Ambrisentan

LETAIRIS® (ambrisentan) tablets for oral use. US prescribing information. Foster City (CA): Gilead Sciences Inc., 2011 Mar. Volibriss R. Summary of product characteristics. Uxbridge: GlaxoSmithKline UK, 2010 Apr 13. Hooper WC, Mensah GA, Haworth SG, et al. Vascular endothelium summary statement V: pulmonary hypertension and acute lung injury: public health implications. Vascul Pharmacol 2007 May; 46(5): 327–9. Heresi GA, Dweik RA. Pulmonary hypertension: evaluation and management. Compr Ther 2007 Fall; 33(3): 150–61. Galie N, Palazzini M, Manes A. Pulmonary arterial hypertension: from the kingdom of the near-dead to multiple clinical trial meta-analyses. Eur Heart J 2010; 31(17): 2080–6. Hoeper MM. Drug treatment of pulmonary arterial hypertension: current and future agents. Drugs 2005; 65(10): 1337–54. Simonneau G, Robbins IM, Beghetti M, et al. Updated clinical classification of pulmonary hypertension. J Am Coll Cardiol 2009 Jun 30; 54 (1 Suppl. S): S43–54. 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Basic science of pulmonary arterial hypertension for clinicians: new concepts and experimental therapies. Circulation 2010; 121(18): 2045–66. Morrell N, Adnot S, Archer SL, et al. Cellular and molecular basis of pulmonary arterial hypertension. J Am Coll Cardiol 2009 Jun 30; 54 (1 Suppl. S): S20–31. Badesh D, Champion HC, Gomez Sanchez MA, et al. Diagnosis and assessment of pulmonary arterial hypertension. J Am Coll Cardiol 2009 Jun 30; 54 (1 Suppl. S): S55–66. Hoeper MM, Barbera JA, Channick RN, et al. Diagnosis, assessment, and treatment of non-pulmonary arterial hypertension pulmonary hypertension. J Am Coll Cardiol 2009 Jun 30; 54 (1 Suppl. S): S85–96. Safdar Z. Targeted oral therapies in the treatment of pulmonary arterial hypertension. Clin Drug Investig 2010; 30(12): 811–26. Croxtall JD, Keam SJ. Ambrisentan. Drugs 2008; 68(15): 2195–204. Cheng JWM. Ambrisentan for the management of pulmonary arterial hypertension. Clin Ther 2008; 30(5): 825–33. Dhillon S, Keating GM. Bosentan: a review of its use in the management of mildly symptomatic pulmonary arterial hypertension. Am J Cardiovasc Drugs 2009; 9(5): 331–50. Croxtall JD, Lyseng-Williamson KA. Tadalafil: in pulmonary arterial hypertension. Drugs 2010; 70(4): 479–88. Croom KF, Curran MP. Sildenafil: a review of its use in pulmonary arterial hypertension. Drugs 2008; 68(3): 383–97. Abman SH. Role of endothelin receptor antagonists in the treatment of pulmonary arterial hypertension. Ann Rev Med 2009; 60: 13–21. Kabunga P, Coghlan G. Endothelin receptor antagonism: role in the treatment of pulmonary arterial hypertension related to scleroderma. Drugs 2008; 68(12): 1635–45. Channick RN, Sitbon O, Barst RJ, et al. Endothelin receptor antagonists in pulmonary arterial hypertension. J Am Coll Cardiol 2004 Jun 16; 43 (12 Suppl. S): 62–67S. Opitz CF, Ewert R, Kirch W, et al. Inhibition of endothelin receptors in the treatment of pulmonary arterial hypertension: does selectivity matter? Eur Heart J 2008; 29(16): 1936–48. Dhaun N, oddard J, Kohan DE, et al. Role of endothelin-1 in clinical hypertension: 20 years on. Hypertension 2008; 52(3): 452–9. Pfizer voluntarily withdraws sitaxsentan from the market worldwide and halts ongoing clinical trials [online]. Available from URL: http://formularyjournal.modernmedicine.com [Accessed 2011 Feb 8]. Vatter H, Seifert V. Ambrisentan, a non-peptide endothelin receptor antagonist. Cardiovasc Drug Rev 2006 Spring; 24(1): 63–76. Galie N, Badesch D, Oudiz R, et al. Ambrisentan therapy for pulmonary arterial hypertension. J Am Coll Cardiol 2005 Aug 2; 46(3): 529–35. Klinger JR, Spence R, Despain D, et al. Long-term haemodynamic improvements with ambrisentan therapy [abstract plus poster 107]. American College of Chest Physicians International Conference; 2009 31 Oct–5 Nov; San Diego (CA). Cartin-Ceba R, Swanson KL, Iyer V. Safety and efficacy of ambrisentan for the treatment of portopulmonary hypertension. Chest 2011; 139(1): 109–14. Blalock SE, Matulevicius S, Mitchell LC, et al. Long-term outcomes with ambrisentan monotherapy in pulmonary arterial hypertension. J Card Fail 2010 Feb; 16(2): 121–7. Vasquez-Ortiz ZY, Pulido T, Espinola-Zavaleta N, et al. Effect of ambrisentan on echocardiographic measures in patients with pulmonary arterial hypertension: an open-label study. Am J Respir Crit Care Med 2009; 179: A3355. Plus poster K88 presented at the American Thoracic Society International Conference; 2009 May 15, A3355. San Diego (CA). Harrison B, Magee MH, Mandagere A, et al. Effects of rifampicin (rifampin) on the pharmacokinetics and safety of ambrisentan in healthy subjects: a single-sequence, open-label study. Clin Drug Invest 2010; 30(12): 875–85. Hartman JC, Brouwer K, Mandagere A, et al. Evaluation of the endothelin receptor antagonists ambrisentan, darusentan, bosentan, and sitaxsentan as substrates and inhibitors of hepatobiliary transporters in sandwich-cultured human hepatocytes. Can J Physiol Pharmacol 2010 Jun; 88(6): 682–91. Richards DB, Walker GA, Mandagere A, et al. Effect of ketoconazole on the pharmacokinetic profile of ambrisentan. J Clin Pharmacol 2009 Jun; 49(6): 719–24. Harrison B, Despain D, Mandagere A, et al. Omeprazole has no clinically relevant effect on the pharmacokinetics of ambrisentan. Am J Respir Crit Care Med 2009; 179: A3348. Plus poster K81 presented at the American Thoracic Society International Conference; 2009 May 15–20; San Diego (CA). Spence R, Mandagere A, Dufton C, et al. Pharmacokinetics and safety of ambrisentan in combination with sildenafil in healthy volunteers. J Clin Pharmacol 2008; 48(12): 1451–9. Spence R, Mandagere A, Harrison B, et al. No clinically relevant pharmacokinetic and safety interactions of ambrisentan in combination with tadalafil in healthy volunteers. J Pharm Sci 2009 Dec; 98(12): 4962–74. Walker G, Mandagere A, Dufton C, et al. The pharmacokinetics and pharmacodynamics of warfarin in combination with ambrisentan in healthy volunteers. Br J Clin Pharmacol 2009 May; 67(5): 527–34. Richards DB, Spence R, Mandagere A, et al. Effects of multiple doses of ambrisentan on the pharmacokinetics of a single dose of digoxin in healthy volunteers. J Clin Pharmacol 2011; 51: 102–6. Spence R, Mandagere A, Walker G, et al. Effect of steady-state ambrisentan on the pharmacokinetics of a single dose of the oral contraceptive norethindrone (norethisterone) 1 mg/ethinylestradiol 35 microg in healthy subjects: an open-label, single-sequence, single-centre study. Clin Drug Investig 2010; 30(5): 313–24. Gillies HC, Wang X, Staehr P, et al. PAH therapy in HIV: lack of drug-drug interaction between ambrisentan and ritonavir. Am J Respir Crit Care Med 2011; 183: A5913. Plus poster A29 presented at the American Thoracic Society International Conference; 2011 May 13–18; Denver (CO). Mandagere A, Coar B, Bird SW, et al. Steady-state tacrolimus has no effect on the steady-state pharmacokinetics of ambrisentan in healthy subjects. Am J Respir Crit Care Med 2010; 181: A3352. Plus poster B23 presented at the American Thoracic Society International Conference; 2010 May 14–19; New Orleans (LA). Mandagere A, Coar B, Bird SW, et al. Absence of a clinically relevant pharmacokinetic interaction between ambrisentan and mycophenolate mofetil. Am J Respir Crit Care Med 2010; 181: A3356. Plus poster B27 presented at the American Thoracic Society International Conference; 2010 May 14–19; New Orleans (LA). Spence R, Mandagere A, Richards DB, et al. Potential for pharmacokinetic interactions between ambrisentan and cyclosporine. Clin Pharmacol Ther 2010 Oct; 88(4): 513–20. Gilead Sciences. ARIES — Ambrisentan in patients with moderate to severe pulmonary aterial hypertension (PAH). [ClinicalTrials.gov identifier NCT00091598] US National Institutes of Health, ClinicalTrials.gov [online]. Available from URL: http://clinicaltrials.gov [Accessed 2011 Feb 15]. Galie N, Olschewski H, Oudiz RJ, et al. Ambrisentan for the treatment of pulmonary arterial hypertension: results of the ambrisentan in pulmonary arterial hypertension, randomized, double-blind, placebo-controlled, multicenter, efficacy (ARIES) study 1 and 2. Circulation 2008; 117: 3010–9. Gilead Sciences. A long term study of ambrisentan in pulmonary arterial hypertension subjects having completed AMB-320 or AMB-321. [Clinical Trials.gov identifier NCT00578786] US National Institutes of Health, ClinicalTrials.gov [online]. Available from URL: http://clinicaltrials.gov [Accessed 2011 Feb 16]. Oudiz RJ, Galie N, Olschewski H, et al. Long-term ambrisentan therapy for the treatment of pulmonary arterial hypertension. J Am Coll Cardiol 2009 Nov 17; 54(21): 1971–81. Badesch DB, Feldman J, Keogh A, et al. ARIES-3: ambrisentan therapy in a diverse population of patients with pulmonary hypertension. Am J Respir Crit Care Med 2009; 179: A3357. Plus poster K79 presented at the American Thoracic Society International Conference; 2009 May 15–20; San Diego (CA). Gilead Sciences. Safety and efficacy study of ambrisentan in subjects with pulmonary hypertension. [ClinicalTrials.gov identifier NCT00380068] US National Institutes of Health, ClinicalTrials.gov. [online]. Available from URL: http://clinicaltrials.gov [Accessed 2011 Feb 16]. Gilead Sciences. (ARTEMIS-IPF) randomized, placebo-controlled study to evaluate safety and effectiveness of ambrisentan in IPF. [ClinicalTrials.gov identifier NCT00768300] US National Institutes of Health, ClinicalTrials.gov [online]. Available from URL: http://clinicaltrials.gov [Accessed 2011 May 12]. Olschewski H, Galie N, Rubin LJ, et al. Ambrisentan improves exercise capacity and dyspnoea in WHO functional class II and III patients with pulmonary arterial hypertension. Am J Respir Crit Care Med 2007 Apr; 175: A1001. Plus poster 2873 presented at the American Thoracic Society International Conference; 2007 May 18–23; San Francisco (CA). Waxman AB, on behalf of the ARIES Study Group. A short-term delay of endothelin receptor antagonist therapy results in a decreased long-term improvement in exercise capacity [abstract plus poster 103]. American College of Chest Physicians International Conference; 2009 31 Oct–5 Nov; San Diego (CA). Torres F, on behalf of the ARIES Study Group. Long-term ambrisentan therapy in patients with pulmonary arterial hypertension: an analysis by WHO functional class. Am J Respir Crit Care Med 2009; 179: A3370. Plus poster K102 presented at the American Thoracic Society International Conference; 2009 May 15–20; San Diego (CA). Pulido T, on behalf of the ARIES Study Group. Long-term ambrisentan therapy for pulmonary arterial hypertension: comparison by etiology. Am J Respir Crit Care Med 2009; 179: A3356. Plus poster K89 presented at the American Thoracic Society International Conference; 2009 May 15–20; San Diego (CA). Torres F, on behalf of the ARIES Study Group. Ambrisentan two-year results in patients with pulmonary arterial hypertension: an analysis of monotherapy and combination therapy [abstract plus poster 110]. American College of Chest Physicians International Conference; 2009 Oct 31–Nov 5; San Diego (CA). McGoon M, on behalf of the ARIES-3 Study Group. Ambrisentan therapy in patients with pulmonary arterial hypertension receiving concomitant sildenafil therapy: an analysis of the ARIES-3 study. Am J Respir Crit Care Med 2010; 181: A3351. Plus poster B22 presented at the American Thoracic Society International Conference; 2010 May 14–19; New Orleans (LA). US Food and Drug Administration. FDA modifies boxed warning for pulmonary arterial hypertension drug Letairis [online]. Available from URL: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm245848.htm [Accessed 2011 Mar 15]. McGoon M, Peschel T, Pizzuti D, et al. Post-marketing hepatic safety profile of ambrisentan in patients with pulmonary arterial hypertension [abstract plus poster 1061]. 9th International Pulmonary Hypertension Conference and Scientific Sessions; 2010 June 25–27. McGoon MD, Frost AE, Oudiz RJ, et al. Ambrisentan therapy in patients with pulmonary arterial hypertension who discontinued bosentan or sitaxsentan due to liver function test abnormalities. Chest 2009 Jan; 135(1): 122–9. Feldman JP, Keogh A, on behalf of the ARIES-3 Study Group. ARIES-3: long-term ambrisentan therapy in patients with pulmonary hypertension who previously discontinued bosentan or sitaxsentan due to liver function abnormalities [abstract plus poster 697]. American Thoracic Society International Conference; 2008 Oct 25–30; Philadelphia (PA). Data on file, Gilead. 2011. US Food and Drug Administration. FDA drug safety communication: liver injury warning to be removed from Letairis (ambrisentan) tablets [online]. Available from URL: http://www.fda.gov/Drugs/DrugSafety/ucm245852.htm [Accessed 2011 Mar 14]. Gilead Sciences. Study of ambrisentan and phosphodiesterase type-5 inhibitor (PDE-5i) to treat pulmonary arterial hypertension (ATHENA-1) [Clinical Trials.gov identifier NCT00617305]. US National Institutes of Health, ClinicalTrials.gov [online]. Available from URL: http://clinicaltrials.gov [Accessed 2011 Mar 11]. Gilead Sciences. A study of first-line ambrisentan and tadalafil combination therapy in subjects with pulmonary arterial hypertension (PAH) (AMBITION). [ClinicalTrials.gov identifier NCT01178073]. US National Institutes of Health, ClinicalTrials.gov [online]. Available from URL: http://clinicaltrials.gov [Accessed 2011 Mar 11].