PMID- 32298185
OWN - NLM
STAT- MEDLINE
DCOM- 20210429
LR  - 20210429
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 36
IP  - 6
DP  - 2020 Jun
TI  - Long-term treatment of pulmonary arterial hypertension with macitentan in 
      Japanese patients.
PG  - 921-928
LID - 10.1080/03007995.2020.1756234 [doi]
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.
FAU - Tahara, Nobuhiro
AU  - Tahara N
AUID- ORCID: 0000-0003-2011-8201
AD  - Division of Cardiovascular Medicine, Department of Medicine, Kurume University 
      School of Medicine, Fukuoka, Japan.
FAU - Dobashi, Hiroaki
AU  - Dobashi H
AD  - Division of Hematology, Rheumatology and Respiratory Medicine, Department of 
      Internal Medicine, Faculty of Medicine, Kagawa University, Kagawa, Japan.
FAU - Fukuda, Keiichi
AU  - Fukuda K
AD  - Department of Cardiology, Keio University School of Medicine, Tokyo, Japan.
FAU - Funauchi, Masanori
AU  - Funauchi M
AUID- ORCID: 0000-0003-4423-5103
AD  - Department of Hematology and Rheumatology, Kindai University Faculty of Medicine, 
      Osaka, Japan.
FAU - Hatano, Masaru
AU  - Hatano M
AD  - Department of Cardiovascular Medicine, Graduate School of Medicine, The 
      University of Tokyo, Tokyo, Japan.
AD  - Department of Therapeutic Strategy for Heart Failure, Graduate School of 
      Medicine, The University of Tokyo, Tokyo, Japan.
FAU - Ikeda, Satoshi
AU  - Ikeda S
AD  - Department of Cardiovascular Medicine, Nagasaki University Graduate School of 
      Biomedical Sciences, Nagasaki, Japan.
FAU - Joho, Shuji
AU  - Joho S
AD  - Second department of internal medicine, Toyama University Hospital, Toyama, 
      Japan.
FAU - Kihara, Yasuki
AU  - Kihara Y
AD  - Department of Cardiovascular Medicine, Hiroshima University Graduate School of 
      Biomedical and Health Sciences, Hiroshima, Japan.
FAU - Kondo, Takahisa
AU  - Kondo T
AD  - Department of Advanced Medicine in Cardiopulmonary Disease, Nagoya University 
      Graduate School of Medicine, Aichi, Japan.
FAU - Matsushita, Masakazu
AU  - Matsushita M
AD  - Department of Internal Medicine and Rheumatology, Juntendo University School of 
      Medicine, Tokyo, Japan.
FAU - Minamino, Tohru
AU  - Minamino T
AD  - Department of Cardiovascular Biology and Medicine, Niigata University Graduate 
      School of Medical and Dental Sciences, Niigata, Japan.
FAU - Nakanishi, Norifumi
AU  - Nakanishi N
AD  - Endowed Department of Pulmonary Hypertension and Pulmonary Vascular Medicine, 
      National Cerebral and Cardiovascular Center Research Institute, Osaka, Japan.
FAU - Okano, Yoshiaki
AU  - Okano Y
AD  - Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto 
      University, Kyoto, Japan.
AD  - Department of Internal Medicine, Hanwa Dai-ni Senboku Hospital, Osaka, Japan.
FAU - Ozaki, Yukio
AU  - Ozaki Y
AD  - Department of Cardiology, Fujita Health University School of Medicine, Aichi, 
      Japan.
FAU - Saji, Tsutomu
AU  - Saji T
AD  - Advanced and Integrated Cardiovascular Research Course in the Young and 
      Adolescence, Toho University, Tokyo, Japan.
FAU - Sakai, Satoshi
AU  - Sakai S
AD  - Cardiovascular Division, Department of Clinical Medicine, Faculty of Medicine, 
      University of Tsukuba, Ibaraki, Japan.
FAU - Tanabe, Nobuhiro
AU  - Tanabe N
AD  - Department of Respirology, Graduate School of Medicine, Chiba University, Chiba, 
      Japan.
AD  - Department of Advanced Medicine in Pulmonary Hypertension, Graduate School of 
      Medicine, Chiba University, Chiba, Japan.
FAU - Watanabe, Hiroshi
AU  - Watanabe H
AD  - Department of Clinical Pharmacology and Therapeutics, Hamamatsu University School 
      of Medicine, Shizuoka, Japan.
FAU - Yamada, Hidehiro
AU  - Yamada H
AD  - Division of Rheumatology and Allergy, Department of Internal Medicine, St. 
      Marianna University School of Medicine, Kanagawa, Japan.
FAU - Yoshioka, Koichiro
AU  - Yoshioka K
AD  - Department of Cardiovascular Medicine, Tokai University School of Medicine, 
      Kanagawa, Japan.
FAU - Hatta, Motonori
AU  - Hatta M
AD  - Data Management & Biometry, Actelion Pharmaceuticals Japan, Tokyo, Japan.
FAU - Sasayama, Shigetake
AU  - Sasayama S
AD  - Uji hospital, Kyoto, Japan.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20200512
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Endothelin Receptor Antagonists)
RN  - 0 (Peptide Fragments)
RN  - 0 (Pyrimidines)
RN  - 0 (Sulfonamides)
RN  - 0 (pro-brain natriuretic peptide (1-76))
RN  - 114471-18-0 (Natriuretic Peptide, Brain)
RN  - Z9K9Y9WMVL (macitentan)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Endothelin Receptor Antagonists/*therapeutic use
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Natriuretic Peptide, Brain/blood
MH  - Peptide Fragments/blood
MH  - Pulmonary Arterial Hypertension/blood/*drug therapy
MH  - Pyrimidines/adverse effects/*therapeutic use
MH  - Sulfonamides/adverse effects/*therapeutic use
OTO - NOTNLM
OT  - Pulmonary arterial hypertension
OT  - efficacy and safety
OT  - endothelin receptor antagonist
OT  - long-term treatment
OT  - macitentan
EDAT- 2020/04/17 06:00
MHDA- 2021/04/30 06:00
CRDT- 2020/04/17 06:00
PHST- 2020/04/17 06:00 [pubmed]
PHST- 2021/04/30 06:00 [medline]
PHST- 2020/04/17 06:00 [entrez]
AID - 10.1080/03007995.2020.1756234 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2020 Jun;36(6):921-928. doi: 10.1080/03007995.2020.1756234. 
      Epub 2020 May 12.