title: Efficacy, safety, and pharmacokinetics of ambrisentan in Japanese adults with pulmonary arterial hypertension.
abstract: OBJECTIVE
  To investigate the efficacy, safety, and pharmacokinetics of ambrisentan in Japanese adults with pulmonary arterial hypertension (PAH).
  
  
  METHODS
  In this open-label, uncontrolled, dose-escalation study, 25 Japanese patients with PAH were scheduled to receive 5 mg of ambrisentan once daily for the first 12 weeks, and 10 mg once daily for an additional 12 weeks. The primary endpoint was improvement in exercise capacity from baseline which was indicated by 6-minute walk distance; the secondary endpoints included World Health Organization functional class, Borg dyspnea index, plasma brain natriuretic peptide level, and cardiopulmonary hemodynamics.
  
  
  BACKGROUND
  NCT00540436.
  
  
  RESULTS
  At week 24, improvements were noted in all endpoints, with no clinically significant elevation of serum aminotransferase level. Pharmacokinetics in these Japanese patients was similar to that of non-Japanese populations, suggesting that once-daily dosing is appropriate in Japanese patients. Ambrisentan was generally well tolerated. No new safety signals were identified.
  
  
  CONCLUSIONS
  This study lacked a control group and was insufficiently powered to reach definitive conclusions on the efficacy of ambrisentan.
  
  
  CONCLUSIONS
  Ambrisentan is considered as safe and effective for Japanese adults with PAH.
authors.affiliation: Division of Rheumatology and Infectious Diseases, Department of Internal Medicine, Fujita Health University School of Medicine, Aichi, Japan. yoshida@fujita-hu.ac.jp
authors.forename: Shunji
authors.initials: S
authors.lastname: Yoshida
authors.forename: Kunio
authors.initials: K
authors.lastname: Shirato
authors.forename: Ryutaro
authors.initials: R
authors.lastname: Shimamura
authors.forename: Norie
authors.initials: N
authors.lastname: Nakahara
authors.forename: Takayuki
authors.initials: T
authors.lastname: Iwase
authors.forename: Hiromu
authors.initials: H
authors.lastname: Nakajima
mesh_terms: D000328:Adult; D000368:Aged; D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000009:adverse effects; D044466:Asian People; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004347:Drug Interactions; D011464:Epoprostenol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D065627:Familial Primary Pulmonary Hypertension; D005260:Female; D006801:Humans; D006976:Hypertension, Pulmonary / Q000188:drug therapy* / Q000208:ethnology / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D010666:Phenylpropionates / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics*; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D011724:Pyridazines / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics*; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents; D010666:Phenylpropionates; D010975:Platelet Aggregation Inhibitors; D011724:Pyridazines; C048081:beraprost; D011464:Epoprostenol; C467894:ambrisentan