Authors
Lipid study group
Title
Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels
References
N Engl J Med. 1998 Nov 5;339(19):1349-57.
Background
In patients with coronary heart disease and a broad range of cholesterol levels, cholesterol-lowering therapy reduces the risk of coronary events, but the effects on mortality from coronary heart disease and overall mortality have remained uncertain.
Purpose
To determine the effect of pravastatin among patients with CAD and a broad range of initial cholesterol levels on cardiovascular death.
Design
Randomized, double-blind, placebo-controlled trial 9014 patients (aged 31-75 years) with a history of myocardial infarction or unstable angina (3-36 months prior to study entry) Initial cholesterol levels 4.0 – 7.0 mmol/L (155-271mg/dL)
Exclusion Criteria
Clinically significant medical or surgical event within three months prior to study entry Congestive heart failure Renal or liver disease Concurrent use of any cholesterol lowering agent
Follow-Up
6.1 years
Treatment Regimen
Pravastatin 40 mg vs. placebo (both groups received dietary advice) Lipids measured at 6 months and then yearly thereafter
Results
Primary Endpoints Death from coronary heart disease: 6.4% (pravastatin) vs. 8.3% (placebo); p<0.001 Secondary Outcomes (see study for complete list) Overall mortality: 11.0% (pravastatin) vs. 14.1% (placebo); p<0.001 Reduction in myocardial infarction (29%; p<0.001), death from coronary heart disease or non-fatal MI (24%; p<0.001), stroke (19%; p<0.048) in pravastatin treated group
Summary
Pravastatin therapy reduced mortality from coronary heart disease and overall mortality, as compared with the rates in the placebo group, as well as the incidence of all prespecified cardiovascular events in patients with a history of myocardial infarction or unstable angina who had a broad range of initial cholesterol levels.