接受阿齐利特治疗以控制心房颤动或心房扑动的患者心律失常复发时的症状：随机试验结果

Symptoms at the time of arrhythmia recurrence in patients receiving azimilide for control of atrial fibrillation or flutter: results from randomized trials.

作者信息

Connolly Stuart J, Schnell Daniel J, Page Richard L, Wilkinson William E, Marcello Stephen R, Pritchett Edward L C

机构信息

Department of Medicine, McMaster University, Hamilton, Ontario, Canada.

出版信息

Am Heart J. 2003 Sep;146(3):489-93. doi: 10.1016/S0002-8703(03)00250-3.

DOI:10.1016/S0002-8703(03)00250-3

PMID:12947368

Abstract

BACKGROUND

Azimilide is a new antiarrhythmic agent being developed for the management for atrial fibrillation and flutter (AF). Four randomized, placebo-controlled, double-blind trials have been performed that investigated the effect of azimilide on time to first recurrence of symptomatic AF. This paper examines the data collected during those studies regarding the symptoms reported by patients at the time of AF recurrence

METHODS

At the time that patients reported their first documented symptomatic recurrence of arrhythmia, they were systematically asked whether or not they were experiencing any of the following 6 symptoms: palpitation, fatigue, chest pain, shortness of breath, dizziness, or sweating. Patients were required to answer yes or no. A symptom score was created varying from 0 to 6, in increasing order of number of symptoms reported. This was compared for patients receiving either of 2 doses of azimilide or placebo. The relationship between the number of symptoms, heart rate at time of arrhythmia recurrence and treatment was analyzed.

RESULTS

In 2 separate studies, azimilide at a dose of 125 mg/day significantly reduced the number of symptoms at the time of arrhythmia recurrence compared to placebo. On the other hand, in 2 studies, the dose of 100 mg/day did not significantly reduce symptom burden. The individual symptoms significantly reduced by azimilide125 mg/day were fatigue, shortness of breath, chest pain and dizziness. Palpitations and sweating were not significantly reduced. Modeling of heart rate at the time of arrhythmia recurrence, symptoms and treatment indicated that a small reduction in heart rate with azimilide accounted for only a small part of the symptom reduction. There was another effect of azimilide: an average reduction of 0.38 symptoms (P <.01) that was independent of heart rate.

CONCLUSION

Azimilide (125 mg/day) reduces the number of symptoms reported at the time of AF recurrence.

摘要

背景

阿齐利特是一种正在研发用于治疗心房颤动和心房扑动（房颤）的新型抗心律失常药物。已经进行了四项随机、安慰剂对照、双盲试验，研究阿齐利特对有症状房颤首次复发时间的影响。本文检查了在这些研究期间收集的关于患者房颤复发时报告的症状的数据。

方法

在患者报告首次记录的有症状心律失常复发时，系统询问他们是否正在经历以下6种症状中的任何一种：心悸、疲劳、胸痛、呼吸急促、头晕或出汗。患者需回答是或否。创建了一个症状评分，范围从0到6，按报告症状的数量递增顺序排列。对接受两种剂量阿齐利特或安慰剂之一的患者进行了比较。分析了症状数量、心律失常复发时的心率与治疗之间的关系。

结果

在两项单独的研究中，与安慰剂相比，每天125毫克剂量的阿齐利特在心律失常复发时显著减少了症状数量。另一方面，在两项研究中，每天100毫克的剂量并未显著减轻症状负担。每天125毫克阿齐利特显著减轻的个体症状是疲劳、呼吸急促、胸痛和头晕。心悸和出汗没有显著减轻。对心律失常复发时的心率、症状和治疗进行建模表明，阿齐利特使心率略有降低，这仅占症状减轻的一小部分。阿齐利特还有另一个作用：平均减少0.38个症状（P<.01），且与心率无关。