title: Efficacy and Safety of a Novel Endothelin Receptor Antagonist, Macitentan, in Japanese Patients With Pulmonary Arterial Hypertension.
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.
  
  
  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 plasmaN-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. (
  
  
  BACKGROUND
  JAPIC Clinical Trials Information [JapicCTI-121986].) (Circ J 2016; 80: 1478-1483).
authors.affiliation: Department of Medicine, Division of Cardiovascular Medicine, Kurume University School of Medicine.
authors.forename: Nobuhiro
authors.initials: N
authors.lastname: Tahara
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Dobashi
authors.forename: Keiichi
authors.initials: K
authors.lastname: Fukuda
authors.forename: Masanori
authors.initials: M
authors.lastname: Funauchi
authors.forename: Masaru
authors.initials: M
authors.lastname: Hatano
authors.forename: Satoshi
authors.initials: S
authors.lastname: Ikeda
authors.forename: Shuji
authors.initials: S
authors.lastname: Joho
authors.forename: Yasuki
authors.initials: Y
authors.lastname: Kihara
authors.forename: Takeshi
authors.initials: T
authors.lastname: Kimura
authors.forename: Takahisa
authors.initials: T
authors.lastname: Kondo
authors.forename: Masakazu
authors.initials: M
authors.lastname: Matsushita
authors.forename: Tohru
authors.initials: T
authors.lastname: Minamino
authors.forename: Norifumi
authors.initials: N
authors.lastname: Nakanishi
authors.forename: Yukio
authors.initials: Y
authors.lastname: Ozaki
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Saji
authors.forename: Satoshi
authors.initials: S
authors.lastname: Sakai
authors.forename: Nobuhiro
authors.initials: N
authors.lastname: Tanabe
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Watanabe
authors.forename: Hidehiro
authors.initials: H
authors.lastname: Yamada
authors.forename: Koichiro
authors.initials: K
authors.lastname: Yoshioka
authors.forename: Shigetake
authors.initials: S
authors.lastname: Sasayama
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D044466:Asian People; D065128:Endothelin Receptor Antagonists / Q000627:therapeutic use*; D005080:Exercise Test; D005260:Female; D006439:Hemodynamics / Q000187:drug effects; D006801:Humans; D006976:Hypertension, Pulmonary / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D061214:Patient Safety; D011651:Pulmonary Artery / Q000503:physiopathology; D011743:Pyrimidines / Q000008:administration & dosage / Q000627:therapeutic use*; D013449:Sulfonamides / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome; D014655:Vascular Resistance / Q000187:drug effects
chemical_list: D065128:Endothelin Receptor Antagonists; D011743:Pyrimidines; D013449:Sulfonamides; C533860:macitentan