Influence of CYP3A5 genetic variation on everolimus maintenance dosing after cardiac transplantation

Clinical Transplantation

Volumn 29, Issue 12, 2015, Pages 1213-1220

  Lesche, Dorothea ^a,b   Sigurdardottir, Vilborg ^c   Setoud, Raschid ^c   Englberger, Lars ^a   Fiedler, Georg M ^a   Largiadèr, Carlo R ^a   Mohacsi, Paul ^c   Sistonen, Johanna ^a  

^a UNIVERSITY OF BERN   (Switzerland)

^b UNIVERSITY OF BERN   (Switzerland)

^c University Hospital ^*  (Switzerland)

Author keywords

3; CYP3A5; Everolimus; Heart transplantation; Pharmacogenomics

Indexed keywords

AZATHIOPRINE; CYCLOSPORIN; EVEROLIMUS; METHYLPREDNISOLONE; MYCOPHENOLATE MOFETIL; PREDNISONE; THYMOCYTE ANTIBODY; CYP3A5 PROTEIN, HUMAN; CYTOCHROME P450 3A; IMMUNOSUPPRESSIVE AGENT;

ABCB1 GENE; ACUTE GRAFT REJECTION; ADOLESCENT; ADULT; AGED; ARTICLE; CARDIAC ALLOGRAFT VASCULOPATHY; CLINICAL ARTICLE; COHORT ANALYSIS; CYP2C8 GENE; CYP3A4 GENE; CYP3A5 GENE; DOSE RESPONSE; FEMALE; GENE; GENETIC VARIABILITY; GENOTYPE; GLOMERULUS FILTRATION RATE; GRAFT RECIPIENT; HEART TRANSPLANTATION; HUMAN; IMMUNOSUPPRESSIVE TREATMENT; KIDNEY DYSFUNCTION; MALE; NR1I2 GENE; PHARMACOKINETIC PARAMETERS; PILOT STUDY; POR GENE; PRIORITY JOURNAL; ADVERSE EFFECTS; FOLLOW UP; GENETIC POLYMORPHISM; GENETICS; GRAFT REJECTION; GRAFT SURVIVAL; MAINTENANCE CHEMOTHERAPY; MIDDLE AGED; POSTOPERATIVE COMPLICATION; PROGNOSIS; RISK FACTOR; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; CYTOCHROME P-450 CYP3A; DOSE-RESPONSE RELATIONSHIP, DRUG; EVEROLIMUS; FEMALE; FOLLOW-UP STUDIES; GRAFT REJECTION; GRAFT SURVIVAL; HEART TRANSPLANTATION; HUMANS; IMMUNOSUPPRESSIVE AGENTS; MAINTENANCE CHEMOTHERAPY; MALE; MIDDLE AGED; PILOT PROJECTS; POLYMORPHISM, GENETIC; POSTOPERATIVE COMPLICATIONS; PROGNOSIS; RISK FACTORS; YOUNG ADULT;

EID: 84983203344     PISSN: 09020063     EISSN: 13990012     Source Type: Journal    
DOI: 10.1111/ctr.12653     Document Type: Article

References (38)

1. Eisen HJ, Tuzcu EM, Dorent R et al. Everolimus for the prevention of allograft rejection and vasculopathy in cardiac-transplant recipients. N Engl J Med 2003: 349: 847.
2. Chapman JR. Chronic calcineurin inhibitor nephrotoxicity-lest we forget. Am J Transplant 2011: 11: 693.
3. Lund LH, Edwards LB, Kucheryavaya AY et al. The registry of the International Society for Heart and Lung Transplantation: thirty-first official adult heart transplant report-2014; focus theme: retransplantation. J Heart Lung Transplant 2014: 33: 996.
4. Eisen HJ, Kobashigawa J, Starling RC et al. Everolimus versus mycophenolate mofetil in heart transplantation: a randomized, multicenter trial. Am J Transplant 2013: 13: 1203.
5. Arora S, Gude E, Sigurdardottir V et al. Improvement in renal function after everolimus introduction and calcineurin inhibitor reduction in maintenance thoracic transplant recipients: the significance of baseline glomerular filtration rate. J Heart Lung Transplant 2012: 31: 259.
6. Andreassen AK, Andersson B, Gustafsson F et al. Everolimus initiation and early calcineurin inhibitor withdrawal in heart transplant recipients: a randomized trial. Am J Transplant 2014: 14: 1828.
7. Kovarik JM, Eisen H, Dorent R et al. Everolimus in de novo cardiac transplantation: pharmacokinetics, therapeutic range, and influence on cyclosporine exposure. J Heart Lung Transplant 2003: 22: 1117.
8. Baur B, Oroszlan M, Hess O et al. Efficacy and safety of sirolimus and everolimus in heart transplant patients: a retrospective analysis. Transplant Proc 2011: 43: 1853.
9. Schaffer SA, Ross HJ. Everolimus: efficacy and safety in cardiac transplantation. Expert Opin Drug Saf 2010: 9: 843.
10. Kirchner GI, Meier-Wiedenbach I, Manns MP. Clinical pharmacokinetics of everolimus. Clin Pharmacokinet 2004: 43: 83.
11. Lesche D, Sigurdardottir V, Setoud R et al. CYP3A5*3 and POR*28 genetic variants influence the required dose of tacrolimus in heart transplant recipients. Ther Drug Monit 2014: 36: 710.
12. Rodriguez-Antona C, Niemi M, Backman JT et al. Characterization of novel CYP2C8 haplotypes and their contribution to paclitaxel and repaglinide metabolism. Pharmacogenomics J 2008: 8: 268.
13. Terrazzino S, Quaglia M, Stratta P et al. The effect of CYP3A5 6986A>G and ABCB1 3435C>T on tacrolimus dose-adjusted trough levels and acute rejection rates in renal transplant patients: a systematic review and meta-analysis. Pharmacogenet Genomics 2012: 22: 642.
14. Schoeppler KE, Aquilante CL, Kiser TH et al. The impact of genetic polymorphisms, diltiazem, and demographic variables on everolimus trough concentrations in lung transplant recipients. Clin Transplant 2014: 28: 590.
15. Hesselink DA, Ngyuen H, Wabbijn M et al. Tacrolimus dose requirement in renal transplant recipients is significantly higher when used in combination with corticosteroids. Br J Clin Pharmacol 2003: 56: 327.
16. Billaud EM, Antoine C, Berge M et al. Management of metabolic cytochrome P450 3A4 drug-drug interaction between everolimus and azole antifungals in a renal transplant patient. Clin Drug Investig 2009: 29: 481.
17. Levey AS, Stevens LA, Schmid CH et al. A new equation to estimate glomerular filtration rate. Ann Intern Med 2009: 150: 604.
18. Schwartz GJ, Munoz A, Schneider MF et al. New equations to estimate GFR in children with CKD. J Am Soc Nephrol 2009: 20: 629.
19. Staples A, LeBlond R, Watkins S et al. Validation of the revised Schwartz estimating equation in a predominantly non-CKD population. Pediatr Nephrol 2010: 25: 2321.
20. Tang HL, Xie HG, Yao Y et al. Lower tacrolimus daily dose requirements and acute rejection rates in the CYP3A5 nonexpressers than expressers. Pharmacogenet Genomics 2011: 21: 713.
21. de Jonge H, Metalidis C, Naesens M et al. The P450 oxidoreductase *28 SNP is associated with low initial tacrolimus exposure and increased dose requirements in CYP3A5-expressing renal recipients. Pharmacogenomics 2011: 12: 1281.
22. 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.
23. Fredericks S, Moreton M, Reboux S et al. Multidrug resistance gene-1 (MDR-1) haplotypes have a minor influence on tacrolimus dose requirements. Transplantation 2006: 82: 705.
24. Excoffier L, Lischer HE. Arlequin suite ver 3.5: a new series of programs to perform population genetics analyses under Linux and Windows. Mol Ecol Resour 2010: 10: 564.
25. Excoffier L, Laval G, Balding D. Gametic phase estimation over large genomic regions using an adaptive window approach. Hum Genomics 2003: 1: 7.
26. Akhlaghi F, Keogh AM, McLachlan AJ et al. Pharmacokinetics of cyclosporine in heart transplant recipients receiving metabolic inhibitors. J Heart Lung Transplant 2001: 20: 431.
27. Aumente Rubio MD, Arizon del Prado JM, Lopez Malo de Molina MD et al. Clinical pharmacokinetics of tacrolimus in heart transplantation: new strategies of monitoring. Transplant Proc 2003: 35: 988.
28. 1000 Genomes project. Phase 3 release 20150527. Available from: http://www.1000genomes.org/. Cited 2015, June 10, 2015.
29. Lemaitre F, Bezian E, Goldwirt L et al. Population pharmacokinetics of everolimus in cardiac recipients: comedications, ABCB1, and CYP3A5 polymorphisms. Ther Drug Monit 2012: 34: 686.
30. Kniepeiss D, Renner W, Trummer O et al. The role of CYP3A5 genotypes in dose requirements of tacrolimus and everolimus after heart transplantation. Clin Transplant 2011: 25: 146.
31. Anglicheau D, Le Corre D, Lechaton S et al. Consequences of genetic polymorphisms for sirolimus requirements after renal transplant in patients on primary sirolimus therapy. Am J Transplant 2005: 5: 595.
32. Le Meur Y, Djebli N, Szelag JC et al. CYP3A5*3 influences sirolimus oral clearance in de novo and stable renal transplant recipients. Clin Pharmacol Ther 2006: 80: 51.
33. Moes DJ, Swen JJ, den Hartigh J et al. Effect of CYP3A4*22, CYP3A5*3, and CYP3A combined genotypes on cyclosporine, everolimus, and tacrolimus pharmacokinetics in renal transplantation. CPT Pharmacometrics Syst Pharmacol 2014: 3: 1.
34. Zuckermann A, Wang SS, Epailly E et al. Everolimus immunosuppression in de novo heart transplant recipients: what does the evidence tell us now? Transplant Rev 2013: 27: 76.
35. Gullestad L, Iversen M, Mortensen SA et al. Everolimus with reduced calcineurin inhibitor in thoracic transplant recipients with renal dysfunction: a multicenter, randomized trial. Transplantation 2010: 89: 864.
36. Gullestad L, Mortensen SA, Eiskjaer H et al. Two-year outcomes in thoracic transplant recipients after conversion to everolimus with reduced calcineurin inhibitor within a multicenter, open-label, randomized trial. Transplantation 2010: 90: 1581.
37. Dunn C, Croom KF. Everolimus: a review of its use in renal and cardiac transplantation. Drugs 2006: 66: 547.
38. Neumayer HH, Paradis K, Korn A et al. Entry-into-human study with the novel immunosuppressant SDZ RAD in stable renal transplant recipients. Br J Clin Pharmacol 1999: 48: 694.