Department of Pharmacy, University of Peshawar , Peshawar, Khyber Pakhtunkhwa, Pakistan.
Expert Opin Drug Saf. 2021 Jan;20(1):101-107. doi: 10.1080/14740338.2021.1846717. Epub 2020 Nov 13.
: This study aimed to measure the association of various H1-antihistamines (H1A) with Torsade de Pointes (TdP), and present a comprehensive overview of H1A-induced TdP cases reported to the Food and Drug Administration Adverse Event Reporting System (FAERS). : All H1A-induced TdP cases (n = 406) were retrieved from the FAERS database using the preferred term 'Torsade de Pointes' of MedDRA version-22 from 1990 to 2019. Four data-mining algorithms were used for disproportionality analysis: Reporting Odds Ratio (ROR); Proportional Reporting Ratio (PRR), Empirical Bayes Geometric Mean (EBGM), and Information Content (IC). H1A with >3 TdP cases were included. : A total of 12 signals (Astemizole, cetirizine, chlorpheniramine, clemastine, desloratadine, diphenhydramine, hydroxyzine, loratadine, meclizine, promethazine, terfenadine, and trimeprazine) were identified including six new signals (cetirizine, chlorpheniramine, clemastine, desloratadine, loratadine, and meclizine). The number of risk factors (p = 0.031) and concomitant QT-prolonging drugs (p = <0.001) were significantly lower among new signals vs old signals. Moreover, new signals were strongly associated with QT-prolongation, cardiac reactions, and electrolyte abnormalities as compared with old signals. : Our study found the increased torsadogenic potential of new signals compared with previously known old signals, hence necessitating clinical studies to determine the actual torsadogenic potential of newly identified signals.
本研究旨在测量各种 H1 抗组胺药(H1A)与尖端扭转型室性心动过速(TdP)的关联,并全面概述向食品和药物管理局不良事件报告系统(FAERS)报告的 H1A 引起的 TdP 病例。
使用 MedDRA 版本 22 的首选术语“尖端扭转型室性心动过速”,从 1990 年到 2019 年,从 FAERS 数据库中检索到所有 H1A 引起的 TdP 病例(n=406)。使用四种数据挖掘算法进行不成比例分析:报告比值比(ROR);比例报告比(PRR),经验贝叶斯几何平均值(EBGM)和信息量(IC)。包括 H1A 有>3 例 TdP 病例。
共确定了 12 个信号(阿司咪唑、西替利嗪、氯苯那敏、氯马斯汀、地氯雷他定、苯海拉明、羟嗪、氯雷他定、美克洛嗪、异丙嗪、特非那定和曲美苄嗪),包括 6 个新信号(西替利嗪、氯苯那敏、氯马斯汀、地氯雷他定、氯雷他定和美克洛嗪)。新信号的风险因素数量(p=0.031)和同时使用 QT 延长药物(p<0.001)明显低于旧信号。此外,与旧信号相比,新信号与 QT 延长、心脏反应和电解质异常强烈相关。
我们的研究发现,新信号与先前已知的旧信号相比,致扭转型潜力增加,因此需要进行临床研究以确定新确定信号的实际致扭转型潜力。