Efficacy and safety of a novel endothelin receptor antagonist, macitentan, in japanese patients with pulmonary arterial hypertension

Nobuhiro Tahara, Hiroaki Dobashi, Keiichi Fukuda, Masanori Funauchi, Masaru Hatano, Satoshi Ikeda, Shuji Joho, Yasuki Kihara, Takeshi Kimura, Takahisa Kondo, Masakazu Matsushita, Tohru Minamino, Norifumi Nakanishi, Yukio Ozaki, Tsutomu Saji, Satoshi Sakai, Nobuhiro Tanabe, Hiroshi Watanabe, Hidehiro Yamada, Koichiro YoshiokaShigetake Sasayama

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6 Citations (Scopus)

Abstract

Background: Macitentan is a novel, dual endothelin receptor antagonist with sustained receptor binding, used for the long-term treatment of pulmonary arterial hypertension (PAH). In the present study, we assessed the efficacy and safety of macitentan in Japanese patients with PAH. Methods and Results: Macitentan was administered at a once-daily dose of 10 mg in 30 patients. The primary endpoint was change in pulmonary vascular resistance (PVR) from baseline to week 24. Change to week 24 in the other hemodynamic parameters, 6-min walk distance (6MWD), World Health Organization (WHO) functional class, and plasma N-terminal pro-brain natriuretic peptide (NT-pro-BNP), as well as time to clinical deterioration up to week 52 were also assessed as secondary endpoints. In the 28 patients on per-protocol analysis, PVR decreased from 667±293 to 417±214 dyn·sec·cm-5(P<0.0001). 6MWD increased from 427±128 to 494±116 m (P<0.0001). WHO functional class improved in 13 patients (46.4%) and was maintained in 15 patients (53.6%), and NT-pro-BNP was reduced by 18% (P<0.0001). The favorable treatment effect on PVR was apparent regardless of concomitant therapy for PAH. Conclusions: Macitentan was efficacious and well tolerated and improved the hemodynamic parameters, exercise capacity, symptoms, and clinical biomarkers in Japanese PAH patients. Macitentan can be a valuable therapeutic option for Japanese patients with PAH. (Trial registration: JAPIC Clinical Trials Information [JapicCTI-121986].).

Original languageEnglish
Pages (from-to)1478-1483
Number of pages6
JournalCirculation Journal
Volume80
Issue number6
DOIs
Publication statusPublished - 01-01-2016

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

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    Tahara, N., Dobashi, H., Fukuda, K., Funauchi, M., Hatano, M., Ikeda, S., Joho, S., Kihara, Y., Kimura, T., Kondo, T., Matsushita, M., Minamino, T., Nakanishi, N., Ozaki, Y., Saji, T., Sakai, S., Tanabe, N., Watanabe, H., Yamada, H., ... Sasayama, S. (2016). Efficacy and safety of a novel endothelin receptor antagonist, macitentan, in japanese patients with pulmonary arterial hypertension. Circulation Journal, 80(6), 1478-1483. https://doi.org/10.1253/circj.CJ-15-1305