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VA-HIT: A Randomized Controlled Trial

Sander J. Robins, MD; Dorothea Collins, ScD; Janet T. Wittes, PhD; Vasilios Papademetriou, MD; Prakash C. Deedwania, MD; Ernst J. Schaefer, MD; Judith R. McNamara, MT; Moti L. Kashyap, MD; Jerome M. Hershman, MD; Laura F. Wexler, MD; Hanna Bloomfield Rubins, MD,MPH; for the VA-HIT Study Group

JAMA. 2001;285:1585-1591.

Context  A low plasma level of high-density lipoprotein cholesterol (HDL-C) is a major risk factor for coronary heart disease (CHD). A secondary prevention study, the Veterans Affairs High-Density Lipoprotein Intervention Trial (VA-HIT), demonstrated that CHD events were significantly reduced during a median follow-up of 5.1 years by treating patients with the fibric acid derivative gemfibrozil when the predominant lipid abnormality was low HDL-C.

Objective  To determine if the reduction in major CHD events with gemfibrozil in VA-HIT could be attributed to changes in major plasma lipid levels.

Design  Multicenter, randomized, double-blind, placebo-controlled trial conducted from September 1991 to August 1998.

Setting  The Department of Veterans Affairs Cooperative Studies Program, in which 20 VA medical centers were participating sites.

Participants  A total of 2531 men with a history of CHD who had low HDL-C levels (mean, 32 mg/dL [0.83 mmol/L] ) and low low-density lipoprotein cholesterol (LDL-C) levels (mean, 111 mg/dL [2.88 mmol/L]).

Intervention  Participants were randomly assigned to receive gemfibrozil, 1200 mg/d (n = 1264), or matching placebo (n = 1267).

Main Outcome Measure  Relation of lipid levels at baseline and averaged during the first 18 months of gemfibrozil treatment with the combined incidence of nonfatal myocardial infarction and CHD death.

Results  Concentrations of HDL-C were inversely related to CHD events. Multivariable Cox proportional hazards analysis showed that CHD events were reduced by 11% with gemfibrozil for every 5-mg/dL (0.13-mmol/L) increase in HDL-C (P = .02). Events were reduced even further with gemfibrozil beyond that explained by increases in HDL-C values, particularly in the second through fourth quintiles of HDL-C values during treatment. During gemfibrozil treatment, only the increase in HDL-C significantly predicted a lower risk of CHD events; by multivariable analysis, neither triglyceride nor LDL-C levels at baseline or during the trial predicted CHD events.

Conclusions  Concentrations of HDL-C achieved with gemfibrozil treatment predicted a significant reduction in CHD events in patients with low HDL-C levels. However, the change in HDL-C levels only partially explained the beneficial effect of gemfibrozil.

Author Affiliations: Department of Medicine, Boston University School of Medicine, Boston, Mass (Dr Robins); VAMC Cooperative Studies Program Coordinating Center, West Haven, Conn (Dr Collins); Statistics Collaborative, Washington, DC (Dr Wittes); Lipid Research Laboratory, Tufts University School of Medicine, Boston (Dr Schaefer and Ms McNamara); and Departments of Medicine, Veterans Affairs Medical Centers, Washington, DC (Dr Papademetriou), Fresno, Calif (Dr Deedwania), Long Beach, Calif (Dr Kashyap), Los Angeles, Calif (Dr Hershman), Cincinnati, Ohio (Dr Wexler), and Minneapolis, Minn (Dr Rubins).
A listing of the members of the Veterans Affairs High-Density Lipoprotein Intervention Trial (VA-HIT) was published previously (N Engl J Med. 1999;341:417-418).

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