The impact of genetic polymorphisms, diltiazem, and demographic variables on everolimus trough concentrations in lung transplant recipients

Clinical Transplantation

Volumn 28, Issue 5, 2014, Pages 590-597

  Schoeppler, Kelly E ^a   Aquilante, Christina L ^b   Kiser, Tyree H ^b   Fish, Douglas N ^b   Zamora, Martin R ^b  

^a UNIVERSITY OF COLORADO HOSPITAL   (United States)

^b UNIVERSITY OF COLORADO   (United States)

Author keywords

Cystic fibrosis; Diltiazem; Everolimus; Lung transplantation; Pharmacogenetics

Indexed keywords

AZITHROMYCIN; CYCLOSPORIN; CYTOCHROME P450 2C8; CYTOCHROME P450 3A4; CYTOCHROME P450 3A5; DILTIAZEM; EVEROLIMUS; METOCLOPRAMIDE; MULTIDRUG RESISTANCE PROTEIN 1; PANCREAS ENZYME; PREDNISONE; PREGNANE X RECEPTOR; PROTON PUMP INHIBITOR; TACROLIMUS; ABCB1 PROTEIN, HUMAN; BIOLOGICAL MARKER; CYP2C8 PROTEIN, HUMAN; CYP3A4 PROTEIN, HUMAN; CYP3A5 PROTEIN, HUMAN; CYTOCHROME P450 3A; IMMUNOSUPPRESSIVE AGENT; MULTIDRUG RESISTANCE PROTEIN; RAPAMYCIN; STEROID RECEPTOR; UNSPECIFIC MONOOXYGENASE; VASODILATOR AGENT;

ABCB1 GENE; ADULT; AGED; ARTICLE; CYP2C8 GENE; CYP3A4 GENE; CYP3A5 GENE; CYSTIC FIBROSIS; DRUG BLOOD LEVEL; FEMALE; GENE; GENOTYPE; GRAFT RECIPIENT; HAPLOTYPE; HUMAN; LUNG TRANSPLANTATION; MAJOR CLINICAL STUDY; MALE; NR1I2 GENE; OUTCOME ASSESSMENT; POLYMERASE CHAIN REACTION; PRIORITY JOURNAL; PYROSEQUENCING; SINGLE NUCLEOTIDE POLYMORPHISM; ANALOGS AND DERIVATIVES; CROSS-SECTIONAL STUDY; DEMOGRAPHY; DRUG EFFECTS; FOLLOW UP; GENE EXPRESSION REGULATION; GENETIC POLYMORPHISM; GENETICS; LUNG DISEASES; METABOLISM; MIDDLE AGED; PROGNOSIS; TISSUE DISTRIBUTION;

ARYL HYDROCARBON HYDROXYLASES; BIOLOGICAL MARKERS; CROSS-SECTIONAL STUDIES; CYTOCHROME P-450 CYP2C8; CYTOCHROME P-450 CYP3A; DEMOGRAPHY; DILTIAZEM; FEMALE; FOLLOW-UP STUDIES; GENE EXPRESSION REGULATION; GENOTYPE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; LUNG DISEASES; LUNG TRANSPLANTATION; MALE; MIDDLE AGED; P-GLYCOPROTEINS; POLYMORPHISM, GENETIC; PROGNOSIS; RECEPTORS, STEROID; SIROLIMUS; TISSUE DISTRIBUTION; TRANSPLANT RECIPIENTS; VASODILATOR AGENTS;

EID: 84899917672     PISSN: 09020063     EISSN: 13990012     Source Type: Journal    
DOI: 10.1111/ctr.12350     Document Type: Article

References (40)

1. Kirchner GI, Meier-Wiedenbach I, Manns MP. Clinical pharmacokinetics of everolimus. Clin Pharmacokinet 2004: 43: 83.
2. Kovarik JM, Kahan BD, Kaplan B et al. Longitudinal assessment of everolimus in de novo renal transplant recipients over the first post-transplant year: pharmacokinetics, exposure-response relationships, and influence on cyclosporine. Clin Pharmacol Ther 2001: 69: 48.
3. Cibrik D, Silva HT Jr, Vathsala A et al. Randomized trial of everolimus-facilitated calcineurin inhibitor minimization over 24 months in renal transplantation. Transplantation 2013: 95: 933.
4. Lorber MI, Ponticelli C, Whelchel J et al. Therapeutic drug monitoring for everolimus in kidney transplantation using 12-month exposure, efficacy, and safety data. Clin Transplant 2005: 19: 145.
5. Zortress [Prescribing Information]. East Hanover, NJ: Novartis Pharmaceuticals Corp., February 2013.
6. Crowe A, Bruelisauer A, Duerr L, Guntz P, Lemaire M. Absorption and intestinal metabolism of SDZ-RAD and rapamycin in rats. Drug Metab Dispos 1999: 27: 627.
7. Jacobsen W, Serkova N, Hausen B, Morris RE, Benet LZ, Christians U. Comparison of the in vitro metabolism of the macrolide immunosuppressants sirloimus and RAD. Transplant Proc 2001: 33: 514.
8. Istrate MA, Nussler AK, Eichelbaum M, Burk O. Regulation of CYP3A4 by pregnane X receptor: the role of nuclear receptors competing for response element binding. Biochem Biophys Res Commun 2010: 393: 688.
9. Tompkins LM, Wallace AD. Mechanisms of cytochrome P450 induction. J Biochem Mol Toxicol 2007: 21: 176.
10. Kovarik JM, Kalbag J, Figueiredo J, Rouilly M, Frazier OL, Rordorf C. Differential influence of two cyclosporine formulations on everolimus pharmacokinetics: a clinically relevant pharmacokinetic interaction. J Clin Pharmacol 2002: 42: 95.
11. Kovarik JM, Beyer D, Bizot MN, Jiang Q, Allison MJ, Schmouder RL. Pharmacokinetic interaction between verapamil and everolimus in healthy subjects. Br J Clin Pharmacol 2005: 60: 434.
12. Kovarik JM, Hartmann S, Figueiredo J, Rouilly M, Port A, Rordorf C. Effect of rifampin on apparent clearance of everolimus. Ann Pharmacother 2002: 36: 981.
13. Kovarik JM, Beyer D, Bizot MN, Jiang Q, Shenouda M, Schmouder RL. Blood concentrations of everolimus are markedly increased by ketoconazole. J Clin Pharmacol 2005: 45: 514.
14. Kovarik JM, Beyer D, Bizot MN, Jiang Q, Shenouda M, Schmouder RL. Effect of multiple-dose erythromycin on everolimus pharmacokinetics. Eur J Clin Pharmacol 2005: 61: 35.
15. Azzola A, Havryk A, Chhajed P et al. Everolimus and mycophenolate mofetil are potent inhibitors of fibroblast proliferation after lung transplantation. Transplantation 2004: 77: 275.
16. Kauffman HM, Cherikh WS, Cheng Y, Hanto DW, Kahan BD. Maintenance immunosuppression with target of rapamycin inhibitors is associated with a reduced-incidence of de novo malignancies. Transplantation 2005: 80: 883.
17. 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.
18. Doyle RL, Hertz MI, Dunitz JM et al. RAD in stable lung and heart/lung transplant recipients: safety, tolerability, pharmacokinetics, and impact of cystic fibrosis. J Heart Lung Transplant 2001: 20: 330.
19. Kovarik JM, Hsu CH, McMahon L, Berthier S, Rordorf C. Population pharmacokinetics of everolimus in de novo renal transplant patients: impact of ethnicity and comedications. Clin Pharmacol Ther 2001: 70: 247.
20. U.S. Food and Drug Administration. Drug development and drug interactions: table of substrates, inhibitors and inducers. Available at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInteractionsLabeling/ucm093664.htm. Accessed July 7, 2013.
21. Christians U, Jacobsen W, Serkova N et al. Automated, fast and sensitive quantification of drugs in blood by liquid chromatography-mass spectrometry with on-line extraction: immunosuppressants. J Chromatogr B Biomed Sci Appl 2000: 748: 41.
22. Salm P, Taylor PJ, Lynch SV, Pillans PI. Quantification and stability of everolimus (SDZ RAD) in human blood by high-performance liquid chromatography-electrospray tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci 2002: 772: 283.
23. Streit F, Armstrong VW, Oellerich M. Rapid liquid chromatography-tandem mass spectrometry routine method for simultaneous determination of sirolimus, everolimus, tacrolimus, and cyclosporine A in whole blood. Clin Chem 2002: 48: 955.
24. Stephens M, Smith N, Donnelly P. A new statistical method for haplotype reconstruction from population data. Am J Hum Genet 2001: 6: 978.
25. Stephens M, Donnelly P. A comparison of Bayesian methods for haplotype reconstruction from population genotype data. Am J Hum Genet 2003: 73: 1162.
26. 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.
27. 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.
28. Picard N, Rouguieg-Malki K, Kamar N, Rostaing L, Marquet P. CYP3A5 genotype does not influence everolimus in vitro metabolism and clinical pharmacokinetics in renal transplant recipients. Transplantation 2011: 91: 652.
29. Moes DJ, Press RR, den Hartigh J, van der Straaten T, de Fijter JW, Guchelaar HJ. Population pharmacokinetics and pharmacogenetics of everolimus in renal transplant patients. Clin Pharmacokinet 2012: 51: 467.
30. Elens L, Bouamar R, Hesselink DA et al. A new function CYP3A4 intron 6 polymorphism significantly affects tacrolimus pharmacokinetics in kidney transplant recipients. Clin Chem 2011: 57: 1574.
31. Anglieau 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. Mourad M, Wallemacq P, De Meyer M et al. The influence of genetic polymorphisms of cytochrome P4503A5 and ABCB1 on starting dose- and weight-standardized tacrolimus trough concentrations after kidney transplantation in relation to renal function. Clin Chem Lab Med 2006: 44: 1192.
33. Zochowska D, Wyzgal J, Paczek L. The impact of CYP3A4*1B and CYP3A5*3 polymorphisms on the pharmacokinetics of cyclosporine and sirolimus in renal transplant recipients. Ann Transplant 2012: 17: 36.
34. Mourad M, Mourad G, Wallemacq P et al. Sirolimus and tacrolimus concentrations and dose requirements after kidney transplantation in relation to CYP3A5 and MDR1 polymorphisms and steroids. Transplantation 2005: 80: 977.
35. Haufroid V, Mourad M, Van Kerckhove V et al. The effect of CYP3A5 and MDR1 (ABCB1) polymorphisms on cyclosporine and tacrolimus dose requirements and trough blood levels in stable renal transplant recipients. Pharmacogenetics 2004: 14: 147.
36. Lorber MI, Mulgaonkar S, Butt KM et al. Everolimus versus mycophenolate mofetil in prevention of rejection in de novo renal transplant recipients: a 3-year randomized, multicenter, phase III study. Transplantation 2005: 80: 244.
37. Vítko S, Margreiter R, Weimar W et al. Three-year efficacy and safety results from a study of everolimus versus mycophenolate mofetil in de novo renal transplant patients. Am J Transplant 2005: 5: 2521.
38. Salvadori M, Scolari MP, Bertoni E et al. Everolimus with very low-exposure cyclosporine a exposure in de novo kidney transplantation: a multicenter randomized, controlled trial. Transplantation 2009: 88: 1194.
39. Shennib H, Auger JL. Diltiazem improves cyclosporine dosage in cystic fibrosis lung transplant recipients. J Heart Lung Transplant 1994: 13: 292.
40. Valantine H, Keogh A, McIntosh N, Hunt S, Oyer P, Schroeder J. Cost containment: coadministration of diltiazem with cyclosporine after heart transplantation. J Heart Lung Transplant 1992: 11: 1.