"Pravastatin in the Primary Prevention of Coronary Events".The New England Journal of Medicine. 1995. 333(20):1301-1307.
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Contents
1 Clinical Question 2 Bottom Line 3 Major Points 4 Guidelines 5 Design 6 Population 6.1 Inclusion Criteria 6.2 Exclusion Criteria 6.3 Baseline Characteristics 7 Interventions 8 Outcomes 8.1 Primary Outcome 8.2 Secondary Outcomes 9 Funding 10 Further Reading
In men with hypercholesterolemia and no history of myocardial infarction, does the administration of pravastatin reduce the risk of coronary events?
In men with moderate hypercholesterolemia and no history of myocardial infarction, treatment with pravastatin significantly reduced the incidence of myocardial infarction and death from cardiovascular causes without adversely affecting the risk of death from noncardiovascular causes.
Earlier trials of lipid-lowering drugs in the primary prevention of coronary heart disease had shown mixed results in terms of their impact on reducing mortality from coronary and other causes. The West of Scotland Coronary Prevention Study (WOSCOPS) showed clear benefits from using a statin (pravastatin) in the primary prevention setting, initiating a paradigm shift in managing hypercholesterolemia with statins to prevent cardiovascular events.
As of the last knowledge update, various guidelines recommend statin therapy for the primary prevention of cardiovascular disease in patients with multiple risk factors, including those with high LDL cholesterol levels.
- Multicenter, double-blind, parallel-group, randomized, placebo-controlled trial - N=6,595 men with moderate hypercholesterolemia - Pravastatin 40mg PO daily (n=3,302) - Placebo (n=3,293) - Setting: Multiple centers in Scotland - Mean follow-up: 4.9 years - Analysis: Intention-to-treat
Inclusion Criteria
- Men aged 45 to 64 years - No history of myocardial infarction - Fasting plasma LDL cholesterol ≥155 mg/dl
Exclusion Criteria
- Serious ECG abnormalities - History of myocardial infarction or serious illness - Active liver disease or certain other conditions
Baseline Characteristics
- Mean cholesterol level: 272±23 mg/dl - Mean LDL cholesterol level: 192±17 mg/dl - Mean HDL cholesterol level: 44±9 mg/dl - Prevalence of smoking: 44% - Prevalence of hypertension: 16% - Evidence of angina (from Rose questionnaire): 5%
- Pravastatin (40 mg each evening) or placebo - Lipid-lowering dietary advice - Fasting lipoprotein profile every six months - Annual ECG and physician examination
Primary Outcome
- Combined incidence of nonfatal myocardial infarction and death from coronary heart disease: 31% relative reduction with pravastatin (P<0.001)
- Nonfatal myocardial infarction: Significant reduction with pravastatin (P<0.001) - Death from coronary heart disease: 28% reduction with pravastatin (P=0.13 for definite cases; P=0.042 for definite plus suspected cases) - Death from all cardiovascular causes: 32% reduction with pravastatin (P=0.033) - Overall mortality: 22% reduction with pravastatin (P=0.051) - Coronary revascularization procedures: 37% reduction with pravastatin (P=0.009)
Supported by a research grant from the Bristol-Myers Squibb Pharmaceutical Research Institute.
Authors' full text and PubMed.