The pharmacoepidemiological study on the adverse reaction of novel therapeutic agent for type 2 diabetes mellitus and the application

2017 Fiscal Year Final Research Report

• Project/Area Number: 15K08124
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Research Field: Medical pharmacy
• Research Institution: National Institute of Health Sciences
• Principal Investigator: Imatoh Takuya 国立医薬品食品衛生研究所, 医薬安全科学部, 主任研究官 (20368989)
• Co-Investigator(Kenkyū-buntansha): 堀 雄史 浜松医科大学, 医学部附属病院, 薬剤師 (20436786) ; 川上 純一 浜松医科大学, 医学部附属病院, 教授 (50272539)
• Project Period (FY): 2015-04-01 – 2018-03-31
• Keywords: 薬剤疫学 / 糖尿病治療薬

Outline of Final Research Achievements

We conducted a pharmacoepidemiological study on SGLT2 inhibitors and DPP4 inhibitors which are a new class of anti-diabetes treatment. First, we compared adverse reactions by therapeutic category using JADER. As a result, we observed that combination of DPP4 inhibitors and other anti-diabetic drugs induced the development of hypoglycemia. Next, we assessed the association between DPP4 inhibitors combination therapy and acute pancreatitis using self-controlled case series design. There were no significant association between DPP4 inhibitors combination therapy and development of acute pancreatitis. Finally, we conducted a retrospective cohort study by using health care insurance claims data. The use of DPP4 inhibitors was associated with an increased risk of UTI. Moreover, elderly male patients with prostatic hyperplasia who received DPP4 inhibitors had a higher risk of UTI than SU users without prostatic hyperplasia.

Free Research Field

疫学