Drug-drug interaction study to assess the effects of multiple-dose pitavastatin on steady-state warfarin in healthy adult volunteers

Journal of Clinical Pharmacology

Volumn 51, Issue 9, 2011, Pages 1302-1309

  Inagaki, Yoichiro ^a   Hunt, Thomas ^b   Arana, Bill ^a   Gosho, Masahiko ^c,d   Morgan, Roger ^a  

^a Kowa Research Institute   (United States)

^b Pharmaceutical Product Development   (United States)

^c TOKYO UNIVERSITY OF SCIENCE   (Japan)

^d KOWA COMPANY LTD   (Japan)

Author keywords

Clinical pharmacology; CYP2C9; drug drug interaction; pharmacodynamics; pharmacokinetics and drug metabolism; pitavastatin; statin; warfarin

Indexed keywords

PITAVASTATIN; VITAMIN K GROUP; WARFARIN;

ABDOMINAL PAIN; ADD ON THERAPY; ADULT; APHTHOUS STOMATITIS; AREA UNDER THE CURVE; ARTICLE; CLINICAL ARTICLE; CONSTIPATION; DIARRHEA; DIZZINESS; DRUG BLOOD LEVEL; DRUG DOSE TITRATION; DRUG EFFECT; DRUG ELIMINATION; DRUG INDUCED HEADACHE; DRUG INTERACTION; DRUG TOLERABILITY; EPISTAXIS; HUMAN; INTERNATIONAL NORMALIZED RATIO; MALE; MONOTHERAPY; MUSCULOSKELETAL PAIN; NAUSEA; PHARMACODYNAMICS; PHARMACOKINETICS; PROTHROMBIN TIME; PRURITUS; RHINOPHARYNGITIS; TREATMENT DURATION; URINALYSIS;

ADULT; CROSS-OVER STUDIES; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG INTERACTIONS; DRUG THERAPY, COMBINATION; FOLLOW-UP STUDIES; HUMANS; INTERNATIONAL NORMALIZED RATIO; MALE; QUINOLINES; WARFARIN; YOUNG ADULT;

EID: 80051625423     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270010379811     Document Type: Article

References (20)

1. Princeton, NJ: Bristol-Myers Squibb Company ; 2009 :
2. Trager W Metabolic Drug Interactions. Philadelphia: Lippincott Williams & Wilkins ; 2000 :
3. Fujino H, Yamada I, Kojima J, Hirano M, Matsumoto H, Yoneda M. Studies on the metabolic fate of NK-104, a new inhibitor HMG-CoA reductase (5): in vitro metabolism and plasma protein binding in animals and human. Xenobio Metab Dispos. 1999 ; 14 (6). 415-424
4. Fujino H, Kojima J, Yamada Y, Kanda H, Kimata H. Studies on the metabolic fate of NK-104-, a new inhibitor of HMG-CoA reductase (4): interspecies variation in laboratory animals and humans. Xenobio Metab Dispos. 1999 ; 14 (2). 79-91
5. Shirata Y, Sugiyama Y. Pharmacokinetic and pharmacodynamic alterations of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors: drug-drug interactions and interindividual differences in transporter and metabolic enzyme functions. Pharmacol Ther. 2006 ; 112 (1). 71-105 (Pubitemid 44301483)
6. Fujino H, Yamada I, Shimada S, Nagao T, Yoneda M. Metabolic fate of pitavastatin (NK-104), a new inhibitor of 3-hydroxy-3 methyl-glutaryl-coenzyme A reductase. Arzneim Forsch Drug Res. 2002 ; 52: 745-753
7. Fujino H, Yamada I, Shimada S, Yoneda M, Kojima J. Metabolic fate of pitavastatin, a new inhibitor of HMG-CoA reductase: human UDP- glucurosyltransferase enzymes involved in lactonisation. Xenobiotica. 2003 ; 33 (1). 27-41 (Pubitemid 36071761)
8. Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation and Treatment of High Blood Cholesterol in Adults. Circulation. 2002 ; 106: 3143
9. Guidance for Industry: In Vivo Drug Metabolism/Drug Interaction Studies-Study Design, Data Analysis, and Recommendation for Dosing and Labeling. Rockville, MD: Food and Drug Administration ; 1999 :
10. Guidance for Industry: Drug Interaction Studies, Study Design, Data Analysis and Implications for Dosing and Labeling. Rockville, MD: Food and Drug Administration ; 2006 :
11. Jindal D, Tandon M, Sharma S, Pillai K. Pharmacodynamic evaluation of warfarin and rosuvastatin co-administration in healthy subjects. Eur J Clin Pharmacol. 2005 ; 61: 621-625
12. Schall R, Müller O, Hundt H, et al. No pharmacokinetic or pharmacodynamic interaction between rivastatin and warfarin. J Clin Pharmacol. 1995 ; 35: 306-313
13. Yin T, Miyata T. Warfarin dose and the pharmacogenomics of CYP2C9 and VKORC1: rationale and perspectives. Thromb Res. 2007 ; 120: 1-10 (Pubitemid 46601582)
14. Simonson S, Martin P, Mitchell P, Lasseter K, Gibson G, Schneck D. Effect of rosuvastatin on warfarin pharmacodynamics and pharmacokinetics. J Clin Pharmacol. 2005 ; 45: 927-934 (Pubitemid 41060232)
15. Lin J, Ito M, Stolley S, et al. The effect of converting from pravastatin to simvastatin on the pharmacodynamics of warfarin. J Clin Pharmacol. 1999 ; 39: 86-90 (Pubitemid 29053156)
16. Williams D, Feely J. Pharmacokinetic-pharmacodynamic drug interactions with HMG-CoA reductase inhibitors. Clin Pharmacokinet. 2000 ; 41 (5). 343-370
17. Hickmott H, Wynne H, Kamali F. The effect of simvastatin co-medication on warfarin anticoagulation response and dose requirements [letter]. Thromb Haemost. 2003 ; 89: 949-950 (Pubitemid 36603441)
18. Pan Y. Clinical pharmacology of pravastatin, selective inhibitor of HMG-CoA reductase. Eur J Clin Pharmacol. 1991 ; 40 (suppl 1). S15 - S18
19. Trenque T, Choisy H, Germain M. Pravastatin: interaction with oral anticoagulant? [abstract]. BMJ. 1996 ; 312: 886
20. Kline S, Harrell C. Potential warfarin-fluvastatin interaction [letter]. Ann Pharmacother. 1997 ; 31: 790