| Long-term ambrisentan therapy for the treatment of pulmonary arterial hypertension. | |
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MedLine Citation:
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PMID: 19909879 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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 approximately 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). |
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Authors:
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Ronald J Oudiz; Nazzareno Galiè; Horst Olschewski; Fernando Torres; Adaani Frost; Hossein A Ghofrani; David B Badesch; Michael D McGoon; Vallerie V McLaughlin; Ellen B Roecker; Brooke C Harrison; Darrin Despain; Christopher Dufton; Lewis J Rubin; |
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Publication Detail:
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Type: Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial |
Journal Detail:
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Title: Journal of the American College of Cardiology Volume: 54 ISSN: 1558-3597 ISO Abbreviation: J. Am. Coll. Cardiol. Publication Date: 2009 Nov |
Date Detail:
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Created Date: 2009-11-13 Completed Date: 2009-12-15 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8301365 Medline TA: J Am Coll Cardiol Country: United States |
Other Details:
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Languages: eng Pagination: 1971-81 Citation Subset: AIM; IM |
Affiliation:
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LA Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, California, USA. roudiz@labiomed.org |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Administration, Oral Dose-Response Relationship, Drug Double-Blind Method Exercise Tolerance / drug effects Female Follow-Up Studies Humans Hypertension, Pulmonary / drug therapy*, mortality, physiopathology Male Middle Aged Phenylpropionates / administration & dosage* Pulmonary Wedge Pressure / drug effects Pyridazines / administration & dosage* Survival Rate / trends Time Factors Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Phenylpropionates; 0/Pyridazines; 177036-94-1/ambrisentan |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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