Helsinski Heart Study - Helsinki Heart Study

Description:

Gemfibrozil in hypercholesterolemia for primary prevention of coronary heart disease

Hypothesis:

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.

Study Design

Study Design:

Patients Screened: 18,966
Patients Enrolled: 4081
NYHA Class: Not reported
Mean Follow Up: Mean 60.4 months
Mean Patient Age: average 47 years
Female: 0
Mean Ejection Fraction: Not evaluated

Patient Populations:

4,081 Finnish men 40 to 55 years of age with a non-HDL cholesterol level of ≥200 mg/dL.

Exclusions:

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

Primary Endpoints:

Cardiac death and MI

Secondary Endpoints:

All-cause mortality

Drug/Procedures Used:

Gemfibrozil 600 mg twice daily or placebo.

Principal Findings:

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%).

Interpretation:

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.

References:

N Engl J Med 1987; 317: 1237-45. Primary results. JAMA 1988; 260: 641-51. Lipid level data.

Clinical Topics: Diabetes and Cardiometabolic Disease, Dyslipidemia, Prevention, Homozygous Familial Hypercholesterolemia, Lipid Metabolism, Nonstatins

Keywords: Cholesterol, Gemfibrozil, Hypolipidemic Agents, Coronary Disease, Hypercholesterolemia, Triglycerides, Primary Prevention


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