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Signal Detection of DPP-IV Inhibitors using Spontaneous Adverse Event Reporting System in Korea

자발적 부작용 보고 데이터베이스를 이용한 DPP- IV inhibitor의 약물이상사례 분석

  • Hyejung Pyo (College of Pharmacy and the Graduate School of Converging Clinical & Public Health, Ewha Womans University) ;
  • Tae Young Kim (College of Pharmacy, Chungbuk National University) ;
  • Su Been Choi (College of Pharmacy, Chungbuk National University) ;
  • Hyeong Jun Jo (College of Pharmacy, Chungbuk National University) ;
  • Hae Lee Kang (College of Pharmacy, Chungbuk National University) ;
  • Jung Sun Kim (College of Pharmacy and Graduate School of Pharmaceutical Sciences, Ewha Womans University) ;
  • Hye Sun Gwak (College of Pharmacy and Graduate School of Pharmaceutical Sciences, Ewha Womans University) ;
  • Ji Min Han (College of Pharmacy, Chungbuk National University)
  • 표혜정 (이화여자대학교 임상보건융합대학원) ;
  • 김태영 (충북대학교 약학대학) ;
  • 최수빈 (충북대학교 약학대학) ;
  • 조형준 (충북대학교 약학대학) ;
  • 강해리 (충북대학교 약학대학) ;
  • 김정선 (이화여자대학교 약학대학) ;
  • 곽혜선 (이화여자대학교 약학대학) ;
  • 한지민 (충북대학교 약학대학)
  • Received : 2024.03.24
  • Accepted : 2024.05.23
  • Published : 2024.06.30

Abstract

Background: The purpose of this study was to detect signals of adverse events (AEs) of DPP-IV inhibitors using the KIDs-Korea Adverse Event Reporting System (KAERS) database. Methods: This study was conducted using AEs reported from January 2009 to December 2018 in the KIDs-KAERS database. For signal detection, disproportionality analysis was performed. Signals of DPP-IV inhibitor that satisfied the data-mining indices of reporting odds ratio (ROR) were detected. Results: Among the total number of 10,364 AEs to all oral hypoglycemic agents, the number of reported AEs related to DPP-IV inhibitors was 1,674. Analysis of reported AEs of DPP-IV inhibitors at the SOC levels showed that Respiratory system disorders were the highest at 4.31 (95% CI 3.01-6.17), followed by Skin and appendages disorders at 2.04 (95% CI 1.74-2.38). When analyzing AEs reported at the PT level, pharyngitis was the highest at 73.90 (95% CI 17.59-310.49), followed by arthralgia at 6.08 (95% CI 2.04-18.11), and coughing at 5.21 (95% CI 2.07-13.15). Conclusions: Based on the result of the study, deeper consideration is required according to the characteristics of the patients in prescribing DPP-IV inhibitors among oral hypoglycemic agents, and continuous monitoring of the occurrence of related Adverse Drug Reactions during administration is also required.

Keywords

Acknowledgement

이 논문은 2020학년도 충북대학교 학술연구지원사업의 연구비 지원에 의해 연구되었음.

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