Gemfibrozil for the Secondary Prevention of Coronary Heart Disease in Men with Low Levels of High-Density Lipoprotein Cholesterol
Hanna Bloomfield Rubins, M.D., M.P.H., Sander J. Robins, M.D., Dorothea Collins, Sc.D., Carol L. Fye, R.Ph., M.S., James W. Anderson, M.D., Marshall B. Elam, M.D., Ph.D., Fred H. Faas, M.D., Esteban Linares, M.D., Ernst J. Schaefer, M.D., Gordon Schectman, M.D., Timothy J. Wilt, M.D., M.P.H., Janet Wittes, Ph.D., for The Veterans Affairs High-Density Lipoprotein Cholesterol Intervention Trial Study Group
Background Although it is generally accepted that lowering elevatedserum levels of low-density lipoprotein (LDL) cholesterol inpatients with coronary heart disease is beneficial, there arefew data to guide decisions about therapy for patients whoseprimary lipid abnormality is a low level of high-density lipoprotein(HDL) cholesterol.
Methods We conducted a double-blind trial comparing gemfibrozil(1200 mg per day) with placebo in 2531 men with coronary heartdisease, an HDL cholesterol level of 40 mg per deciliter (1.0mmol per liter) or less, and an LDL cholesterol level of 140mg per deciliter (3.6 mmol per liter) or less. The primary studyoutcome was nonfatal myocardial infarction or death from coronarycauses.
Results The median follow-up was 5.1 years. At one year, themean HDL cholesterol level was 6 percent higher, the mean triglyceridelevel was 31 percent lower, and the mean total cholesterol levelwas 4 percent lower in the gemfibrozil group than in the placebogroup. LDL cholesterol levels did not differ significantly betweenthe groups. A primary event occurred in 275 of the 1267 patientsassigned to placebo (21.7 percent) and in 219 of the 1264 patientsassigned to gemfibrozil (17.3 percent). The overall reductionin the risk of an event was 4.4 percentage points, and the reductionin relative risk was 22 percent (95 percent confidence interval,7 to 35 percent; P=0.006). We observed a 24 percent reductionin the combined outcome of death from coronary heart disease,nonfatal myocardial infarction, and stroke (P< 0.001). Therewere no significant differences in the rates of coronary revascularization,hospitalization for unstable angina, death from any cause, andcancer.
Conclusions Gemfibrozil therapy resulted in a significant reductionin the risk of major cardiovascular events in patients withcoronary disease whose primary lipid abnormality was a low HDLcholesterol level. The findings suggest that the rate of coronaryevents is reduced by raising HDL cholesterol levels and loweringlevels of triglycerides without lowering LDL cholesterol levels.
Source Information
From the Center for Chronic Disease Outcomes Research, Veterans Affairs Medical Center, Minneapolis (H.B.R., T.J.W.); the Department of Medicine, Boston University School of Medicine, Boston (S.J.R.); the Department of Veterans Affairs Cooperative Studies Program Coordinating Center, West Haven, Conn. (D.C.); the Clinical Research Pharmacy Coordinating Center, Albuquerque, N.M. (C.L.F.); the Medicine Service, Veterans Affairs Medical Center, Lexington, Ky. (J.W.A.); the Medicine Service, Veterans Affairs Medical Center, Memphis, Tenn. (M.B.E.); the Medicine Service, Veterans Affairs Medical Center, Little Rock, Ark. (F.H.F.); the Medicine Service, Veterans Affairs Medical Center, San Juan, P.R. (E.L.); the Lipid Research Laboratory, Tufts University School of Medicine, Boston (E.J.S.); the Medicine Service, Veterans Affairs Medical Center, Milwaukee (G.S.); and Statistics Collaborative, Washington, D.C. (J.W.).
Address reprint requests to Dr. Rubins at the Section of General Internal Medicine (111O), Veterans Affairs Medical Center, Minneapolis, MN 55417, or at bloom013{at}tc.umn.edu.
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