title: ARIES-3: ambrisentan therapy in a diverse population of patients with pulmonary hypertension.
abstract: BACKGROUND
  Ambrisentan is an oral, once daily, endothelin receptor antagonist approved for treatment of pulmonary arterial hypertension (PAH). Previous studies of ambrisentan were limited to patients with Group 1 PAH and often excluded patients receiving other pulmonary hypertension (PH) therapies.
  
  
  OBJECTIVE
  ARIES-3 was an open-label study evaluating efficacy and safety of ambrisentan in patients with various PH etiologies and background PH medications. Patients received 5 mg ambrisentan once daily for 24 weeks. The primary endpoint was change from baseline in 6-minute walk distance (6MWD) at week 24.
  
  
  RESULTS
  A total of 224 patients with PH due to idiopathic and familial PAH (31%), connective tissue disease (18%), chronic hypoxemia (22%), chronic thromboembolic disease (13%), or other etiologies (16%) were enrolled and 53% of patients received stable background PAH therapies. After 24 weeks of therapy, an increase in 6MWD (+21 m; 95% CI: 12-29) and a decrease in B-type natriuretic peptide (-26%; 95% CI: -34 to -16%) was observed in the overall population compared to baseline; however, increases in 6MWD were not observed in several non-Group 1 PH subpopulations. Peripheral edema, headache, and dyspnea were the most common adverse events.
  
  
  CONCLUSIONS
  This study reconfirms the results of previous placebo-controlled studies, which demonstrate that ambrisentan is well tolerated and provides benefit in patients with PAH. Definitive conclusions regarding the safety and efficacy of ambrisentan in specific non-Group 1 PH etiologies cannot be determined and larger, controlled studies will be necessary to determine the efficacy and safety of ambrisentan in these populations.
authors: University of Colorado, 12401 E. 17th Avenue, Aurora, CO 80045, USA. David.Badesch@ucdenver.edu
authors: David B
authors: DB
authors: Badesch
authors: Jeremy
authors: J
authors: Feldman
authors: Anne
authors: A
authors: Keogh
authors: Michael A
authors: MA
authors: Mathier
authors: Ronald J
authors: RJ
authors: Oudiz
authors: Shelley
authors: S
authors: Shapiro
authors: Harrison W
authors: HW
authors: Farber
authors: Michael
authors: M
authors: McGoon
authors: Adaani
authors: A
authors: Frost
authors: Martine
authors: M
authors: Allard
authors: Darrin
authors: D
authors: Despain
authors: Christopher
authors: C
authors: Dufton
authors: Lewis J
authors: LJ
authors: Rubin
mesh_terms: D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D065130:Endothelin A Receptor Antagonists; D017079:Exercise Tolerance; D005260:Female; D006801:Humans; D006976:Hypertension, Pulmonary / Q000188:drug therapy*; D008134:Long-Term Care; D008297:Male; D008875:Middle Aged; D020097:Natriuretic Peptide, Brain; D010666:Phenylpropionates / Q000009:adverse effects / Q000627:therapeutic use*; D011724:Pyridazines / Q000009:adverse effects / Q000627:therapeutic use*; D013534:Survival; D016896:Treatment Outcome; D016138:Walking / Q000502:physiology
chemical_list: D065130:Endothelin A Receptor Antagonists; D010666:Phenylpropionates; D011724:Pyridazines; D020097:Natriuretic Peptide, Brain; C467894:ambrisentan