Authors
Sacks FM, Moyé LA, Davis BR, et al.
Title
The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels
References
N Engl J Med. 1996;335:1001–1009.
Background
In patients with high cholesterol levels, lowering the cholesterol level reduces the risk of coronary events, but the effect of lowering cholesterol levels in the majority of patients with coronary disease, who have average levels, is less clear.
Purpose
To study the effectiveness of lowering LDL cholesterol in a typical population to prevent coronary events after myocardial infarction
Design
Multicenter, randomized, control trial 4159 patients (aged 21-75 yrs) who had a myocardial infarction between 3 and 20 months prior to randomization Total cholesterol <6.21 mmol/L (240 mg/dL), LDL-C between 2.97-4.5 mmol/L (115-174 mg/dL) usual care group received self management educational materials with information for moderate intensity activity for 30 minutes (as tolerated) most days of the week
Exclusion Criteria
Fasting glucose >12.2 mmol/L LVEF<25% Symptomatic heart failure
Follow-Up
Median 5 years (range 4.0-6.2 years)
Treatment Regimen
Pravastatin 40 mg/day vs. placebo Follow-up visits at 6, 12 weeks after randomization, quarterly for the first year and then semi-annually thereafter. Lipids measured. If not at target as per NCEP guidelines, dietary then cholestyramine was administered.
Results
Primary Endpoints Death from coronary heart disease or non-fatal myocardial infarction: 10.2% (pravastatin) vs. 13.2% (placebo); p=0.003 Secondary Outcomes Stroke reduced by 31% in pravastatin arm (p=0.03) No differences in overall mortality or mortality from non-CV causes Pravastatin lowers the rate of coronary events more among women and in those with a higher pre-treatment LDL level
Summary
The benefit of cholesterol lowering therapy extends to the majority of patients with coronary artery disease who have average cholesterol levels.