ORLANDO (EGMN) – The novel multichannel-blocking antiarrhythmic agent dronedarone cut the risk of cardiovascular hospitalization or all-cause mortality by 24% in a meta-analysis of five placebo-controlled, randomized trials involving 6,157 patients with atrial fibrillation or atrial flutter.

Although this decrease in the combined end point was driven mainly by fewer cardiovascular hospitalizations, patients on dronedarone also experienced highly significant 29% and 51% reductions in cardiovascular death and sudden death, respectively, Dr. Stefan H. Hohnloser reported at the annual meeting of the American College of Cardiology.

Patients assigned to dronedarone took 400 mg twice daily for a collective 3,684 patient-years.

Dronedarone exhibited a favorable safety profile, most importantly with regard to its reassuringly low proarrhythmia potential. Only one case of torsade de pointes occurred in a dronedarone-treated patient, who had multiple torsade risk factors.

Cardiovascular hospitalization or death from any cause occurred in 25.9% of the dronedarone group compared with 34.3% of those on placebo. This is the only antiarrhythmic agent ever shown to reduce morbidity and mortality in patients with atrial fibrillation or flutter, observed Dr. Hohnloser, professor of medicine at J.W. Goethe University, Frankfurt.

The most common side effects in dronedarone-treated patients were diarrhea or nausea/vomiting, which occurred in 15% of these patients, compared with 9% on placebo. Among those on the antiarrhythmic agent, 10% developed a rash, as did 7% of those on placebo. A rise in serum creatinine level occurred in 4% of those on dronedarone and 1.1% on of those placebo.

Prior analyses have established that dronedarone is effective both in controlling ventricular rate and in maintaining normal sinus rhythm.

The new meta-analysis incorporated the DAFNE, ADONIS, ATHENA, ERATO, and EURIDIS trials. The meta-analysis is timely, as a U.S. Food and Drug Administration advisory panel voted 10-3 in March to recommend marketing approval for dronedarone, a Sanofi-Aventis drug.

Dr. Hohnloser disclosed serving as a paid consultant to Sanofi-Aventis, Cardiome, ARYx Therapeutics, and Bristol-Myers Squibb.

Copyright (c) 2009 Elsevier Global Medical News. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

奥兰多(EGMN) ——一项纳入5项安慰剂对照研究、总共6157例房颤或房扑患者的参与的随机临床试验，荟萃分析显示，治疗心律失常的新型多通道阻滞剂决奈达隆（dronedarone）可降低患者的心血管病住院风险及全因病死率下降24%。

尽管上述降低最终主要是由心血管病住院率的降低所致，但决奈达隆组患者的心血管病病死率和猝死率也分别有29%和51%的大幅降低。上述结果是由Stefan H. Hohnloser博士在美国心脏病学会（ACC）年会上报道的。

决奈达隆组患者接受决奈达隆治疗，400 mg，每天2次，几年内共计随访了3,684 位患者。

决奈达隆显示出了良好的安全性，尤为重要的是其促心律失常危险较低。仅1例决奈达隆治疗者发生了尖端扭转型室速，且该患者本身存在发生尖端扭转型室速的多个危险因素。

决奈达隆组患者的心血管病住院率及全因病死率为25.9%，低于安慰剂组的34.3%。时任德国法兰克福J.W. Goethe大学内科学教授的Hohnloser博士观察到，决奈达隆是迄今为止第一个有助于降低房颤或房扑患者心血管病发病率和病死率的药物。

决奈达隆治疗者的最常见不良反应为腹泻或恶心、呕吐，这类不良反应在决奈达隆组和安慰剂组的发生率分布为15%和9%。此外，决奈达隆组和安慰剂组的皮疹发生率分别为10%和7%，血肌酐水平增高率分别为4%和1.1%。

此前的分析已经证实，决奈达隆在控制心室率和维持正常的窦性节律方面兼具疗效。

该最新荟萃分析则是对DAFNE、ADONIS、ATHENA、ERATO和EURIDIS等试验的汇总分析。该荟萃分析的公布也是非常及时的，此前一个美国食品药品监督管理局（FDA）顾问委员会已于今年3月份以Hohnloser博士被披露同时担任Sanofi-Aventis、Cardiome、ARYx Therapeutics和Bristol-Myers Squibb等公司的付费咨询师。

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