[The Roman coronary heart disease prevention program. Final results].

The Rome Project of Coronary Heart Disease Prevention (PPCC) is a primary prevention trial of coronary heart disease; it represents the Italian section of the WHO European Multifactor Preventive Trial of CHD. The study has been carried out in 4 working groups of male subjects aged 40-59 years at entry, two groups (a total of 3,131 men) being assigned to treatment and the other two (a total of 2,896 men) to control, with a 6-year follow-up. The preventive intervention aimed at reducing or modifying: mean levels of serum cholesterol (generally through dietary prescriptions and, in a smaller number of subjects, with drug treatment), smoking habits (subjects were advised to reduce or stop smoking); overweight (by means of diet); sedentary life-style (with increased physical activity). The intervention program has also involved other factors such as high levels of serum triglycerides, blood glucose and serum uric acid. The treatment was carried out through individual sessions on about one third of subjects belonging to the upper part of an estimated coronary risk score, while mass education was administered to the remaining two thirds. No intervention at all was offered to the control groups. Changes in the levels of risk factors were measured through periodical examinations of the whole population enrolled in the trial. Monitoring of both fatal and non fatal morbid events provided data on mortality and incidence trends. Over the 6 years of follow-up, the mean reduction in the mean levels of the main coronary risk factors in treated groups, as compared to controls, was as follows: serum cholesterol: 4.8%; systolic blood pressure: 4.6%; number of cigarettes per day: 8.7%; body weight: 2.4%; estimated coronary risk: 38.9%. At the end of the 6 years of observation, mortality for all causes was lower by 6.0% to 10.7% in treated groups than in controls; mortality for coronary heart disease was also lower (by 26.8% to 30.2%), as well as the incidence of fatal plus non-fatal coronary heart disease (by 25.4% to 30.9%). These differences were dependent on the different types of analysis. Those concerning coronary mortality and coronary incidence--hard criteria--are statistically significant.

RCT Entities:   Population Interventions Outcomes