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Adobe Flash Player is required to view this feature. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. Original Article 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., and Christopher J. Packard, D.Sc., for the West of Scotland Coronary Prevention Study Group N Engl J Med 1995; 333:1301-1308 DOI: 10.1056/NEJM32001.
Results Pravastatin lowered plasma cholesterol levels by 20 percent and low-density lipoprotein cholesterol levels by 26 percent, whereas there was no change with placebo. There were 248 definite coronary events (specified as nonfatal myocardial infarction or death from coronary heart disease) in the placebo group, and 174 in the pravastatin group (relative reduction in risk with pravastatin, 31 percent; 95 percent confidence interval, 17 to 43 percent; P. Earlier trials of lipid-lowering drugs in the primary prevention of coronary heart disease have demonstrated that lowering cholesterol levels in middle-aged men with hypercholesterolemia reduces the incidence of myocardial infarction. However, these studies, because of their design and low rates of observed events, were unable to show a clear effect of therapy on the risk of death from coronary heart disease or death from any cause. A meta-analysis of the trials provided support for the likelihood that therapy lowered the risk of death from coronary heart disease, but it also aroused concern that the risk of death from noncardiovascular causes might be increased by treatment. Whether this latter association was due to chance, to the reduction in cholesterol itself, or to an adverse effect of the drugs is not clear.
Recently, a new class of lipid-lowering drug, the 3-hydroxy-3-methylglutaryl–coenzyme A reductase inhibitors, has been introduced into clinical practice. These drugs block endogenous synthesis of cholesterol and reduce the levels of low-density lipoprotein (LDL) cholesterol. They slow the progression of coronary disease and reduce the incidence of death from coronary causes and death from any cause in men with manifest coronary heart disease.
The present study was designed to evaluate the effectiveness of a reductase inhibitor, pravastatin (Pravachol), in preventing coronary events in men with moderate hypercholesterolemia and no history of myocardial infarction. Design The objective was to enroll approximately 6000 middle-aged men, randomly assigned in a double-blind fashion to receive either pravastatin (40 mg each evening) or placebo and to record their clinical progress over a period of five years. The details of the study design, including the definitions of the end points, have been described previously. Pmp Fastrack V8 License Serial Number. Briefly, the primary end point of the study was the occurrence of nonfatal myocardial infarction or death from coronary heart disease as a first event; these two categories were combined. Other principal end points were the occurrence of death from coronary heart disease and nonfatal myocardial infarction.
In all categories, the events were classified as either definite or suspected. In addition to the main end points, the effect of treatment on death from cardiovascular causes, death from any cause, and the frequency of coronary revascularization procedures was analyzed. Alpine Windows Media Player Skin Mode. All subjects provided written informed consent.
The study was approved by the ethics committees of the University of Glasgow and all participating health boards. Recruitment and Follow-up Coronary screening clinics were established in primary medical care facilities throughout the West of Scotland district. Approximately 160,000 men ranging in age from 45 to 64 years were invited to attend the clinics to assess their coronary risk factors. A total of 81,161 appeared for the first visit, and those whose nonfasting plasma cholesterol level was at least 252 mg per deciliter (6.5 mmol per liter) but who had no history of myocardial infarction were given lipid-lowering dietary advice and asked to return four weeks later. A total of 20,914 men returned for the second visit, at which time a lipoprotein profile was obtained that measured plasma cholesterol, the cholesterol content of LDL and high-density lipoprotein (HDL), and plasma triglycerides while the subjects were fasting. If on this occasion the LDL cholesterol level was at least 155 mg per deciliter (4.0 mmol per liter) and the subject had no exclusion criteria, he was advised to stay on the lipid-lowering diet for a further four weeks and then to return for a third visit (13,654 attended), at which time a second lipoprotein profile and a 12-lead electrocardiogram (ECG) were obtained. Intel Hd Graphics 4000 Driver Windows 10. Laboratory Analyses The cholesterol measurement during the first visit was performed on a Reflotron bench-top analyzer (Boehringer–Mannheim, Lewes, Kent, United Kingdom).