Safety and efficacy of amiodarone and dronedarone for early rhythm control in EAST-AFNET 4.

IF 3.8 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

Clinical Research in Cardiology Pub Date : 2025-05-19 DOI:10.1007/s00392-025-02637-0

Laura Rottner, Marc D Lemoine, Lars Eckardt, Katrin Borof, A John Camm, Andreas Goette, Günter Breithardt, Andreas Metzner, Ulrich Schotten, Antonia Zapf, Hein Heidbüchel, Stephan Willems, Harry Crijns, Renate B Schnabel, Larissa Fabritz, Christina Magnussen, Andreas Rillig, Paulus Kirchhof

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引用次数: 0

Abstract

Aims: Concerns exist about the safety of amiodarone and dronedarone. We assessed the long-term outcome of both drugs for early rhythm control (ERC) in the EAST-AFNET 4 trial.

Methods and results: Patients randomized for ERC and treated with amiodarone or dronedarone were compared to other ERC-therapies. Patients receiving amiodarone or dronedarone at initial therapy (n = 653/1395) were older with more comorbidities and less paroxysmal atrial fibrillation (AF, 29%) compared to patients never receiving amiodarone or dronedarone (Amiodarone/Dronedarone^never, 43% paroxysmal AF). Patients treated with amiodarone had more often heart failure (HF, 42%) and persistent AF (40%) compared to patients treated with dronedarone (16% HF, 15% persistent AF) and Amiodarone/Dronedarone^never (25% HF, 22% persistent AF). 115/398 amiodarone-treated patients (6.7/100 patient-years) and 51/255 dronedarone-treated patients (4.2/100 patient-years) experienced a primary efficacy outcome (cardiovascular death, stroke, HF-hospitalization or acute coronary syndrome), while 98/398 (5.3/100 patient-years) and 43/255 (3.4/100 patient-years) experienced a primary safety outcome (death, stroke or serious adverse events related to rhythm-control therapy). Serious adverse events related to drug therapy were similar for amiodarone (1.4/100 patient-years), dronedarone (1.2/100 patient-years), and other ERC (0.8/100 patient-years). Dronedarone (hazard ratio (HR) 0.5; CI 0.28-0.91), age (HR 1.05; CI 1.03-1.07), coronary artery disease (HR 1.84; CI 1.38-2.46) and stable HF (HR 1.66; CI 1.28-2.16) were associated with efficacy outcome upon multivariate Cox regression. Age (HR 1.07; CI 1.05-1.09) and left ventricular hypertrophy (HR 1.94; CI 1.13-3.32) were associated with safety outcome.

Conclusion: Early rhythm control using amiodarone or dronedarone rarely led to drug-related serious adverse events in EAST-AFNET 4.

Clinical trial registration: ISRCTN04708680, NCT01288352, EudraCT2010-021258-20.

查看原文本刊更多论文

胺碘酮和drone - edarone用于EAST-AFNET早期心律控制的安全性和有效性。

目的：人们对胺碘酮和无人机酮的安全性存在担忧。我们在EAST-AFNET 4试验中评估了两种药物用于早期心律控制（ERC）的长期结果。方法和结果：随机选择接受胺碘酮或drone -酮治疗的ERC患者与其他ERC治疗进行比较。初始治疗时接受胺碘酮或drone - edarone治疗的患者（n = 653/1395）比从未接受胺碘酮或drone - edarone治疗的患者年龄更大，合并症更多，发作性房颤（AF, 29%）更少（胺碘酮/ drone - edarononnever， 43%发作性房颤）。胺碘酮治疗的患者发生心力衰竭（心衰，42%）和持续性房颤（40%）的频率高于非胺碘酮治疗的患者（心衰16%，持续性房颤15%）和胺碘酮/非胺碘酮（心衰25%，持续性房颤22%）。115/398胺碘酮治疗患者（6.7/100患者-年）和51/255非甾体酮治疗患者（4.2/100患者-年）的主要疗效结局（心血管死亡、卒中、hf住院或急性冠状动脉综合征），而98/398（5.3/100患者-年）和43/255（3.4/100患者-年）的主要安全性结局（死亡、卒中或与心律控制治疗相关的严重不良事件）。与药物治疗相关的严重不良事件与胺碘酮（1.4/100患者-年）、drone -酮（1.2/100患者-年）和其他ERC（0.8/100患者-年）相似。Dronedarone(风险比（HR） 0.5；CI 0.28-0.91)，年龄(HR 1.05；CI 1.03-1.07)，冠状动脉疾病(HR 1.84；CI 1.38-2.46)和稳定HF (HR 1.66；多因素Cox回归结果显示，CI 1.28-2.16)与疗效结果相关。年龄(HR 1.07；CI 1.05-1.09)和左室肥厚(HR 1.94；CI 1.13-3.32)与安全性结果相关。结论：在EAST-AFNET患者中，早期使用胺碘酮或非奈达酮控制心律很少导致药物相关的严重不良事件。临床试验注册：ISRCTN04708680， NCT01288352, EudraCT2010-021258-20。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical Research in Cardiology 医学-心血管系统

CiteScore

11.40

自引率

4.00%

发文量

140

审稿时长

4-8 weeks

期刊介绍： Clinical Research in Cardiology is an international journal for clinical cardiovascular research. It provides a forum for original and review articles as well as critical perspective articles. Articles are only accepted if they meet stringent scientific standards and have undergone peer review. The journal regularly receives articles from the field of clinical cardiology, angiology, as well as heart and vascular surgery. As the official journal of the German Cardiac Society, it gives a current and competent survey on the diagnosis and therapy of heart and vascular diseases.