Korean Journal of Clinical Pharmacy (한국임상약학회지)

Korean College Of Clinical Pharmacy (한국임상약학회)
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Signal detection for adverse event of varenicline in Korea Adverse Event Reporting System

의약품부작용보고시스템을 이용한 바레니클린의 이상사례 실마리정보 도출

  • Jang, Min-Gyo (College of Pharmacy, Research Institute of Pharmaceutical Sciences, Kyungpook National University) ;
  • Gu, Hyun-Jin (College of Pharmacy, Research Institute of Pharmaceutical Sciences, Kyungpook National University) ;
  • Kim, Junwoo (Daegu Health College Hospital, Department of Family Medicine) ;
  • Shin, Kwang-Hee (College of Pharmacy, Research Institute of Pharmaceutical Sciences, Kyungpook National University)
  • 장민교 (경북대학교 약학대학, 약학연구소) ;
  • 구현진 (경북대학교 약학대학, 약학연구소) ;
  • 김준우 (대구보건대학교병원 가정의학과) ;
  • 신광희 (경북대학교 약학대학, 약학연구소)
  • Received : 2021.11.27
  • Accepted : 2022.03.03
  • Published : 2022.03.31
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Abstract

Objective: The purpose of this study was to detect signals of Adverse Events (AEs) after varenicline treatment using spontaneous AEs reporting system in Korea. Methods: This study was conducted by Korea Institute of Drug Safety and Risk Management-Korea Adverse Event Reporting System Database (KIDS-KD) reported from January 2013 to December 2017 through Korea Adverse Event Reporting System. Signals of varenicline that satisfied the data-mining indices, proportional reporting ratio, reporting odds ratio and information component were defined. The detected signals were checked whether they included in drug labels in South Korea and United States of America (USA). Results: A total number of drug AE reports associated with all drugs in the KIDS-KD reported between January 2013 and December 2017 was 2,665,429. Among them, the number of AE reports associated with varenicline was 1,398. Eighteen meaningful signals of varenicline were detected that satisfied with the criteria of data-mining indices. Finally, two signals such as hypotonia, incorrected dose administered were not included in the drug labels. Conclusion: New AE signals of varenicline that were not listed on the drug labels in South Korea and USA were detected. However, further pharmacoepidemiological studies such as randomized controlled trial are needed to evaluate the causality of the signals of varenicline.

Keywords

Acknowledgement

본 연구는 한국연구재단 이공학개인기초기본연구 지원 사업의 지원을 수행되었다(NRF-2018R1D1A1B07050267). 본 논문은 교육부 및 한국연구재단의 4단계 두뇌한국21 사업(4단계 BK21 사업)으로 지원된 연구이다(5199990614732).

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