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
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: (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. (Trial registration: JAPIC Clinical Trials Information [JapicCTI-111667]).