Effect of Pravastatin on Coronary Events After Myocardial Infarction in Patients with Average Cholesterol Levels (CARE Trial)

The CARE (Cholesterol and Recurrent Events) trial enrolled 4,159 patients with prior myocardial infarction and average cholesterol levels (baseline LDL-C 115–174 mg/dL, mean 139 mg/dL) — a population below the hypercholesterolemia threshold that characterized earlier statin trials like 4S. Patients were randomized to pravastatin 40 mg or placebo.

Pravastatin reduced the risk of fatal CHD or nonfatal MI by 24%, coronary revascularization by 25%, and stroke by 31% — all statistically significant. Total mortality was not significantly reduced over the 5-year follow-up period. The LDL-C reduction was approximately 28%.

The CARE trial was pivotal because it extended statin benefit beyond hypercholesterolemia. Prior to CARE, clinical guidelines could argue that statins were indicated only for patients with elevated LDL-C. CARE demonstrated that post-MI patients with “average” LDL-C levels still benefited from pravastatin — establishing the principle that absolute cardiovascular risk (driven by prior MI) is a more appropriate treatment indication than LDL-C threshold alone.

Together with 4S (demonstrating benefit in high-cholesterol post-MI patients) and WOSCOPS (primary prevention in hypercholesterolemia), CARE completed the early evidence base that established statins as the foundation of cardiovascular prevention across the LDL-C spectrum.

We rate the evidence strong. A landmark secondary prevention RCT extending statin benefit to patients with average LDL-C — establishing that cardiovascular risk level, not just LDL-C level, should guide statin prescribing.