Authors
Robins SJ, Collins D, Wittes JT, et al.
Title
Relation of Gemfibrozil Treatment and Lipid Levels With Major Coronary EventsVA-HIT: A Randomized Controlled Trial
References
JAMA. 2001;285(12):1585-1591
Background
Considerable epidemiologic data show that a low concentration of plasma high-density lipoprotein cholesterol (HDL-C) is a major risk factor for coronary heart disease (CHD). In the United States, a low HDL-C concentration is the most prevalent lipid abnormality in men with known CHD. Moreover, a low HDL-C level better distinguishes populations with and without CHD than does a high level of low-density lipoprotein cholesterol (LDL-C).
Purpose
The VA High-Density Lipoprotein Intervention Trial (VA-HIT) was undertaken to test the hypothesis that drug therapy to increase a low HDL-C level would decrease the incidence of major CHD events.
Design
Multicenter, randomized, double-blind, placebo-controlled trial conducted from September 1991 to August 1998 20 VA medical centers were participating sites A total of 2531 men with a history of CHD who had low HDL-C levels (mean, 0.83 mmol/L [32 mg/dL ] ) and low low-density lipoprotein cholesterol (LDL-C) levels (mean, 2.88 mmol/L [111 mg/dL])
Exclusion Criteria
Women No history of CAD Alcohol abuse Significant LV dysfunction Any other clinically significant, coexisting condition
Follow-Up
Minimum 5 years, maximum 7 years. Median 5.1 years
Treatment Regimen
Participants were randomly assigned to receive gemfibrozil, 1200 mg/d (n = 1264), or matching placebo (n = 1267).
Results
Primary Endpoints Relation of lipid levels during gemfibrozil treatment with the combined incidence of nonfatal myocardial infarction and CHD death CHD events were reduced by 11% with gemfibrozil for every 5-mg/dL (0.13 mmol/L) increase in HDL-C (p=0.02)
Summary
Concentrations of HDL-C achieved with gemfibrozil treatment predicted a significant reduction in CHD events in patients with low HDL-C levels.