伊布利特用于印度患者房颤或房扑转复的临床疗效与安全性：一项多中心研究

Clinical Efficacy and Safety of Ibutilide in Cardioversion of Atrial Fibrillation or Flutter in Indian Patients: A Multicenter Study.

作者信息

Dewan Bhupesh, Navale Sanjaykumar, Shinde Siddheshwar, Chaudhary Janaki

机构信息

Zuventus Healthcare Limited, Mumbai, Maharashtra, India.

Medical Services, Zuventus Healthcare Limited, Mumbai, Maharashtra, India.

出版信息

Indian J Crit Care Med. 2025 Jan;29(1):45-51. doi: 10.5005/jp-journals-10071-24885. Epub 2024 Dec 30.

DOI:10.5005/jp-journals-10071-24885

PMID:39802251

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11719548/

Abstract

AIM AND BACKGROUND

To assess the efficacy and safety of Ibutilide infusion for cardioversion of atrial fibrillation (AF) or flutter (AFL) to sinus rhythm.

MATERIALS AND METHODS

This open-label, multicenter phase IV study was conducted at six sites across India. The study enrolled 120 patients (108 with AF, 12 with AFL), each receiving up to two, 10-minute intravenous doses of 1.0 mg Ibutilide. The primary endpoints were the proportion of patients achieving cardioversion and the mean time taken to achieve cardioversion. Secondary endpoints included the proportion of patients maintaining sinus rhythm at 24 hours and the incidence of adverse events.

RESULTS

The cardioversion rate at 4 hours post-Ibutilide infusion among 120 patients was 65.83% ( = 79), with an average conversion time of 35.12 ± 36.71 minutes. At 24 hours, 85 patients (70.8%) had successful cardioversion, with a mean time of 107.24 minutes. The majority of patients (71.76%) had achieved cardioversion within 30 minutes. Of the 85 patients who achieved successful conversion, 82 (68.3%) maintained sinus rhythm at 24 hours. A total of 66 patients (55%) achieved cardioversion with the first bolus whereas 19 (15.8%) needed a second bolus. Atrial fibrillation patients had a higher conversion rate (75%) compared to AFL patients (33%). A total of 10 adverse events were recorded in eight patients (6.67%), including nausea, headache, palpitations, and bradycardia. Three severe cardiac events, one case of ventricular tachycardia, and two of tachycardia necessitated discontinuation of Ibutilide. No fatalities or serious adverse events (SAE) were reported.

CONCLUSION

Ibutilide was found to be effective and well-tolerated for rapid restoration of sinus rhythm in patients with AF or AFL.

CLINICAL TRIAL REGISTRY OF INDIA

CTRI/2018/01/011248.

HOW TO CITE THIS ARTICLE

Dewan B, Navale S, Shinde S, Chaudhary J. Clinical Efficacy and Safety of Ibutilide in Cardioversion of Atrial Fibrillation or Flutter in Indian Patients: A Multicenter Study. Indian J Crit Care Med 2025;29(1):45-51.

摘要

目的和背景

评估静脉输注伊布利特转复心房颤动（AF）或心房扑动（AFL）为窦性心律的有效性和安全性。

材料和方法

这项开放标签、多中心IV期研究在印度的6个地点进行。该研究纳入了120例患者（108例AF患者，12例AFL患者），每位患者接受最多两次、每次10分钟静脉注射1.0mg伊布利特。主要终点是实现转复的患者比例以及实现转复所需的平均时间。次要终点包括24小时维持窦性心律的患者比例和不良事件的发生率。

结果

120例患者在伊布利特输注后4小时的转复率为65.83%（n = 79），平均转复时间为35.12±36.71分钟。在24小时时，85例患者（70.8%）成功转复，平均时间为107.24分钟。大多数患者（71.76%）在30分钟内实现转复。在85例成功转复的患者中，82例（68.3%）在24小时时维持窦性心律。共有66例患者（55%）首次推注后实现转复，而19例（15.8%）需要第二次推注。AF患者的转复率（75%）高于AFL患者（33%）。共8例患者（6.67%）记录到10次不良事件，包括恶心、头痛、心悸和心动过缓。3例严重心脏事件、1例室性心动过速和2例心动过速需要停用伊布利特。未报告死亡或严重不良事件（SAE）。