Pritchett E L, Page R L, Connolly S J, Marcello S R, Schnell D J, Wilkinson W E
Department of Medicine, Duke University Medical Center, Durham, North Carolina, USA.
J Am Coll Cardiol. 2000 Sep;36(3):794-802. doi: 10.1016/s0735-1097(00)00773-7.
The purpose of this study was to assess the effectiveness of azimilide, a class III antiarrhythmic drug, in reducing the frequency of symptomatic arrhythmia recurrences in patients with atrial fibrillation, atrial flutter or both.
Atrial fibrillation is an increasingly common disorder of the heart rhythm, and most patients with this problem are identified because they have symptoms associated with their arrhythmia. New antiarrhythmic therapies are needed to treat patients with this problem.
A total of 384 patients with a history of atrial fibrillation, atrial flutter or both were randomly assigned to receive once daily doses of placebo or azimilide; recurrent symptomatic arrhythmias were documented using transtelephonic electrocardiogram (ECG) recording. Azimilide 50 mg, 100 mg or 125 mg was tested; the primary efficacy analysis compared the time to first symptomatic recurrence in the combined azimilide 100 mg and 125 mg dose groups with that in the placebo group using the log-rank test.
In the primary efficacy analysis, the time to first symptomatic arrhythmia recurrence was significantly prolonged in the combined azimilide 100 mg and 125 mg daily dose group compared with the placebo group (chi-square 7.96, p = 0.005); the hazard ratio (placebo: azimilide) for this comparison was 1.58 (95% confidence interval [CI] = 1.15, 2.16). In comparisons between individual doses and placebo, the hazard ratio for the 50 mg daily dose was 1.17 (95% CI = 0.83, 1.66; p = 0.37); for the 100 mg group, dose was 1.38 (95% CI = 0.96, 1.98; p = 0.08), and for the 125 mg group, dose was 1.83 (95% CI = 1.24, 2.70; p = 0.002).
Azimilide significantly lengthened the symptomatic arrhythmia-free interval in patients with a history of atrial fibrillation, atrial flutter or both.
本研究旨在评估Ⅲ类抗心律失常药物阿齐利特减少心房颤动、心房扑动或二者兼具患者症状性心律失常复发频率的有效性。
心房颤动是一种日益常见的心律失常疾病，大多数患有该疾病的患者是因为出现与心律失常相关的症状而被确诊。需要新的抗心律失常疗法来治疗这类患者。
共有384例有房颤、房扑或二者兼具病史的患者被随机分配，接受每日一次剂量的安慰剂或阿齐利特治疗；使用经电话心电图（ECG）记录来记录复发性症状性心律失常。对阿齐利特50毫克、100毫克或125毫克进行了测试；主要疗效分析采用对数秩检验，比较阿齐利特100毫克和125毫克联合剂量组与安慰剂组首次出现症状性复发的时间。
在主要疗效分析中，与安慰剂组相比，阿齐利特每日剂量100毫克和125毫克联合组首次出现症状性心律失常复发的时间显著延长（卡方值7.96，p = 0.005）；该比较的风险比（安慰剂：阿齐利特）为1.58（95%置信区间[CI] = 1.15，2.16）。在各剂量与安慰剂的比较中，每日剂量50毫克的风险比为1.17（95%CI = 0.83，1.66；p = 0.37）；100毫克组的风险比为1.38（95%CI = 0.96，1.98；p = 0.08），125毫克组的风险比为1.83（95%CI = 1.24，2.70；p = 0.002）。
阿齐利特显著延长了有房颤、房扑或二者兼具病史患者的无症状性心律失常间期。
