"Pravastatin in the Primary Prevention of Coronary Events".The New England Journal of Medicine. 1995. 333(20):1301-1307.PubMed•Full text•PDF

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

Clinical Question

In men with hypercholesterolemia and no history of myocardial infarction, does the administration of pravastatin reduce the risk of coronary events?

Bottom Line

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.

Major Points

Guidelines

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.

Design

- 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

Population

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%

Interventions

- Pravastatin (40 mg each evening) or placebo
- Lipid-lowering dietary advice
- Fasting lipoprotein profile every six months
- Annual ECG and physician examination

Outcomes

Primary Outcome

- Combined incidence of nonfatal myocardial infarction and death from coronary heart disease: 31% relative reduction with pravastatin (P<0.001)

Secondary Outcomes

- 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)

Funding

Supported by a research grant from the Bristol-Myers Squibb Pharmaceutical Research Institute.

Further Reading

Authors' full text and PubMed.