口服特雷普罗斯尼尔与FREEDOM-EV及其开放式扩展的改善生存率有关
Ekkehard Grünig1, Franck Rahaghi2, Jean Elwing3
1Thoraxklinik-Heidelberg gGmbH, and German Center for Lung Research (DZL), Heidelberg, Germany.
Advances in therapy
|December 6, 2023
概括
口服特雷普罗斯尼尔显著改善了肺动脉高血压 (PAH) 患者的生存率. 最初接受安慰剂治疗,然后转换为口服特西尼尔的患者经历了实质性的功能增长,证明了持久的益处.
科学领域:
- 心脏病学 心脏病学
- 肺部病理学 肺部病理学
- 药理学 药理学是指药理学的学科.
背景情况:
- 肺动脉高血压 (PAH) 是一种严重的疾病.
- 口服特雷普罗斯尼尔在延迟PAH患者的临床恶化方面表现有前途.
- 开放式扩展研究提供了关于治疗疗效和存活率的宝贵长期数据.
研究的目的:
- 评估口服特西尼对PAH患者整体存活时间的影响.
- 评估最初接受安慰剂的患者的功能益处.
- 为了确定特雷普罗斯尼尔的效益的持久性.
主要方法:
- 从FREEDOM-EV试验及其开放标签扩展 (OLE) 的数据分析.
- 卡普兰-梅尔生存分析和考克斯比例危险模型.
- 功能类,6分钟步行距离 (6MWD) 和NT-proBNP水平的评估.
主要成果:
- 最初分配给口服特雷普罗斯尼尔的患者,死亡率降低了9% (HR 0.64,p=0.013).
- 从安慰剂转换为特雷普罗斯尼尔的患者在功能类,6MWD (+84m) 和NT-proBNP (-778 pg/mL) 中显著改善.
- 在患者继续服用prostinil时,观察到高守率 (92%) 和持续的益处.
结论:
- 口服特雷普罗斯尼尔显著改善了PAH患者的存活率.
- 在病情恶化后切换为口服特雷普罗斯尼尔,可提供显著的功能益处.
- 口服特西尼的积极效果是持久的,耐受性很好.
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