An update on the use of ambrisentan in pulmonary arterial hypertension

Therapeutic Advances in Respiratory Disease

Volumn 6, Issue 6, 2012, Pages 331-343

  D'alto, Michele ^a  

^a SECOND UNIVERSITY OF NAPLES   (Italy)

Author keywords

ambrisentan; endothelin receptor antagonists; pulmonary arterial hypertension

Indexed keywords

ALANINE AMINOTRANSFERASE; AMBRISENTAN; ASPARTATE AMINOTRANSFERASE; BOSENTAN; CYCLOSPORIN A; ENDOTHELIN A RECEPTOR; ENDOTHELIN B RECEPTOR; ENDOTHELIN RECEPTOR ANTAGONIST; PROSTACYCLIN; PYRROLE DERIVATIVE; SILDENAFIL; SITAXSENTAN; TADALAFIL; WARFARIN;

ALANINE AMINOTRANSFERASE BLOOD LEVEL; AMINOTRANSFERASE BLOOD LEVEL; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; CONTROLLED CLINICAL TRIAL (TOPIC); DISEASE EXACERBATION; DISEASE SEVERITY; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EXERCISE TOLERANCE; HEADACHE; HUMAN; INCIDENCE; LIVER FUNCTION TEST; LIVER INJURY; LIVER TOXICITY; LUNG HEMODYNAMICS; NOSE OBSTRUCTION; PERIPHERAL EDEMA; PRIORITY JOURNAL; PULMONARY HYPERTENSION; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SIDE EFFECT; SURVIVAL; TREATMENT RESPONSE; WALKING;

ANTIHYPERTENSIVE AGENTS; DISEASE PROGRESSION; DRUG INTERACTIONS; EXERCISE TOLERANCE; HUMANS; HYPERTENSION, PULMONARY; PHENYLPROPIONATES; PYRIDAZINES; QUALITY OF LIFE; RECEPTORS, ENDOTHELIN;

EID: 84870223626     PISSN: 17534658     EISSN: 17534666     Source Type: Journal    
DOI: 10.1177/1753465812458014     Document Type: Review

References (45)

1. Badesch D. Feldman J. Keogh A. Mathier M. Oudiz R. Shapiro S. (2012) ARIES-3: ambrisentan therapy in a diverse population of patients with pulmonary hypertension. Cardiovasc Ther 30: 93–99.
2. Bai Y. Sun L. Hu S. Wei Y. (2011) Combination therapy in pulmonary arterial hypertension: a meta-analysis. Cardiology 120: 157–165.
3. Barst R. Langleben D. Badesch D. Frost A. Lawrence E. Shapiro S. (2006) Treatment of pulmonary arterial hypertension with the selective endothelin-A receptor antagonist sitaxsentan. J Am Coll Cardiol 47: 2049–2056.
4. Ben-Yehuda O. Pizzuti D. Brown A. Littman M. Gillies H. Henig N. (2012) Long-term hepatic safety of ambrisentan in patients with pulmonary arterial hypertension. J Am Coll Cardiol 60: 80–81.
5. Blalock S. Matulevicius S. Mitchell L. Reimold S. Warner J. Peshock R. (2010) Long-term outcomes with ambrisentan monotherapy in pulmonary arterial hypertension. J Card Fail 16: 121–127.
6. Bolli M. Marfurt J. Grisostomi C. Boss C. Binkert C. Hess P. (2004) Novel benzo[1,4]diazepin-2-one derivatives as endothelin receptor antagonists. J Med Chem 47: 2776–2795.
7. Buckley M. Wicks L. Staib R. Kirejczyk A. Varker A. Gibson J. (2011) Pharmacokinetic evaluation of ambrisentan. Expert Opin Drug Metab Toxicol 7: 371–380.
8. Budhiraja R. Tuder R. Hassoun P. (2004) Endothelial dysfunction in pulmonary hypertension. Circulation 109: 159–165.
9. Cartin-Ceba R. Swanson K. Wiesner R. Krowka M. (2011) Safety and efficacy of ambrisentan for the treatment of portopulmonary hypertension. Chest 139: 109–114.
10. Chan S. Loscalzo J. (2008) Pathogenic mechanisms of pulmonary arterial hypertension. J Mol Cell Cardiol 44: 14–30.
11. D–Alto M. Romeo E. Argiento P. Correra A. Sarubbi B. Scognamiglio G. (2012) Ambrisentan for pulmonary arterial hypertension: Long term effects on clinical status, exercise capacity and haemodynamics. Int J Cardiol 156: 244–245.
12. Davenport A. O–Reilly G. Kuc R. (1995) Endothelin ETA and ETB mRNA and receptors expressed by smooth muscle in the human vasculature: majority of the ETA sub-type. Br J Pharmacol 114: 1110–1116.
13. European Medicines Agency (2010) Thelin (sitaxentan) to be withdrawn due to cases of unpredictable serious liver injury, 11 December 2010. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2010/12/news_detail_001161.jsp&murl=menus/news_and_events/news_and_events.jsp&mid=WC0b01ac058004d5c1&jsenabled=true ( Accessed 26 July 2012).
14. Galiè N. Grigioni F. Bacchi-Reggiani L. (1996) Relation of endothelin-1 to survival in patients with primary pulmonary hypertension [abstract 273]. Eur J Clin Invest 26: A48.
15. Galiè N. Hoeper M. Humbert M. Torbicki A. Vachiery J. Barbera J. (2009) Guidelines on diagnosis and treatment of pulmonary hypertension: the Task Force on Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology and of the European Respiratory Society. Eur Heart J 30: 2493–2537.
16. Galiè N. Manes A. Branzi A. (2004) The endothelin system in pulmonary arterial hypertension. Cardiovasc Res 61: 227–237.
17. Galiè N. Olschewski H. Oudiz R. Torres F. Frost A. Ghofrani H. (2008) 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 117: 3010–3019.
18. Gilead Sciences (2011) Letairis [package insert]. Foster City, CA: Gilead Sciences. Available at: http://www.letairis.com ( Accessed May 2012).
19. Greene S. Nunley K. Weber S. Minobe W. Bristow M. (2006) ETA vs. ETB receptor selectivity of endothelin-1 receptor antagonists. J Am Coll Cardiol 47: 307A.
20. Hartman J. Brouwer K. Mandagere A. Melvin L. Gorczynski R. (2010) 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 88: 682–691.
21. Hassoun P. Mouthon L. Barbera J. Eddahib S. Flores S. Grimminger F. (2009) Inflammation, growth factors, and pulmonary vascular remodeling. J Am Coll Cardiol 54: S10's19.
22. Hoeper M. (2009) Liver toxicity: the Achilles’ heel of endothelin receptor antagonist therapy? Eur Respir J 34: 529–530.
23. Hoeper M. Olsson K. Schneider A. Golpon H. (2009) Severe hepatitis associated with sitaxentan and response to glucocorticoid therapy. Eur Respir J 33: 1518–1519.
24. Humbert M. Sitbon O. Chaouat A. Bertocchi M. Habib G. Gressin V. (2006) Pulmonary arterial hypertension in France: results from a national registry. Am J Respir Crit Care Med 173: 1023–1030.
25. Klinger J. Oudiz R. Spence R. Despain D. Dufton C. (2011) Long-term pulmonary hemodynamic effects of ambrisentan in ulmonary arterial hypertension. Am J Cardiol 108: 302–307.
26. Lavelle A. Sugrue R. Lawler G. Mulligan N. Kelleher B. Murphy D. (2009) Sitaxentan-induced hepatic failure in two patients with pulmonary arterial hypertension. Eur Respir J 34: 770–771.
27. Lee W. Kirkham N. Johnson M. Fisher A. Peacock A. (2011) Sitaxentan-induced acute liver failure in a patient with pulmonary arterial hypertension. Eur Respir J 37: 472–474.
28. McGoon M. Frost A. Oudiz R. Badesch B. Galie N. Olschewski H. (2009) Ambrisentan therapy in patients with pulmonary arterial hypertension who discontinued bosentan or sitaxsentan due to liver function test abnormalities. Chest 135: 122–129.
29. Oudiz R. Allard M. Blair C. and Gillies, H. (2011) Ambrisentan therapy in patients with pulmonary arterial hypertension: 3-year outcome. Chest 140: 742A.
30. Oudiz R. Galiè N. Olschewski H. Torres F. Frost A. Ghofrani H. (2009) Long-term ambrisentan therapy for the treatment of pulmonary arterial hypertension. J Am Coll Cardiol 54: 1971–1981.
31. Oudiz R. Shapiro S. Torres F. Frost F. Allard M. Blair G. (2011) ATHENA-1: hemodynamic improvements following the addition of ambrisentan to background PDE5i therapy in patients with pulmonary arterial hypertension. Chest 140: 905A.
32. Peacock A. Murphy N. McMurray J. Caballero L. Stewart S. (2007) An epidemiological study of pulmonary arterial hypertension. Eur Respir J 30: 104–109.
33. Rubens C. Ewert R. Halank M. Wensel R. Orzechowski H. Schultheiss H. (2001) Big endothelin-1 and endothelin-1 plasma levels are correlated with the severity of primary pulmonary hypertension. Chest 120: 1562–1569.
34. Rubin L. Badesch D. Barst R. Galiè N. Black C. Keogh A. (2002) Bosentan therapy for pulmonary arterial hypertension. N Engl J Med 346: 896–903.
35. Scott R.L. Steidley D.E. Gopalan R.S. Kalya A.V. Wenzel A.M. Marchi M.J. (2010) Efficacy of Ambrisentan in Treatment of Porto-Pulmonary Hypertension in Patients with End-Stage Liver Disease. American Journal of Transplantation 10: S266.
36. Shapiro S. Gillies H. Allard M. Blair C. Oudiz R.J. (2012) ATHENA-1: Long Term Clinical Improvements Following the Addition of Ambrisentan to Background PDE5i Therapy in Patients with Pulmonary Arterial Hypertension. Journal of Heart and Lung Transplantation 31(4): S28's29.
37. Spence R. Mandagere A. Richards D. Magee M. Dufton C. Boinpally R. (2010) Potential for pharmacokinetic interactions between ambrisentan and cyclosporine. Clin Pharmacol Ther 88: 513–520.
38. Actelion Pharmaceuticals US (2011) Tracleer [package insert]. South San Francisco, CA: Actelion Pharmaceuticals US.
39. Venitz J. Zack J. Gillies H. Allard M. Regnault J. Dufton C. (2011) Clinical pharmacokinetics and drug–drug interactions of endothelin receptor antagonists in pulmonary arterial hypertension. J Clin Pharmacol 28 December 2011 (epub ahead of print).
40. Verhaar M. Strachan F. Newby D. Cruden N. Koomans H. Rabelink T. (1998) Endothelin-A receptor antagonist-mediated vasodilatation is attenuated by inhibition of nitric oxide synthesis and by endothelin-B receptor blockade. Circulation 97: 752–756.
41. Walker G. Mandagere A. Dufton C. Venitz J. (2009) The pharmacokinetics and pharmacodynamics of warfarin in combination to ambrisentan in healthy volunteers. Br J Clin Pharm 67: 527–534.
42. Yanagisawa M. Kurihara H. Kimura S. Tomobe Y. Kobayashi M. Mitsui Y. (1988) A novel potent vasoconstrictor peptide produced by vascular endothelial cells. Nature 332: 411–415.
43. Yoshida S. Shirato K. Shimamura R. Nakahara N. Iwase T. Nakajima H. (2011) Efficacy, safety, and pharmacokinetics of ambrisentan in Japanese adults with pulmonary arterial hypertension. Curr Med Res Opin 27: 1827–1834.
44. Zhu B. Wang L. Sun L. Cao R. (2012) Combination therapy improves exercise capacity and reduces risk of clinical worsening in patients with pulmonary arterial hypertension: a meta-analysis. J Cardiovasc Pharmacol 11 June (epub ahead of print).
45. Zuckerman W. Leaderer D. Rowan C. Mituniewicz J. Rosenzweig E. (2011) Ambrisentan for pulmonary arterial hypertension due to congenital heart disease. Am J Cardiol 107: 1381–1385.