Abstract：
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
摘要：
血管紧张素受体阻滞剂(ARB)广泛用于治疗高血压和心力衰竭。据报道，血管性水肿是ARB的一种有争议的不良反应，关于个体ARB风险的证据有限。本研究旨在使用美国FDA不良事件报告系统（AERS）数据库评估不同ARB的血管性水肿信号。
■使用监管活动查询医学词典提取了2004-2024年AERS患者以ARB为主要嫌疑人的血管性水肿报告。不相称性分析，包括报告赔率比，比例报告比率，进行贝叶斯置信度传播神经网络和多项目伽马泊松收缩器，以识别单个ARB的安全信号。
■总共3683份独特报告符合选择标准。厄贝沙坦和氯沙坦在所有统计测量中产生信号，其次是替米沙坦和坎地沙坦。缬沙坦的报告计数最高。大多数报告报告住院，血管性水肿导致住院时间延长或危及生命。
■这项使用AERS的药物警戒研究强调了与其他ARB相比，氯沙坦和厄贝沙坦可能发生血管性水肿的风险更高，保证通过前瞻性流行病学研究进行验证，以表征个体ARB安全性。
■使用监管活动查询医学词典提取了2004-2024年AERS患者以ARB为主要嫌疑人的血管性水肿报告。不相称性分析，包括报告赔率比，比例报告比率，进行贝叶斯置信度传播神经网络和多项目伽马泊松收缩器，以识别单个ARB的安全信号。
■总共3683份独特报告符合选择标准。厄贝沙坦和氯沙坦在所有统计测量中产生信号，其次是替米沙坦和坎地沙坦。缬沙坦的报告计数最高。大多数报告报告住院，血管性水肿导致住院时间延长或危及生命。
■这项使用AERS的药物警戒研究强调了与其他ARB相比，氯沙坦和厄贝沙坦可能发生血管性水肿的风险更高，保证通过前瞻性流行病学研究进行验证，以表征个体ARB安全性。
