Résumé :
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[BDSP. Notice produite par INIST-CNRS dR0xw9ri. Diffusion soumise à autorisation]. Context : The worldwide explosive increase in type 2 diabetes mellitus and its cardiovascular morbidity are becoming major health concerns. Objective To evaluate the effect of decreasing postprandial hyperglycemia with acarbose, an alpha-glucosidase inhibitor, on the risk of cardiovascular disease and hypertension in patients with impaired glucose tolerance (IGT). Design, Setting, and Participants : International, multicenter double-blind, placebo-controlled, randomized trial, undertaken in hospitals in Canada, Germany, Austria, Norway, Denmark, Sweden, Finland, Israel, and Spain from July 1998 through August 2001. A total of 1429 patients with IGT were randomized with 61 patients (4%) excluded because they did not have IGT or had no post randomization data, leaving 1368 patients for a modified intent-to-treat analysis. Both men (49%) and women (51%) participated with a mean (SD) age of 54.5 (7.9) years and body mass index of 30.9 (4.2). These patients were followed up for a mean (SD) of 3.3 (1.2) years. Intervention Patients with IGT were randomized to receive either placebo (n=715) or 100 mg of acarbose 3 times a day (n=714). Main Outcome Measures : The development of major cardiovascular events (corn. nary heart disease, cardiovascular death, congestive heart failure, cerebrovascular event, and peripheral vascular disease) and hypertension (>=140/90 mm Hg). Results : Three hundred forty-one patients (24%) discontinued their participation prematurely, 211 in the acarbose-treated group and 130 in the placebo group ; these patients were also followed up for outcome parameters. Decreasing postprandial hyper-glycemia with acarbose was associated with a 49% relative risk reduction in the development of cardiovascular events (hazard ratio [HR], 0.51 ; 95% confidence interval [Cl] ; 0.28-0.95 ; P=03) and a 2.5% absolute risk reduction. Among cardiovascular events, the major reduction was in the risk of myocardial infarction (HR, 0.09 ; 95% Cl, 0.01-0.72 ; P=02). Acarbose was also associated with a 34% relative risk reduction in the incidence of new cases of hypertension (HR, 0.66 ; 95% Cl, 0.49-0.89 ; P=006) and a 5.3% absolute risk reduction. Even after adjusting for major risk factors, the reduction in the risk of cardiovascular events (HR, 0.47 ; 95% Cl, 0.24-0.90 ; P=02) and hypertension (HR, 0.62 ; 95% Cl, 0.45-0.86 ; P=004) associated with acarbose treatment was still statistically significant. Conclusion : This study suggests that treating IGT patients with acarbose is associated with a significant reduction in the risk of cardiovascular disease and hypertension.
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