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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

Author

Listed:
  • Hyunjoo Kim

    (Korea Institute of Drug Safety and Risk Management
    Seoul National University)

  • 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)

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.

Suggested Citation

  • 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 & Y, 2024. "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," Drug Safety, Springer, vol. 47(7), pages 673-686, July.
    • Handle: RePEc:spr:drugsa:v:47:y:2024:i:7:d:10.1007_s40264-024-01418-4
    DOI: 10.1007/s40264-024-01418-4
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