Prevention of Coronary Heart Disease with Pravastatin in Men with Hypercholesterolemia
James Shepherd, M.D., Stuart M. Cobbe, M.D., Ian Ford, Ph.D., Christopher G. Isles, M.D., A. Ross Lorimer, M.D., Peter W. Macfarlane, Ph.D., James H. McKillop, M.D., Christopher J. Packard, D.Sc., for The West of Scotland Coronary Prevention Study Group
Background Lowering the blood cholesterol level may reduce therisk of coronary heart disease. This double-blind study wasdesigned to determine whether the administration of pravastatinto men with hypercholesterolemia and no history of myocardialinfarction reduced the combined incidence of nonfatal myocardialinfarction and death from coronary heart disease.
Methods We randomly assigned 6595 men, 45 to 64 years of age,with a mean (±SD) plasma cholesterol level of 272±23mg per deciliter (7.0±0.6 mmol per liter) to receivepravastatin (40 mg each evening) or placebo. The average follow-upperiod was 4.9 years. Medical records, electrocardiographicrecordings, and the national death registry were used to determinethe clinical end points.
Results Pravastatin lowered plasma cholesterol levels by 20percent and low-density lipoprotein cholesterol levels by 26percent, whereas there was no change with placebo. There were248 definite coronary events (specified as nonfatal myocardialinfarction or death from coronary heart disease) in the placebogroup, and 174 in the pravastatin group (relative reductionin risk with pravastatin, 31 percent; 95 percent confidenceinterval, 17 to 43 percent; P<0.001). There were similarreductions in the risk of definite nonfatal myocardial infarctions(31 percent reduction, P<0.001), death from coronary heartdisease (definite cases alone: 28 percent reduction, P = 0.13;definite plus suspected cases: 33 percent reduction, P = 0.042),and death from all cardiovascular causes (32 percent reduction,P = 0.033). There was no excess of deaths from noncardiovascularcauses in the pravastatin group. We observed a 22 percent reductionin the risk of death from any cause in the pravastatin group(95 percent confidence interval, 0 to 40 percent; P = 0.051).
Conclusions Treatment with pravastatin significantly reducedthe incidence of myocardial infarction and death from cardiovascularcauses without adversely affecting the risk of death from noncardiovascularcauses in men with moderate hypercholesterolemia and no historyof myocardial infarction.
Source Information
From the Departments of Pathological Biochemistry (J.S., C.J.P.), Medical Cardiology (S.M.C., A.R.L., P.W.M.), and Medicine (J.H.M.), University of Glasgow and Royal Infirmary, Glasgow; Robertson Centre for Biostatistics, University of Glasgow, Glasgow (I.F.); and the Department of Medicine, Dumfries and Galloway District General Hospital, Dumfries (C.G.I.) — all in Scotland.
Address reprint requests to Dr. Ford at the Robertson Centre for Biostatistics, Boyd Orr Bldg., University of Glasgow, Glasgow G12 8QQ, Scotland.
Prevention of Coronary Heart Disease with Pravastatin
Rogers S., Samani N. J., de Bono D. P., Davis D. R., Shepherd J., Cobbe S. M., Ford I., The West of Scotland Coronary Prevention Study Group , Pedersen T. R.
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