PMID- 21884013 OWN - NLM STAT- MEDLINE DCOM- 20120703 LR - 20161125 IS - 1755-5922 (Electronic) IS - 1755-5914 (Linking) VI - 30 IP - 2 DP - 2012 Apr TI - ARIES-3: ambrisentan therapy in a diverse population of patients with pulmonary hypertension. PG - 93-9 LID - 10.1111/j.1755-5922.2011.00279.x [doi] AB - INTRODUCTION: 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. AIMS: 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. CONCLUSION: 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. CI - (c) 2011 Blackwell Publishing Ltd. FAU - Badesch, David B AU - Badesch DB AD - University of Colorado, 12401 E. 17th Avenue, Aurora, CO 80045, USA. David.Badesch@ucdenver.edu FAU - Feldman, Jeremy AU - Feldman J FAU - Keogh, Anne AU - Keogh A FAU - Mathier, Michael A AU - Mathier MA FAU - Oudiz, Ronald J AU - Oudiz RJ FAU - Shapiro, Shelley AU - Shapiro S FAU - Farber, Harrison W AU - Farber HW FAU - McGoon, Michael AU - McGoon M FAU - Frost, Adaani AU - Frost A FAU - Allard, Martine AU - Allard M FAU - Despain, Darrin AU - Despain D FAU - Dufton, Christopher AU - Dufton C FAU - Rubin, Lewis J AU - Rubin LJ CN - ARIES-3 Study Group LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20110620 PL - England TA - Cardiovasc Ther JT - Cardiovascular therapeutics JID - 101319630 RN - 0 (Endothelin A Receptor Antagonists) RN - 0 (Phenylpropionates) RN - 0 (Pyridazines) RN - 114471-18-0 (Natriuretic Peptide, Brain) RN - HW6NV07QEC (ambrisentan) SB - IM MH - Adult MH - Aged MH - Double-Blind Method MH - Endothelin A Receptor Antagonists MH - Exercise Tolerance MH - Female MH - Humans MH - Hypertension, Pulmonary/*drug therapy MH - Long-Term Care MH - Male MH - Middle Aged MH - Natriuretic Peptide, Brain MH - Phenylpropionates/adverse effects/*therapeutic use MH - Pyridazines/adverse effects/*therapeutic use MH - Survival MH - Treatment Outcome MH - Walking/physiology FIR - Badesch, D IR - Badesch D FIR - Baran, D IR - Baran D FIR - Benza, R L IR - Benza RL FIR - Boedefeld, R IR - Boedefeld R FIR - Carroll, J IR - Carroll J FIR - Chakinala, M IR - Chakinala M FIR - Channick, R IR - Channick R FIR - Elton, D IR - Elton D FIR - Elwing, J IR - Elwing J FIR - Engel, P IR - Engel P FIR - Farber, H IR - Farber H FIR - Feldman, J IR - Feldman J FIR - Foley, R J IR - Foley RJ FIR - Frost, A IR - Frost A FIR - Gabbay, E IR - Gabbay E FIR - Garcia, H IR - Garcia H FIR - Gomberg-Maitland, M IR - Gomberg-Maitland M FIR - Gossage, J IR - Gossage J FIR - Gratnon, J IR - Gratnon J FIR - Helmersen, D IR - Helmersen D FIR - Hill, N IR - Hill N FIR - Hsu, V IR - Hsu V FIR - Keogh, A IR - Keogh A FIR - Klapholz, M IR - Klapholz M FIR - Klinger, J IR - Klinger J FIR - Landzberg, M IR - Landzberg M FIR - Markin, C IR - Markin C FIR - Mathier, M IR - Mathier M FIR - McGoon, M IR - McGoon M FIR - Mehta, S IR - Mehta S FIR - Michaelson, J IR - Michaelson J FIR - Michelakis, E IR - Michelakis E FIR - Murali, S IR - Murali S FIR - Oudiz, R IR - Oudiz R FIR - Robbins, M IR - Robbins M FIR - Rosenzweig, E IR - Rosenzweig E FIR - Schilz, R IR - Schilz R FIR - Shapiro, S IR - Shapiro S FIR - Swisher, J IR - Swisher J FIR - Tapson, V IR - Tapson V FIR - Waxman, A IR - Waxman A FIR - White, J IR - White J FIR - Zaiman, A IR - Zaiman A FIR - Abbott, C IR - Abbott C FIR - Adams, L IR - Adams L FIR - Andrews, M IR - Andrews M FIR - Barasa, D IR - Barasa D FIR - Beckmannn, J IR - Beckmannn J FIR - Bomba, J IR - Bomba J FIR - Brady, D IR - Brady D FIR - Bramante, T IR - Bramante T FIR - Brown, K IR - Brown K FIR - Camanga, D IR - Camanga D FIR - Conger, D IR - Conger D FIR - Corrigan, C IR - Corrigan C FIR - Coslet, S IR - Coslet S FIR - Culbreth, R IR - Culbreth R FIR - Danta, I IR - Danta I FIR - Dougherty, M IR - Dougherty M FIR - Dumont, M IR - Dumont M FIR - Evans, S IR - Evans S FIR - Fearon Clarke, J IR - Fearon Clarke J FIR - Fruitger, K IR - Fruitger K FIR - Gabbay, E IR - Gabbay E FIR - Gendreau, P IR - Gendreau P FIR - Grubbs, B IR - Grubbs B FIR - Haney, D IR - Haney D FIR - Hill, W IR - Hill W FIR - Hosn, R IR - Hosn R FIR - Houtchens, J IR - Houtchens J FIR - James, M IR - James M FIR - Jary, C IR - Jary C FIR - Jenkins, K IR - Jenkins K FIR - Jones, C IR - Jones C FIR - Karasick, L IR - Karasick L FIR - Keltonic, P IR - Keltonic P FIR - Kinninger, K IR - Kinninger K FIR - Knechtel, J IR - Knechtel J FIR - Larew, C IR - Larew C FIR - Lawler, L IR - Lawler L FIR - Levato, E IR - Levato E FIR - Logan, C IR - Logan C FIR - Mallory, Y IR - Mallory Y FIR - Mangold, C IR - Mangold C FIR - Marks, J IR - Marks J FIR - Maslanka, N IR - Maslanka N FIR - Mattessich, R IR - Mattessich R FIR - McCloskey, D IR - McCloskey D FIR - McCollister, D IR - McCollister D FIR - McGary, E IR - McGary E FIR - Melegari, C IR - Melegari C FIR - Mituniewicz, J IR - Mituniewicz J FIR - Mulchandani, N IR - Mulchandani N FIR - Oelschlager, K IR - Oelschlager K FIR - Pidoux, A IR - Pidoux A FIR - Purl, H IR - Purl H FIR - Rhodes, P IR - Rhodes P FIR - Rodriguez-Huertas, E IR - Rodriguez-Huertas E FIR - Roessell, L IR - Roessell L FIR - Scovel, P IR - Scovel P FIR - Singh, S IR - Singh S FIR - Smithson, B IR - Smithson B FIR - Stroud, L IR - Stroud L FIR - Thoma, M IR - Thoma M FIR - Tobin, K IR - Tobin K FIR - Van Dijk, J IR - Van Dijk J FIR - Verry, H IR - Verry H FIR - Visnaw, K IR - Visnaw K FIR - Webster, L IR - Webster L FIR - Werff, E IR - Werff E FIR - Witherspoon, F IR - Witherspoon F EDAT- 2011/09/03 06:00 MHDA- 2012/07/04 06:00 CRDT- 2011/09/03 06:00 PHST- 2011/09/03 06:00 [entrez] PHST- 2011/09/03 06:00 [pubmed] PHST- 2012/07/04 06:00 [medline] AID - 10.1111/j.1755-5922.2011.00279.x [doi] PST - ppublish SO - Cardiovasc Ther. 2012 Apr;30(2):93-9. doi: 10.1111/j.1755-5922.2011.00279.x. Epub 2011 Jun 20.