Akagi Satoshi, Dohi Yoshihiro, Ishikawa Kaori, Kubota Kayoko, Horimoto Koshin, Yagi Shusuke, Hirata Tetsuo, Yamamoto Eiichiro, Ito Hiroshi, Nakamura Kazufumi
Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences Okayama Japan.
Department of Cardiology, Kure Kyosai Hospital Kure Japan.
Circ Rep. 2021 Jan 9;3(2):105-109. doi: 10.1253/circrep.CR-20-0133.
The latest guideline from the European Society of Cardiology and European Respiratory Society recommends initial combination therapy with oral pulmonary arterial hypertension (PAH)-specific drugs in PAH patients with World Health Organization functional class (WHO-FC) II or III. However, whether this initial combination therapy improves hemodynamics and clinical failure events regardless of the combination of PAH-specific drugs remains unknown. This study was designed to evaluate whether the initial combination therapy with macitentan plus riociguat or macitentan plus selexipag showed equal efficacy in reducing pulmonary vascular resistance (PVR) 8 months after administration. This study is a multicenter randomized control trial. PAH subjects with WHO-FC II or III will be randomized (1 : 1) into initial combination therapy with either macitentan plus riociguat or macitentan plus selexipag, and will be observed 8 months after the initiation of treatment. The primary endpoint will be the difference in the change ratio of PVR from baseline to after 8 months of treatment. The SETOUCHI-PH study will clarify whether initial combination therapy with macitentan plus riociguat or macitentan plus selexipag results in equal reductions in PVR 8 months after administration.
欧洲心脏病学会和欧洲呼吸学会的最新指南建议，对于世界卫生组织功能分级（WHO-FC）为II级或III级的肺动脉高压（PAH）患者，初始采用口服PAH特异性药物联合治疗。然而，无论PAH特异性药物如何组合，这种初始联合治疗是否能改善血流动力学和临床衰竭事件仍不清楚。本研究旨在评估初始联合使用马昔腾坦加利奥西呱或马昔腾坦加司来帕格在给药8个月后降低肺血管阻力（PVR）方面是否具有同等疗效。本研究是一项多中心随机对照试验。WHO-FC为II级或III级的PAH受试者将被随机（1:1）分为初始联合使用马昔腾坦加利奥西呱或马昔腾坦加司来帕格治疗组，并在治疗开始后观察8个月。主要终点将是治疗8个月后PVR从基线到治疗后的变化率差异。SETOUCHI-PH研究将阐明初始联合使用马昔腾坦加利奥西呱或马昔腾坦加司来帕格在给药8个月后是否能使PVR得到同等程度的降低。
