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Odkazy a zdroje - Studie - HHS



HHS

Helsinki Heart Study

Author(s)
(a) Frick MH, Elo O, Haapa K et al
(b) Heinonen OP, Huttunen JK, Manninen V et al

Title(s)
(a) Helsinki Heart Study: primary-prevention trial with gemfibrozil in middle-aged men with dyslipidemia
(b) The Helsinki Heart Study: coronary heart disease incidence during an extended follow-up

Reference(s)
(a) N Engl J Med 1987;317:1237-45
(b) J Intern Med 1994:235:41-9

Disease
Coronary heart disease

Purpose
To investigate the effect of gemfibrozil on the incidence of coronary heart disease in asymptomatic middle-aged men at high risk because of abnormal concentrations of blood lipids

Study design
(a) Randomised, double-blind, placebo-controlled
(b) Open

Follow-up
Mean, 60.4 months, post-trial period 3.5 years

Patients
(a) 4081 men (2051 gemfibrozil and 2030 placebo; 2859 completed the study), aged 40-55 years, with serum non-HDL cholesterol level (total cholesterol minus HDL cholesterol) ≥ 200 mg/dl
(b) 3889 men of whom 67% chose gemfibrozil treatment

Treatment regimen
Gemfibrozil, 600 mg bid, or placebo

Concomitant therapy
-

Results
(a) Gemfibrozil initially increased the HDL-cholesterol level by more than 10%, followed by a small decline with time. It reduced the total cholesterol by 11%, the LDL cholesterol by 10%, non-HDL cholesterol by 14% and triglyceride by 43%, though this last level increased slightly during the final years of the trial. The overall reduction in cardiac endpoints in the gemfibrozil group was 34.0% (95% CI 8.2-52.6). Total mortality was 2.19% with gemfibrozil vs 2.07% with placebo (p = ns). Gastrointestinal problems were more common with gemfibrozil
(b) Cardiovascular mortality over the entire study period was similar, but all-cause mortality was slightly higher among men of the original gemfibrozil group compared to the placebo group (p = 0.19)