Sex differences in cyclosporine pharmacokinetics and abcb1 gene expression in mononuclear blood cells in african american and caucasian renal transplant recipients

Journal of Clinical Pharmacology

Volumn 53, Issue 10, 2013, Pages 1039-1047

  Tornatore, Kathleen M ^a,b   Brazeau, Daniel ^a   Dole, Kiran ^a   Danison, Ryan ^a   Wilding, Gregory ^a   Leca, Nicolae ^b   Gundroo, Aijaz ^b   Gillis, Kathryn ^a   Zack, Julia ^a   Difrancesco, Robin ^a   Venuto, Rocco C ^b  

^a UNIVERSITY AT BUFFALO   (United States)

^b UNIVERSITY AT BUFFALO   (United States)

Author keywords

Abcb1 gene expression; Cyclosporine pharmacokinetics; Immunosuppression pharmacology; P glycoprotein; Race; Renal transplantation; Sex

Indexed keywords

CYCLOSPORIN A; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; PREDNISONE;

ABCB1 GENE; AFRICAN AMERICAN; AGED; AREA UNDER THE CURVE; ARTICLE; BODY MASS; CAUCASIAN; DRUG CLEARANCE; DRUG EXPOSURE; FEMALE; GENE; GENE EXPRESSION; GRAFT RECIPIENT; HUMAN; KIDNEY GRAFT; MAJOR CLINICAL STUDY; MALE; PERIPHERAL BLOOD MONONUCLEAR CELL; RACE DIFFERENCE; SEX DIFFERENCE;

ABCB1 GENE EXPRESSION; CYCLOSPORINE PHARMACOKINETICS; IMMUNOSUPPRESSION PHARMACOLOGY; P-GLYCOPROTEIN; RACE; RENAL TRANSPLANTATION; SEX;

ADULT; AFRICAN AMERICANS; AGED; ANTI-INFLAMMATORY AGENTS; BODY MASS INDEX; CYCLOSPORINE; EUROPEAN CONTINENTAL ANCESTRY GROUP; FEMALE; GENE EXPRESSION; HUMANS; IMMUNOSUPPRESSIVE AGENTS; KIDNEY TRANSPLANTATION; LEUKOCYTES, MONONUCLEAR; MALE; MIDDLE AGED; MYCOPHENOLIC ACID; P-GLYCOPROTEIN; PREDNISONE; SEX FACTORS;

EID: 84885135794     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1002/jcph.123     Document Type: Article

References (40)

1. Collins AJ, Foley RN, Chavers B, et al. United States renal data system 2011 annual data report: Atlas of chronic kidney disease & end-stage renal disease in the United States. Am J Kidney Dis. 2012;59(1 Suppl. 1):A7, e1-420.
2. Tonelli M, Wiebe N, Knoll G, et al. Systematic review: kidney transplantation compared with dialysis in clinically relevant outcomes. Am J Transplant. 2011;11(10):2093-2109.
3. Young CJ, Gaston RS. Understanding the influence of ethnicity on renal allograft survival. Am J Transplant. 2005;5(11):2603-2604.
4. Hoffmann SC, Stanley EM, Cox ED, et al. Ethnicity greatly influences cytokine gene polymorphism distribution. Am J Transplant. 2002;2(6):560-567. (Pubitemid 36306876)
5. Bjornsson TD, Wagner JA, Donahue SR, et al. A review and assessment of potential sources of ethnic differences in drug responsiveness. J Clin Pharmacol. 2003;43(9):943-967. (Pubitemid 37022739)
6. Neylan JF. Racial differences in renal transplantation after immunosuppression with tacrolimus versus cyclosporine. FK506 Kidney Transplant Study Group. Transplantation. 1998;65(4):515- 523. (Pubitemid 28136494)
7. Min DI, Lee M, Ku YM, Flanigan M. Gender-dependent racial difference in disposition of cyclosporine among healthy African American and white volunteers. Clin Pharmacol Ther. 2000;68 (5):478-486.
8. Tornatore KM, Biocevich DM, Reed K, Tousley K, Singh JP, Venuto RC. Methylprednisolone pharmacokinetics, cortisol response, and adverse effects in black and white renal transplant recipients. Transplantation. 1995;59(5):729-736.
9. Tornatore KM, Sudchada P, Dole K, et al. Mycophenolic acid pharmacokinetics during maintenance immunosuppression in African American and Caucasian renal transplant recipients. J Clin Pharmacol. 2011;51(8):1213-1222.
10. Lindholm A, Welsh M, Alton C, Kahan BD. Demographic factors influencing cyclosporine pharmacokinetic parameters in patients with uremia: racial differences in bioavailability. Clin Pharmacol Ther. 1992;52(4):359-371.
11. Schuetz EG, Furuya KN, Schuetz JD. Interindividual variation in expression of P-glycoprotein in normal human liver and secondary hepatic neoplasms. J Pharmacol Exp Ther. 1995;275(2):1011-1018. (Pubitemid 26023635)
12. Soldin OP, Chung SH, Mattison DR. Sex differences in drug disposition. J Biomed Biotechnol. 2011;2011:187103.
13. Jonge HD, Naesens M, Kuypers DRJ. 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. 2009;31(4):416-435 410.1097/FTD. 1090b1013e3181aa1036cd.
14. Lown KS, Mayo RR, Leichtman AB, et al. Role of intestinal Pglycoprotein (mdr1) in interpatient variation in the oral bioavailability of cyclosporine. Clin Pharmacol Ther. 1997;62(3):248-260. (Pubitemid 27417790)
15. Schroeder T, Cho M, Pollack G, et al. Comparison of two cyclosporine formulations in healthy volunteers: bioequivalence of the new Sang-35 formulation and Neoral. J Clin Pharmacol. 1998;38(9):807-814. (Pubitemid 28450403)
16. Bleck JS, Thiesemann C, Kliem V, et al. Diltiazem increases blood concentrations of cyclized cyclosporine metabolites resulting in different cyclosporine metabolite patterns in stable male and female renal allograft recipients. Br J Clin Pharmacol. 1996;41(6):551-556. (Pubitemid 26184677)
17. Drug safety: most drugs withdrawn from market in recent years had greater risks for women; http://www.gao.gov/new.items. 2010.
18. Halloran PF. Immunosuppressive drugs for kidney transplantation. N Engl J Med. 2004;351(26):2715-2729. (Pubitemid 39665325)
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. 2001;69 (5):317-323. (Pubitemid 32477072)
20. Mizutani T, Masuda M, Nakai E, et al. Genuine functions of Pglycoprotein (ABCB1). Curr Drug Metab. 2008;9(2):167-174.
21. Kock K, Grube M, Jedlitschky G, et al. Expression of adenosine triphosphate-binding cassette (ABC) drug transporters in peripheral blood cells: relevance for physiology and pharmacotherapy. Clin Pharmacokinet. 2007;46(6):449-470. (Pubitemid 46827856)
22. Donnenberg VS, Burkhart G, Donnenberg G. P-glycoprotein function in T cells: implications for organ transplant. Clin Appl Immunol Rev. 2003;4:15-30. (Pubitemid 36814100)
23. Leschziner GD, Andrew T, Pirmohamed M, Johnson MR. ABCB1 genotype and PGP expression, function and therapeutic drug response: a critical review and recommendations for future research. Pharmacogenomics J. 2007;7(3):154-179. (Pubitemid 46794925)
24. Drach D, Zhao S, Drach J, et al. Subpopulations of normal peripheral blood and bone marrow cells express a functional multidrug resistant phenotype. Blood. 1992;80(11):2729-2734.
25. Klimecki W, Futscher B, Grogan T, Dalton W. P-glycoprotein expression and function in circulating blood cells from normal volunteers. Blood. 1994;83(9):2451-2458. (Pubitemid 24135836)
26. Giraud C, Manceau S, Treluyer J-M. ABC transporters in human lymphocytes: expression, activity and role, modulating factors and consequences for antiretroviral therapies. Expert Opin Drug Metab Toxicol. 2010;6(5):571-589.
27. Masuda S, Goto M, Fukatsu S, et al. Intestinal MDR1/ABCB1 level at surgery as a risk factor of acute cellular rejection in living-donor liver transplant patients[ast]. Clin Pharmacol Ther. 2006;79(1):90- 102. (Pubitemid 43069581)
28. Goto M, Masuda S, Kiuchi T, et al. Relation between mRNA expression level of multidrug resistance 1/ABCB1 in blood cells and required level of tacrolimus in pediatric living-donor liver transplantation. J Pharmacol Exp Ther. 2008;325(2):610-616. (Pubitemid 351574803)
29. Grude P, Boleslawski E, Conti F, Chouzenoux S, Calmus Y. MDR1 gene expression in peripheral blood mononuclear cells after liver transplantation. Transplantation. 2002;73(11):1824-1828. (Pubitemid 34655261)
30. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16(1):31-41.
31. Vandesompele J, De Preter K, Pattyn F, et al. Accurate normalization of real-time quantitative RT-PCR data by geometric averaging of multiple internal control genes. Genome Biol. 2002;3(7): RESEARCH0034.
32. Huang SM, Temple R. Is this the drug or dose for you? Impact and consideration of ethnic factors in global drug development, regulatory review, and clinical practice. Clin Pharmacol Ther. 2008;84(3):287-294.
33. Chen ML. Confounding factors for sex differences in pharmacokinetics and pharmacodynamics: focus on dosing regimen, dosage form, and formulation. Clin Pharmacol Ther. 2005;78(4):322-329.
34. Cummins CL, Wu CY, Benet LZ. Sex-related differences in the clearance of cytochrome P450 3A4 substrates may be caused by Pglycoprotein. Clin Pharmacol Ther. 2002;72(5):474-489. (Pubitemid 36237718)
35. Paine MF, Ludington SS, Chen M-L, Stewart PW, Huang S-M, Watkins PB. Do men and women differ in proximal small intestinal CYP3A or P-glycoprotein expression? Drug Metab Dispos. 2005;33 (3):426-433. (Pubitemid 40279944)
36. Morris ME, Lee H-J, Predko LM. Gender differences in the membrane transport of endogenous and exogenous compounds. Pharmacol Rev. 2003;55(2):229-240. (Pubitemid 36666047)
37. Ansermot N, Rebsamen M, Chabert J, et al. Influence of ABCB1 gene polymorphisms and P-glycoprotein activity on cyclosporine pharmacokinetics in peripheral blood mononuclear cells in healthy volunteers. Drug Metabol Lett. 2008;2(2):76-82. (Pubitemid 351983779)
38. Falck P, Asberg A, Guldseth H, et al. Declining intracellular Tlymphocyte concentration of cyclosporine a precedes acute rejection in kidney transplant recipients. Transplantation. 2008;85(2):179- 184. (Pubitemid 351156847)
39. Albermann N, Schmitz-Winnenthal FH, Z'Graggen K, et al. Expression of the drug transporters MDR1/ABCB1, MRP1/ABCC1, MRP2/ABCC2, BCRP/ABCG2, and PXR in peripheral blood mononuclear cells and their relationship with the expression in intestine and liver. Biochem Pharmacol. 2005;70(6):949-958. (Pubitemid 41138860)
40. Farrell RJ, Menconi MJ, Keates AC, Kelly CP. P-glycoprotein-170 inhibition significantly reduces cortisol and ciclosporin efflux from human intestinal epithelial cells and T lymphocytes. Aliment Pharmacol Ther. 2002;16(5):1021-1031. (Pubitemid 34461774)