Circulation Journal
Online ISSN : 1347-4820
Print ISSN : 1346-9843
ISSN-L : 1346-9843
Pulmonary Circulation
Efficacy and Safety of an Orally Administered Selective Prostacyclin Receptor Agonist, Selexipag, in Japanese Patients With Pulmonary Arterial Hypertension
Nobuhiro TanabeSatoshi IkedaNobuhiro TaharaKeiichi FukudaMasaru HatanoHiroshi ItoTomotaka NakayamaToshihisa AnzaiAkiyoshi HashimotoTeruo InoueKouji KajinamiYasuki KiharaHideyuki KinoshitaKoichiro KuwaharaToyoaki MuroharaOsamu OkazakiSatoshi SakaiToru SatohYutaka TakedaYasuchika TakeishiMitsugu TaniguchiHiroshi WatanabeTakeshi YamamotoKeiko Yamauchi-TakiharaKoichiro YoshiokaShigetake Sasayama
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2017 Volume 81 Issue 9 Pages 1360-1367

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Abstract

Background:Selexipag is an orally available prostacyclin receptor (IP receptor) agonist with a non-prostanoid structure. In this open-label Phase II trial, the efficacy and safety of selexipag in Japanese patients with pulmonary arterial hypertension (PAH) is examined.

Methods and Results:Selexipag was administered at 200 μg twice daily and titrated up to 1,600 μg by increments of 200 μg in 37 subjects to reach the individual maximum tolerated dose. At 16 weeks, in 33 patients comprising the per-protocol set, the pulmonary vascular resistance (PVR; primary endpoint) decreased from 683.2±237.3 to 560.3±238.7 dyn·s/cm5(P<0.0001). For the secondary endpoint, the 6-min walk distance (6MWD) increased from 445.0±102.2 to 459.1±112.8 m (P=0.0324); World Health Organization functional class improved in 4 patients (12.1%), and was maintained in 29 patients (87.9%). A decrease in PVR was also shown in patients treated with selexipag, on top of a phosphodiesterase inhibitor and endothelin receptor antagonist. Most of the commonly reported adverse events were consistent with those reported for other PGI2formulations. Thirty-four patients attained the individual maximum tolerated dose (maintenance dose).

Conclusions:The efficacy and tolerability of selexipag in Japanese PAH patients was confirmed by improvement in pulmonary hemodynamics, exercise capacity, symptoms. Selexipag is an efficacious treatment option for Japanese PAH patients. (Trial registration: JAPIC Clinical Trials Information [JapicCTI-111532].)

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© 2017 THE JAPANESE CIRCULATION SOCIETY
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