Population pharmacokinetics of tacrolimus in adult kidney transplant patients: Impact of CYP3A5 genotype on starting dose

Therapeutic Drug Monitoring

Volumn 36, Issue 1, 2014, Pages 62-70

  Bergmann, Troels K ^a,b   Hennig, Stefanie ^a   Barraclough, Katherine A ^a   Isbel, Nicole M ^a   Staatz, Christine E ^a  

^a UNIVERSITY OF QUEENSLAND   (Australia)

^b AARHUS UNIVERSITY   (Denmark)

Author keywords

CYP3A5; kidney transplantation; pharmacogenetics; population pharmacokinetics; tacrolimus

Indexed keywords

BASILIXIMAB; CYTOCHROME P450 3A5; METHYLPREDNISOLONE SODIUM SUCCINATE; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; PREDNISOLONE; TACROLIMUS;

ADULT; AREA UNDER THE CURVE; ARTICLE; COHORT ANALYSIS; COMPUTER PROGRAM; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISPOSITION; DRUG ELIMINATION; FEMALE; GENOTYPE; HALF LIFE TIME; HEMATOCRIT; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; IMMUNOSUPPRESSIVE TREATMENT; KIDNEY TRANSPLANTATION; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; POSTOPERATIVE CARE; PRIORITY JOURNAL; PROSPECTIVE STUDY; SINGLE NUCLEOTIDE POLYMORPHISM; STEADY STATE;

ADULT; ALLELES; COMPUTER SIMULATION; CYTOCHROME P-450 CYP3A; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; GENOTYPE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; KIDNEY TRANSPLANTATION; MALE; MIDDLE AGED; MODELS, BIOLOGICAL; NONLINEAR DYNAMICS; PROSPECTIVE STUDIES; TACROLIMUS;

EID: 84892947151     PISSN: 01634356     EISSN: 15363694     Source Type: Journal    
DOI: 10.1097/FTD.0b013e31829f1ab8     Document Type: Article

References (37)

1. Wallemacq P, Armstrong VW, Brunet M, et al. Opportunities to optimize tacrolimus therapy in solid organ transplantation: report of the European consensus conference. Ther Drug Monit. 2009;31:139-152.
2. Thomson AH, Whiting B. Bayesian parameter estimation and population pharmacokinetics. Clin Pharmacokinet. 1992;22:447-467.
3. Proost JH. Adaptive control of drug dosage regimens using maximum a posteriori probability Bayesian fitting. Int J Clin Pharmacol Ther. 1995;33:531-536.
4. Hesselink DA, van Schaik RH, van der Heiden IP, et al. Genetic polymorphisms of the CYP3A4, CYP3A5, and MDR-1 genes and pharmacokinetics of the calcineurin inhibitors cyclosporine and tacrolimus. Clin Pharmacol Ther. 2003;74:245-254.
5. Staatz CE, Willis C, Taylor PJ, et al. Population pharmacokinetics of tacrolimus in adult kidney transplant recipients. Clin Pharmacol Ther. 2002;72:660-669.
6. Fukatsu S, Yano I, Igarashi T, et al. Population pharmacokinetics of tacrolimus in adult recipients receiving living-donor liver transplantation. Eur J Clin Pharmacol. 2001;57:479-484.
7. Antignac M, Barrou B, Farinotti R, et al. Population pharmacokinetics and bioavailability of tacrolimus in kidney transplant patients. Br J Clin Pharmacol. 2007;64:750-757.
8. Barraclough KA, Isbel NM, McWhinney BC, et al. Evaluation of limited sampling strategies for total and free prednisolone in adult kidney transplant recipients. Eur J Clin Pharmacol. 2011;67:1243-1252.
9. Barraclough KA, Isbel NM, Kirkpatrick CM, et al. Evaluation of limited sampling methods for estimation of tacrolimus exposure in adult kidney transplant recipients. Br J Clin Pharmacol. 2011;71:207-223.
10. Taylor PJ, Franklin ME, Tai CH, et al. Therapeutic drug monitoring of tacrolimus by liquid chromatography-tandem mass spectrometry: is it truly a routine test?. J Chromatogr B Analyt Technol Biomed Life Sci. 2012;883-884:108-112.
11. Keevil BG, McCann SJ, Cooper DP, et al. Evaluation of a rapid micro-scale assay for tacrolimus by liquid chromatography-tandem mass spectrometry. Ann Clin Biochem. 2002;39:487-492.
12. McWhinney BC, Briscoe SE, Ungerer JP, et al. Measurement of cortisol, cortisone, prednisolone, dexamethasone and 11-deoxycortisol with ultra high performance liquid chromatography-tandem mass spectrometry: application for plasma, plasma ultrafiltrate, urine and saliva in a routine laboratory. J Chromatogr B Analyt Technol Biomed Life Sci. 2010;878: 2863-2869.
13. Lindbom L, Ribbing J, Jonsson EN. Perl-speaks-NONMEM (PsN)-a Perl module for NONMEM related programming. Comput Methods Programs Biomed. 2004;75:85-94.
14. Jonsson EN, Karlsson MO. Xpose-an S-PLUS based population pharmacokinetic/pharmacodynamic model building aid for NONMEM. Comput Methods Programs Biomed. 1999;58:51-64.
15. Keizer RJ, van Benten M, Beijnen JH, et al. Pirana and PCluster: a modeling environment and cluster infrastructure for NONMEM. Comput Methods Programs Biomed. 2011;101:72-79.
16. Benkali K, Premaud A, Picard N, et al. Tacrolimus population pharmacokinetic-pharmacogenetic analysis and Bayesian estimation in renal transplant recipients. Clin Pharmacokinet. 2009;48:805-816.
17. Bergstrand M, Hooker AC, Wallin JE, et al. Prediction-corrected visual predictive checks for diagnosing nonlinear mixed-effects models. AAPS J. 2011;13:143-151.
18. McLeay SC, Morrish GA, Kirkpatrick CM, et al. The relationship between drug clearance and body size: systematic review and meta-analysis of the literature published from 2000 to 2007. Clin Pharmacokinet. 2012; 51:319-330.
19. Anderson BJ, Holford NH. Mechanism-based concepts of size and maturity in pharmacokinetics. Annu Rev Pharmacol Toxicol. 2008;48:303-332.
20. Opelz G, Dohler B; for the Collaborative Transplant Study. Influence of time of rejection on long-term graft survival in renal transplantation. Transplantation. 2008;85:661-666.
21. Thervet E, Loriot MA, Barbier S, et al. Optimization of initial tacrolimus dose using pharmacogenetic testing. Clin Pharmacol Ther. 2010; 87:721-726.
22. Zhang GM, Li L, Chen WQ, et al. Population pharmacokinetics of tacrolimus in Chinese renal transplant patients [in Chinese]. Yao Xue Xue Bao. 2008;43:695-701.
23. Woillard JB, de Winter BC, Kamar N, et al. Population pharmacokinetic model and Bayesian estimator for two tacrolimus formulations-twice daily Prograf and once daily Advagraf. Br J Clin Pharmacol. 2011;71:391-402.
24. Velickovic-Radovanovic R, Catic-Djordjevic A, Milovanovic JR, et al. Population pharmacokinetics of tacrolimus in kidney transplant patients. Int J Clin Pharmacol Ther. 2010;48:375-382.
25. Scholten EM, Cremers SC, Schoemaker RC, et al. AUC-guided dosing of tacrolimus prevents progressive systemic overexposure in renal transplant recipients. Kidney Int. 2005;67:2440-2447.
26. Saint-Marcoux F, Debord J, Parant F, et al. Development and evaluation of a simulation procedure to take into account various assays for the Bayesian dose adjustment of tacrolimus. Ther Drug Monit. 2011;33:171-177.
27. Press RR, Ploeger BA, den Hartigh J, et al. Explaining variability in tacrolimus pharmacokinetics to optimize early exposure in adult kidney transplant recipients. Ther Drug Monit. 2009;31:187-197.
28. Barraclough KA, Isbel NM, Lee KJ, et al. NR1I2 polymorphisms are related to tacrolimus dose-adjusted exposure and BK viremia in adult kidney transplantation. Transplantation. 2012;94:1025-1032.
29. Elens L, Bouamar R, Hesselink DA, et al. A new functional CYP3A4 intron 6 polymorphism significantly affects tacrolimus pharmacokinetics in kidney transplant recipients. Clin Chem. 2011;57:1574-1583.
30. Staatz CE, Tett SE. Clinical pharmacokinetics and pharmacodynamics of tacrolimus in solid organ transplantation. Clin Pharmacokinet. 2004;43: 623-653.
31. Zhao W, Elie V, Roussey G, et al. Population pharmacokinetics and pharmacogenetics of tacrolimus in de novo pediatric kidney transplant recipients. Clin Pharmacol Ther. 2009;86:609-618.
32. Sam WJ, Tham LS, Holmes MJ, et al. Population pharmacokinetics of tacrolimus in whole blood and plasma in Asian liver transplant patients. Clin Pharmacokinet. 2006;45:59-75.
33. Wallin JE, Friberg LE, Fasth A, et al. Population pharmacokinetics of tacrolimus in pediatric hematopoietic stem cell transplant recipients: new initial dosage suggestions and a model-based dosage adjustment tool. Ther Drug Monit. 2009;31:457-466.
34. Garcia Sanchez MJ, Manzanares C, Santos-Buelga D, et al. Covariate effects on the apparent clearance of tacrolimus in paediatric liver transplant patients undergoing conversion therapy. Clin Pharmacokinet. 2001; 40:63-71.
35. Antignac M, Hulot JS, Boleslawski E, et al. Population pharmacokinetics of tacrolimus in full liver transplant patients: modelling of the post-operative clearance. Eur J Clin Pharmacol. 2005;61:409-416.
36. Størset E, Holford N, Midtvedt K, et al. Population pharmakokinetics of tacrolimus to aid individualized dosing in kidney transplant recipients [Population Approach Group Europe Website]. 2012, abstract II-252012. Available at: http://www.page-meeting.org/default.asp?abstract=2306. Accessed July 4, 2012.
37. Hennig S, Norris R, Kirkpatrick CM. Target concentration intervention is needed for tobramycin dosing in paediatric patients with cystic fibrosis-a population pharmacokinetic study. Br J Clin Pharmacol. 2008;65:502-510.