Sridharan Kannan, Sivaramakrishnan Gowri
Department of Pharmacology & Therapeutics, College of Medicine & Medical Sciences, Arabian Gulf University, Manama, Kingdom of Bahrain.
Dental Post Graduate Training Department, PHCC, Manama, Kingdom of Bahrain.
Expert Opin Drug Saf. 2024 Aug 19:1-8. doi: 10.1080/14740338.2024.2393279.
Angiotensin receptor blockers (ARBs) are widely used for treating hypertension and heart failure. Angioedema has been reported as a controversial adverse effect of ARBs and the evidence on individual ARB risks is limited. This study aimed to assess signals of angioedema with different ARBs using the US FDA Adverse Event Reporting System (AERS) database.
Reports of angioedema from 2004 to 2024 in AERS with an ARB as the primary suspect were extracted using Medical Dictionary for Regulatory Activities queries. Disproportionality analyses including reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network and multi-item gamma Poisson shrinker were conducted to identify safety signals for individual ARBs.
A total of 3,683 unique reports met the selection criteria. Irbesartan and losartan generated signals in all statistical measures, followed by telmisartan and candesartan in some measures. Valsartan had the highest report count. Most reports reported hospitalization, prolonged hospitalization or life-threatening outcomes consequent to angioedema.
This pharmacovigilance study using AERS highlights potential higher risks of angioedema with losartan and irbesartan compared to other ARBs, warranting validation through prospective epidemiological studies to characterize individual ARB safety profiles.
血管紧张素受体阻滞剂（ARBs）被广泛用于治疗高血压和心力衰竭。血管性水肿已被报道为ARBs的一种有争议的不良反应，且关于个别ARB风险的证据有限。本研究旨在使用美国食品药品监督管理局不良事件报告系统（AERS）数据库评估不同ARBs引起血管性水肿的信号。
使用《监管活动医学词典》查询，从2004年至2024年AERS中提取以ARB为主要怀疑对象的血管性水肿报告。进行了包括报告比值比、比例报告比、贝叶斯置信传播神经网络和多项目伽马泊松收缩器在内的不成比例分析，以识别个别ARBs的安全信号。
共有3683份独特报告符合入选标准。厄贝沙坦和氯沙坦在所有统计方法中均产生信号，其次是替米沙坦和坎地沙坦在某些方法中产生信号。缬沙坦的报告数量最多。大多数报告称血管性水肿导致住院、延长住院时间或出现危及生命的后果。
这项使用AERS的药物警戒研究强调，与其他ARBs相比，氯沙坦和厄贝沙坦引起血管性水肿的潜在风险可能更高，需要通过前瞻性流行病学研究进行验证，以明确个别ARB的安全性概况。
