Acarbose for the prevention of diabetes, hypertension, and cardiovascular disease in subjects with impaired glucose tolerance: the Study to Prevent Non-Insulin-Dependent Diabetes Mellitus (STOP-NIDDM) Trial.

OBJECTIVE: To evaluate, in subjects with impaired glucose tolerance (IGT), the effect of acarbose on the incidence of diabetes, hypertension, and cardiovascular disease.

METHODS: The Study to Prevent Non-Insulin-Dependent Diabetes Mellitus (STOP-NIDDM) Trial was an international, multicenter, double-blind, placebo-controlled, randomized investigation, undertaken in 9 participating countries from December 1995 through August 2001. Patients were randomly assigned to receive placebo (N = 715) or acarbose, 100 mg three times a day (N = 714), and underwent follow-up for a mean of 3.3 years. Sixty-one subjects (4%) were excluded from the study because they did not have IGT or had no postrandomization data; thus, 1,368 subjects remained for intent-to-treat analysis. The outcome measures were the development of diabetes based on a single oral glucose tolerance test, the development of hypertension ((3) 140/90 mm Hg), and the development of major cardiovascular events, including coronary heart disease, cardiovascular death, stroke, and peripheral vascular disease.

RESULTS: Two hundred eleven subjects in the acarbose-treated group and 130 in the placebo group discontinued treatment prematurely; however, they underwent follow-up for assessment of end points. Acarbose treatment resulted in a 25% relative risk reduction in the development of type 2 diabetes (hazards ratio [HR], 0.75; 95% confidence interval [CI], 0.63 to 0.90; P = 0.0015), in a 34% risk reduction in the development of new cases of hypertension (HR, 0.66; 95% CI, 0.49 to 0.89; P = 0.0059), and in a 49% risk reduction in the development of cardiovascular events (HR, 0.51; 95% CI, 0.28 to 0.95; P = 0.03). A post hoc cost-effectiveness analysis done from the Swedish perspective showed that acarbose treatment was likely to be cost-effective in the management of subjects with IGT.

CONCLUSION: The STOP-NIDDM Trial demonstrated that, in subjects with IGT, acarbose treatment was effective in reducing the risk of type 2 diabetes. It also suggested that it was associated with a reduction in hypertension and cardiovascular disease.