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Title
a. Design and recruitment in the United States of a
multicenter quantitative angiographic trial of pravastatin
to limit atherosclerosis in the coronary arteries (PLAC
I).
b. Pravastatin, lipids and atherosclerosis in the carotid
arteries (PLAC-II).
c. Reduction in coronary events during treatment with
pravastatin.
Disease
Hyperlipidemia
Purpose
To assess the effects of pravastatin on progression
and regression of coronary artery disease in patients
with moderate hypercholesterolemia.
Design
Randomized, double blind, placebo controlled, multicenter
.
Patients
559 patients (PLAC I: 408 patients, age £ 75
years, with documented ³ 1 stenosis ³ 50%
in a major epicardial coronary artery, LDL cholesterol
130-289 mg/dL, and triglycerides £ 350 mg/dL were
included. Patients with secondary hyperlipidemia, diabetes
mellitus, congestive heart failure, and other serious
concomitant diseases were excluded. PLAC II: 151 patients
with coronary artery disease and extracranial carotid
lesion. Same criteria as above.
Follow-up
Clinical follow-up for 3 years. Coronary angiography
at baseline and after 36 months (PLAC I).
Treatment regimen
Pravastatin 40 mg /d or placebo for 3 years in PLAC-1,
20-40 mg/d in PLAC-II.
Additional therapy
Patients whose LDL cholesterol remained ³ 190
mg/dL received cholestyramine, and then 5-10 mg open
label pravastatin or placebo. If these measures failed,
the patient was withdrawn from the study.
Results
• The incidence of coronary events was 4.0%/ year
in the placebo vs. 1.8%/year in the pravastatin patients
(55% risk reduction, p=0.014).
• A similar effect was seen in patients < 65
years and ³ 65 years of age.
• 11 patients vs. 7 patients in the placebo and
pravastatin groups died (40% risk reduction, p=0.31).
• Nonfatal myocardial infarction occurred in 24
patients of the placebo vs. 9 of the pravastatin group
(67% risk reduction,
p=0.006).
Conclusion
Pravastatin therapy was associated with reduction of
clinical events in coronary patients with mild to moderate
hyperlipidemia.
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