Ex) Article Title, Author, Keywords
Ex) Article Title, Author, Keywords
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.
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*
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.
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.
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