Gao Shujun, Dai Wanju, Zhang Ling, Juhaeri Juhaeri, Wang Yunxun, Caubel Patrick
Clinical Safety and Pharmacovigilance, Daiichi Sankyo, Edison, NJ 08837, USA.
Global Pharmacovigilance and Epidemiology, Sanofi, Bridgewater, 08807, USA.
J Atr Fibrillation. 2013 Dec 31;6(4):890. doi: 10.4022/jafib.890. eCollection 2013 Dec.
No published studies have evaluated the risks of cardiovascular (CV) events, stroke, congestive heart failure (CHF), interstitial lung disease (ILD), and severe acute liver injury (ALI) related to antiarrhythmics treatment in real-world clinical practice setting. We examined the relationship between the above events and the selected antiarrhythmics in the real-world setting in the US. Using a retrospective cohort design, the hazard ratios of the outcome events were analyzed from 10,455 adult patients with a diagnosis of atrial fibrillation/atrial flutter and a new treatment with dronedarone (comparison drug), amiodarone, sotalol, flecainide, or propafenone between 07/20/2009 and 12/31/2010 from the Clinformatics Data MartTM database. The patients were followed until: 1) switch to another antiarrhythmic drug, 2) occurrence of the outcome event, 3) end of enrollment, or 4) end of the study period, whichever occurred first. No significant differences were observed in the hazard ratios of the outcome events between dronedarone, amiodarone, and the other antiarrhythmics, except that amiodarone was associated with a higher risk of CV events (adjusted HR = 1.7, 95%CI: 1.1-2.4) and stroke (adjusted HR = 2.0, 95%CI: 1.33.2), compared to dronedarone, especially amongst patients without a CHF history (adjusted HR = 2.4, 95%CI: 1.4-3.8 and 2.2, 95%CI: 1.23.9). A higher risk of CHF was also associated with amiodarone in patients without history of CHF at baseline (adjusted HR = 2.7, 95%CI: 2.03.6). In this real-world investigation, no difference in risk was observed between dronedarone, sotalol, and propafenone initiators for CV events, stroke, CHF, ILD, and ALI. Amiodarone was associated with higher risks of CV events, stroke, and CHF than dronedarone in patients without a CHF history, indicating dronedarone could be an alternative therapy option with lower risk of CV events than amiodarone for the above patients.
尚无已发表的研究评估在实际临床实践环境中与抗心律失常药物治疗相关的心血管（CV）事件、中风、充血性心力衰竭（CHF）、间质性肺疾病（ILD）和严重急性肝损伤（ALI）的风险。我们在美国的实际环境中研究了上述事件与所选抗心律失常药物之间的关系。采用回顾性队列设计，从Clinformatics Data MartTM数据库中分析了2009年7月20日至2010年12月31日期间10455例诊断为房颤/房扑且新接受决奈达隆（对照药物）、胺碘酮、索他洛尔、氟卡尼或普罗帕酮治疗的成年患者的结局事件风险比。对患者进行随访直至：1）换用另一种抗心律失常药物，2）发生结局事件，3）入组结束，或4）研究期结束，以先发生者为准。在决奈达隆、胺碘酮与其他抗心律失常药物之间，结局事件的风险比未观察到显著差异，但与决奈达隆相比，胺碘酮与更高的CV事件风险（调整后HR = 1.7，95%CI：1.1 - 2.4）和中风风险（调整后HR = 2.0，95%CI：1.3 - 3.2）相关，尤其是在无CHF病史的患者中（调整后HR = 2.4，95%CI：1.4 - 3.8和2.2，95%CI：1.2 - 3.9）。在基线无CHF病史的患者中，胺碘酮也与更高的CHF风险相关（调整后HR = 2.7，95%CI：2.0 - 3.6）。在这项实际调查中，在CV事件、中风、CHF、ILD和ALI方面，决奈达隆、索他洛尔和普罗帕酮起始治疗者之间未观察到风险差异。在无CHF病史的患者中，胺碘酮与CV事件、中风和CHF的风险高于决奈达隆，表明对于上述患者，决奈达隆可能是一种CV事件风险低于胺碘酮的替代治疗选择。
