薬理と治療

Abstract

Objectives A post︱marketing surveillance was conducted to collect information on the safety and efficacy of long︱term combination therapy of mitiglinide calcium hydrate（GLUFAST(R) Tablet）, a short-acting insulin secretagogue, and a thiazolidine derivative in patients with type 2 diabetes. Methods This surveillance was conducted using a prospective central registration method from July 2009 to June 2012. An observation period was 18 months. Information including the background of patients, concomitant medications, laboratory values and adverse events was collected. Results Adverse drug reactions were observed in 49 （4.6％）out of 1071 patients in the safety analysis set. The most frequent adverse drug reaction was hypoglycaemia, which occurred in 23 cases（2.1％）. There was no increase in the incidence of adverse drug reactions and hypoglycaemia with long︱term combination therapy. HbA1c（NGSP）was 7.75 ±1.25％ at the start of combination therapy, and 6.98±0.97％ and 6.88±1.00％ at 12 and 18 months after starting combination therapy, respectively. The change in HbA1c from the start of combination therapy at 12 and 18 months was －0.72 ±1.07％ and －0.78±1.16％, respectively, with these being significant decreases at both time points（both P＜0.001）. The improvement in blood glucose levels was maintained during 18 months of combination therapy. Conclusions In this surveillance, information on more than 1000 patients treated with this combination therapy was collected and the safety and efficacy were evaluated. No new relevant safety findings were observed during the 18 months of combination therapy period. With regard to efficacy, sustained improvement in blood glucose levels was observed.