Comparison of pharmacokinetics and pharmacogenetics of once-and twice-daily tacrolimus in the early stage after renal transplantation

Transplantation

Volumn 94, Issue 10, 2012, Pages 1013-1019

  Niioka, Takenori ^a   Satoh, Shigeru ^a   Kagaya, Hideaki ^a   Numakura, Kazuyuki ^a   Inoue, Takamitsu ^a   Saito, Mitsuru ^a   Narita, Shintaro ^a   Tsuchiya, Norihiko ^a   Habuchi, Tomonori ^a   Miura, Masatomo ^a  

^a AKITA UNIVERSITY SCHOOL OF MEDICINE   (Japan)

Author keywords

ABCB1 C3435T; Advagraf; CYP3A5 polymorphism; Prograf; Tacrolimus

Indexed keywords

ADENINE; ANGIOTENSIN RECEPTOR ANTAGONIST; BASILIXIMAB; CORTICOSTEROID; COTRIMOXAZOLE; CYTOCHROME P450 3A5; CYTOSINE; GUANINE; METHYLPREDNISOLONE; MULTIDRUG RESISTANCE PROTEIN 1; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; PREDNISOLONE; RABEPRAZOLE; RITUXIMAB; TACROLIMUS; THYMINE;

ABCB1 GENE; ADULT; AGED; ALLELE; AREA UNDER THE CURVE; ARTICLE; CONTINUOUS INFUSION; CONTROLLED STUDY; CYP3A5 GENE; DNA POLYMORPHISM; DOSAGE SCHEDULE COMPARISON; DRUG BLOOD LEVEL; DRUG DOSE REDUCTION; DRUG ELIMINATION; DRUG FORMULATION; DRUG HALF LIFE; DRUG MEGADOSE; FEMALE; GENE EXPRESSION; GENETIC ASSOCIATION; GENOTYPE; GRAFT RECIPIENT; HETEROZYGOTE; HUMAN; KIDNEY GRAFT; KIDNEY GRAFT REJECTION; KIDNEY TRANSPLANTATION; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; PHARMACOGENETICS; PHARMACOKINETICS; PRIORITY JOURNAL; TIME TO MAXIMUM PLASMA CONCENTRATION;

ADULT; AGED; ALLELES; AREA UNDER CURVE; CYTOCHROME P-450 CYP3A; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; GENOTYPE; GRAFT REJECTION; HUMANS; IMMUNOSUPPRESSIVE AGENTS; KIDNEY TRANSPLANTATION; MALE; MIDDLE AGED; P-GLYCOPROTEIN; PHARMACOGENETICS; REGRESSION ANALYSIS; TACROLIMUS;

EID: 84870238834     PISSN: 00411337     EISSN: None     Source Type: Journal    
DOI: 10.1097/TP.0b013e31826bc400     Document Type: Article

References (37)

1. Barraclough KA, Isbel NM, Johnson DW, et al. Once-versus twicedaily tacrolimus. Are the formulations truly equivalent? Drugs 2011; 71: 1561.
2. Hougardy JM, de Jonge H, Kuypers D, et al. The once-daily formulation of tacrolimus: a step forward in kidney transplantation? Transplantation 2012; 93: 241.
3. Alloway R, Steinberg S, Khalil K, et al. Conversion of stable kidney transplant recipients from a twice daily Prograf-based regimen to a once daily modified release tacrolimus-based regimen. Transplant Proc 2005; 37: 867.
4. Florman S, Alloway R, Kalayoglu M, et al. Conversion of stable liver transplant recipients from a twice-daily Prograf-based regimen to a once-daily modified release tacrolimus-based regimen. Transplant Proc 2005; 37: 1211.
5. Cross SA, Perry CM. Tacrolimus once-daily formulation: in the prophylaxis of tacrolimus rejection in renal or liver allograft recipients. Drugs 2007; 67: 1931.
6. Wlodarczyk Z, Squifflet JP, Ostrowski M, et al. Pharmacokinetics of once-versus twice-daily tacrolimus formulations in de novo kidney transplantation: a randomized, open-label trial. Am J Transplant 2009: 9: 2505.
7. de Jonge H, Kuypers DR, Verbeke K, et al. Reduced C0 concentrations and increased dose requirements in renal allograft recipients converted to the novel once-daily tacrolimus formulation. Transplantation 2010; 90: 523.
8. Wu MJ, Cheng CY, Chen CH, et al. Lower variability of tacrolimus trough concentration after conversion from Prograf to Advagraf in stable kidney transplant recipients. Transplantation 2011; 92: 648.
9. Hougardy JM, Broeders N, Kianda M, et al. Conversion from Prograf to Advagraf among kidney transplant recipients Results in sustained decrease in tacrolimus exposure. Transplantation 2011; 91: 566.
10. Crespo M, Mir M, Marin M, et al. De novo kidney transplant recipients need higher doses of Advagraf compared with Prograf to get therapeutic levels. Transplant Proc 2009: 41: 2115.
11. 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.
12. Tsuchiya N, Satoh S, Tada H, et al. Influence of CYP3A5 and MDR1 (ABCB1) polymorphisms on the pharmacokinetics of tacrolimus in renal transplant recipients. Transplantation 2004; 78: 1182.
13. Haufroid V, Wallemacq P, VanKerckhove V, et al. CYP3A5 and ABCB1 polymorphisms and tacrolimus pharmacokinetics in renal transplant candidates: guidelines from an experimental study. Am J Transplant 2006: 6: 2706.
14. Wehland M, Bauer S, Brakemeier S, et al. Differential impact of the CYP3A5*1 and CYP3A5*3 alleles on pre-dose concentraions of two tacrolimus formulations. Pharmacogenet Genomics 2011; 21: 179.
15. Glowacki F, Lionet A, Hammelin JP, et al. Influence of cytochrome P450 3A5 (CYP3A5) genetic polymorphism on the pharmacokinetics of the prolonged-release, once-daily formulation of tacrolimus in stable renal transplant recipients. Clin Pharmacokinet 2011; 50: 451.
16. Watkins PB. The barrier function of CYP3A4 and P-glycoprotein in the small bowel. Adv Drug Deliv Rev 1997; 15: 161.
17. Hoffmeyer S, Burk O, von Richter O, et al. Functional polymorphisms of the human multidrug-resistance gene: multiple sequence variations and correlation of one allele with P-glycoprotein expression and activity in vivo. Proc Natl Acad Sci USA 2000; 97: 3473.
18. Kuypers DR, de Jonge H, Naessens M, et al. CYP3A5 and CYP3A4 but not MDR1 single-nucleotide polymorphisms determine long-term tacrolimus disposition and drug-related nephrotoxicity in renal recipients. Clin Pharmacol Ther 2007; 82: 711.
19. Miura M, Satoh S, Kagaya H, et al. Impacr of the CYP3A4*1G polymorphism and its combination with CYP3A5 genotypes on tacrolimus pharmacokinetics in renal transplant patients. Pharmacogenomics 2011; 12: 977.
20. Miura M, Satoh S, Kagaya H, et al. No impact of age on dose-adjusted pharmacokinetics of tacrolimus, mycophenolic acid and prednisolone 1month after renal transplantation. Eur J Clin Pharmacol 2009; 65: 1047.
21. Staatz CE, Tett SE. Clinical pharmacokinetics and pharmacodynamics of tacrolimus in solid organ transplantation. Clin Pharmacokinet 2004; 43: 623.
22. Miura M, Niioka T, Kagaya H, et al. Pharmacogenetic determinants for interindividual difference of tacrolimus pharmacokinetics 1 year after renal transplantation. J Clin Pharm Ther 2011; 36: 208.
23. Kramer BK, Charpentier B, Backman L, et al. Tacrolimus once daily (Advagraf ) versus twice daily (Prograf ) in de novo renal transplantation: a randomized phase III study. Am J Transplant 2010; 10: 2632.
24. Trunecka P, Boillot O, Seehofer D, et al. Once-daily prolonged-release tacrolimus (Advagraf ) versus twice-daily tacrolimus (Prograf ) in liver transplantation. Am J Transplant 2010: 10: 2313.
25. Guirado L, Cantarell C, Franco A, et al. Efficacy and safety of conversion from twice-daily to once-daily in a large cohort of stable kidney transplant recipients. Am J Transplant 2011; 11: 1965.
26. Wlodarczyk Z, Ostrowski M, Mourad M, et al. Tacrolimus pharmacokinetics of once-versus twice-daily formulations in de novo kidney transplantation: a study of a randomized phase III trial. Ther Drug Monit 2012; 34: 143.
27. Born J, Lange T, Hansen K, et al. Effects of sleep and circadian rhythm on human circulating immune cells. J Immunol 1997; 158: 4454.
28. Tada H, Satoh S, Iinuma M, et al. Chronopharmacokinetics of tacrolimus in kidney transplant recipients: occurrence of acute rejection. J Clin Pharmacol 2003; 43: 859.
29. Satoh S, Tada H, Murakami M, et al. Circadian pharmacokinetics of mycophenolic acid and implication of genetic polymorphisms for early clinical events in renal transplant recipients. Transplantation 2006; 82: 486.
30. Satoh S, Kagaya H, Saito M, et al. Lack of tacrolimus circadian pharmacokinetics and CYP3A5 pharmacogenetics in the early and maintenance stages in Japanese renal transplant recipients. Br J Clin Pharmacol 2008; 66: 207.
31. Saint-Marcoux F, Debord J, Undre N, et al. Pharmacokinetic modeling and development of Bayesian estimators in kidney transplant patients receiving the tacrolimus once-daily formulation. Ther Drug Monit 2010; 32: 129.
32. Canaparo R, Finnstrom N, Serpe L, et al. Expression of CYP3A isoforms and P-glycoprotein in human stomach, jejunum and ileum. Clin Exp Pharmacol Physiol 2007; 34: 1138.
33. Macphee IA, Fredericks S, Tai T, et al. Tacrolimus pharmacogenetics: polymorphisms associated with expression of cytochrome p4503A5 and P-glycoprotein correlate with dose requirement. Transplantation 2002; 74: 1486.
34. Anglicheau D, Verstuyft C, Laurent-Puig P, et al. Association of the multidrug resistance-1 gene single-nucleotide polymorphisms with the tacrolimus dose requirements in renal transplant recipeints. J Am Soc Nephrol 2003; 14: 1889.
35. Miura M, Satoh S, Inoue K, et al. Influence of lansoprazole and rabeprazole on mycophenolic acid pharmacokinetics one year after renal transplantation. Ther Drug Monit 2008; 30: 46.
36. Miura M, Satoh S, Tada H, et al. Influence of ABCB1 C3435T polymorphism on the pharmakinetics of lansoprazole and gastroesophageal symptoms in Japanese renal transplant recipients classified as CYP2C19 extesive metabolizers and treated with tacrolimus. Int J clin Pharmacol Ther 2006; 44: 605.
37. Miura Y, Satoh S, Saito M, et al. Factors increasing quantitiative interstitial fibrosis from 0 hr to 1 year in living kidney transplant patiens receiving tacrorimus. Transplantation 2011; 91: 78.