Angiotensin Receptor Blockers and the Risk of Suspected Drug-Induced Liver Injury: A Retrospective Cohort Study Using Electronic Health Record-Based Common Data Model in South Korea

Hyunjoo Kim, Nayeong Son, Dahee Jeong, Myungsik Yoo, In Young Choi, Wona Choi, Yeon Woong Chung, Sung Woo Ko, Seonjeong Byun, Sun Im, Da Woon Sim, Jewon Seo, Min-Gyu Kang, Jun Kyu Lee, Young-Gyun Seo, Hye-Ji An, Yeesuk Kim, Sungeu Chae, Dae Won Jun, Dong-Jin Chang, Seong Geun Kim, Siyeon Yi, Hyeon-Jong Yang, Inho Lee, Hye Jung Park, Jae-Hyun Lee, Bonggi Kim () and Eunkyung Euni Lee ()
Additional contact information
Hyunjoo Kim: Korea Institute of Drug Safety and Risk Management
Nayeong Son: Korea Institute of Drug Safety and Risk Management
Dahee Jeong: Korea Institute of Drug Safety and Risk Management
Myungsik Yoo: Korea Institute of Drug Safety and Risk Management
In Young Choi: The Catholic University of Korea
Wona Choi: The Catholic University of Korea
Yeon Woong Chung: The Catholic University of Korea
Sung Woo Ko: The Catholic University of Korea
Seonjeong Byun: The Catholic University of Korea
Sun Im: The Catholic University of Korea
Da Woon Sim: Chonnam National University Medical School
Jewon Seo: Chonnam National University Hospital
Min-Gyu Kang: Chungbuk National University Hospital and Chungbuk National College of Medicine
Jun Kyu Lee: Dongguk University Ilsan Hospital
Young-Gyun Seo: Hallym University Sacred Heart Hospital
Hye-Ji An: Hallym University Sacred Heart Hospital
Yeesuk Kim: Hanyang University
Sungeu Chae: Hanyang University
Dae Won Jun: Hanyang University
Dong-Jin Chang: HD Junction Inc
Seong Geun Kim: Inje University Sanggye Paik Hospital
Siyeon Yi: Seoul National University College of Medicine
Hyeon-Jong Yang: Soonchunhyang University Medical Center
Inho Lee: Soonchunhyang University Medical Center
Hye Jung Park: Yonsei University College of Medicine
Jae-Hyun Lee: Yonsei University College of Medicine
Bonggi Kim: Korea Institute of Drug Safety and Risk Management
Eunkyung Euni Lee: Seoul National University

Drug Safety, 2024, vol. 47, issue 7, No 6, 673-686

Abstract: Abstract Introduction Angiotensin receptor blockers are widely used antihypertensive drugs in South Korea. In 2021, the Korea Ministry of Food and Drug Safety acknowledged the need for national compensation for a drug-induced liver injury (DILI) after azilsartan use. However, little is known regarding the association between angiotensin receptor blockers and DILI. Objective We conducted a retrospective cohort study in incident users of angiotensin receptor blockers from a common data model database (1 January, 2017–31 December, 2021) to compare the risk of DILI among specific angiotensin receptor blockers against valsartan. Methods Patients were assigned to treatment groups at cohort entry based on prescribed angiotensin receptor blockers. Drug-induced liver injury was operationally defined using the International DILI Expert Working Group criteria. Cox regression analyses were conducted to derive hazard ratios and the inverse probability of treatment weighting method was applied. All analyses were performed using R. Results In total, 229,881 angiotensin receptor blocker users from 20 university hospitals were included. Crude DILI incidence ranged from 15.6 to 82.8 per 1000 person-years in treatment groups, most were cholestatic and of mild severity. Overall, the risk of DILI was significantly lower in olmesartan users than in valsartan users (hazard ratio: 0.73 [95% confidence interval 0.55–0.96]). In monotherapy patients, the risk was significantly higher in azilsartan users than in valsartan users (hazard ratio: 6.55 [95% confidence interval 5.28–8.12]). Conclusions We found a significantly higher risk of suspected DILI in patients receiving azilsartan monotherapy compared with valsartan monotherapy. Our findings emphasize the utility of real-world evidence in advancing our understanding of adverse drug reactions in clinical practice.

Date: 2024
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DOI: 10.1007/s40264-024-01418-4

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