The pharmacokinetics and pharmacodynamics of warfarin in combination with ambrisentan in healthy volunteers

British Journal of Clinical Pharmacology

Volumn 67, Issue 5, 2009, Pages 527-534

  Walker, Gennyne ^a,c   Mandagere, Arun ^a   Dufton, Christopher ^a   Venitz, Jürgen ^b  

^a Gilead Sciences Inc   (United States)

^b VIRGINIA COMMONWEALTH UNIVERSITY   (United States)

^c GILEAD SCIENCES   (United States)

Author keywords

Ambrisentan; Endothelin receptor antagonist; International Normalized Ratio; Pharmacodynamics; Pharmacokinetics; Pulmonary arterial hypertension; R warfarin; S warfarin

Indexed keywords

AMBRISENTAN; WARFARIN;

ADULT; AREA UNDER THE CURVE; ARTICLE; BLEEDING; CHAPPED LIPS; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG EFFECT; DRUG EXPOSURE; DRUG INDUCED HEADACHE; DRUG POTENTIATION; DRUG SAFETY; DRUG SCREENING; DRUG TOLERABILITY; DRY SKIN; FEMALE; HUMAN; INTERNATIONAL NORMALIZED RATIO; MALE; MAXIMUM PLASMA CONCENTRATION; MULTIPLE CYCLE TREATMENT; NORMAL HUMAN; OPEN STUDY; PHARMACODYNAMICS; PHARMACOKINETICS; PRIORITY JOURNAL; RISK ASSESSMENT; SIDE EFFECT; SINGLE DRUG DOSE; STEADY STATE; THIRST;

ADOLESCENT; ADULT; ANTICOAGULANTS; ANTIHYPERTENSIVE AGENTS; AREA UNDER CURVE; CROSS-OVER STUDIES; DRUG INTERACTIONS; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; HYPERTENSION; MALE; MIDDLE AGED; PHENYLPROPIONATES; PYRIDAZINES; WARFARIN; YOUNG ADULT;

EID: 65349181831     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2009.03384.x     Document Type: Article

References (17)

1. Rubin LJ. Primary pulmonary hypertension. N Engl J Med 1997 336 : 111 7.
2. Farber HW, Loscalzo J. Pulmonary arterial hypertension. N Engl J Med 2004 351 : 1655 65.
3. Barst RJ, Rubin LJ, McGoon MD, Caldwell EJ, Long WA, Levy PS. Survival in primary pulmonary hypertension with long-term continuous intravenous prostacyclin. Ann Intern Med 1994 121 : 409 15.
4. Humbert M, Sitbon O, Simmonneau G. Treatment of pulmonary arterial hypertension. N Engl J Med 2004 351 : 1425 36.
5. Takahashi H, Echizen H. Pharmacogenetics of warfarin elimination and its clinical implications. Clin Pharmacokinet 2001 40 : 587 603.
6. Chan E, McLachlan A, O'Reilly R, Rowland M. Stereochemical aspects of warfarin drug interactions: use of a combined pharmacokinetic-pharmacodynamic model. Clin Pharmacol Ther 1994 56 : 286 94.
7. Kaminsky LS, Zhang ZY. Human P450 metabolism of warfarin. Pharmacol Ther 1997 73 : 67 74.
8. Rubin LJ, Badesch DB, Barst RJ, Galie N, Black CM, Keogh A, Pulido T, Frost A, Roux S, Leconte I, Landzberg M, Simonneau G. Bosentan therapy for pulmonary arterial hypertension. N Engl J Med 2002 346 : 896 903.
9. Barst RJ, Langleben D, Frost A, Horn EM, Oudiz R, Shapiro S, McLaughlin V, Hill N, Tapson VF, Robbins IM, Zwicke D, Duncan B, Dixon RAF, Frumkin LR. Sitaxsentan therapy for pulmonary arterial hypertension. Am J Respir Crit Care Med 2004 169 : 441 7.
10. Galie N, Badesch D, Oudiz R, Simonneau G, McGoon MD, Keogh AM, Frost AE, Zwicke D, Naeije R, Shapiro S, Olschewski H, Rubin LJ. Ambrisentan therapy for pulmonary arterial hypertension. J Am Coll Cardiol 2005 46 : 529 35.
11. Rubin LJ, Dufton C, Gerber M. Ambrisentan for pulmonary arterial hypertension. Future Cardiol 2005 1 : 1 8.
12. Gilead Sciences I. Letairis (ambrisentan) tablets for oral use. United States Food and Drug Administration Drug Product Label, 6-15-2007.
13. Naidong W, Lee JW. Development and validation of a high-performance liquid chromatographic method for the quantitation of warfarin enantiomers in human plasma. J Pharm Biomed Anal 1993 11 : 785 92.
14. Weber C, Banken L, Birnboeck H, Schulz R. Effect of the endothelin-receptor antagonist bosentan on the pharmacokinetics and pharmacodynamics of warfarin. J Clin Pharmacol 1999 39 : 847 54.
15. Dingemanse J, Van Giersbergen PL. Clinical pharmacology of bosentan, a dual endothelin receptor antagonist. Clin Pharmacokinet 2004 43 : 1089 115.
16. 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 92.
17. Actelion Pharmaceuticals Ltd. Tracleer (bosentan) tablets. United States Food and Drug Administration Drug Product Label, 2006.