固定剂量延长释放纳尔特雷/布罗在临床实践中的心血管安全性
Michael Kyle1, Dustin Burns2, Catherine Rogers Murray3
1Currax Pharmaceuticals, LLC, Brentwood, TN, USA.
Obesity pillars
|March 19, 2025
概括
在超重和肥胖患者中,纳尔特雷克松/布延长释放 (NB-ER) 与洛卡林相比,显示出类似的心血管安全性. 这项研究发现,在现实临床实践中,NB-ER与NB-ER并没有增加主要不良心血管事件 (MACE) 的风险.
科学领域:
- 心血管安全研究研究心血管安全研究
- 药理学研究 药理学研究
- 治疗肥胖的治疗结果.
背景情况:
- 延长释放型纳尔特雷克松/布普罗 (NB-ER) 是用于与饮食和运动一起治疗超重和肥胖症的药物.
- 这项研究评估了使用NB-ER与lorcaserin的患者的主要不良心血管事件 (MACE).
- 洛卡赛林 (Lorcaserin) 被用作一个活跃的比较剂,尽管它已经从美国市场中被删除.
研究的目的:
- 为了比较Naltrexone/bupropion延长释放 (NB-ER) 和lorcaserin开始治疗的患者之间主要心血管不良事件 (MACE) 的发生率.
- 评估特定MACE组件的风险,包括非致命的急性心肌梗塞 (AMI),非致命的中风和心血管死亡.
- 为提供NB-ER在成人肥胖治疗中的心血管安全概况提供现实世界的证据.
主要方法:
- 一个回顾性队列研究,采用新用户,主动比较器设计.
- 分析了从2012年6月到2020年2月的电子健康记录和保险索赔数据.
- 用倾向分数 (PS) 权衡的考克斯比例危险模型用于治疗意向分析,以估计调整后的危险比率 (aHR).
主要成果:
- 该研究包括12475名开始NB-ER的患者和12171名开始洛卡赛林的患者,平均随访时间为4.7年.
- 在对PS进行加权后,NB-ER和lorcaserin队列之间的基线特征得到了平衡.
- 与洛卡林相比,NB-ER显示MACE的统计学上相似率 (aHR,0.76;95%CI,0.48-1.22) ,没有增加非致命AMI或中风的风险.
结论:
- 与洛卡林相比,启动纳尔特雷/布罗延长释放疗法 (NB-ER) 与类似的心血管安全性有关.
- 该研究强调需要谨慎解释,因为依赖PS方法和使用lorcaserin作为比较剂.
- 建议在前性随机对照试验中进行进一步评估,以确认NB-ER的心血管安全性.
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