基于FAERS数据库的双膦酸盐类药物相关心律失常的不成比例性分析。

A disproportionality analysis of cardiac arrhythmia associated with bisphosphonates based on the FAERS database.

作者信息

Wang Feifei, Xu Guishui, Wang Qian, Wu Xinan

机构信息

Department of Pharmacy, Hefei BOE Hospital, Intersection of Dongfang Avenue and Wenzhong Road, Xinzhan District, Hefei, 230000, People's Republic of China.

Orthopaedic Department of the First People's Hospital of Anqing, Anqing, 246000, People's Republic of China.

出版信息

Sci Rep. 2025 Jul 1;15(1):20753. doi: 10.1038/s41598-025-00900-y.

Abstract

The impact of bisphosphonates on cardiac arrhythmia has always been controversial. We aimed to evaluate the risk of bisphosphonates (BPs) on arrhythmia and to characterize the main features of BP-induced arrhythmia by data mining the FDA adverse event Reporting System (FAERS). From the first quarter of 2016 to the second quarter of 2022, reports for BP-related cardiac arrhythmia adverse event (AE) from FAERS database were analyzed in this study. The reporting odds ratio (ROR) and information components (IC) were used to identify disproportionate reporting of BP-related cardiac arrhythmias. We identified a total of 2377 BP-related cardiac arrhythmias cases which appeared to influence more women (61.88%) than men (28.02%), with a median age of 70 (interquartile range [IQR] 59-78) years. Compared with the full database, BPs were detected with pharmacovigilance of cardiac arrhythmias (ROR025 = 1.43, [1.39-1.47]). All studied bisphosphonates except ibandronate sodium and clodronate disodium were correlated with the reporting frequency of cardiac arrhythmia (HLGT), with ROR ranging from 1.28 with pamidronate disodium to 11.08 with etidronate disodium. The spectrum of arrhythmias induced by BPs differed among therapeutic regimens. There were significant differences in the onset time among BP regimens. Bisphosphonates use is associated with adverse cardiac arrhythmias, with the exception of ibandronate sodium and clodronate disodium. Our data support differential effects of BPs on cardiac arrhythmias.

摘要

双膦酸盐对心律失常的影响一直存在争议。我们旨在通过挖掘美国食品药品监督管理局不良事件报告系统(FAERS)的数据,评估双膦酸盐(BPs)导致心律失常的风险,并描述BP诱发心律失常的主要特征。本研究分析了2016年第一季度至2022年第二季度FAERS数据库中与BP相关的心律失常不良事件(AE)报告。报告比值比(ROR)和信息成分(IC)用于识别与BP相关的心律失常的不成比例报告。我们共识别出2377例与BP相关的心律失常病例,其中女性(61.88%)受影响的人数似乎多于男性(28.02%),中位年龄为70岁(四分位间距[IQR]59 - 78岁)。与完整数据库相比,检测到BPs与心律失常的药物警戒性相关(ROR025 = 1.43,[1.39 - 1.47])。除伊班膦酸钠和氯膦酸二钠外,所有研究的双膦酸盐均与心律失常的报告频率(HLGT)相关,ROR范围从帕米膦酸二钠的1.28到依替膦酸二钠的11.08。不同治疗方案中BP诱发的心律失常谱有所不同。BP治疗方案之间的发病时间存在显著差异。除伊班膦酸钠和氯膦酸二钠外,双膦酸盐的使用与不良心律失常有关。我们的数据支持BPs对心律失常的不同影响。

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