Population pharmacokinetic model and Bayesian estimator for two tacrolimus formulations - twice daily Prograf® and once daily Advagraf®

British Journal of Clinical Pharmacology

Volumn 71, Issue 3, 2011, Pages 391-402

  Woillard, Jean Baptiste ^a   De Winter, Brenda C M ^a   Kamar, Nassim ^b,c,d   Marquet, Pierre ^a,e,f   Rostaing, Lionel ^b,c,d   Rousseau, Annick ^a,e  

^a Univ Limoges   (France)

^b TOULOUSE UNIVERSITY HOSPITAL   (France)

^c CHU PURPAN   (France)

^d UNIVERSITÉ PAUL SABATIER   (France)

^e UNIVERSITY OF LIMOGES   (France)

^f LIMOGES UNIVERSITY HOSPITAL   (France)

Author keywords

Advagraf ; Bayesian estimator; Kidney transplantation; Population pharmacokinetics; Prograf ; Tacrolimus

Indexed keywords

MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; PREDNISOLONE; TACROLIMUS;

ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; BAYES THEOREM; COMPARTMENT MODEL; DOSAGE SCHEDULE COMPARISON; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG ELIMINATION; DRUG FORMULATION; DRUG RELEASE; FEMALE; HUMAN; KIDNEY GRAFT; MAJOR CLINICAL STUDY; MALE; POPULATION MODEL; PRIORITY JOURNAL;

ADOLESCENT; ADULT; AGED; AREA UNDER CURVE; BAYES THEOREM; CYTOCHROME P-450 ENZYME SYSTEM; DELAYED-ACTION PREPARATIONS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; GENOTYPE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; KIDNEY TRANSPLANTATION; MALE; MIDDLE AGED; MODELS, BIOLOGICAL; POLYMORPHISM, SINGLE NUCLEOTIDE; RENAL INSUFFICIENCY; TACROLIMUS; YOUNG ADULT;

EID: 79251642984     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2010.03837.x     Document Type: Article

References (26)

1. Venkataramanan R, Swaminathan A, Prasad T, Jain A, Zuckerman S, Warty V, McMichael J, Lever J, Burckart G, Starzl T. Clinical pharmacokinetics of tacrolimus. Clin Pharmacokinet 1995; 29: 404-30.
2. Weng FL, Israni AK, Joffe MM, Hoy T, Gaughan CA, Newman M, Abrams JD, Kamoun M, Rosas SE, Mange KC, Strom BL, Brayman KL, Feldman HI. Race and electronically measured adherence to immunosuppressive medications after deceased donor renal transplantation. J Am Soc Nephrol 2005; 16: 1839-48.
3. Laskow DA, Vincenti F, Neylan JF, Mendez R, Matas AJ. An open-label, concentration-ranging trial of FK506 in primary kidney transplantation: a report of the United States Multicenter FK506 Kidney Transplant Group. Transplantation 1996; 62: 900-5.
4. Silva HT. Tacrolimus once-daily formulation in the prophylaxis of transplant rejection in renal or liver allograft recipients: a viewpoint by Helio Tedesco Silva Jr. Drugs 2007; 67: 1944-5.
5. Alloway R, Steinberg S, Khalil K, Gourishankar S, Miller J, Norman D, Hariharan S, Pirsch J, Matas A, Zaltzman J, Wisemandle K, Fitzsimmons W, First MR. Two years postconversion from a Prograf-based regimen to a once-daily tacrolimus extended-release formulation in stable kidney transplant recipients. Transplantation 2007; 83: 1648-51.
6. Crespo M, Mir M, Marin M, Hurtado S, Estadella C, Guri X, Rap O, Moral R, Puig JM, Lloveras J. De novo kidney transplant recipients need higher doses of Advagraf compared with Prograf to get therapeutic levels. Transplant Proc 2009; 41: 2115-7.
7. Wallemacq P, Armstrong VW, Brunet M, Haufroid V, Holt DW, Johnston A, Kuypers D, Le Meur Y, Marquet P, Oellerich M, Thervet E, Toenshoff B, Undre N, Weber LT, Westley IS, Mourad M. Opportunities to optimize tacrolimus therapy in solid organ transplantation: report of the European consensus conference. Ther Drug Monit 2009; 31: 139-52.
8. Kuehl P, Zhang J, Lin Y, Lamba J, Assem M, Schuetz J, Watkins PB, Daly A, Wrighton SA, Hall SD, Maurel P, Relling M, Brimer C, Yasuda K, Venkataramanan R, Strom S, Thummel K, Boguski MS, Schuetz E. Sequence diversity in CYP3A promoters and characterization of the genetic basis of polymorphic CYP3A5 expression. Nat Genet 2001; 27: 383-91.
9. Hesselink DA, van Schaik RH, van der Heiden IP, van der Werf M, Gregoor PJ, Lindemans J, Weimar W, van Gelder T. Genetic polymorphisms of the CYP3A4, CYP3A5, and MDR-1 genes and pharmacokinetics of the calcineurin inhibitors cyclosporine and tacrolimus. Clin Pharmacol Ther 2003; 74: 245-54.
10. Press RR, Ploeger BA, den Hartigh J, van der Straaten T, van Pelt J, Danhof M, de Fijter JW, Guchelaar HJ. Explaining variability in tacrolimus pharmacokinetics to optimize early exposure in adult kidney transplant recipients. Ther Drug Monit 2009; 31: 187-97.
11. Musuamba FT, Mourad M, Haufroid V, Delattre IK, Verbeeck RK, Wallemacq P. Time of drug administration, CYP3A5 and ABCB1 genotypes, and analytical method influence tacrolimus pharmacokinetics: a population pharmacokinetic study. Ther Drug Monit 2009; 31: 734-42.
12. Benkali K, Rostaing L, Premaud A, Woillard JB, Saint-Marcoux F, Urien S, Kamar N, Marquet P, Rousseau A. Population pharmacokinetics and bayesian estimation of tacrolimus exposure in renal transplant recipients on a new once-daily formulation. Clin Pharmacokinet 2010; 49: 683-92.
13. Staatz CE, Willis C, Taylor PJ, Tett SE. Population pharmacokinetics of tacrolimus in adult kidney transplant recipients. Clin Pharmacol Ther 2002; 72: 660-9.
14. Antignac M, Barrou B, Farinotti R, Lechat P, Urien S. Population pharmacokinetics and bioavailability of tacrolimus in kidney transplant patients. Br J Clin Pharmacol 2007; 64: 750-7.
15. Benkali K, Premaud A, Picard N, Rerolle JP, Toupance O, Hoizey G, Turcant A, Villemain F, Le Meur Y, Marquet P, Rousseau A. Tacrolimus population pharmacokinetic-pharmacogenetic analysis and Bayesian estimation in renal transplant recipients. Clin Pharmacokinet 2009; 48: 805-16.
16. Saint-Marcoux F, Knoop C, Debord J, Thiry P, Rousseau A, Estenne M, Marquet P. Pharmacokinetic study of tacrolimus in cystic fibrosis and non-cystic fibrosis lung transplant patients and design of Bayesian estimators using limited sampling strategies. Clin Pharmacokinet 2005; 44: 1317-28.
17. Saint-Marcoux F, Debord J, Undre N, Rousseau A, Marquet P. Pharmacokinetic modeling and development of Bayesian estimators in kidney transplant patients receiving the tacrolimus once-daily formulation. Ther Drug Monit 2010; 32: 129-35.
18. Le Meur Y, Djebli N, Szelag JC, Hoizey G, Toupance O, Rerolle JP, Marquet P. CYP3A5*3 influences sirolimus oral clearance in de novo and stable renal transplant recipients. Clin Pharmacol Ther 2006; 80: 51-60.
19. Boekmann AJ, Sheiner LB, Beal SL. NONMEM User's Guide - Part V: Introductory Guide. 1994.
20. Rousseau A, Leger F, Le Meur Y, Saint-Marcoux F, Paintaud G, Buchler M, Marquet P. Population pharmacokinetic modeling of oral cyclosporin using NONMEM: comparison of absorption pharmacokinetic models and design of a Bayesian estimator. Ther Drug Monit 2004; 26: 23-30.
21. Frame B, Miller R, Lalonde RL. Evaluation of mixture modeling with count data using NONMEM. J Pharmacokinet Pharmacodyn 2003; 30: 167-83.
22. Wahlby U, Jonsson EN, Karlsson MO. Comparison of stepwise covariate model building strategies in population pharmacokinetic-pharmacodynamic analysis. AAPS PharmSci 2002; 4: E27.
23. Urien S. Rfn, R for NONMEM. A graphical interface for NONMEM outputs. 2009.
24. Sheiner BL, Beal SL. Evaluation of methods for estimating population pharmacokinetic parameters. II. Biexponential model and experimental pharmacokinetic data. J Pharmacokinet Biopharm 1981; 9: 635-51.
25. Staatz CE, Tett SE. Clinical pharmacokinetics and pharmacodynamics of tacrolimus in solid organ transplantation. Clin Pharmacokinet 2004; 43: 623-53.
26. Undre NA, Schafer A. Factors affecting the pharmacokinetics of tacrolimus in the first year after rasqenal transplantation. European Tacrolimus Multicentre Renal Study Group. Transplant Proc 1998; 30: 1261-3.