A Short-Term, Randomized, Double-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Dronedarone versus Amiodarone in Patients with Persistent Atrial Fibrillation: The DIONYSOS Study
A Short-Term, Randomized, Double-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Dronedarone versus Amiodarone in Patients with Persistent Atrial Fibrillation: The DIONYSOS Study
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DOI：
10.1111/j.1540-8167.2010.01764.x
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发表时间：
2010-06-01
影响因子：
2.7
通讯作者：
Davy, Jean-Marc
中科院分区：
文献类型：
--
作者：
Le Heuzey, Jean-Yves;De Ferrari, Gaetano M.;Davy, Jean-Marc
方法：540例未使用胺碘酮的患者随机分为两组，分别接受单次400 mg （n = 249）或600 mg (qd)，连续28天，然后再接受200 mg (n = 255)，连续至少6个月。主要综合终点为房颤复发（包括不成功的电复律、无自发转复和无电复律）或过早终止研究。主要安全终点（MSE）是甲状腺、肝脏、肺、神经、皮肤、眼睛或胃肠道特异性事件的发生，或不良事件后过早停药。结果：中位治疗时间为7个月。在12个月时，drone edarone和胺碘酮的主要复合终点分别为75.1和58.8%（风险比[HR] 1.59； 95%可信区间[CI] 1.28-1.98; P < 0.0001），主要是由于drone edarone与胺碘酮的房颤复发（63.5 vs 42.0%）。非甾体酮和胺碘酮组心律转复成功后的房颤复发率分别为36.5%和24.3%。过早停药的情况在drone - edarone组较少（10.4% vs 13.3%）。在12个月时，drone - edarone组和胺碘酮组的MSE分别为39.3和44.5% (HR = 0.80; 95% CI 0.60-1.07; P = 0.129)，主要是由于drone - edarone组的甲状腺、神经、皮肤和眼部事件较少。结论：在这项短期研究中，无人机酮在减少房颤复发方面不如胺碘酮有效，但具有更好的安全性，特别是在甲状腺和神经系统事件方面，并且缺乏与口服抗凝药物的相互作用。（J cardiovascular Electrophysiol, Vol. 21, pp. 597-605, 2010年6月）。
Methods: Five hundred and four amiodarone-naive patients were randomized to receive dronedarone 400 mg bid (n = 249) or amiodarone 600 mg qd for 28 days then 200 mg qd (n = 255) for at least 6 months. Primary composite endpoint was recurrence of AF (including unsuccessful electrical cardioversion, no spontaneous conversion and no electrical cardioversion) or premature study discontinuation. Main safety endpoint (MSE) was occurrence of thyroid-, hepatic-, pulmonary-, neurologic-, skin-, eye-, or gastrointestinal-specific events, or premature study drug discontinuation following an adverse event.Results: Median treatment duration was 7 months. The primary composite endpoint was 75.1 and 58.8% with dronedarone and amiodarone, respectively, at 12 months (hazard ratio [HR] 1.59; 95% confidence interval [CI] 1.28-1.98; P < 0.0001), mainly driven by AF recurrence with dronedarone compared with amiodarone (63.5 vs 42.0%). AF recurrence after successful cardioversion was 36.5 and 24.3% with dronedarone and amiodarone, respectively. Premature drug discontinuation tended to be less frequent with dronedarone (10.4 vs 13.3%). MSE was 39.3 and 44.5% with dronedarone and amiodarone, respectively, at 12 months (HR = 0.80; 95% CI 0.60-1.07; P = 0.129), and mainly driven by fewer thyroid, neurologic, skin, and ocular events in the dronedarone group.Conclusion: In this short-term study, dronedarone was less effective than amiodarone in decreasing AF recurrence, but had a better safety profile, specifically with regard to thyroid and neurologic events and a lack of interaction with oral anticoagulants. (J Cardiovasc Electrophysiol, Vol. 21, pp. 597-605, June 2010).