TY - JOUR
T1 - Long-term treatment of pulmonary arterial hypertension with macitentan in Japanese patients
AU - Tahara, Nobuhiro
AU - Dobashi, Hiroaki
AU - Fukuda, Keiichi
AU - Funauchi, Masanori
AU - Hatano, Masaru
AU - Ikeda, Satoshi
AU - Joho, Shuji
AU - Kihara, Yasuki
AU - Kondo, Takahisa
AU - Matsushita, Masakazu
AU - Minamino, Tohru
AU - Nakanishi, Norifumi
AU - Okano, Yoshiaki
AU - Ozaki, Yukio
AU - Saji, Tsutomu
AU - Sakai, Satoshi
AU - Tanabe, Nobuhiro
AU - Watanabe, Hiroshi
AU - Yamada, Hidehiro
AU - Yoshioka, Koichiro
AU - Hatta, Motonori
AU - Sasayama, Shigetake
N1 - Funding Information:
Statistical analyses and medical writing were supported by Actelion Pharmaceuticals Japan Ltd. (Actelion) and Nippon Shinyaku Co., Ltd. (Nippon Shinyaku). The authors express their sincere gratitude to sub-investigators and clinical coordinators.
Funding Information:
The present study was sponsored by Actelion Pharmaceuticals Japan Ltd. and Nippon Shinyaku Co., Ltd. The sponsors of the study were involved in the study design and in the collection, analysis, and interpretation of data.
Publisher Copyright:
© 2020, © 2020 Informa UK Limited, trading as Taylor & Francis Group.
PY - 2020/6/2
Y1 - 2020/6/2
N2 - 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.
AB - 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.
KW - Pulmonary arterial hypertension
KW - efficacy and safety
KW - endothelin receptor antagonist
KW - long-term treatment
KW - macitentan
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U2 - 10.1080/03007995.2020.1756234
DO - 10.1080/03007995.2020.1756234
M3 - Article
C2 - 32298185
AN - SCOPUS:85084848550
SN - 0300-7995
VL - 36
SP - 921
EP - 928
JO - Current Medical Research and Opinion
JF - Current Medical Research and Opinion
IS - 6
ER -