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

Research Project

Project/Area Number 15K08124
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Research Field Medical pharmacy
Research InstitutionNational 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
Project Status Completed (Fiscal Year 2017)
Budget Amount *help
¥4,940,000 (Direct Cost: ¥3,800,000、Indirect Cost: ¥1,140,000)
Fiscal Year 2017: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
Fiscal Year 2016: ¥1,690,000 (Direct Cost: ¥1,300,000、Indirect Cost: ¥390,000)
Fiscal Year 2015: ¥1,690,000 (Direct Cost: ¥1,300,000、Indirect Cost: ¥390,000)
Keywords薬剤疫学 / 糖尿病治療薬 / DPP4阻害薬 / 尿路感染症 / 副作用 / 糖尿病薬
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.

Report

(4 results)
  • 2017 Annual Research Report   Final Research Report ( PDF )
  • 2016 Research-status Report
  • 2015 Research-status Report
  • Research Products

    (1 results)

All 2018

All Journal Article (1 results) (of which Peer Reviewed: 1 results)

  • [Journal Article] Association between dipeptidyl peptidase-4 inhibitors and urinary tract infection in elderly patients: a retrospective cohort study2018

    • Author(s)
      Takuya Imatoh, Takumi Nishi, Midori Yasui, Toshiki Maeda, Kimie Sai, Yoshiro Saito, Hiroshi Une, Akira Babazono
    • Journal Title

      Pharmacoepidemiology & Drug Safety

      Volume: 印刷中

    • Related Report
      2017 Annual Research Report
    • Peer Reviewed

URL: 

Published: 2015-04-16   Modified: 2019-03-29  

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