Effect of combined clofibrate-nicotinic acid treatment in ischemic heart disease An interim report

Abstract

Over a three and a half year period beginning in December 1972, 555 survivors of myocardial infarction (442 men and 113 women) under the age of 70 years were recruited from one hospital for a therapeutic trial aimed to reduce serum lipids and to study the effect on subsequent morbidity and mortality. Following a stabilization period of 3 months after infarction, patients were given a dietary program to reduce serum lipids. Patients were then randomly divided into (a) a treatment group which received a combined regimen of nicotinic acid (up to 3 g daily) and 2 g of clofibrate daily, and (b) a control group on diet alone. By April 1979, 59 and 57 patients in the control and drug-treated groups respectively had completed 5 years in the trial. In the same respective groups, 101 and 99 patients continued in the study. In comparison with the control group serum cholesterol and triglycerides showed mean falls of 14 and 19% respectively in the drug-treated group over the 5-year period. During the trial there were 39 and 25 IHD deaths in the control and drug-treated groups respectively (P = 0.06). Further mortality in the year after leaving the trial brought the totals to 53 and 31 IHD deaths (P < 0.01) in the same respective groups. Non-fatal infarcts occurred at rates of 4.6 and 2.5 (P < 0.05) per 100 man- years in control and drug groups respectively, while all combined major IHD events were, again respectively, 8.6 and 5.2 per 100 man-years (P < 0.01). There were no significant differences in number of other causes of deaths between the groups. The importance of achieving significant serum lipid lowering for obtaining effects on IHD is stressed.