里奥西瓜特用于肺高血压患者,由静脉左心室功能障碍引起:一项IIb期双盲,随机,安慰剂控制,剂量可变的血液动力学研究
Diana Bonderman1, Stefano Ghio, Stephan B Felix
1Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria.
Circulation
|June 19, 2013
概括
里奥西瓜特改善了心脏指数,并降低了肺高血压患者的血管阻力,这是由于缩性左心室功能障碍,尽管未达到主要终点. 治疗耐受性很好,显示了管理这种疾病的潜力.
科学领域:
- 心脏病学 心脏病学
- 肺部医学 肺部医学
- 药理学 药理学 是一个学科.
背景情况:
- 由于缩性左心室功能障碍引起的肺高血压,在没有经批准的治疗方法的情况下,会带来重大健康风险.
- 溶性甘酸环酶刺激剂是治疗心血管疾病的一类新疗法.
研究的目的:
- 为了评估里奥西瓜特在患有由静缩左心室功能障碍引起的肺高血压患者的疗效和安全性.
- 评估里奥西瓜特对血液动力学参数的影响,包括肺动脉平均压力和心脏指数.
主要方法:
- 一个随机,双盲,安慰剂控制的试验,涉及201名患者.
- 患者接受了口服安慰剂或利奥西瓜特 (0.5,1或2毫克) 每天三次,持续16周.
- 主要结局:第16周肺动脉平均压力的安慰剂校正变化.
主要成果:
- 里奥西瓜特 (2毫克) 显著增加了心脏指数和中风体积指数,但没有影响心率或血压.
- 肺和全身血管阻力都在2毫克里奥西瓜特的使用下显著降低.
- 明尼苏达州生活与心力衰竭的得分得到了改善,用西瓜特;治疗中止率在各组之间是相似的.
结论:
- 里奥西瓜特在这个患者群体中表现出有利的血液动力学效应,包括改善心脏指数和降低血管阻力.
- 虽然主要终点没有达到,但里奥西瓜特耐受性很好,对心力衰竭患者和肺高血压患者显示出潜在的益处.
- 进一步的研究可能会探索 riociguat 在治疗与缩性左心室功能障碍相关的肺高血压方面的作用.
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