Therapy with individual 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) has been shown conclusively to diminish coronary event rates and mortality in both primary and secondary prevention. To date, scant attention has been paid to whether initiation of such regimens in the hospital phase of acute coronary syndromes might confer cardioprotective benefits. The purpose of this study was to determine the safety and tolerability of early initiation of statin therapy in patients with acute coronary syndromes. In this randomised, double-blind, three-month, pilot study, 100 patients with acute myocardial infarction or unstable angina and low-density lipoprotein cholesterol > 3.5 mmol/l were randomly assigned to pravastatin 40 mg daily or placebo initiated within 48 hours of hospital admission. Pravastatin proved safe and well tolerated in these patients, who were well matched at baseline. No statistically significant differences in death, MI and drug-related adverse events were observed in the pravastatin group compared with control subjects. This pilot study shows that therapy with pravastatin early after an acute coronary event is safe and well tolerated. Larger, long-term studies are needed to confirm these findings.