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
{"title":"血管紧张素受体阻滞剂与疑似药物性肝损伤风险：基于韩国电子健康记录通用数据模型的回顾性队列研究》。","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","doi":"10.1007/s40264-024-01418-4","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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]).</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"673-686"},"PeriodicalIF":4.0000,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11182788/pdf/","citationCount":"0","resultStr":"{\"title\":\"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\",\"doi\":\"10.1007/s40264-024-01418-4\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>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.</p><p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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]).</p><p><strong>Conclusions: </strong>We found a significantly higher risk of suspected DILI in patients receiving azilsartan monotherapy compared with valsartan monotherapy. 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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.
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.
期刊介绍：
Drug Safety is the official journal of the International Society of Pharmacovigilance. The journal includes:
Overviews of contentious or emerging issues.
Comprehensive narrative reviews that provide an authoritative source of information on epidemiology, clinical features, prevention and management of adverse effects of individual drugs and drug classes.
In-depth benefit-risk assessment of adverse effect and efficacy data for a drug in a defined therapeutic area.
Systematic reviews (with or without meta-analyses) that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement.
Original research articles reporting the results of well-designed studies in disciplines such as pharmacoepidemiology, pharmacovigilance, pharmacology and toxicology, and pharmacogenomics.
Editorials and commentaries on topical issues.
Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Drug Safety Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.
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