尼拉登二酸盐对心力衰竭患者的运动能力的影响:随机临床试验
Sanjiv J Shah1, Adriaan A Voors2, John J V McMurray3
1Northwestern University Feinberg School of Medicine, Chicago, Illinois.
JAMA
|June 5, 2019
概括
在心力衰竭患者中,尼拉登没有显著改善射分数 (HFpEF). 这种类别中的第一个腺A1受体激动剂没有显示出最佳剂量,这表明需要新的方法来治疗HFpEF.
科学领域:
- 心脏病学
- 药理学
背景情况:
- 心脏衰竭与保存的喷射分数 (HFpEF) 是一种具有有限有效治疗选择的疾病.
- 在临床前研究中,新型的部分腺素A1受体激动剂尼拉登松双酸具有改善心力衰竭相关心脏异常的潜力.
研究的目的:
- 评估neladenoson在提高HFpEF患者的运动能力,身体活动,心脏生物标志物和生活质量的有效性.
- 为了确定neladenoson治疗HFpEF的最佳剂量.
主要方法:
- 一个2b期随机临床试验,涉及305名NYHAII/ III类HFpEF患者.
- 患者在20周内接受了不同剂量的内拉登 (5-40毫克) 或安慰剂.
- 主要终点是6分钟步行测试距离的变化,使用多种建模技术进行剂量反应分析.
主要成果:
- 与安慰剂相比,在任何内拉登群中都没有观察到6分钟步行测试距离的显著增加.
- 没有发现有统计学意义的剂量反应关系来改善运动能力.
- 在内拉登和安慰剂组中,不良事件的发生率,包括心律失常,是相似的.
结论:
- 在患有HFpEF的患者中,内拉登没有显著的剂量反应影响.
- 需要进一步研究新的治疗策略来治疗HFpEF.
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