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著者: Takeshi Ogo, Hiroto Shimokawahara, Hideyuki Kinoshita, Seiichiro Sakao, Kohtaro Abe, Satoaki Matoba, Hirohiko Motoki, Noriaki Takama, Junya Ako, Yasuhiro Ikeda, Shuji Joho, Hisataka Maki, Takahiro Saeki, Teruyasu Sugano, Ichizo Tsujino, Koichiro Yoshioka, Naoki Shiota, Shinichi Tanaka, Chieko Yamamoto, Nobuhiro Tanabe, Koichiro Tatsumi, Study Group
雑誌名: Eur Respir J. 2021 Nov 25;. doi: 10.1183/13993003.01694-2021. Epub 2021 Nov 25.
Abstract/Text
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 endpoint was the change in pulmonary vascular resistance (PVR) from baseline to week 20. The secondary endpoints were changes in other haemodynamic parameters, 6-min walk distance (6 WMD), Borg Dyspnoea Scale score, World Health Organisation (WHO) functional class, EuroQol 5 dimensions 5-level 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% confidence interval, -156.8, -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. 6WMD and WHO functional class were not significantly improved. The common adverse events in the selexipag group were corresponded to those generally observed following a prostacyclin analogue is administered.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.
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PMID 34824052 Eur Respir J. 2021 Nov 25;. doi: 10.1183/13993003.01694-2021. Epub 2021 Nov 25.
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