Effect of the novel oral dipeptidyl peptidase IV inhibitor vildagliptin on the pharmacokinetics and pharmacodynamics of warfarin in healthy subjects

Current Medical Research and Opinion

Volumn 23, Issue 5, 2007, Pages 1131-1138

  He, Yan Ling ^a   Sabo, Ron ^b   Riviere, Gilles Jacques ^c   Sunkara, Gangadhar ^b   Leon, Selene ^b   Ligueros Saylan, Monica ^b   Rosenberg, Mitchell ^d   Dole, William P ^a   Howard, Dan ^b  

^a NOVARTIS INSTITUTES FOR BIOMEDICAL RESEARCH   (United States)

^b NOVARTIS PHARMA AG   (Switzerland)

^c NOVARTIS PHARMA K K   (Japan)

^d Parkway Research Center Inc ^*  (United States)

Author keywords

Drug interaction; International normalized ratio; Pharmacokinetics; Prothrombin time; Vildagliptin; Warfarin

Indexed keywords

PARACETAMOL; PLACEBO; VILDAGLIPTIN; WARFARIN;

ADULT; AREA UNDER THE CURVE; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONFERENCE PAPER; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG BLOOD LEVEL; DRUG EFFECT; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; GLYCEMIC CONTROL; HUMAN; HUMAN EXPERIMENT; INTERNATIONAL NORMALIZED RATIO; MALE; MAXIMUM ALLOWABLE CONCENTRATION; MONOTHERAPY; NON INSULIN DEPENDENT DIABETES MELLITUS; NORMAL HUMAN; PROTHROMBIN TIME; RANDOMIZED CONTROLLED TRIAL; UPPER RESPIRATORY TRACT INFECTION;

ADAMANTANE; ADMINISTRATION, ORAL; ADULT; ANTICOAGULANTS; ANTIGENS, CD26; CROSS-OVER STUDIES; DRUG ADMINISTRATION SCHEDULE; DRUG INTERACTIONS; FEMALE; HEALTH; HUMANS; HYPOGLYCEMIC AGENTS; MALE; NITRILES; PYRROLIDINES; WARFARIN;

EID: 34249032779     PISSN: 03007995     EISSN: None     Source Type: Journal    
DOI: 10.1185/030079907X188008     Document Type: Conference Paper

References (22)

1. Brandt I, Joossens J, Chen X, et al. Inhibition of dipeptidylpeptidase IV catalyzed peptide truncation by Vildagliptin ((2S)-{[(3-hydroxyadamantan-1-yl) amino]acetyl}-pyrrolidine-2-carbonitrile). Biochem Pharmacol 2005;70:134-43
2. Ahren B, Gomis R, Standi E, et al. Twelve- and 52-week efficacy of the dipeptidyl peptidase IV inhibitor LAF237 in metformin-treated patients with type 2 diabetes. Diabetes Care 2004;27:2874-80
3. Ristic S, Byiers S, Foley J, et al. Improved glycaemic control with dipeptidyl peptidase-4 inhibition in patients with type 2 diabetes: vildagliptin (LAF237) dose response. Diabetes Obes Metab 2005;7:692-8
4. Ahren B, Pacini G, Foley JE, et al. Improved meal-related beta-cell function and insulin sensitivity by the dipeptidyl peptidase-IV inhibitor vildagliptin in metformin-treated patients with type 2 diabetes over 1 year. Diabetes Care 2005;28:1936-40
5. Mari A, Sallas WM, He YL, et al. Vildagliptin, a dipeptidyl peptidase-IV inhibitor, improves model-assessed beta-cell function in patients with type 2 diabetes. J Clin Endocrinol Metab 2005;90:4888-94
6. Hirsh J. Oral anticoagulant drugs. N Engl J Med 1991;324:1865-75
7. Ansell J, Hirsh J, Poller L, et al. The pharmacology and management of the vitamin K antagonists: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004;126:204S-33
8. Kirkwood TB. Calibration of reference thromboplastins and standardisation of the prothrombin time ratio. Thromb Haemost 1983;49:238-44
9. Johnston M, Harrison L, Moffat K, et al. Reliability of the international normalized ratio for monitoring the induction phase of warfarin: comparison with the prothrombin time ratio. J Lab Clin Med 1996;128:214-7
10. Ufer M. Comparative pharmacokinetics of vitamin K antagonists: warfarin, phenprocoumon and acenocoumarol. Clin Pharmacokinet 2005;44:1227-46
11. Takahashi H, Echizen H. Pharmacogenetics of warfarin elimination and its clinical implications. Clin Pharmacokinet 2001;40:587-603
12. Black DJ, Kunze KL, Wienkers LC, et al. Warfarin-fluconazole. II. A metabolically based drug interaction: in vivo studies. Drug Metab Dispos 1996;24:422-8
13. Rettie AE, Korzekwa KR, Kunze KL, et al. Hydroxylation of warfarin by human cDNA-expressed cytochrome P-450: a role for P-4502C9 in the etiology of (S)-warfarin-drug interactions. Chem Res Toxicol 1992;5:54-9
14. Serlin MJ, Breckenridge AM. Drug interactions with warfarin. Drugs 1983;25:610-20
15. Van Hecken A, Depre M, Verbesselt R, et al. Effect of montelukast on the pharmacokinetics and pharmacodynamics of warfarin in healthy volunteers. J Clin Pharmacol 1999;39:495-500
16. Jiang X, Williams KM, Liauw WS, et al. Effect of St John's wort and ginseng on the pharmacokinetics and pharmacodynamics of warfarin in healdiy subjects. Br J Clin Pharmacol 2004;57:592-9
17. Anderson DM, Shelley S, Crick N, et al. No effect of the novel antidiabetic agent nateglinide on the pharmacokinetics and anticoagulant properties of warfarin in healthy volunteers. J Clin Pharmacol 2002;42:1358-65
18. Freedman MD, Olatidoye AG. Clinically significant drug interactions with the oral anticoagulants. Drug Saf 1994;10:381-94
19. O'Reilly RA, Goulart DA, Kunze KL, et al. Mechanisms of the stereoselective interaction between miconazole and racemic warfarin in human subjects. Clin Pharmacol Ther 1992;51:656-67
20. Cropp JS, Bussey HI. A review of enzyme induction of warfarin metabolism with recommendations for patient management. Pharmacotherapy 1997;17:917-28
21. Schall R, Muller FO, Hundt HK, et al. No pharmacokinetic or pharmacodynamic interaction between rivastatin and warfarin. J Clin Pharmacol 1995;35:306-13
22. Zhou H, Patat A, Parks V, et al. Absence of a pharmacokinetic interaction between etanercept and warfarin. J Clin Pharmacol 2004;44:543-50