Efficacy, safety, and pharmacokinetics of ambrisentan in Japanese adults with pulmonary arterial hypertension

Current Medical Research and Opinion

Volumn 27, Issue 9, 2011, Pages 1827-1834

  Yoshida, Shunji ^a   Shirato, Kunio ^b   Shimamura, Ryutaro ^c   Nakahara, Norie ^c   Iwase, Takayuki ^c   Nakajima, Hiromu ^c  

^a FUJITA HEALTH UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^b Saito Hospital   (Japan)

^c Development and Medical Affairs Division   (Japan)

Author keywords

6 minute walk distance; Dose escalation study; Endothelin receptor antagonist; Hemodynamics; Pulmonary arterial hypertension; World Health Organization functional class

Indexed keywords

AMBRISENTAN; AMINOTRANSFERASE; BERAPROST; BRAIN NATRIURETIC PEPTIDE; WARFARIN;

ADULT; AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; AREA UNDER THE CURVE; ARTICLE; BACTERIAL INFECTION; CARDIOPULMONARY HEMODYNAMICS; CLINICAL ARTICLE; CLINICAL TRIAL; DIZZINESS; DRUG BLOOD LEVEL; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG ERUPTION; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; EPISTAXIS; EXERCISE; FATIGUE; FEMALE; FLUSHING; HEADACHE; HOT FLUSH; HUMAN; HYPOTENSION; INSOMNIA; LEUKOPENIA; LUNG HEMORRHAGE; MALAISE; MALE; MAXIMUM PLASMA CONCENTRATION; PAIN; PERIPHERAL EDEMA; PLEURA EFFUSION; PNEUMONIA; PROTEIN BLOOD LEVEL; PROTHROMBIN TIME; PULMONARY HYPERTENSION; PYELONEPHRITIS; RHINOPHARYNGITIS; SIDE EFFECT; SOMNOLENCE; TREATMENT OUTCOME; VITREOUS HEMORRHAGE; WALKING;

ADULT; AGED; ANTIHYPERTENSIVE AGENTS; ASIAN CONTINENTAL ANCESTRY GROUP; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; DRUG INTERACTIONS; EPOPROSTENOL; FEMALE; HUMANS; HYPERTENSION, PULMONARY; MALE; MIDDLE AGED; PHENYLPROPIONATES; PLATELET AGGREGATION INHIBITORS; PYRIDAZINES; TREATMENT OUTCOME;

EID: 80051756414     PISSN: 03007995     EISSN: 14734877     Source Type: Journal    
DOI: 10.1185/03007995.2011.605440     Document Type: Article

References (24)

1. Galiè N, Hoeper MM, Humbert M, et al. Guidelines for the diagnosis and treatment of pulmonary hypertension: The Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS), endorsed by the International Society of Heart and Lung Transplantation (ISHLT). Eur Heart J 2009;30:2493-537
2. D'Alonzo GE, Barst RJ, Ayres SM, et al. Survival in patients with primary pulmonary hypertension. Results from a national prospective registry. Ann Intern Med 1991;115:343-349
3. Galiè N, Manes A, Branzi A. The endothelin system in pulmonary arterial hypertension. Cardiovasc Res 2004;61:227-237 (Pubitemid 38091763)
4. Reinhart GA, Preusser LC, Opgenorth TJ, et al. Endothelin and ET(A) receptors in long-term arterial pressure homeostasis in conscious nonhuman primates. Am J Physiol Regul Integr Comp Physiol 2000;279:R1701-1706
5. Stewart DJ, Levy RD, Cernacek P, Langleben D. Increased plasma endothelin-1 in pulmonary hypertension: marker or mediator of disease? Ann Intern Med 1991;114:464-469
6. Giaid A, Yanagisawa M, Langleben D, et al. Expression of endothelin-1 in the lungs of patients with pulmonary hypertension. N Engl J Med 1993;328:1732-1739 (Pubitemid 23170122)
7. Barst RJ, Langleben D, Badesch D, et al. Treatment of pulmonary arterial hypertension with the selective endothelin-A receptor antagonist sitaxsentan. J Am Coll Cardiol 2006;47:2049-2056
8. Galiè 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;117:3010-3019
9. Rubin LJ, Badesch DB, Barst RJ, et al. Bosentan therapy for pulmonary arterial hypertension. N Engl J Med 2002;346:896-903 (Pubitemid 34984638)
10. Barst RJ, Langleben D, Frost A, et al. Sitaxsentan therapy for pulmonary arterial hypertension. Am J Respir Crit Care Med 2004;169:441-447 (Pubitemid 38187114)
11. McLaughlin VV, Sitbon O, Badesch DB, et al. Survival with first-line bosentan in patients with primary pulmonary hypertension. Eur Respir J 2005;25:244-249 (Pubitemid 40246523)
12. Billman GE. Ambrisentan (Myogen). Curr Opin Investig Drugs 2002;3:1483-1486
13. Galiè N, Badesch D, Oudiz R, et al. Ambrisentan therapy for pulmonary arterial hypertension. J Am Coll Cardiol 2005;46:529-535 (Pubitemid 41040298)
14. 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;135:122-129
15. Oudiz RJ, Galiè N, Olschewski H, et al. Long-term ambrisentan therapy for the treatment of pulmonary arterial hypertension. J Am Coll Cardiol 2009;54:1971-1981
16. Barst RJ. A review of pulmonary arterial hypertension: role of ambrisentan. Vasc Health Risk Manag 2007;3:11-22 (Pubitemid 46860713)
17. Gilead Sciences, Inc. Food and Drug Administration New Drug Application 22-Filed Dec. 18, 2006. Approved June 15, 2007. Application available at: http://www.accessdata.fda.gov/drugsatfda-docs/nda/2007/022081s000-ClinPharmR-P8. pdf. Accessed July 12, 2010
18. Gilead Sciences, Inc. Food and Drug Administration New Drug Application 22-081 Filed Dec. 18, 2006. Approved June 15, 2007. Application available at: http://www.accessdata.fda.gov/drugsatfda-docs/nda/2007/022081s000-PharmR-P1.pdf. Accessed July 12, 2010
19. Burgess G, Hoogkamer H, Collings L, Dingemanse J. Mutual pharmacokinetic interactions between steady-state bosentan and sildenafil. Eur J Clin Pharmacol 2008;64:43-50
20. Horn EM, Widlitz AC, Barst RJ. Sitaxsentan, a selective endothelin-A receptor antagonist for the treatment of pulmonary arterial hypertension. Expert Opin Investig Drugs 2004;13:1483-1492 (Pubitemid 39530200)
21. Wrishko RE, Dingemanse J, Yu A, et al. Pharmacokinetic interaction between tadalafil and bosentan in healthy male subjects. J Clin Pharmacol 2008;48:610-618 (Pubitemid 351503516)
22. Walker G, Mandagere A, Dufton C, Venitz J. The pharmacokinetics and pharmacodynamics of warfarin in combination with ambrisentan in healthy volunteers. Br J Clin Pharmacol 2009;67:527-534
23. Spence R, Mandagere A, Dufton C, Venitz J. Pharmacokinetics and safety of ambrisentan in combination with sildenafil in healthy volunteers. J Clin Pharmacol 2008;48:1451-1459
24. 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;98:4962-4974