PROVE-IT Trial

This study randomized 4,126 patients who had been hospitalized for an acute coronary syndrome within the preceding 10 days. The goal of the study was to establish the non-inferiority of pravastatin versus atorvastatin in terms of the time to an end-point event. Standard therapy of pravastatin, 40 mg/day, was compared with intensive therapy of atorvastatin, 80 mg/day. The primary end point was a composite of death from any cause, myocardial infarction, documented unstable angina requiring rehospitalization, revascularization (performed at least 30 days after randomization) and stroke. Followup lasted 18 to 36 months, with the mean being 24 months. Patients receiving pravastatin achieved a median lowdensity lipoprotein cholesterol (LDL-C) of 2.46 mmol/L, compared to an LDL-C level of 1.60 mmol/L achieved in the high-dose atorvastatin group (p < 0.001). Estimates of the rates of the primary end point at two years were 26.3% and 22.4% in the pravastatin and atorvastatin groups, respectively, reflecting a 16% reduction in the hazard ratio in favour of atorvastatin (p = 0.005). The authors concluded that an intensive, lipid-lowering statin regimen is superior to a standard regimen in providing protection against death or major cardiovascular events among patients who have recently had an acute coronary syndrome. Furthermore, these findings indicate such patients benefit from early and continued lowering of LDL-C to levels substantially below current targets.