Tian Xiaoxue, Zheng Shufen, Wang Jing, Yu Meiling, Lin Zhuoheng, Qin Min, Wu Yuanyuan, Chen Shiyu, Zhong Shilong
Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China.
Guangdong Provincial Key Laboratory of Coronary Heart Disease Prevention, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China.
Expert Opin Drug Saf. 2022 Dec;21(12):1505-1510. doi: 10.1080/14740338.2022.2078301. Epub 2022 May 27.
Although cardiac disorder-related adverse events (AEs) have been reported in patients treated with aryl hydrocarbon receptor (AHR) agonists, their safety profiles remain unknown. Here, we identified significant cardiac disorders associated with AHR agonists and further evaluated their relevance.
Database queries were performed using OpenVigil 2.1 and AEs voluntarily submitted to Food and Drug Administration Adverse Event Reporting System (FAERS) between 2004 and 2020 were included. This study based on the Medical Dictionary for Regulatory Activities and the standardized MedDRA Queries to define the preferred terms, and we used reporting odd ratio to detect signals.
In the FAERS database, 14,078 cardiac disorder-related AEs were identified in patients receiving AHR agonists. Among all AHR agonists, the number of cardiac disorder-related PTs with positive signals for AHR agonists was 93. Peripheral swelling (n = 1572) and atrial fibrillation (n = 1277) were the most reported cardiac disorder-related AEs among AHR agonists in disproportionately reported PTs. Moreover, several AHR agonists were highly associated with tachyarrhythmia.
By mining the FAERS database, we provided more information on the association between AHR agonist use and cardiac disorder-related AEs.
尽管在接受芳烃受体（AHR）激动剂治疗的患者中已报告了与心脏疾病相关的不良事件（AE），但其安全性概况仍不清楚。在此，我们确定了与AHR激动剂相关的重大心脏疾病，并进一步评估了它们之间的相关性。
使用OpenVigil 2.1进行数据库查询，并纳入2004年至2020年间自愿提交给美国食品药品监督管理局不良事件报告系统（FAERS）的不良事件。本研究基于《监管活动医学词典》和标准化的MedDRA查询来定义首选术语，并使用报告比值比来检测信号。
在FAERS数据库中，接受AHR激动剂治疗的患者中确定了14,078例与心脏疾病相关的不良事件。在所有AHR激动剂中，AHR激动剂阳性信号的与心脏疾病相关的首选术语数量为93个。外周水肿（n = 1572）和心房颤动（n = 1277）是AHR激动剂中报告最多的与心脏疾病相关的不良事件，属于不成比例报告的首选术语。此外，几种AHR激动剂与快速性心律失常高度相关。
通过挖掘FAERS数据库，我们提供了更多关于使用AHR激动剂与心脏疾病相关不良事件之间关联的信息。
