在患有肺动脉高血压的患者中进行RalinepagII期开放式扩展研究
Joan Barberà1,2, Pavel Jansa3, Elizabeth Klings4
1Department of Pulmonary Medicine, Hospital Clínic-IDIBAPS, University of Barcelona, Barcelona, Spain. jbarbera@clinic.cat.
Advances in therapy
|January 10, 2024
概括
对肺动脉高血压的拉林巴格治疗显示,在24个月内,运动能力持续改善,肺血管阻力显著降低,安全性可控.
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,其特点是肺动脉中的高血压.
- 作为口服前环素 (IP) 受体激活剂的Ralinepag在第二阶段研究中显示出降低肺血管抵抗 (PVR) 的有效性.
- 长期安全性和耐受性数据对于评估慢性PAH治疗至关重要.
研究的目的:
- 评估拉林帕格在患有肺动脉高血压的患者中长期的安全性和耐受性.
- 通过检查功能能力和血液动力学参数的变化来评估ralinepag的持续疗效.
- 调查过渡到延长释放配方的效果.
主要方法:
- 一项开放式扩展 (OLE) 研究招募了先前第二阶段试验的参与者.
- 参与者接受了持续的即时释放 (IR) ralinepag,或者如果先前接受安慰剂,则被定位为耐受剂量.
- 关键评估包括不良事件,6分钟步行距离 (6MWD),功能类和血液动力学测量 (PVR,肺动脉压).
主要成果:
- 45名参与者完成了OLE研究;常见的不良事件与前环素相关 (头痛,腹,下疼痛),并且在稳定的剂量下降.
- 在24个月后,6分钟的步行距离显著增加 (平均36.3米),大多数参与者保持了功能类 (84.8%).
- 观察到PVR持续下降 (中位数为52.2d.s/cm5) 和肺动脉压 (中位数为2.0mmHg).
结论:
- 在PAH患者中,Ralinepag提供了持续和持久的运动能力 (6MWD) 和血液动力学参数 (PVR) 的改善.
- 该药物具有可管理的安全性,已知与前环素相关的不良事件.
- 继续服用拉林巴格的患者保持了功能状态,而从安慰剂转换的患者通常表现出功能改善.
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