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Analysis of adverse event after concomitant use of lifestyle disease medications using spontaneous reporting system database

Research Project

Project/Area Number 15K19219
Research Category

Grant-in-Aid for Young Scientists (B)

Allocation TypeMulti-year Fund
Research Field Epidemiology and preventive medicine
Research InstitutionUniversity of Tsukuba

Principal Investigator

Gosho Masahiko  筑波大学, 医学医療系, 教授 (70701019)

Project Period (FY) 2015-04-01 – 2018-03-31
Project Status Completed (Fiscal Year 2017)
Budget Amount *help
¥3,640,000 (Direct Cost: ¥2,800,000、Indirect Cost: ¥840,000)
Fiscal Year 2017: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
Fiscal Year 2016: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000)
Fiscal Year 2015: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000)
Keywordsシグナル検出法 / データベース研究 / 薬物相互作用 / 安全性 / 副作用 / シグナル検出 / データベース / 生活習慣病 / 相互作用 / 薬剤併用
Outline of Final Research Achievements

We proposed a statistical criterion to detect drug-drug interactions causing adverse drug reactions in spontaneous reporting systems. The proposed criterion controlled false positives at an acceptable level and had higher sensitivity than that of an existing criterion when events were rare. We also applied the proposed criterion to a spontaneous reporting system database in order to explore drug-drug interactions that result in hypoglycemia and rhabdomyolysis. We detected combination therapy with the antidiabetic, antihypertensive, and antihyperlipidemic drugs as potential interactions that could result in hypoglycemia and rhabdomyolysis.

Report

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

    (4 results)

All 2018 2017 2016

All Journal Article (2 results) (of which Peer Reviewed: 2 results,  Acknowledgement Compliant: 1 results) Presentation (2 results) (of which Int'l Joint Research: 2 results)

  • [Journal Article] Risk of hypoglycemia after concomitant use of antidiabetic, antihypertensive, and antihyperlipidemic medications: A database study2018

    • Author(s)
      Gosho Masahiko
    • Journal Title

      Journal of Clinical Pharmacology

      Volume: 印刷中

    • Related Report
      2017 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Utilization of chi-square statistics for screening adverse drug-drug interactions in spontaneous reporting systems2017

    • Author(s)
      Gosho, M., Maruo, K., Tada, K., Hirakawa, A.
    • Journal Title

      European Journal of Clinical Pharmacology

      Volume: 73 Issue: 6 Pages: 779-786

    • DOI

      10.1007/s00228-017-2233-3

    • Related Report
      2016 Research-status Report
    • Peer Reviewed / Acknowledgement Compliant
  • [Presentation] Statistical methods for screening adverse drug interactions, with an application to spontaneous reporting systems database2017

    • Author(s)
      Gosho Masahiko
    • Organizer
      28th Annual Conference of the International Society for Clinical Biostatistics
    • Related Report
      2017 Annual Research Report
    • Int'l Joint Research
  • [Presentation] A novel method for detecting adverse drug interactions in spontaneous reporting systems2016

    • Author(s)
      Gosho, M., Tada, K.
    • Organizer
      27th Annual Conference of the International Society for Clinical Biostatistics
    • Place of Presentation
      International Convention Centre (ICC), Birmingham, UK
    • Year and Date
      2016-08-21
    • Related Report
      2016 Research-status Report
    • Int'l Joint Research

URL: 

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

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