PROVE-IT
Pravastatin or Atorvastatin Evaluation and Infection Therapy — Thrombolysis in Myocardial Infarction 22 (PROVE IT-TIMI 22)
Patient / Population Intervention / Exposure Comparison Outcome
In 4,162 patients after acute coronary syndrome, intensive atorvastatin 80 mg reduced death or major cardiovascular events compared with moderate pravastatin 40 mg (16% relative reduction, P=0.005).
N
4,162
Design
Double-blind, double-dummy, randomised active-comparator trial
Endpoint
Composite of death, MI, unstable angina requiring rehospitalisation, revascularization, or stroke
Relevance
2
ResultPrimary composite 22.4% with intensive atorvastatin 80 mg vs 26.3% with pravastatin 40 mg (16% relative reduction; 95% CI 5-26; P=0.005). Median achieved LDL-C 62 vs 95 mg/dL.
Cannon CP, et al. N Engl J Med. 2004;350(15):1495-1504. 10.1056/NEJMoa040583
Discussion & critique
Design confounds statin intensity with two different agents/doses so benefit cannot be attributed to LDL lowering alone. Established the 'lower is better' paradigm and high-intensity statin therapy as standard after acute coronary syndrome.