• Cardiovasc Ther · Apr 2012

    Randomized Controlled Trial Multicenter Study

    ARIES-3: ambrisentan therapy in a diverse population of patients with pulmonary hypertension.

    • David B Badesch, Jeremy Feldman, Anne Keogh, Michael A Mathier, Ronald J Oudiz, Shelley Shapiro, Harrison W Farber, Michael McGoon, Adaani Frost, Martine Allard, Darrin Despain, Christopher Dufton, Lewis J Rubin, and ARIES-3 Study Group.
    • University of Colorado, 12401 E. 17th Avenue, Aurora, CO 80045, USA. David.Badesch@ucdenver.edu
    • Cardiovasc Ther. 2012 Apr 1; 30 (2): 93-9.

    IntroductionAmbrisentan 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.AimsARIES-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.ResultsA 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.ConclusionThis 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.© 2011 Blackwell Publishing Ltd.

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