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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 12-week observation period in Japanese patients with type 2 diabetes and examined its safety and efficacy. In this study, the case data were collected via a central registration method using an electronic data capture system. In the safety population(n=3273), 335 patients reported a total of 391 episodes of adverse drug reactions(ADRs); the incidence was 10.2%. The frequent ADRs were diarrhea(114 episodes), abdominal distension(62 episodes), and flatulence(32 episodes). Three cases of serious ADRs were noted: hypoglycemia, lacunar infarction, and liver dysfunction(1 patient each). The incidence of ADRs related to hepatic function disorder, including abnormal liver function test values, was 1.2%(39╱3273 patients), and no deterioration in liver function test values was observed. Furthermore, the incidence of ADRs did not increase in patients with liver disorder, renal disorder, and those aged 65 years or older; thus, miglitol could be used safely in these patients. In terms of efficacy, the amount of changes in HbA1c value and casual blood glucose, fasting blood glucose, 1 h post-load blood glucose, and 2 h post-load blood glucose levels at 12 weeks after the administration of miglitol was -0.66% and -28.9, -19.3, -63.1, and -43.5 mg╱dL, respectively, which indicated significant differences(P<0.05). These results show that miglitol is clinically safe and effective for use in patients with type 2 diabetes.
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