© American Diabetes Association ®, Inc., 2004
The Prove It Study: Is It Really a Landmark Study or Another Piece of a Very Important Puzzle?
Cannon CP, Braunwald E, McCabe CH, Rader DJ, Rouleau JL, Belder R, Joyal SV, Hill KA, Pfeffer MA, Skene AM, for the Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction 22 Investigators: Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med350 : 1495-1504,2004
Design. This was a randomized, blinded, double placebo-controlled, comparison of pravastatin, 40 mg daily, versus atorvastatin, 80 mg daily, in patients who presented to hospitals with an acute coronary syndrome (ACS). The goal of the study was to determine if "standard" therapy to lower LDL cholesterol levels to the recommended goal of about 100 mg/dl with 40 mg pravastatin was as effective in preventing further coronary events as more aggressive therapy that lowered LDL cholesterol levels to about 70 mg/dl with 80 mg atorvastatin. ACS was defined as an acute myocardial infarction (MI) or high-risk unstable angina. Subjects. The study enrolled 4,162 adults with an average age of 58 years. Twenty-two percent of the subjects were female, and 90% were white. Eighteen percent had diabetes, 18% had had a previous MI, and 11% had undergone previous coronary bypass surgery. One-third presented with high-risk unstable angina and the rest with an acute MI (with or without ST elevation). Sixtynine percent had a percutaneous transluminal coronary angioplasty (PTCA) procedure during their hospitalization. The baseline median LDL cholesterol level, obtained either within 24 hours of admission or within the previous 6 months, was 106 mg/dl, and 25% of the subjects were on statin treatment at the time of admission. The median baseline HDL cholesterol level was 38 mg/dl, and the median baseline triglyceride level was 155 mg/dl.
Methods.
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