薬理と治療

Abstract

Objective A post︱marketing surveillance was conducted to obtain information on the safety and efficacy of mitiglinide calcium hydrate, a short︱acting insulin secretagogue（Glufast® Tablet）, for a long︱term combination therapy with α︱glucosidase inhibitor in patient with TypeⅡdiabetes. Methods This surveillance was conducted using a prospective central registration method. An observation period was 18 months. The collected information included the patientʼs background, concomitant medication, laboratory test values and adverse events. Results Adverse drug reactions were reported in 45 of 972 patients（4.63％）. The most frequently reported adverse drug reaction was hypoglycaemia, which was observed in 27 cases （2.78％）, no cases of serious hypoglycaemia were reported. There were no reports of an increased incidence rate of adverse drug reactions and hypoglycaemia related to long︱term concomitant treatment. HbA1c levels（NGSP）were measured to be 7.88±1.29％ at the start of concomitant therapy, 7.13 ±1.09％ after 12 months and 7.10±0.99％ after 18 months. HbA1c levels measured at each of the assessment time︱points were significantly lower（both P＜0.01）than that measured at the baseline, and showed that improvement of the glycemic control was maintained during the 18 months of concomitant therapy. Conclusions In this surveillance, information of approximately 1000 patients was collected and safety and efficacy were investigated. The results showed no new safety issues during the 18 months of concomitant therapy, and a continuous improvement of glycemic control was observed.