薬理と治療

Abstract

Objectives The aim of this prospective observational post︱marketing surveillance of the specified drug︱use survey was to evaluate the clinical safety and efficacy of long︱term combination therapy of pioglitazone with biguanide︱based medicine in patients with type 2 diabetes mellitus. Methods This survey was conducted from February 2009 to January 2012 with the central registration system. Pioglitazone （15︱45 mg）was administered once daily for 12 months additionally to patients with type 2 diabetes mellitus who had inadequate glycemic control despite traetment with biguanide. Results The incidence of adverse drug reactions was 8.98％ （79╱880 subjects）. The frequent adverse drug reactions were edema（2.27％）, body weight increase（1.82％）and peripheral edema（0.68％）. Hypoglycemia was reported in 3 subjects（0.34％, 3 events）, but all those events were not serious and recovered. HbA1c was reduced from 8.34±1.217％ at baseline to 7.49±1.163％ at final evaluation. The reduction of HbA1c was observed at 3 months and maintained until 12 months in this survey. Similar finding was also observed for fasting blood glucose. These results of efficacy were consistent with the previous studies and revealed no significant safety issues. Conclusion Our findings suggest that the combination therapy with pioglitazone and bigua-nide︱based medicine in patients with type 2 diabetes mellitus is clinically safe, efficacious and useful.