Selexipag for the treatment of chronic thromboembolic pulmonary hypertension.
Selexipag for the treatment of chronic thromboembolic pulmonary hypertension.
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司来帕格治疗慢性血栓栓塞性肺动脉高压。
DOI：
10.1183/13993003.01694-2021
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发表时间：
2022-07
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无法手术的慢性血栓栓塞性肺动脉高压（CTEPH）的治疗选择仍然有限。司来帕格是一种获批用于治疗肺动脉高压的口服选择性IP前列环素受体激动剂，是CTEPH的潜在治疗选择。在这项多中心、随机化、双盲、安慰剂对照研究中，78例患有肺动脉内膜切除术和/或球囊肺血管成形术后无法手术的CTEPH或持续性/复发性肺动脉高压的日本患者被随机分配接受安慰剂或司来帕格治疗。主要终点是肺血管阻力（PVR）从基线至第20周的变化。次要终点为其他血流动力学参数的变化：6分钟步行距离（6 MWD）、博格呼吸困难量表评分、世界卫生组织（WHO）功能分级、EuroQol五维五级工具和N末端脑钠肽前体。司来帕格组和安慰剂组PVR的变化分别为−98.2±111.3 dyn·s·cm−5和−4.6±163.6 dyn·s·cm−5（平均差异−93.5 dyn·s·cm−5; 95% CI −156.8至−30.3; p=0.006）。 与安慰剂相比，心脏指数（p<0.001）和博格呼吸困难量表评分（p=0.036）的变化也有显著改善。6 MWD和WHO功能分级改善不明显。司来帕格组的常见不良事件与前列环素类似物给药后通常观察到的不良事件一致。司来帕格显著改善CTEPH患者的PVR和其他血液动力学变量，但运动能力保持不变。有必要进行进一步的大规模研究，以证明司来帕格在CTEPH中的作用。司来帕格显著改善慢性血栓栓塞性肺动脉高压患者的肺血管阻力和其他血流动力学，但运动能力保持不变https://bit.ly/3HfPA9s
Treatment options for inoperable chronic thromboembolic pulmonary hypertension (CTEPH) remain limited. Selexipag, an oral selective IP prostacyclin receptor agonist approved for pulmonary arterial hypertension, is a potential treatment option for CTEPH. In this multicentre, randomised, double-blind, placebo-controlled study, 78 Japanese patients with inoperable CTEPH or persistent/recurrent pulmonary hypertension after pulmonary endarterectomy and/or balloon pulmonary angioplasty were randomly assigned to receive placebo or selexipag. The primary end-point was the change in pulmonary vascular resistance (PVR) from baseline to week 20. Secondary end-points were changes in other haemodynamic parameters: 6-min walk distance (6MWD), Borg dyspnoea scale score, World Health Organization (WHO) functional class, EuroQol five-dimension five-level tool and N-terminal pro-brain natriuretic peptide. The change in PVR was −98.2±111.3 dyn·s·cm−5 and −4.6±163.6 dyn·s·cm−5 in the selexipag and placebo groups, respectively (mean difference −93.5 dyn·s·cm−5; 95% CI −156.8 to −30.3; p=0.006). The changes in cardiac index (p<0.001) and Borg dyspnoea scale score (p=0.036) were also significantly improved over placebo. 6MWD and WHO functional class were not significantly improved. The common adverse events in the selexipag group corresponded to those generally observed following administration of a prostacyclin analogue. Selexipag significantly improved PVR and other haemodynamic variables in patients with CTEPH, although exercise capacity remained unchanged. Further large-scale investigation is necessary to prove the role of selexipag in CTEPH. Selexipag significantly improved pulmonary vascular resistance and other haemodynamics in patients with chronic thromboembolic pulmonary hypertension, although exercise capacity remained unchanged https://bit.ly/3HfPA9s
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