Dronedarone for maintenance of sinus rhythm in atrial fibrillation or flutter
Dronedarone for maintenance of sinus rhythm in atrial fibrillation or flutter
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DOI：
10.1056/nejmoa054686
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发表时间：
2007-09-06
影响因子：
158.5
通讯作者：
Hohnloser, Stefan H.
中科院分区：
文献类型：
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作者：
Singh, Bramah N.;Connolly, Stuart J.;Hohnloser, Stefan H.
背景胺碘酮可有效维持心房颤动的窦性心律，但具有潜在的严重毒性作用。决奈达隆是一种新型抗心律失常药，药理学上与胺碘酮相关，但旨在降低副作用风险。 方法 在两项相同的多中心、双盲、随机试验中，一项在欧洲进行（ClinicalTrials.gov 编号，NCT000259428），另一项在美国、加拿大、澳大利亚、南非和阿根廷进行（称为非欧洲试验， NCT000259376），我们评估了决奈达隆的疗效，828 名患者每天两次服用 400 毫克该药物，409 名患者接受安慰剂。在第 2、3 和 5 天通过电话监测心律； 3、5、7 和 10 个月时；心律失常复发期间；以及 12 个月期间的 9 次定期访问。主要终点是心房颤动或扑动首次复发的时间。结果在欧洲试验中，心律失常复发的中位时间安慰剂组为 41 天，决奈达隆组为 96 天（P=0.01）。非欧洲试验的相应持续时间分别为 59 和 158 天（P=0.002）。在欧洲试验中心律失常复发时，安慰剂组的平均（+/-SD）心室率为每分钟 117.5+/-29.1 次，决奈达隆组为每分钟 102.3+/-24.7 次（P
BackgroundAmiodarone is effective in maintaining sinus rhythm in atrial fibrillation but is associated with potentially serious toxic effects. Dronedarone is a new antiarrhythmic agent pharmacologically related to amiodarone but developed to reduce the risk of side effects.MethodsIn two identical multicenter, double-blind, randomized trials, one conducted in Europe (ClinicalTrials.gov number, NCT000259428) and one conducted in the United States, Canada, Australia, South Africa, and Argentina (termed the non-European trial, NCT000259376), we evaluated the efficacy of dronedarone, with 828 patients receiving 400 mg of the drug twice daily and 409 patients receiving placebo. Rhythm was monitored transtelephonically on days 2, 3, and 5; at 3, 5, 7, and 10 months; during recurrence of arrhythmia; and at nine scheduled visits during a 12-month period. The primary end point was the time to the first recurrence of atrial fibrillation or flutter.ResultsIn the European trial, the median times to the recurrence of arrhythmia were 41 days in the placebo group and 96 days in the dronedarone group (P=0.01). The corresponding durations in the non-European trial were 59 and 158 days (P=0.002). At the recurrence of arrhythmia in the European trial, the mean (+/-SD) ventricular rate was 117.5+/-29.1 beats per minute in the placebo group and 102.3+/-24.7 beats per minute in the dronedarone group (P