Efficacy and Safety of an Orally Administered Selective Prostacyclin Receptor Agonist, Selexipag, in Japanese Patients With Pulmonary Arterial Hypertension

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  • Tanabe Nobuhiro
    Department of Advanced Medicine in Pulmonary Hypertension, Graduate School of Medicine, Chiba University
  • Ikeda Satoshi
    Department of Cardiovascular Medicine, Nagasaki University Graduate School of Biomedical Sciences
  • Tahara Nobuhiro
    Department of Medicine, Division of Cardiovascular Medicine, Kurume University School of Medicine
  • Fukuda Keiichi
    Department of Cardiology, Keio University School of Medicine
  • Hatano Masaru
    Department of Therapeutic Strategy for Heart Failure, The University of Tokyo Hospital
  • Ito Hiroshi
    Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine
  • Nakayama Tomotaka
    Department of Pediatrics, Toho University Omori Medical Center
  • Anzai Toshihisa
    Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center
  • Hashimoto Akiyoshi
    Department of Cardiovascular, Renal and Metabolic Medicine, Sapporo Medical University Hospital
  • Inoue Teruo
    Department of Cardiovascular Medicine, Dokkyo Medical University School of Medicine
  • Kajinami Kouji
    Department of Cardiology, Kanazawa Medical University
  • Kihara Yasuki
    Department of Cardiovascular Medicine, Hiroshima University Graduate School of Biomedical and Health Sciences
  • Kinoshita Hideyuki
    Department of Community Medicine Supporting System, Kyoto University Graduate School of Medicine
  • Kuwahara Koichiro
    Department of Cardiovascular Medicine, Shinshu University School of Medicine
  • Murohara Toyoaki
    Department of Cardiology, Nagoya University Graduate School of Medicine
  • Okazaki Osamu
    Department of Cardiology, National Center for Global Health and Medicine
  • Sakai Satoshi
    Cardiovascular Division, Department of Clinical Medicine, Faculty of Medicine, University of Tsukuba
  • Satoh Toru
    Division of Cardiology Department of Medicine, Kyorin University Hospital
  • Takeda Yutaka
    Department of Cardio-Renal Medicine and Hypertension, Nagoya City University Graduate School of Medical Sciences
  • Takeishi Yasuchika
    Department of Cardiovascular Medicine, Fukushima Medical University
  • Taniguchi Mitsugu
    Department of Cardiology, Osaka Pref. Saiseikai Tondabayashi Hospital
  • Watanabe Hiroshi
    Department of Clinical Pharmacology and Therapeutics, Hamamatsu University School of Medicine
  • Yamamoto Takeshi
    Faculty of Health Science, Yamaguchi University Graduate School of Medicine
  • Yamauchi-Takihara Keiko
    Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine
  • Yoshioka Koichiro
    Graduate School of Medicine, Tokai University
  • Sasayama Shigetake
    Uji Hospital

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Abstract

<p>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.</p><p>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).</p><p>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].)</p>

Journal

  • Circulation Journal

    Circulation Journal 81 (9), 1360-1367, 2017

    The Japanese Circulation Society

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