CYP3A5 and CYP3A4 but not MDR1 single-nucleotide polymorphisms determine long-term tacrolimus disposition and drug-related nephrotoxicity in renal recipients

Clinical Pharmacology and Therapeutics

Volumn 82, Issue 6, 2007, Pages 711-725

  Kuypers, D R J ^a   De Jonge, H ^a   Naesens, M ^a   Lerut, E ^a   Verbeke, K ^a   Vanrenterghem, Y ^a  

^a UNIVERSITY HOSPITALS LEUVEN   (Belgium)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIDIABETIC AGENT; CREATININE; CYTOCHROME P450 3A4; CYTOCHROME P450 3A5; METHYLPREDNISOLONE; MULTIDRUG RESISTANCE PROTEIN 1; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; TACROLIMUS;

ACUTE GRAFT REJECTION; ACUTE KIDNEY TUBULE NECROSIS; ADULT; AREA UNDER THE CURVE; ARTICLE; BK VIRUS; CHRONIC ALLOGRAFT NEPHROPATHY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATININE CLEARANCE; DIABETES MELLITUS; DOSE TIME EFFECT RELATION; DRUG CLEARANCE; DRUG DISPOSITION; DRUG INDUCED DISEASE; FEMALE; FOLLOW UP; GENOTYPE; GLOMERULOPATHY; GRAFT RECIPIENT; GRAFT SURVIVAL; HETEROZYGOSITY; HUMAN; HYPERLIPIDEMIA; HYPERTENSION; INTERSTITIAL NEPHRITIS; KIDNEY ALLOGRAFT; KIDNEY BIOPSY; KIDNEY GRAFT; LOADING DRUG DOSE; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; NEPHROTOXICITY; ORAL GLUCOSE TOLERANCE TEST; PHARMACOGENETICS; POSTOPERATIVE PERIOD; PRIORITY JOURNAL; RECURRENT DISEASE; SINGLE NUCLEOTIDE POLYMORPHISM; STEADY STATE;

ADULT; AGED; AREA UNDER CURVE; BIOPSY; CONFOUNDING FACTORS (EPIDEMIOLOGY); CYTOCHROME P-450 ENZYME SYSTEM; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; GENOTYPE; GRAFT SURVIVAL; HUMANS; IMMUNOSUPPRESSIVE AGENTS; KIDNEY; KIDNEY FAILURE, CHRONIC; KIDNEY TRANSPLANTATION; MALE; MIDDLE AGED; MULTIVARIATE ANALYSIS; P-GLYCOPROTEIN; POLYMORPHISM, SINGLE NUCLEOTIDE; PROPORTIONAL HAZARDS MODELS; PROSPECTIVE STUDIES; TACROLIMUS; TIME FACTORS;

EID: 36148985704     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/sj.clpt.6100216     Document Type: Article

References (39)

1. Kuypers, D.R.J. et al. Time-related clinical determinants of long-term tacrolimus pharmacokinetics in combination therapy with mycophenolic acid and corticosteroids: a prospective study in one hundred de novo renal transplant recipients. Clin. Pharmacokinet. 43, 741-762 (2004).
2. Masuda, S. & Inui, K. An up-date review on individualized dosage adjustment of calcineurin inhibitors in organ transplant patients. Pharmacol. Ther. 112, 184-198 (2006).
3. Lampen, A. et al. Metabolism of the immunosuppressant tacrolimus in the small intestine: cytochrome P450, drug interactions, and interindividual variability. Drug. Metab. Dispos. 23, 1315-1324 (1995).
4. Kamdem, L.K. et al. Contribution of CYP3A5 to the in vitro hepatic clearance of Tacrolimus. Clin. Chem. 51, 1374-1381 (2005).
5. Hesselink, D.A. et al. Genetic polymorphisms of the CYP3A4, CYP3A5, and MDR-1 genes and pharmacokinetics of the calcineurin inhibitors cyclosporine and tacrolimus. Clin. Pharmacol. Ther. 74, 245-254 (2003).
6. Tsuchiya, N. et al. Influence of CYP3A5 and MDR1 (ABCB1) polymorphisms on the pharmacokinetics of Tacrolimus in renal transplant recipients. Transplantation 78, 1182-1187 (2004).
7. MacPhee, I.A.M. et al. Tacrolimus pharmacogenetics: the CYP3A5*1 allele predicts low dose-normalized Tacrolimus blood concentrations in whites and South Asians. Transplantation 79, 499-502 (2005).
8. MacPhee, I.A.M. et al. The influence of pharmacogenetics on the time to achieve target Tacrolimus concentrations after kidney transplantation. Am. J. Transplant. 4, 914-919 (2004).
9. Haufroid, V. et al. CYP3A5 and ABCB1 polymorphisms and tacrolimus pharmacokinetics in renal transplant candidates: guidelines from an experimental study. Am. J. Transplant. 6, 2706-2713 (2006).
10. Roy, J.N., Barama, A., Poirier, C., Vinet, B. & Roger, M. CYP3A4, CYP3A5, and MDR-1 genetic influences on tacrolimus pharmacokinetics in renal transplant recipients. Pharmacogenet. Genomics 16, 659-665 (2006).
11. Anglicheau, D. et al. Association of the multidrug resistance-1 gene single-nucleotide polymorphisms with the tacrolimus dose requirements in renal transplant recipients. J. Am. Soc. Nephrol. 14, 1889-1896 (2003).
12. Mai, I. et al. MDR1 haplotypes derived from exons 21 and 26 do not affect the steady-state pharmacokinetics of tacrolimus in renal transplant patients. Br. J. Clin. Pharmacol. 58, 548-553 (2004).
13. Fredericks, S. et al. Multidrug resistance gene-1 (MDR-1) haplotypes have a minor influence on Tacrolimus dose requirements. Transplantation 82, 705-708 (2006).
14. Yamauchi, A. et al. Neurotoxicity induced by tacrolimus after liver transplantation: relation to genetic polymorphisms of the ABCB1 (MDR1) gene. Transplantation 74, 571-578 (2002).
15. Numakura, K. et al. Clinical and genetic risk factors for posttransplant diabetes mellitus in adult renal transplant recipients treated with tacrolimus. Transplantation 80, 1419-1424 (2005).
16. Krämer, B.K. et al. Cardiovascular risk factors and estimated risk for CAD in a randomized trial comparing calcineurin inhibitors in renal transplantation. Am. J. Transplant. 3, 982-987 (2003).
17. Meier-Kriesche, H.U., Baliga, R. & Kaplan, B. Decreased renal function is a strong risk factor for cardiovascular death after renal transplantation. Transplantation 75, 1291-1295 (2003).
18. Racusen, L. et al. Antibody-mediated rejection criteria - an addition to the Banff '97 classification of renal allograft rejection. Am. J. Transplant. 3, 708-714 (2003).
19. Venkataramanan, R. et al. Clinical pharmacokinetics of tacrolimus. Clin. Pharmacokinet. 29, 404-430 (1995).
20. Staatz, C.E. & Tett, S.E. Clinical pharmacokinetics and pharmacodynamics of tacrolimus in solid organ transplantation. Clin. Pharmacokinet. 43, 623-653 (2004).
21. Shimada, T. et al. Lowered blood concentration of tacrolimus and its recovery with changes in expression of CYP3A and P-glycoprotein after high-dose steroid therapy. Transplantation 74, 1419-1424 (2002).
22. van Duijnhoven, E.M. et al. Increase in tacrolimus trough levels after steroid withdrawal. Transpl. Int. 16, 721-725 (2003).
23. Sun, H., Huang, Y., Frassetto, L. & Benet, L.Z. Effects of uremic toxins on hepatic uptake and metabolism of erythromycin. Drug Metab. Dispos. 32, 1239-1246 (2004).
24. Okabe, H., Yano, I., Hashimoto, Y., Saito, H. & Inui, K. Evaluation of increased bioavailability of tacrolimus in rats with experimental renal dysfunction. J. Pharm. Pharmacol. 54, 65-70 (2002).
25. Hoffmeyer, S. 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 97, 3473-3478 (2000).
26. Kim, R. et al. Identification of functionally variant MDR1 alleles among European Americans and African Americans. Clin. Pharmacol. Ther. 70, 189-199 (2001).
27. Kuehl, P. et al. Sequence diversity in CYP3A promoters and characterization of the genetic basis of polymorphic CYP3A5 expression. Nat. Genet. 27, 383-391 (2001).
28. Dai, Y. et al. Effect of CYP3A5 polymorphism on Tacrolimus metabolic clearance in vitro. Drug Metab. Dispos. 34, 836-847 (2006).
29. McCune, J. et al. Contribution of CYP3A5 to hepatic and renal ifosfamide N-dechloroethylation. Drug Metab. Dispos. 33, 1074-1081 (2005).
30. Nankivell, B. et al. The natural history of chronic allograft nephropathy. N. Engl. J. Med. 349, 2326-2333 (2003).
31. Staatz, C., Taylor, P. & Tett, S. Low tacrolimus concentrations and increased risk of early acute rejection in adult renal transplantation. Nephrol. Dial. Transplant. 16, 1905-1909 (2001).
32. Kuypers, D.R.J., Claes, K., Evenepoel, P., Maes, B. & Vanrenterghem, Y. Clinical efficacy and toxicity profile of tacrolimus and mycophenolic acid in relation to combined long-term pharmacokinetics in de novo renal allograft recipients. Clin. Pharmacol. Ther. 75, 434-447 (2004).
33. Cockcroft, D. & Gault, M. Prediction of creatinine clearance from serum creatinine. Nephron 16, 31-41 (1976).
34. Miller, S., Dykes, D. & Polesky, H. A simple salting out procedure for extracting DNA from nucleated cells. Nucleic Acids Res. 16, 1215 (1988).
35. Cascorbi, I. et al. Frequency of single nucleotide polymorphisms in the P-glycoprotein drug transporter MDR1 gene in white subjects. Clin. Pharmacol. Ther. 69, 169-174 (2001).
36. Cavalli, S.A., Hirata, M.H. & Hirata, R.D.C. Detection of Mboll polymorphism at the 5′ promoter region of CYP3A4. Clin. Chem. 47, 348-351 (2001).
37. Cogill, J.L. et al. Evaluation of the tacrolimus II microparticle enzyme immunoassay (MEIA II) in liver and renal transplant recipients. Clin. Chem. 44, 1942-1946 (1998).
38. Kuzuya, T., Ogura, Y., Motegi, Y., Moriyama, N. & Nabeshima, T. Interference of hematocrit in the tacrolimus II microparticle enzyme immunoassay. Ther. Drug Monit. 24, 507-511 (2002).
39. Moreton, M. et al. CYP3A5 genotype does not influence the blood concentration of tacrolimus measured with the Abbott immunoassay. Clin. Chem. 51, 2214-2215 (2005).