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The STOP-NIDDM Trial

Jean-Louis Chiasson, MD; Robert G. Josse, MBBS; Ramon Gomis, MD; Markolf Hanefeld, DSC; Avraham Karasik, MD; Markku Laakso, MD; for The STOP-NIDDM Trial Research Group

JAMA. 2003;290:486-494.

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 -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 postrandomization 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 (coronary 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 hyperglycemia with acarbose was associated with a 49% relative risk reduction in the development of cardiovascular events (hazard ratio [HR], 0.51; 95% confidence interval [CI]; 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% CI, 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% CI, 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% CI, 0.24-0.90; P = .02) and hypertension (HR, 0.62; 95% CI, 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.

Author Affiliations: Research Centre, Centre Hospitalier de l'Université de Montréal–Hôtel-Dieu and Department of Medicine, Université de Montréal, Montreal, Quebec (Dr Chiasson); Department of Medicine, St Michael's Hospital, University of Toronto, Toronto, Ontario (Dr Josse); Diabetes Unit, Hospital Clinic, Universitari de Barcelona, Barcelona, Spain (Dr Gomis); Centre for Clinical Studies GWT, Dresden Technical University, Dresden, Germany (Handefeld); Institute of Endocrinology, Chaim Sheba Medical Centre, Tel Hashomer, Israel (Dr Karasik); and Department of Medicine, University of Kuopio, Kuopio, Finland (Dr Laakso).

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