Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
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SHR Neuro Krebs Kardio Lipid Stoffw Microb
Oudiz, RJ; Galie, N; Olschewski, H; Torres, F; Frost, A; Ghofrani, HA; Badesch, DB; McGoon, MD; McLaughlin, VV; Roecker, EB; Harrison, BC; Despain, D; Dufton, C; Rubin, LJ.
Long-term ambrisentan therapy for the treatment of pulmonary arterial hypertension.
J AMER COLL CARDIOL. 2009; 54(21): 1971-1981.
Doi: 10.1016/j.jacc.2009.07.033
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- Olschewski Horst
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- Abstract:
- Objectives This study evaluated the safety and efficacy of ambrisentan for a period of 2 years in patients with pulmonary arterial hypertension (PAH). Background Ambrisentan is an oral, once-daily endothelin receptor antagonist that is selective for the endothelin type A receptor. The ARIES-1 (Ambrisentan in Pulmonary Arterial Hypertension, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Studies) and ARIES-2 trials were the pivotal 12-week, placebo-controlled studies that led to the regulatory approval of ambrisentan (5 and 10 mg) for the treatment of PAH. Methods In the ARIES-1 and -2 studies, and the subsequent long-term extension protocol, the ARIES-E study, 383 patients received ambrisentan (2.5, 5, or 10 mg). Efficacy and safety assessments are presented from the time of the first dose of ambrisentan for all patients with post-baseline data. Results After 2 years of ambrisentan exposure, the mean change from baseline in 6-min walk distance was improved for the 5-mg (+23 m; 95% confidence interval: 9 to 38 m) and 10-mg (+28 m; 95% confidence interval: 11 to 45 m) groups. Estimates of survival and freedom from clinical worsening for the combined dose group were 94% and 83%, respectively, at 1 year and 88% and 72%, respectively, at 2 years. The annualized risk of aminotransferase abnormalities >3x the upper limit of normal was similar to 2% per year; most of these events were mild and did not lead to discontinuation of drug. Conclusions Two years of ambrisentan treatment was associated with sustained improvements in exercise capacity and a low risk of clinical worsening and death in patients with PAH. Ambrisentan was generally well tolerated and had a low risk of aminotransferase abnormalities over the 2-year study period. (A Long Term Study of Ambrisentan in Pulmonary Arterial Hypertension Subjects Having Completed AMB-320 or AMB-321; NCT00578786) (J Am Coll Cardiol 2009; 54: 1971-81) (C) 2009 by the American College of Cardiology Foundation
- Find related publications in this database (using NLM MeSH Indexing)
- Administration, Oral -
- Dose-Response Relationship, Drug -
- Double-Blind Method -
- Exercise Tolerance - drug effects
- Female -
- Follow-Up Studies -
- Humans -
- Hypertension, Pulmonary - drug therapy
- Male -
- Middle Aged -
- Phenylpropionates - administration and dosage
- Pulmonary Wedge Pressure - drug effects
- Pyridazines - administration and dosage
- Survival Rate - trends
- Time Factors -
- Treatment Outcome -
- Find related publications in this database (Keywords)
- ambrisentan
- exercise capacity
- endothelin
- hypertension
- pulmonary
- long-term survival