Selexipag for chronic thromboembolic pulmonary hypertension in japanese patients - A double-blind, randomized, placebo-controlled, multicenter phase II study

Nobuhiro Tanabe, Keiichi Fukuda, Hiromi Matsubara, Norifumi Nakanishi, Nobuhiro Tahara, Satoshi Ikeda, Takuya Kishi, Toru Satoh, Ken Ichi Hirata, Teruo Inoue, Hiroshi Kimura, Yoshiaki Okano, Osamu Okazaki, Masataka Sata, Ichizo Tsujino, Shuichi Ueno, Norikazu Yamada, Atsushi Yao, Takayuki Kuriyama

Research output: Contribution to journalArticlepeer-review

1 Citation (Scopus)

Abstract

Background: Selexipag is an oral prostacyclin receptor (IP receptor) agonist with a non-prostanoid structure. This study examined its efficacy and safety in Japanese patients with non-operated or persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH). Methods and Results: This Phase II study was a randomized, double-blind, placebo-controlled parallel-group comparison. The primary endpoint was a change in pulmonary vascular resistance (PVR) from baseline to week 17. The main analysis involved a per-protocol set group of 28 subjects. The change in PVR (mean ±SD) after 17 weeks of treatment in the selexipag group was -104±191dyn·s/cm5, whereas that in the placebo group was 26±180dyn·s/cm5. Thus, the treatment effect after 17 weeks of selexipag treatment was calculated as -130±189dyn·s/cm5(P=0.1553). Although the primary endpoint was not met, for the group not concomitantly using a pulmonary vasodilator the PVR in the selexipag group was significantly decreased compared with placebo group (P=0.0364). The selexipag group also showed improvement in total pulmonary resistance and cardiac index. Conclusions: Selexipag treatment improved pulmonary hemodynamics in Japanese patients with CTEPH, but PVR did not show a significant difference between the selexipag and placebo groups.

Original languageEnglish
Pages (from-to)1866-1874
Number of pages9
JournalCirculation Journal
Volume84
Issue number10
DOIs
Publication statusPublished - 2020 Sep 25

Keywords

  • Chronic thromboembolic pulmonary hypertension
  • Prostacyclin receptor agonist
  • Pulmonary hemodynamics
  • Safety
  • Selexipag

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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