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医汇心血管学术 > 重度心衰时使用决奈达隆会增加死亡率

重度心衰时使用决奈达隆会增加死亡率

发表于 2014-10-09 14:38:21
(新英格兰医学杂志)背景:决奈达隆是一种有着胺碘酮相似的电生理特性的新型抗心律失常药物,但是它不含有碘,不会导致碘相关的副反应。因此,它在治疗心力衰竭的病人上可能有其独特的价值。方法:本研究是一个多中心随机双盲研究,1000名有症状性心律衰竭和严重左室收缩功能异常的住院患者分为治疗组和安慰剂组两组,治疗组接受决奈达隆400mg 2/日的治疗。本研究初级终点为任何原因的死亡和因心力衰竭住院治疗。结果:在对数据进行分析后,结合安全监测委员会早期制定的一些规定,出于对安全的的考虑,本研究提早终止,因此本研究共纳入627名 (决奈达隆治疗组 310 ,在安慰剂组317名 )患者。在随后为期中位随访期2个月期间,决奈达隆治疗组有25名(8.1%)患者死亡,安慰剂组有21名(3.8%) 患者死亡(治疗组死亡风险为 2.13,95% 可信区间为1.07- 4.25,P=0.03)。死亡率较高的原因主要与心衰恶化有关(治疗组和安慰剂组分别为10例和2例)。两组的初级终点无显著性差异,治疗组和安慰剂组分别为53例 (17.1%) 和40 例 (12.6%) (风险比为 1.38,95%可信区间为 0.92-2.09; P=0.12)。与安慰剂组相比,治疗组因肌酐升高导致严重不良反应的更多。结论:严重心力衰竭和左室收缩功能异常的患者,决奈达隆治疗可增加心衰恶化相关的早期死亡率。来源:丁香园The NEW ENGLAND JOURNAL of MEDICINE Volume 358:2678-2687 June 19,2008 Number25ABSTRACTBackground Dronedarone is a novel antiarrhythmic drug with electrophysiological properties that are similar to those of amiodarone, but it does not contain iodine and thus does not cause iodine-related adverse reactions. Therefore, it may be of value in the treatment of patients with heart failure. Methods In a multicenter study with a double-blind design, we planned to randomly assign 1000 patients who were hospitalized with symptomatic heart failure and severe left ventricular systolic dysfunction to receive 400 mg of dronedarone twice a day or placebo. The primary end point was the composite of death from any cause or hospitalization for heart failure.Results After inclusion of 627 patients (310 in the dronedarone group and 317 in the placebo group), the trial was prematurely terminated for safety reasons, at the recommendation of the data and safety monitoring board, in accordance with the board’s predefined rules for termination of the study. During a median follow-up of 2 months, 25 patients in the dronedarone group (8.1%) and 12 patients in the placebo group (3.8%) died (hazard ratio in the dronedarone group, 2.13; 95% confidence interval [CI], 1.07 to 4.25; P=0.03). The excess mortality was predominantly related to worsening of heart failure — 10 deaths in the dronedarone group and 2 in the placebo group. The primary end point did not differ significantly between the two groups; there were 53 events in the dronedarone group (17.1%) and 40 events in the placebo group (12.6%) (hazard ratio, 1.38; 95% CI, 0.92 to 2.09; P=0.12). More increases in the creatinine concentration were reported as serious adverse events in the dronedarone group than in the placebo group.Conclusions In patients with severe heart failure and left ventricular systolic dysfunction, treatment with dronedarone was associated with increased early mortality related to the worsening of heart failure.
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