Department of Emergency Medicine, University of Ottawa, Ottawa, Canada.
Am Heart J. 2010 Jun;159(6):1095-101. doi: 10.1016/j.ahj.2010.02.035.
The efficacy and safety of vernakalant, a relatively atrial-selective antiarrhythmic agent, in converting atrial fibrillation (AF) to sinus rhythm (SR) were evaluated in this multicenter, open-label study of patients with AF lasting >3 hours and < or =45 days (RCT no. NCT00281554).
Adult patients with AF and an indication for conversion to SR received a 10-minute intravenous infusion of vernakalant (3 mg/kg). If after a 15-minute observation period AF was present, a second 10-minute infusion of intravenous vernakalant (2 mg/kg) was given. The primary efficacy end point was the proportion of patients with recent-onset AF (AF lasting >3 hours to < or =7 days) who converted to SR within 90 minutes of the start of the first infusion. Safety evaluations included vital signs, telemetry and Holter monitoring, 12-lead electrocardiography, clinical laboratory tests, physical examinations, and adverse events (AEs).
A total of 236 hemodynamically stable patients with AF received intravenous vernakalant. Among them, 167 (71%) had recent-onset AF and were eligible for the primary efficacy end point. Vernakalant rapidly converted recent-onset AF to SR in 50.9% of patients, with a median time to conversion of 14 minutes among responders. The most common AEs were dysgeusia, sneezing, and paresthesia. These occurred at the time of vernakalant infusion, were transient, and resolved spontaneously. Ten patients (4.2%) discontinued vernakalant treatment because of AEs, most commonly (in 4 of 10) hypotension. There were no episodes of torsades de pointes, ventricular fibrillation, or sustained ventricular tachycardia.
Vernakalant rapidly converted recent-onset AF to SR, was well tolerated, and may be a valuable therapeutic alternative for reestablishing SR in patients with recent-onset AF.
维纳卡兰是一种相对心房选择性抗心律失常药物，在将心房颤动（AF）转为窦性心律（SR）方面具有疗效和安全性，在一项多中心、开放标签的研究中，对持续时间超过 3 小时且≤45 天的 AF 患者（RCT 编号：NCT00281554）进行了评估。
患有 AF 且有转为 SR 指征的成年患者接受 10 分钟静脉输注维纳卡兰（3mg/kg）。如果在 15 分钟观察期后仍存在 AF，则给予第二次 10 分钟静脉维纳卡兰输注（2mg/kg）。主要疗效终点是在第一次输注开始后 90 分钟内最近发作的 AF（AF 持续时间超过 3 小时至≤7 天）患者转为 SR 的比例。安全性评估包括生命体征、遥测和 Holter 监测、12 导联心电图、临床实验室检查、体格检查和不良事件（AE）。
共有 236 例血流动力学稳定的 AF 患者接受了静脉维纳卡兰治疗。其中，167 例（71%）有最近发作的 AF，符合主要疗效终点的入选标准。维纳卡兰在 50.9%的患者中迅速将最近发作的 AF 转为 SR，反应者的中位转复时间为 14 分钟。最常见的 AE 是味觉障碍、打喷嚏和感觉异常。这些事件发生在维纳卡兰输注时，是短暂的，并且会自行缓解。有 10 名患者（4.2%）因 AE 而停止了维纳卡兰治疗，最常见的是（10 例中的 4 例）低血压。没有尖端扭转型室性心动过速、心室颤动或持续性室性心动过速的发生。
维纳卡兰可迅速将最近发作的 AF 转为 SR，耐受性良好，可能是最近发作的 AF 患者恢复 SR 的一种有价值的治疗选择。
