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; Eunkyung Euni Lee

doi:10.1007/s40264-024-01418-4

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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

Authors: 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 ; Eunkyung Euni Lee

Citation: DRUG SAFETY, Vol.47(7) : 673-686, 2024-07

Journal Title: DRUG SAFETY

ISSN: 0114-5916

Issue Date: 2024-07

MeSH: Adult ; Aged ; Angiotensin Receptor Antagonists* / adverse effects ; Antihypertensive Agents / adverse effects ; Benzimidazoles / adverse effects ; Chemical and Drug Induced Liver Injury* / epidemiology ; Chemical and Drug Induced Liver Injury* / etiology ; Cohort Studies ; Electronic Health Records* / statistics & numerical data ; Female ; Humans ; Incidence ; Male ; Middle Aged ; Republic of Korea / epidemiology ; Retrospective Studies ; Risk Factors ; Valsartan / adverse effects

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.