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Abstract：
Objective: This study aimed to identify the different associations between antiarrhythmic drugs (AADs) and arrhythmias, and to determine whether pharmacokinetic drug interactions involving AADs increase the risk of AAD-related arrhythmias compared to using AADs alone. Materials and methods: The disproportionality analysis of AAD-associated cardiac arrhythmias, including AAD monotherapies and concomitant use of pharmacokinetic interacting agents involving AADs, was conducted by using reporting odds ratio (ROR) and information component (IC) as detection of potential safety signals based on FAERS data from January 2016 to June 2022. We compared the clinical features of patients reported with AAD-associated arrhythmias between fatal and non-fatal groups, and further investigated the onset time (TTO) following different AAD regimens. Results: A total of 11754 AAD-associated cardiac arrhythmias reports were identified, which was more likely to occur in the elderly (52.17%). Significant signals were detected between cardiac arrhythmia and all AAD monotherapies, with ROR ranging from 4.86 with mexiletine to 11.07 with flecainide. Regarding four specific arrhythmias in High Level Term (HLT) level, the AAD monotherapies with the highest ROR were flecainide in cardiac conduction disorders (ROR025 = 21.18), propafenone in rate and rhythm disorders (ROR025 = 10.36), dofetilide in supraventricular arrhythmias (ROR025 = 17.61), and ibutilide in ventricular arrhythmias (ROR025 = 4.91). Dofetilide/ibutilide, ibutilide, mexiletine/ibutilide and dronedarone presented no signal in the above four specific arrhythmias respectively. Compared with amiodarone monotherapy, sofosbuvir plus amiodarone detected the most significantly increased ROR in arrhythmias. Conclusion: The investigation showed the spectrum and risk of AAD-associated cardiac arrhythmias varied among different AAD therapies. The early identification and management of AAD-associated arrhythmias are of great importance in clinical practice.
摘要：
目的：本研究旨在确定抗心律失常药物（AADs）与心律失常之间的不同关联。并确定与单独使用AAD相比，涉及AAD的药代动力学药物相互作用是否会增加AAD相关心律失常的风险。材料和方法：AAD相关心律失常的不相称性分析，包括AAD单一疗法和伴随使用涉及AAD的药代动力学相互作用剂，根据2016年1月至2022年6月的FAERS数据，通过使用报告比值比（ROR）和信息成分（IC）检测潜在的安全性信号。我们比较了致命组和非致命组之间报告的AAD相关心律失常患者的临床特征。并进一步研究了不同AAD方案后的起效时间（TTO）。结果：共确认11754例AAD相关心律失常报告，这更容易发生在老年人身上(52.17%)。在心律失常和所有AAD单一疗法之间检测到显著信号，ROR范围从4.86美西律到11.07氟卡尼。关于高水平术语（HLT）水平的四种特异性心律失常，ROR最高的AAD单一疗法是氟卡尼治疗心脏传导障碍（ROR025=21.18），普罗帕酮在心率和节律紊乱中的作用（ROR025=10.36），多非利特治疗室上性心律失常（ROR025=17.61），和伊布利特在室性心律失常中的作用（ROR025=4.91）。多非利特/伊布利特,伊布替利德,美西律/伊布利特和决奈达隆分别在上述四种特异性心律失常中均无信号。与胺碘酮单药治疗相比，索非布韦加胺碘酮在心律失常中检测到最显著的ROR增加。结论：研究表明，AAD相关心律失常的频谱和风险在不同的AAD疗法中有所不同。AAD相关心律失常的早期识别和治疗在临床实践中非常重要。
