THE HELSINKI-HEART-STUDY - CORONARY HEART-DISEASE INCIDENCE DURING ANEXTENDED FOLLOW-UP

Objectives. To confirm that coronary heart disease (CHD) can be preven ted by gemfibrozil treatment and to estimate the long-term effect of t he treatment. Design. All participants of the Helsinki Heart Study, a controlled 5-year CHD primary prevention trial with gemfibrozil and pl acebo, were offered gemfibrozil treatment and biannual follow-up for 3 .5 more years. Setting. By the end of the multi-clinic double-blind tr ial, a 34% difference in definite cardiac events (56 vs. 84;P < 0.2) h ad developed between the gemfibrozil and placebo groups. Subjects. The re were 2046 dyslipidaemic men in the gemfibrozil group at randomizati on, 1961 started the extended follow-up; the comparison group comprise d 2035 men, and 5 years later 1928 men. Interventions. Gemfibrozil was selected by 66.3% of gemfibrozil and 68.5% of placebo men without pre vious CHD end-points. Main outcome measures. Definite fatal and non-fa tal CHD events are reported, possible CHD events were recorded but rep orted selectively. Results. During the post-trial period the numbers o f 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 simil ar to that in the placebo group 5 years earlier. The post-trial CHD in cidence was lowest amongst the placebo group men who later selected ge mfibrozil. Cardiovascular mortality over the entire study period was s imilar 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 o f atherosclerosis and mechanisms related to acute cardiac events.