Consideration of the ethnic prevalence of genotypes in the clinical use of tacrolimus

Pharmacogenomics

Volumn 17, Issue 16, 2016, Pages 1737-1740

  Andrews, Louise M ^a   De Winter, Brenda CM ^a   Van Gelder, Teun ^a   Hesselink, Dennis A ^a  

^a ERASMUS MEDICAL CENTER   (Netherlands)

Author keywords

CYP3A5; ethnicity; tacrolimus; transplantation

Indexed keywords

CYTOCHROME P450 3A5; TACROLIMUS; CYP3A5 PROTEIN, HUMAN; CYTOCHROME P450 3A; IMMUNOSUPPRESSIVE AGENT;

AFRICAN AMERICAN; CAUCASIAN; CYP3A5 GENE; DOSE RESPONSE; DRUG CLEARANCE; ETHNICITY; GENE; GENE EXPRESSION; GENE FREQUENCY; GENETIC ASSOCIATION; GENETIC POLYMORPHISM; GENETIC VARIABILITY; GENOTYPE; HISPANIC; HUMAN; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; ALLELE; ETHNIC GROUP; GENETICS; ORGAN TRANSPLANTATION;

ALLELES; CYTOCHROME P-450 CYP3A; ETHNIC GROUPS; HUMANS; IMMUNOSUPPRESSIVE AGENTS; ORGAN TRANSPLANTATION; TACROLIMUS;

EID: 84995609186     PISSN: 14622416     EISSN: 17448042     Source Type: Journal    
DOI: 10.2217/pgs-2016-0136     Document Type: Review

References (28)

1. De Jonge H, Naesens M, Kuypers DR. New insights into the pharmacokinetics and pharmacodynamics of the calcineurin inhibitors and mycophenolic acid: possible consequences for therapeutic drug monitoring in solid organ transplantation. Ther. Drug Monit. 31(4), 416-435 (2009).
2. Antignac M, Barrou B, Farinotti R, Lechat P, Urien S. Population pharmacokinetics and bioavailability of tacrolimus in kidney transplant patients. Brit. J. Clin. Pharmacol. 64(6), 750-757 (2007).
3. Dai Y, Hebert MF, Isoherranen N et al. Effect of CYP3A5 polymorphism on tacrolimus metabolic clearance in vitro. Drug Metab. Dispos. 34(5), 836-847 (2006).
4. Kuehl P, Zhang J, Lin Y et al. Sequence diversity in CYP3A promoters and characterization of the genetic basis of polymorphic CYP3A5 expression. Nat. Genet. 27(4), 383-391 (2001).
5. Picard N, Bergan S, Marquet P et al. Pharmacogenetic biomarkers predictive of the pharmacokinetics and pharmacodynamics of immunosuppressive drugs. Ther. Drug Monit. 38(Suppl. 1), S57-S69 (2016).
6. Macphee IA, Fredericks S, Tai T et al. The influence of pharmacogenetics on the time to achieve target tacrolimus concentrations after kidney transplantation. Amer. J. Transplant. 4(6), 914-919 (2004).
7. Thervet E, Loriot MA, Barbier S et al. Optimization of initial tacrolimus dose using pharmacogenetic testing. Clin. Pharmacol. Ther. 87(6), 721-726 (2010).
8. Shuker N, Bouamar R, Van Schaik RH et al. A randomized controlled trial comparing the efficacy of CYP3A5 genotypebased with bodyweight-based tacrolimus dosing after living donor kidney transplantation. Amer. J. Transplant. 16(7), 2085-2096 (2016).
9. Van Gelder T, Hesselink DA. Dosing tacrolimus based on CYP3A5 genotype: will it improve clinical outcome? Clin. Pharmacol. Ther. 87(6), 640-641 (2010).
10. De Jonge H, De Loor H, Verbeke K, Vanrenterghem Y, Kuypers DR. In vivo CYP3A4 activity, CYP3A5 genotype, and hematocrit predict tacrolimus dose requirements and clearance in renal transplant patients. Clin. Pharmacol. Ther. 92(3), 366-375 (2012).
11. Elens L, Van Schaik RH, Panin N et al. Effect of a new functional CYP3A4 polymorphism on calcineurin inhibitors' dose requirements and trough blood levels in stable renal transplant patients. Pharmacogenomics 12(10), 1383-1396 (2011).
12. Werk AN, Lefeldt S, Bruckmueller H et al. Identification and characterization of a defective CYP3A4 genotype in a kidney transplant patient with severely diminished tacrolimus clearance. Clin. Pharmacol. Ther. 95(4), 416-422 (2014).
13. Organ Procurement and Transplantation Network. https://optn. Transplant. hrsa. gov/
14. Narayanan M, Pankewycz O, Shihab F, Wiland A, Mccague K, Chan L. Long-term outcomes in African American kidney transplant recipients under contemporary immunosuppression: a four-yr analysis of the Mycophenolic acid Observational REnal transplant (MORE) study. Clin. Transplant. 28(2), 184-191 (2014).
15. Oetting WS, Schladt DP, Guan W et al. Genomewide association study of tacrolimus concentrations in African American kidney transplant recipients identifies multiple CYP3A5 alleles. Amer. J. Transplant. 16(2), 574-582 (2016).
16. Tang JT, Andrews LM, Van Gelder T et al. Pharmacogenetic aspects of the use of tacrolimus in renal transplantation: recent developments and ethnic considerations. Expert Opin. Drug Metab. Toxicol. 12(5), 555-565 (2016).
17. Vadivel N, Garg A, Holt DW, Chang RW, Macphee IA. Tacrolimus dose in black renal transplant recipients. Transplantation 83(7), 997-999 (2007).
18. Sanghavi K, Brundage RC, Miller MB et al. Genotypeguided tacrolimus dosing in African-American kidney transplant recipients. Pharmacogenomics J. doi:10. 1038/ tpj. 2015. 87 (2015) (Epub ahead of print).
19. Stein CM, Sadeque AJ, Murray JJ, Wandel C, Kim RB, Wood AJ. Cyclosporine pharmacokinetics and pharmacodynamics in African American and white subjects. Clin. Pharmacol. Ther. 69(5), 317-323 (2001).
20. Andrews LM, Riva N, De Winter BC et al. Dosing algorithms for initiation of immunosuppressive drugs in solid organ transplant recipients. Expert Opin. Drug Metab. Toxicol. 11(6), 921-936 (2015).
21. Passey C, Birnbaum AK, Brundage RC, Oetting WS, Israni AK, Jacobson PA. Dosing equation for tacrolimus using genetic variants and clinical factors. Brit. J. Clin. Pharmacol. 72(6), 948-957 (2011).
22. Boughton O, Borgulya G, Cecconi M, Fredericks S, Moreton-Clack M, Macphee IA. A published pharmacogenetic algorithm was poorly predictive of tacrolimus clearance in an independent cohort of renal transplant recipients. Brit. J. Clin. Pharmacol. 76(3), 425-431 (2013).
23. Nigro V, Glicklich A, Weinberg J. Improved Bioavailability of MELTDOSE once-daily formulation of tacrolimus (LCPTacro) with controlled agglomeration allows for consistent absorption over 24 hrs: a scintigraphic and pharmacokinetic evaluation. Amer. J. Transplant. 13(Suppl. 5), 339 (2013).
24. Thörn M, Finnström N, Lundgren S, Rane A, Lööf L. Cytochromes P450 and MDR1 mRNA expression along the human gastrointestinal tract. Brit. J. Clin. Pharmacol. 60(1), 54-60 (2005).
25. Budde K, Bunnapradist S, Grinyo JM et al. Novel oncedaily extended-release tacrolimus (LCPT) versus twice-daily tacrolimus in de novo kidney transplants: one-year results of Phase III, double-blind, randomized trial. Amer. J. Transplant. 14(12), 2796-2806 (2014).
26. Langone A, Steinberg SM, Gedaly R et al. Switching study of kidney transplant patients with tremor to LCP-Tacro (STRATO): an open-label, multicenter, prospective Phase 3b study. Clin. Transplant. 29(9), 796-805 (2015).
27. European Medicines Agency. www. ema. europa. eu/
28. Trofe-Clark J, Brennan D, West-Thielke P, Milone M, Lim M, Bloom R. A randomized cross-over Phase 3b study of the pharmacokinetics of once-daily extended release MeltDose® tacrolimus (Envarsus® XR) versus twice-daily tacrolimus in African-Americans (ASERTAA). Amer. J. Transplant. 15(Suppl. 3), Abstract (2015). www. atcmeetingabstracts. com/