Pharmacoepidemiol Risk Manage.  2024 Mar;16(1):79-89. 10.56142/perm.24.0009.

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

• Yoon J
• Kim HJ
• Ko YH
• Yi S
• Ahn KM
• Jeong J
• Lee JH
• Kim K
• Kang HR

• KMID: 2556395
• DOI: http://doi.org/10.56142/perm.24.0009

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.

Keyword

Fimasartan; Losartan; Drug-induced liver injury; Common data model