薬理と治療

Abstract

Objectives To examine the safety and efficacy of mitiglinide╱voglibose fixed-dose combination tablets（mitiglinide calcium hydrate╱voglibose）, a post-marketing surveillance was conducted in patients with type 2 diabetes. Methods This surveillance was conducted using a prospective central registration method. Patients were observed for 12 months or until discontinuation of the drug. Information including patient backgrounds, drug administration status, concomitant medications, adverse events, and laboratory values was collected. Results In total, 124 adverse drug reactions were observed in 101（5.55％）of 1819 patients. The most frequent adverse drug reaction was hypoglycemia; 26 events occurred in 22 patients （1.12％）. Two severe hypoglycemia events were observed in 2 patients, both of whom recovered with appropriate treatment. There was no increase in the cumulative incidence of adverse drug reactions with long-term treatment. HbA1c was 7.48±1.23％ at the baseline and 6.89±0.95％ at 12 months after treatment, and was significantly decreased at all time points from 3 months after treatment, as compared with the start of treatment（P＜0.0001）. Conclusions No increase in adverse drug reactions or the incidence of hypoglycemia was observed with long-term administration of GLUBES® combination tablets, such that there were no new safety concerns. The therapeutic efficacy on diabetes persisted for up to 12 months.