Limited sampling strategy of S-warfarin concentrations, but not warfarin S/R ratios, accurately predicts, S-warfarin AUC during baseline and inhibition in CYP2C9 extensive metabolizers

Journal of Clinical Pharmacology

Volumn 44, Issue 6, 2004, Pages 570-576

  Ma, Joseph D ^a   Nafziger, Anne N ^a,b   Kashuba, Angela D M ^c   Kim, Myong Jin ^d   Gaedigk, Andrea ^e   Rowland, Elizabeth ^c   Kim, Jooran S ^a   Bertino Jr , Joseph S ^a,b  

^a BASSETT RESEARCH INSTITUTE   (United States)

^b University of North Carolina ^*  (United States)

^c UNIVERSITY OF NORTH CAROLINA   (United States)

^d CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^e CHILDREN S MERCY HOSPITAL   (United States)

Author keywords

CYP2C9; Drug metabolism; Limited sampling strategy; S warfarin; Warfarin S R ratios

Indexed keywords

CYTOCHROME P450 2C9; FLUINDOSTATIN; PHYTOMENADIONE; WARFARIN;

ADULT; AREA UNDER THE CURVE; ARTICLE; BLOOD SAMPLING; CONTROLLED STUDY; CORRELATION ANALYSIS; DIAGNOSTIC ACCURACY; DRUG CLEARANCE; DRUG INHIBITION; DRUG METABOLISM; DRUG SCREENING; ENZYME ACTIVITY; ENZYME INHIBITION; FEMALE; GENOTYPE; HUMAN; HUMAN CELL; HUMAN EXPERIMENT; LINEAR REGRESSION ANALYSIS; MALE; MULTIPLE LINEAR REGRESSION ANALYSIS; NORMAL HUMAN; VALIDATION PROCESS;

ADULT; ANTICOAGULANTS; AREA UNDER CURVE; ARYL HYDROCARBON HYDROXYLASES; BLOOD SPECIMEN COLLECTION; FEMALE; GENOTYPE; HUMANS; MALE; METABOLIC CLEARANCE RATE; STEREOISOMERISM; WARFARIN;

EID: 2442716553     PISSN: 00912700     EISSN: None     Source Type: Journal    
DOI: 10.1177/0091270004265366     Document Type: Article

References (30)

1. Ingelman-Sundberg M, Oscarson M, McLellan RA: Polymorphic human cytochrome P450 enzymes: an opportunity for individualized drug treatment. Trends Pharmacol Sci 1999;20:342-349.
2. Miners JO, Birkett DJ: Cytochrome P450 2C9: an enzyme of major importance in human drug metabolism. Br J Clin Pharmacol 1998; 45:525-538.
3. Rogers JF, Nafziger AN, Bertino JS: Pharmacogenetics affects dosing, efficacy, and toxicity of cytochrome P450-metabolized drugs. Am J Med 2002;113:746-750.
4. Ingelman-Sundberg M, Daly AK, Nebert DW (eds.): Cytochrome P450 (CYP) Allele Nomenclature Committee. Available at: www.imm.ki.se/CYPalleles/. Accessed February 17, 2004.
5. Bjornsson TD, Callaghan JT, Einolf JH, Fischer V, Gan L, Grimm S, et al: The conduct of in vitro and in vivo drug-drug interaction studies: a PhRMA perspective. J Clin Pharmacol 2003;43:443-469.
6. Kaminsky LS, Zhang ZY: Human P450 metabolism of warfarin. Pharmacol Ther 1997;73:67-74.
7. O'Sullivan TA, Wang JP, Unadkat JD, Al-Habet SMH, Trager WF, Smith AL, et al: Disposition of drugs in cystic fibrosis: V. In vivo CYP2C9 activity as probed by (S)-warfarin is not enhanced in cystic fibrosis. Clin Pharmacol Ther 1993;54:323-328.
8. Scordo MG, Pengo V, Spina E, Dahl ML, Gusella M, Padrini R: Influence of CYP2C9 and CYP2C19 genetic polymorphisms on warfarin maintenance dose and metabolic clearance. Clin Pharmacol Ther 2002;72:702-710.
9. David OJ, Johnston A: Limited sampling strategies for estimating cyclosporin area under the concentration-time curve: review of current algorithms. Ther Drug Monit 2001;23:100-114.
10. Filler G, Mai I: Limited sampling strategy for mycophenolic acid area under the curve. Ther Drug Monit 2000;22:169-173.
11. Di Paolo A, Danesi R, Vannozzi F, Falcone A, Mini E, Cionini L, et al: Limited sampling model for the analysis of 5-flurouracil pharmacokinetics in adjuvant chemotherapy for colorectal cancer. Clin Pharmacol Ther 2002;72:627-637.
12. Scavone JM, Greenblatt DJ, Blyden GT, Luna BG, Harmatz JS: Validity of a two-point acetaminophen pharmacokinetic study. Ther Drug Monit 1990;12:35-39.
13. Suarez-Kurtz G, Vicente FL, Ponte CG, Buy VLM, Struchiner CJ: Limited-sampling strategy models for estimating the area under the plasma concentration-time curve for amlodipine. Eur J Clin Pharmacol 1999;55:651-657.
14. Kim JS, Nafziger AN, Tsunoda SM, Choo EF, Streetman DS, Kashuba ADM, et al: Limited sampling strategy to predict AUC of the CYP3A phenotyping probe midazolam in adults: application to various assay techniques. J Clin Pharmacol 2002;42:376-382.
15. Kim JS, Nafziger AN, Gaedigk A, Dickmann LJ, Rettie AE, Bertino JS: Effects of oral vitamin K on S- and R-warfarin pharmacokinetics and pharmacodynamics: enhanced safety of warfarin as a CYP2C9 probe. J Clin Pharmacol 2001;41:1-8.
16. Chainuvati S, Nafziger AN, Leeder JS, Gaedigk A, Kearns GL, Sellers E, et al: Combined phenotypic assessment of CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP3A, NAT2, and XO with the "Cooperstown 5+1 Cocktail." Clin Pharmacol Ther 2003;74:437-447.
17. Kim MJ, LaCourse J, Nafziger AN, Wallace AL, Kashuba AD, Rowland E, et al: Effect of cigarette smoking on CYP2C9 activity. Clin Pharmacol Ther 2003;73:P14.
18. Shelepova T, Nafziger AN, Victory J, Kashuba ADM, Rowland E, Zhang Y, et al: Effect of oral contraceptives (OCS) on drug metabolizing enzymes (DMES) as measured by the validated Cooperstown 5+1 cocktail. Clin Pharmacol Ther 2003;73:P14.
19. Fischer V, Johanson L, Heitz F, Tullman R, Graham E, Baldeck JP, et al: The 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor fluvastatin: effect on human cytochrome P-450 and implications for metabolic drug interactions. Drug Metab Dispos 1999;27:410-416.
20. Transon C, Leemann T, Dayer P: In vitro comparative inhibition profiles of major human drug metabolising cytochrome P450 isozymes (CYP2C9, CYP2D6, and CYP3A4) by HMG-CoA reductase inhibitors. Eur J Clin Pharmacol 1996;50:209-215.
21. Transon C, Leemann T, Vogt N, Dayer P: In vivo inhibition profile of cytochrome P450TB (CYP2C9) by (±)-fluvastatin. Clin Pharmacol Ther 1995;58:412-417.
22. Henne KR, Gaedigk A, Gupta G, Leeder JS, Rettie AE: Chiral phase analysis of warfarin enantiomers in patient plasma in relation to CYP2C9 genotype. J Chromatogr 1998;710:143-148.
23. Stubbins MJ, Harries LW, Smith G, Tarbit MH, Wolf CR: Genetic analysis of the human cytochrome P450 CYP2C9 locus. Pharmacogenetics 1996;6:429-439.
24. Sullivan-Klose TH, Ghanayem BI, Bell DA, Zhang ZY, Kaminsky LS, Shenfield GM, et al: The role of the CYP2C9-Leu359 variant in the tolbutamide polymorphism. Pharmacogenetics 1996;6:341-349.
25. Sheiner LB, Beal SL: Some suggestions for measuring predictive performance. J Pharmacokinet Biopharm 1981;9:503-512.
26. Leeder JS, Gaedigk A, Gupta G, Simon S, Henne K, Allen K, et al: Determinants of warfarin S:R ratio in orthopedic surgery (OS) patients. Clin Pharmacol Ther 1999;65:194.
27. Lee CR, Goldstein JA, Pieper JA: Cytochrome P450 2C9 polymorphisms: a comprehensive review of the in-vitro and human data. Pharmacogenetics 2002;12:251-263.
28. Goldstein JA: Clinical relevance of genetic polymorphisms in the human CYP2C subfamily. Br J Clin Pharmacol 2001;52:349-355.
29. Takahashi H, Wilkinson GR, Caraco Y, Muszkat M, Kim RB, Kashima T, et al: Population differences in S-warfarin metabolism between CYP2C9 genotype-matched Caucasian and Japanese patients. Clin Pharmacol Ther 2003;73:253-263.
30. Lin YS, Lockwood GF, Graham MA, Brian WR, Loi CM, Dobrinska MR, et al: In-vivo phenotyping for CYP3A by a single-point determination of midazolam plasma concentration. Pharmacogenetics 2001;11:781-791.