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Issue 121 Item 6 EASD: Acarbose Prevents Diabetes in Pre-Diabetes Patients

May 5, 2002
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A 25 percent reduction in the incidence of type 2 diabetes mellitus during the course of the trial.

An in-depth analysis of the data collected during the long-term, international "Study TO Prevent Non-Insulin-Dependent Diabetes Mellitus" (STOP-NIDDM) trial indicates that different subgroups of patients with impaired glucose tolerance (IGT) have different levels of benefits from taking acarbose with each meal.

 

 

The data were presented at the 38th annual meeting of EASD.

Initial results of the STOP-NIDDM trial, which were released earlier this year in The Lancet (Vol. 359, No. 9323:2072-2077), show that, overall, there was a 25 percent reduction in the incidence of type 2 diabetes mellitus during the course of the trial among IGT patients taking acarbose.

The study was an international, multicenter, double-blind, placebo-controlled randomized trial. The researchers randomly assigned 1429 subjects with IGT (age 54.5 ±7.9 years, BMI 30.9 ±4.2 kg/m²) to receive either placebo or acarbose (100 mg 3 times a day) with each meal, for a mean follow-up time of 3.3 years.

The results showed that acarbose reduced the conversion from IGT to type 2 diabetes mellitus by 25 percent (relative hazard [RH]: 0.75, p=0.0015) in subjects with one abnormal oral glucose tolerance test (OGTT) at the beginning of the study. When the diagnosis of IGT was based on two subsequent (abnormal) OGTTs, the reduction in type 2 diabetes mellitus was 36 percent.

No serious side effects were observed with drug treatment. Therefore, this study provides evidence that prevention of type 2 diabetes is achievable in a high-risk group, without harmful side-effects.

Subsequent analysis of the data revealed that the likelihood of preventing T2DM in patients with IGT varied among different subgroups of patients. For example, females appeared to benefit slightly more than men did (RH: 0.71 vs 0.77, p=0.009 vs 0.04). In general, subgroups with IGT are different in their risk to develop diabetes, the researchers noted. "Acarbose is effective in all subject groups investigated, with pronounced effects in elderly subjects, women, subjects with BMI<30, and those with normal insulin and blood pressure levels," they concluded.
The study was funded by an educational grant from Bayer, the manufacturer of acarbose.