Journal Article

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

Sim, Da Woon, An, Hye-Ji, Lee, Jae-Hyun, Kim, Bonggi, Ko, Sung Woo, Chung, Yeon Woong, Kim, Seong Geun, Jeong, Dahee, Kim, Yeesuk, Choi, In Young, Lee, Inho, Park, Hye Jung, Im, Sun, Kim, Hyunjoo, Lee, Jun Kyu, Chang, Dong-Jin, Jun, Dae Won, Choi, Wona, Seo, Jewon, Seo, Young-Gyun, Yi, Siyeon, Chae, Sungeu, Yang, Hyeon-Jong, Byun, Seonjeong, Lee, Eunkyung Euni, Kang, Min-Gyu, Yoo, Myungsik, Son, Nayeong

2024

Overview

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.

• Publisher: Springer International Publishing,Springer Nature B.V
• Subject: Angiotensin / Antihypertensives / Clinical significance / Cohort analysis / Confidence intervals / Contraindications / Data models / Drug Safety and Pharmacovigilance / Electronic health records / Electronic medical records / FDA approval / Health services / Injuries / Liver / Medical records / Medicine / Medicine & Public Health / Original / Original Research Article / Patient safety / Patients / Pharmaceutical industry / Pharmacology/Toxicology / Pharmacovigilance / Prescription drugs / Product safety / Receptors / Regression analysis / Risk / Side effects / Statistical analysis / Weighting methods / Working groups