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Pharmacoepidemiology and Risk Management 2024; 16(1): 79-89

Published online March 31, 2024 https://doi.org/10.56142/perm.24.0009

Copyright © Korean Society for Pharmacoepidemiology and Risk Management.

Comparison of Drug-Induced Liver Injury in Fimasartan and Losartan Using Common Data Model and Clinical Data Warehouse: A Single Hospital Retrospective Cohort Study

공통데이터 모델과 임상 데이터 웨어하우스를 이용한 Fimasartan과 Losartan의 약물 유발 간 손상의 발생 비교: 단일 의료기관 후향적 코호트 연구

Jin Yoon1,2*, Hyun Jee Kim1,2, Yeh-Hee Ko3, Siyeon Yi4, Kyung-Min Ahn1,2, Jiung Jeong5, Ji-Hyang Lee1,2, Kwangsoo Kim6,7*, Hye-Ryun Kang1,2,5*

윤진1,2*, 김현지1,2, 고예희3, 이시연4, 안경민1,2, 정지웅5, 이지향1,2, 김광수6,7*, 강혜련1,2,5*

1Drug Safety Center, Seoul National University Hospital, Seoul, Korea
2Regional Pharmacovigilance Center, Seoul National University Hospital, Seoul, Korea
3Biomedical Informatics Lab, Seoul National University Hospital, Seoul, Korea
4Interdisciplinary Program of Medical Informatics, Seoul National University College of Medicine, Seoul, Korea
5Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea
6Department of Transdisciplinary Medicine, Institute of Convergence Medicine with Innovative Technology, Seoul National University Hospital, Seoul, Korea
7Department of Medicine, Seoul National University College of Medicine, Seoul, Korea

1서울대학교병원 약물안전센터, 2서울대학교병원 지역의약품안전센터, 3서울대학교병원 의생명정보학연구실, 4서울대학교 의과대학 협동과정 의료정보학전공, 5서울대학교 의과대학 내과학교실, 6서울대학교병원 융합의학기술원 융합의학과, 7서울대학교 의과대학 의학과

Correspondence to:Hye-Ryun Kang
Department of Internal Medicine, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul 03080, Korea
Tel: +82-2-2072-0820
Fax: +82-2-742-3291
E-mail: helenmed@snu.ac.kr

Kwangsoo Kim
Department of Transdisciplinary Medicine, Institute of Convergence Medicine with Innovative Technology, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul 03080, Korea
Tel: +82-2-2072-4489
Fax: +82-2-6072-5304
E-mail: kksoo716@gmail.com

*These authors equally contributed to this work.

Received: March 7, 2024; Revised: March 21, 2024; Accepted: March 22, 2024

This is an Open-Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Objective: Fimasartan, an angiotensin II receptor blocker (ARB) with superior potency and longer-lasting effects than losartan, demonstrates a good safety profile. However, recent case reports have emerged, linking fimasartan to hepatotoxicity. The aim of the study is to compare the occurrence of liver injury induced by fimasartan. Methods: Patients prescribed with fimasartan and losartan from 2011 to 2021 were identified from electronic health recordbased Common Data Model (CDM) of Seoul National University Hospital. Using clinical data warehouse, clinical information was collected and employed to cross-reference the results retrieved from the CDM. To assess causality and compare the incidence of drug-induced liver injury (DILI), 100 randomly selected patients with liver function abnormalities were evaluated. Results: The CDM analysis included 3,063 patients on fimasartan and 9,688 patients on losartan, among which 302 patients (2.37%) exhibited liver function abnormalities within the first year of ARB therapy. Specifically, 107 (3.49%) patients on fimasartan showed elevated serum alanine aminotransferase or aspartate aminotransferase, compared to 195 (2.01%) patients on losartan. However, when causality was assessed, patients with causality graded as probable or certain did not show any significant difference between the two medications. Conclusion: Although patients taking fimasartan exhibited a slightly higher incidence of mild liver enzyme elevations, this study did not find a significant difference in the occurrence of DILI. Consequently, fimasartan is less safe than losartan in terms of hepatotoxicity cannot be asserted. However, similar to other ARBs, fimasartan poses a risk of DILI, underscoring the importance of monitoring liver function tests to promote safer use of the medication.

KeywordsFimasartan, Losartan, Drug-induced liver injury, Common data model

Korean Society for Pharmacoepidemiology and Risk Management

Vol.16 No.2
September, 2024

eISSN 2982-5954

Frequency: Bimonthly

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