Long-term treatment of pulmonary arterial hypertension with macitentan in Japanese patients

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

Research output: Contribution to journalArticle

Abstract

Objective: Macitentan, a novel dual endothelin receptor antagonist, was approved for the treatment of pulmonary arterial hypertension (PAH) in Japan. However, long-term effects in Japanese patients of macitentan are currently unavailable. This study sought to assess the long-term efficacy and safety of macitentan in Japanese patients with PAH. Methods: In this multicenter, open-label, clinical extension study (JapicCTI-121986), efficacy was evaluated based on the change from baseline at 24, 48, 72, 96 and 120-week in the 6-minute walk distance (6MWD), World Health Organization (WHO) functional class, and serum N-terminal pro-brain natriuretic peptide (NT-pro-BNP) levels. In addition, the time to a hospitalization related to PAH and a morbidity/mortality event was determined. As for safety, the incidence of adverse events and changes in laboratory data and vital signs were assessed. Results: Macitentan was administered at a once-daily dose of 10 mg in 30 PAH patients with a median treatment period of 2.4 years (range, 229–1037 days). The improvements in 6MWD, WHO functional class and NT-pro-BNP at week 24 were maintained throughout the long-term follow-up. Hospitalization related to PAH occurred in 2 patients. Levels of liver enzyme and hemoglobin remained unchanged throughout the study period. Conclusions: This study suggests that the long-term use of macitentan is well tolerated and effective in Japanese patients with PAH. We concluded that macitentan can be a possible approach to reduce morbidity/mortality in Japanese PAH patients.

Original languageEnglish
Pages (from-to)921-928
Number of pages8
JournalCurrent Medical Research and Opinion
Volume36
Issue number6
DOIs
Publication statusPublished - 02-06-2020

All Science Journal Classification (ASJC) codes

  • Medicine(all)

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    Tahara, N., Dobashi, H., Fukuda, K., Funauchi, M., Hatano, M., Ikeda, S., Joho, S., Kihara, Y., Kondo, T., Matsushita, M., Minamino, T., Nakanishi, N., Okano, Y., Ozaki, Y., Saji, T., Sakai, S., Tanabe, N., Watanabe, H., Yamada, H., ... Sasayama, S. (2020). Long-term treatment of pulmonary arterial hypertension with macitentan in Japanese patients. Current Medical Research and Opinion, 36(6), 921-928. https://doi.org/10.1080/03007995.2020.1756234