. Rutherford, M.D., Thomas G. Cole, Ph.D., Lisa Brown, M.P.H., J. Wayne Warnica, M.D., J. Malcolm O. Arnold, M.D., Chuan-Chuan Wun, Ph.D., Barry R. Davis, M.D., Ph.D., Eugene Braunwald, M.D., The Cholesterol and, for Recurrent Events Trial Investigators
Background In patients with high cholesterol levels, loweringthe cholesterol level reduces the risk of coronary events, butthe effect of lowering cholesterol levels in the majority ofpatients with coronary disease, who have average levels, isless clear.
Methods In a double-blind trial lasting five years, we administeredeither 40 mg of pravastatin per day or placebo to 4159 patients(3583 men and 576 women) with myocardial infarction who hadplasma total cholesterol levels below 240 mg per deciliter (mean,209) and low-density lipoprotein (LDL) cholesterol levels of115 to 174 mg per deciliter (mean, 139). The primary end pointwas a fatal coronary event or a nonfatal myocardial infarction.
Results The frequency of the primary end point was 10.2 percentin the pravastatin group and 13.2 percent in the placebo group,an absolute difference of 3 percentage points and a 24 percentreduction in risk (95 percent confidence interval, 9 to 36 percent;P = 0.003). Coronary bypass surgery was needed in 7.5 percentof the patients in the pravastatin group and 10 percent of thosein the placebo group, a 26 percent reduction (P = 0.005), andcoronary angioplasty was needed in 8.3 percent of the pravastatingroup and 10.5 percent of the placebo group, a 23 percent reduction(P = 0.01). The frequency of stroke was reduced by 31 percent(P = 0.03). There were no significant differences in overallmortality or mortality from noncardiovascular causes. Pravastatinlowered the rate of coronary events more among women than amongmen. The reduction in coronary events was also greater in patientswith higher pretreatment levels of LDL cholesterol.
Conclusions These results demonstrate that the benefit of cholesterol-loweringtherapy extends to the majority of patients with coronary diseasewho have average cholesterol levels.
Source Information
From the Departments of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.S., M.A.P., L.B., E.B.); the University of Texas School of Public Health, Houston (L.A.M., C.-C.W., B.R.D.); the University of Sherbrooke, Sherbrooke, Que., Canada (J.L.R.); the University of Texas Southwestern Medical Center, Dallas (J.D.R.); Washington University, St. Louis (T.G.C.); Foothills Hospital, Calgary, Alta., Canada (J.W.W.); and Victoria Hospital, London, Ont., Canada (J.M.O.A.). Other contributing authors were Pierre Theroux, M.D., Montreal Heart Institute, Montreal; David T. Nash, M.D., State University of New York Health Sciences Center, Syracuse; and C. Morton Hawkins, D.Sc., University of Texas School of Public Health, Houston.
Address reprint requests to Dr. Sacks at Brigham and Women's Hospital, 75 Francis St., Boston, MA 02115.
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Brookhart, M. A., Patrick, A. R., Schneeweiss, S., Avorn, J., Dormuth, C., Shrank, W., van Wijk, B. L. G., Cadarette, S. M., Canning, C. F., Solomon, D. H.
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