Helsinski Heart Study - Helsinki Heart Study
Gemfibrozil in hypercholesterolemia for primary prevention of coronary heart disease
To investigate the effect of the fibric acid derivative gemfibrozil on the incidence of coronary heart disease in asymptomatic middle-aged men at high risk because of elevated lipid levels.
Patients Screened: 18,966
Patients Enrolled: 4081
NYHA Class: Not reported
Mean Follow Up: Mean 60.4 months
Mean Patient Age: average 47 years
Mean Ejection Fraction: Not evaluated
4,081 Finnish men 40 to 55 years of age with a non-HDL cholesterol level of ≥200 mg/dL.
Clinical manifestations of coronary heart disease or ECG abnormalities and congestive heart failure, or any other disease that could have an influence on study outcome
Cardiac death and MI
Gemfibrozil 600 mg twice daily or placebo.
Averaged over the 5 years of the trial, gemfibrozil therapy, compared to placebo, resulted in mean reductions of 10% in serum total cholesterol, 14% in non-HDL cholesterol, 11% in LDL choleterol, 35% in triglycerides, and 11% increase in HDL cholesterol. Gemfibrozil use was associated with 34% reduction in the primary endpoint of cardiac death or nonfatal MI (7.3 vs. 41.4/1,000, p < 0.02); this reduction first became apparent in the second year. There was no significant mortality difference was detected between the two groups (2.19% vs. 2.07%).
Modification of lipoprotein levels with gemfibrozil reduced the incidence of a composite endpoint for coronary heart disease progression in men with dyslipidemia. There was no mortality benefit, but the trial was underpowered to detect such a benefit.
N Engl J Med 1987; 317: 1237-45. Primary results. JAMA 1988; 260: 641-51. Lipid level data.
Keywords: Cholesterol, Gemfibrozil, Hypolipidemic Agents, Coronary Disease, Hypercholesterolemia, Triglycerides, Primary Prevention
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