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Odkazy a zdroje - Studie - PROVE-IT



PROVE-IT

Pravastatin or Atorvastatin Evaluation and Infection Therapy

Author(s)
Cannon CP, Braunwald E, McCabe CH, Rader DJ, Rouleau JL, Belder R, Joyal SV, Hill KA, Pfeffer MA, Skene AM; Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction 22 Investigators.

Title(s)
Intensive versus moderate lipid lowering with statins after acute coronary syndromes

Reference(s)
N Engl J Med. 2004 Apr 8;350(15):1495-504

Disease
CHD - acute coronary syndrome within the preceding 10 days

Purpose
To compare the effect of intensive vs. moderate lipid lowering for the prevention of cardiovascular events

Study design
Randomized, double-blind, placebo controlled trial conducted in 349 centers in the USA, Canada and UK.
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

Follow-up
Mean 24 months

Patients
4162 patients who had been hospitalized for an acute coronary syndrome within the preceding 10 days, with total cholesterol levels below 6.21 mmol/l without lipid lowering therapy or 5.18 mmol/l on lipid lowering therapy

Treatment regimen
Patients were randomly assigned to receive treatment with pravastatin, 40 mg/d , or atorvastatin, 80 mg/d

Concomitant therapy
-

Results
The median LDL cholesterol level achieved during treatment was 95 mg per deciliter (2.46 mmol per liter) in the standard-dose pravastatin group and 62 mg per deciliter (1.60 mmol per liter) in the high-dose atorvastatin group (P<0.001). Kaplan-Meier estimates of the rates of the primary end point at two years were 26.3 percent in the pravastatin group and 22.4 percent in the atorvastatin group, reflecting a 16 percent reduction in the hazard ratio in favor of atorvastatin (P=0.005; 95 percent confidence interval, 5 to 26 percent). The study did not meet the prespecified criterion for equivalence but did identify the superiority of the more intensive regimen.
In summary, among patients who have recently had an acute coronary syndrome, an intensive lipid-lowering statin regimen provides greater protection against death or major cardiovascular events than does a standard regimen. These findings indicate that such patients benefit from early and continued lowering of LDL cholesterol to levels substantially below current target levels.