薬理と治療

Abstract

We conducted a post-marketing prospective study of long-term use（52 weeks）of miglitol （SEIBULE(R)）, an α-glucosidase inhibitor, in combination with insulin therapy in Japanese patients with type 1 diabetes and 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＝568）, 198 patients reported a total of 242 episodes of adverse drug reactions（ADRs）; the incidence was 34.9％. The frequent ADRs were hypoglycemia（104 episodes）, diarrhea（33 episodes）, and abdominal distension（23 episodes）. Five serious ADRs were noted: cerebral infarction, lymphoma, hypoglycemia, hypoglycemic unconsciousness, and hepatobiliary disorders（in 1 patient each）. The incidence of ADRs in patients with type 1 and type 2 diabetes was 45.6％（26╱57 patients）and 33.6％（170╱506 cases）, respectively. The incidence of hypoglycemia in patients with type 1 and type 2 diabetes was 36.8％（21╱57 patients）and 16.2％（82╱506 cases）, respectively. Both incidences were lower than those observed in clinical trials in combination with insulin therapy. No problems were observed after the development of hypoglycemia, gastrointestinal disorders, liver dysfunction, and severe cardiovascular disorders. At 52 weeks after the administration of miglitol to patients with type 1 diabetes, the amount of changes in HbA1c and casual blood glucose and fasting blood glucose levels was －0.35％ and －23.8 and －86.0 mg╱dL, respectively. Whereas in patients with type 2 diabetes, the amount of changes was －0.66％ and －37.9 and －22.4 mg╱dL, respectively；which indicated significant differences（P＜0.05）. These results show that miglitol is clinically safe and effective for long-term use in patients with type 1 and type 2 diabetes in combination with insulin therapy.