The association of highly active antiretroviral therapy (HAART) regimens including protease inhibitors (PIs) with metabolic and somatic disorders raised concern on the possibility of an increased risk of coronary artery disease (CAD) in HIV-infected subjects. Aim of the study was to assess the incidence of CAD over time in previously untreated HIV-infected patients according to the antiretroviral therapeutic regimen.PATIENTS AND METHODS: 1551 HIV-infected subjects (mean age 35) were randomly assigned to receive HAART either with PIs (Group PIs+:n=776) or without PIs (Group PIs-: n=775). During the course of the study, clinical examination and laboratory tests were performed every four months. The cumulative incidence of CAD-related events, in terms of recently developed angina, unstable angina, fatal and nonfatal myocardial infarction was the primary outcome of the study.The median duration of follow-up was 36 months (range 34 to 42 months).Statistical analysis was by intention-to-treat.RESULTS: During the follow-up period CAD-related events were observed in 23 patients of group PIs and in 2 patients of Group PIs- (OR: 11.8; 95% CI: 2.4 to 50.2). The cumulative annual incidence of CAD-related events was 9.8/1000 Group PIs+ and 0.8/1000 in Group PIs- (P<0.001). The annual incidence of myocardial infarction was 5.1/1000 in Group PIs+ and 0.4/1000 in Group PIs- (P<0.001). Multivariate analysis showed that the incidence of CAD-related events was related to dyslipidemia (OR:14.2; 95% CI:3.06-26.7),to lipodystrophy (OR:11.2; 95% CI:4.8-32.4), to smoking (OR:9.7;95% CI:3.5-16.7) and to male gender (OR:5.28; 95% CI: 1.7 to 18.3), independently of age of the patients.CONCLUSIONS AND CLINICAL IMPLICATIONS: PIs-including HAART may accelerate the onset CAD-related events in young male smokers who develop metabolic disorders and lipodistrophy. Subjects with increased coronary risk should receive a careful cardiologic monitoring if treated with PIs.
G. Barbaro, None.