Article type
Year
Abstract
Introduction: An alpha-glucosidase inhibitor is considered as one of the promising oral medication classes for non-insulin-dependent diabetes mellitus (NIDDM). Despite the limited clinical data so far in Japan, a quantitative overview must be useful.
Objective: We quantitatively assessed the relative efficacy and safety of alpha-glucosidase inhibitors vs placebo for the treatment of NIDDM.
Methods: Literature search was performed using the JAPIC-DOB biomedical database and contacted to the two production companies. Drugs already on market were two in Japan: acarbose and voglibose. Placebo-controlled randomized trials have been published in two articles on acarbose and three articles on voglibose.
Results: The primary endpoint was a global improvement scale of blood glucose, rated in a 5-point scale. The best two categories were recognized as effective. Efficacy rate was defined by the proportion of effective cases among all the treated patients by each arm. Overall odds ratio for efficacy was 2.79 (95% CI: 1.54 to 5.04, 2P <0.001) and the difference in efficacy was 21.1% (95% CI: 7.6 to 34.6%), where the efficacy rate in a placebo group was 19.8% (95% CI: 15.9 to 24.5%). Risk for flatulence was estimated as the odds ratio of 3.1 (95% CI: 1.7 to 5.7), and the risk difference was 13.7% (95% CI: 4.7 to 22.8%). However, a large amount of heterogeneity among trials was found; 18%, 29% for acarbose; 17%, 5%, 5% for voglibose. The overall risk for flatulence in placebo was estimated to be 13.5%.
Discussion: An alpha-glucosidase inhibitor might be effective for the patients with NIDDM. Acarbose showed an exceptionally high flatulence incidence in contrast with voglibose, which was 25% higher than placebo.
Objective: We quantitatively assessed the relative efficacy and safety of alpha-glucosidase inhibitors vs placebo for the treatment of NIDDM.
Methods: Literature search was performed using the JAPIC-DOB biomedical database and contacted to the two production companies. Drugs already on market were two in Japan: acarbose and voglibose. Placebo-controlled randomized trials have been published in two articles on acarbose and three articles on voglibose.
Results: The primary endpoint was a global improvement scale of blood glucose, rated in a 5-point scale. The best two categories were recognized as effective. Efficacy rate was defined by the proportion of effective cases among all the treated patients by each arm. Overall odds ratio for efficacy was 2.79 (95% CI: 1.54 to 5.04, 2P <0.001) and the difference in efficacy was 21.1% (95% CI: 7.6 to 34.6%), where the efficacy rate in a placebo group was 19.8% (95% CI: 15.9 to 24.5%). Risk for flatulence was estimated as the odds ratio of 3.1 (95% CI: 1.7 to 5.7), and the risk difference was 13.7% (95% CI: 4.7 to 22.8%). However, a large amount of heterogeneity among trials was found; 18%, 29% for acarbose; 17%, 5%, 5% for voglibose. The overall risk for flatulence in placebo was estimated to be 13.5%.
Discussion: An alpha-glucosidase inhibitor might be effective for the patients with NIDDM. Acarbose showed an exceptionally high flatulence incidence in contrast with voglibose, which was 25% higher than placebo.