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薬理と治療
Abstract
We conducted a post-marketing prospective study of miglitol(SEIBULE(R)), an α-glucosidase inhibitor, over a 24-week observation period in Japanese patients with type 2 diabetes and liver dysfunction, and examined its safety and efficacy, with particular focus on the presence or absence of fatty liver. In this study, the case data were collected via a central registration method using an electronic data capture system. Before administration, the mean AST and ALT levels in the safety population(n=156) was 49.6 and 64.1 U╱L, respectively. In the safety population, 19 patients reported a total of 27 episodes of adverse drug reactions(ADRs);the incidence was 12.2%. The frequent ADRs were diarrhea(11 episodes) and abdominal distension(4 episodes). No serious ADRs were observed. The incidence of ADRs did not increase in patients with type 2 diabetes and fatty liver. In addition, neither severe liver dysfunction nor abnormal liver function test values nor new safety problems were observed in patients with type 2 diabetes and fatty liver. Furthermore, in cases with fatty liver, at 24 weeks after the amount of changes in AST and ALT levels was -14.1 and -18.1 U╱L, respectively; these values indicated significant differences(P<0.05). In terms of efficacy, the amount of changes in HbA1c value and fasting blood glucose level at 24 weeks after the administration of miglitol was -0.69% and -12.8 mg╱dL, respectively, HbA1c value and fasting blood glucose level indicated significant differences(P<0.05). Whereas in cases with fatty liver, the amount of changes in HbA1c value and fasting blood glucose level was -0.77% and -14.5 mg╱dL, respectively; these values indicated significant differences(P<0.05) These results show that miglitol is clinically safe and effective for use in patients with type 2 diabetes and relatively mild liver dysfunction, and did not indicate any problems, regardless of the presence or absence of fatty liver.
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