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Abstract
Eleven-year mortality rates were studied in middle aged men who had participated in a randomised 5-year multifactorial primary prevention trial on cardiovascular diseases during 1974–1980. The men were given health education advice before the study. The 5-year trial markedly improved the risk factor status in the men in the intervention group (n = 612), but their 5-year incidence of total coronary events tended to be higher than in the randomised non-treated control group (n = 610) and significantly higher than in a non-randomised, non-treated low risk group (n = 593). During the six years following the discontinuation of the trial, 11 deaths from cardiovascular disease occurred both in the intervention and in the control groups and three in the non-randomised low risk group. Thus, the cumulative eleven-year cardiovascular mortality rates and their 95% confidence intervals (Cl95) were 2.45% (Cl95: 1.38, 3.67) in the intervention group and 1.97% (Cl95: 1.01, 3.34) in the randomised high risk control group. In the non-randomised low risk group the mortality rate was 0.51 (CI95: 0.01,1.46). Multiple logistic regression analysis showed that overweight and hypercholesterolaemia, and smoking in the high risk controls, were the initial risk factors associated with the 11-year cardiovascular mortality. The latter was not accumulated in any treatment measure during the prevention period. Furthermore, despite the unfavourable effect of β-blocking agents on total cardiac events during the intervention, β-blockers were not associated with cardiac deaths in the 11-year follow up. Thus, despite a significant net reduction of the risk factor level, we could not show any favorable effect on cardiovascular or total mortality in our multifactorial primary prevention trial in middle aged men resistant to pretrial preventive measures intended to lower coronary risk factors.
