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The Helsinki Heart Study: coronary heart disease incidence during an extended follow‐up
Author(s) -
Hein O. P.,
Huttunen J. K.,
Manninen V.,
Mänttäri M.,
Koskinen P.,
Tenkanen L.,
Frick M. H.
Publication year - 1994
Publication title -
journal of internal medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.625
H-Index - 160
eISSN - 1365-2796
pISSN - 0954-6820
DOI - 10.1111/j.1365-2796.1994.tb01030.x
Subject(s) - gemfibrozil , medicine , placebo , incidence (geometry) , randomization , coronary heart disease , placebo group , randomized controlled trial , surgery , pathology , cholesterol , physics , alternative medicine , optics
. Objectives . To confirm that coronary heart disease (CHD) can be prevented by gemfibrozil treatment and to estimate the long‐term effect of the treatment. Design . All participants of the Helsinki Heart Study, a controlled 5‐year CHD primary prevention trial with gemfibrozil and placebo, were offered gemfibrozil treatment and biannual follow‐up for 3.5 more years. Setting . By the end of the multi‐clinic double‐blind trial, a 34% difference in definite cardiac events (56 vs. 84; P < 0.2) had developed between the gemfibrozil and placebo groups. Subjects . There were 2046 dyslipidaemic men in the gemfibrozil group at randomization, 1961 started the extended follow‐up; the comparison group comprised 2035 men, and 5 years later 1928 men. Interventions . Gemfibrozil was selected by 66.3% of gemfibrozil and 68.5% of placebo men without previous CHD end‐points. Main outcome measures . Definite fatal and non‐fatal CHD events are reported, possible CHD events were recorded but reported selectively. Results . During the post‐trial period the numbers of definite CHD events in both groups (54 vs. 47; NS) were smaller than expected without treatment, namely a reduction of around 40% for the original treatment groups. The mean incidence rates were in fact similar to that in the placebo group 5 years earlier. The post‐trial CHD incidence was lowest amongst the placebo group men who later selected gemfibrozil. Cardiovascular mortality over the entire study period was similar but all‐cause mortality was slightly higher amongst men of the original gemfibrozil group compared to the placebo group men ( P = 0.19). Conclusions . Thus prolonged gemfibrozil treatment postpones cardiac events. This protective effect presumably involves both attenuation of atherosclerosis and mechanisms related to acute cardiac events.