Pritchett Edward L C, Kowey Peter, Connolly Stuart, Page Richard L, Kerr Charles, Wilkinson William E
Duke University Medical Center, Durham, NC, USA.
Am Heart J. 2006 May;151(5):1043-9. doi: 10.1016/j.ahj.2005.10.019.
Azimilide dihydrochloride (azimilide) is an investigational antiarrhythmic drug that has been tested in patients with a variety of arrhythmias. In patients with atrial fibrillation, it has shown excellent efficacy in some previous trials and minimal efficacy in others.
Patients who had symptomatic atrial fibrillation for > 48 hours but < 6 months were eligible for this multicenter, randomized, placebo-controlled clinical trial. Patients were admitted to a hospital and randomly assigned to receive either azimilide 125 mg or a matched placebo twice daily for 3 days and then once daily. Patients who were in sinus rhythm spontaneously or had sinus rhythm restored by electric cardioversion on day 4 were discharged from the hospital. Recurrence of atrial fibrillation was documented by electrocardiogram. In the primary efficacy analysis, time to recurrence in the 2 treatment groups was compared with the log-rank test in the subgroup of patients with structural heart disease. Safety was assessed as deaths, adverse events, and serious adverse events.
A total of 446 patients were randomized in the study; 314 were in the subgroup with structural heart disease. The median time to arrhythmia recurrence in both treatment groups with structural heart disease was 13 days, and the difference between treatments was not significant (P = .4596, n = 314). The relative risk for recurrence (placebo:azimilide) was 1.104 (95% CI 0.849-1.436). There was 1 death in the placebo group and 3 in the azimilide group.
Azimilide did not demonstrate clinically important or statistically significant efficacy in reducing the risk for arrhythmia recurrence in patients with structural heart disease who were in atrial fibrillation and converted to sinus rhythm.
盐酸阿齐利特（阿齐利特）是一种正在研究的抗心律失常药物，已在患有各种心律失常的患者中进行了测试。在心房颤动患者中，它在一些先前的试验中显示出优异的疗效，而在其他试验中疗效甚微。
有症状性心房颤动超过48小时但少于6个月的患者符合这项多中心、随机、安慰剂对照临床试验的条件。患者入院后，随机分配接受阿齐利特125毫克或匹配的安慰剂，每日两次，共3天，然后每日一次。在第4天自发转为窦性心律或通过电复律恢复窦性心律的患者出院。通过心电图记录心房颤动的复发情况。在主要疗效分析中，采用对数秩检验比较两个治疗组中患有结构性心脏病患者亚组的复发时间。安全性评估指标为死亡、不良事件和严重不良事件。
共有446例患者参与了本研究；314例属于结构性心脏病亚组。结构性心脏病的两个治疗组中心律失常复发的中位时间均为13天，治疗组之间的差异无统计学意义（P = 0.4596，n = 314）。复发的相对风险（安慰剂：阿齐利特）为1.104（95%可信区间0.849 - 1.436）。安慰剂组有1例死亡，阿齐利特组有3例死亡。
对于患有结构性心脏病且已转为窦性心律的心房颤动患者，阿齐利特在降低心律失常复发风险方面未显示出具有临床重要意义或统计学意义的疗效。
