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.

IF 4 2区医学 Q1 PHARMACOLOGY & PHARMACY Drug Safety Pub Date : 2024-07-01 Epub Date: 2024-03-21 DOI:10.1007/s40264-024-01418-4

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

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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.

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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》。

简介血管紧张素受体阻滞剂是韩国广泛使用的降压药。2021 年，韩国食品药品安全部承认需要对使用阿齐沙坦后引起的药物性肝损伤（DILI）进行国家赔偿。然而，人们对血管紧张素受体阻滞剂与 DILI 之间的关系知之甚少：我们从一个通用数据模型数据库（2017 年 1 月 1 日至 2021 年 12 月 31 日）中对血管紧张素受体阻滞剂的事件使用者进行了一项回顾性队列研究，以比较特定血管紧张素受体阻滞剂与缬沙坦之间的 DILI 风险：根据处方血管紧张素受体阻滞剂将患者分配到治疗组。药物性肝损伤采用国际DILI专家工作组标准进行定义。通过 Cox 回归分析得出危险比，并采用逆概率治疗加权法。所有分析均使用R语言进行：共纳入了 20 家大学医院的 229,881 名血管紧张素受体阻滞剂使用者。各治疗组的粗DILI发生率从每千人年15.6例到82.8例不等，大多数为胆汁淤积型，且病情较轻。总体而言，奥美沙坦使用者的DILI风险明显低于缬沙坦使用者（危险比：0.73 [95%置信区间0.55-0.96]）。在单药治疗患者中，阿齐沙坦使用者的风险明显高于缬沙坦使用者（危险比：6.55 [95% 置信区间：5.28-8.12]）：我们发现，与缬沙坦单药治疗相比，接受阿齐沙坦单药治疗的患者发生疑似DILI的风险明显更高。我们的研究结果表明，真实世界的证据有助于加深我们对临床实践中药物不良反应的理解。

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来源期刊

Drug Safety 医学-毒理学

CiteScore

7.60

自引率

7.10%

发文量

112

审稿时长

6-12 weeks

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.