Reduced methylprednisolone clearance causing prolonged pharmacodynamics in a healthy subject was not associated with CYP3A5*3 allele or a change in diet composition

Journal of Clinical Pharmacology

Volumn 46, Issue 5, 2006, Pages 515-526

  Lee, Su Jun ^a   Jusko, William J ^b   Salaita, Christine G ^c   Calis, Karim A ^c   Jann, Michael W ^d   Spratlin, Vicky E ^d   Goldstein, Joyce A ^a   Yuen, Yi Hon ^c,d  

^a NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES   (United States)

^b UNIVERSITY AT BUFFALO   (United States)

^c NATIONAL INSTITUTES OF HEALTH   (United States)

^d MERCER UNIVERSITY   (United States)

Author keywords

CYP3A5*3 allele; Genotyping method; Low carbohydrate diet; Methylprednisolone clearance; Steroid pharmacodynamics

Indexed keywords

CYTOCHROME P450 3A4; CYTOCHROME P450 3A5; METHYLPREDNISOLONE SODIUM SUCCINATE;

ALLELISM; ARTICLE; ARTIFICIAL DIET; CARBOHYDRATE DIET; CONTROLLED STUDY; DIET; DRUG CLEARANCE; DRUG METABOLISM; EVALUATION; FOOD COMPOSITION; FOOD DRUG INTERACTION; FOOD INTAKE; GENE FREQUENCY; GENETIC ANALYSIS; GENOTYPE; HEREDITY; HOMOZYGOSITY; HUMAN; HUMAN EXPERIMENT; NORMAL HUMAN; PHARMACOGENETICS; POLYMERASE CHAIN REACTION; PREVALENCE; STATISTICAL SIGNIFICANCE; VOLUNTEER;

ADULT; ALLELES; CYTOCHROME P-450 CYP3A; CYTOCHROME P-450 ENZYME SYSTEM; DIET; HISTAMINE; HUMANS; HYDROCORTISONE; MALE; METABOLIC CLEARANCE RATE; METHYLPREDNISOLONE; POLYMORPHISM, SINGLE NUCLEOTIDE;

EID: 33645804424     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270006287588     Document Type: Article

References (64)

1. Cytochrome P450 Drug-Interaction Table. November 23, 2005. Available at: http://medicine.iupui.edu/nockhart/table.htm. Accessed December 27, 2005.
2. Jusko WJ, Ludwig EA. Corticosteroids. In: Evans WE, Schentag JJ, Jusko WJ, eds. Applied Pharmacokinetics: Principles of Therapeutic Drug Monitoring. Vancouver, Wash: Applied Therapeutics, Inc; 1992:27-1-27-34.
3. Booker BM, Magee MH, Blum RA, Lates CD, Jusko WJ. Pharmacokinetic and pharmacodynamic interactions between diltiazem and methylprednisolone in healthy volunteers. Clin Pharmacol Ther. 2002;72:370-382.
4. Slayter KL, Ludwig EA, Lew KH, Middleton E Jr, Ferry JJ, Jusko WJ. Oral contraceptive effects on methylprednisolone pharmacokinetics and pharmacodynamics. Clin Pharmacol Ther 1996;59:312-321.
5. McCrea JB, Majumdar AK, Goldberg MR, et al. Effects of the neurokinin1 receptor antagonist aprepitant on the pharmacokinetics of dexamethasone and methylprednisolone. Clin Pharmacol Ther. 2003;74:17-24.
6. Schuetz JD, Beach DL, Guzelian PS. Selective expression of cytochrome P450 CYP3A mRNAs in embryonic and adult human liver. Pharmacogenetics. 1994;4:11-20.
7. Lamba JK, Lin YS, Schuetz EG, Thummel KE. Genetic contribution to variable human CYP3A-mediated metabolism. Adv Drug Deliv Rev. 2002;54:1271-1294.
8. 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. 2001;27:383-391.
9. Lin YS, Dowling AL, Quigley SD, et al. Co-regulation of CYP3A4 and CYP3A5 and contribution to hepatic and intestinal midazolam metabolism. Mol Pharmacol. 2002;62:162-172.
10. Thummel KE, Wilkinson GR. In vitro and in vivo drug interactions involving human CYP3A. Annu Rev Pharmacol Toxicol. 1998;38:389-430.
11. Williams JA, Ring BJ, Cantrell VE, et al. Comparative metabolic capabilities of CYP3A4, CYP3A5, and CYP3A7. Drug Metab Dispos. 2002;30:883-891.
12. CYP3A4 allele nomenclature. August 30, 2005. Available at: http://www.imm.ki.se/CYPalleles/cyp3a4.htm. Accessed December 27, 2005.
13. Sata F, Sapone A, Elizondo G, et al. CYP3A4 allelic variants with amino acid substitutions in exons 7 and 12: evidence for an allelic variant with altered catalytic activity. Clin Pharmacol Ther. 2000;67:48-56.
14. Eiselt R, Domanski TL, Zibat A, et al. Identification and functional characterization of eight CYP3A4 protein variants. Pharmacogenetics. 2001;11:447-458.
15. Dai D, Tang J, Rose R, et al. Identification of variants of CYP3A4 and characterization of their abilities to metabolize testosterone and chlorpyrifos. J Pharmacol Exp Ther. 2001;299:825-831.
16. Lee SJ, Bell DA, Coulter SJ, Ghanayem B, Goldstein JA. Recombinant CYP3A4*17 is defective in metabolizing the hypertensive drug nifedipine, and the CYP3A4*17 allele may occur on the same chromosome as CYP3A5*3, representing a new putative defective CYP3A haplotype. J Pharmacol Exp Ther. 2005;313:302-309.
17. Lee SJ, Usmani KA, Chanas B, et al. Genetic findings and functional studies of human CYP3A5 single nucleotide polymorphisms in different ethnic groups. Pharmacogenetics. 2003;13:461-472.
18. Saeki M, Saito Y, Nakamura T, et al. Single nucleotide polymorphisms and haplotype frequencies of CYP3A5 in a Japanese population. Hum Mutat. 2003;21:653.
19. Xie HG, Wood AJ, Kim RB, Stein CM, Wilkinson GR. Genetic variability in CYP3A5 and its possible consequences. Pharmacogenomics. 2004;5:243-272.
20. Hon YY, Jusko WJ, Spratlin VE, Jann MW. Altered methylprednisolone pharmacodynamics in healthy subjects with histamine n-methyltransferase C314T genetic polymorphism. J Clin Pharmacol. In press.
21. Ebling WF, Szefler SJ, Jusko WJ. Analysis of cortisol, methylprednisolone, and methylprednisolone hemisuccinate: absence of effects of troleandomycin on ester hydrolysis. J Chromatogr. 1984;305:271-280.
22. Lee SJ, Goldstein JA. Functionally defective or altered CYP3A4 and CYP3A5 single nucleotide polymorphisms and their detection with genotyping tests. Pharmacogenomics. 2005;6:357-371.
23. Hustert E, Haberl M, Burk O, et al. The genetic determinants of the CYP3A5 polymorphism. Pharmacogenetics. 2001;11:773-779.
24. Wilkinson GR. Pharmacokinetics: the dynamics of drug absorption, distribution, and elimination. In: Hardman JG, Limbird LE, Gilman AG, eds. Goodman and Gilman's The Pharmacological Basis of Therapeutics. New York, New York: McGraw-Hill; 2001:3-29.
25. Alvares AP, Anderson KE, Conney AH, Kappas A. Interactions between nutritional factors and drug biotransformations in man. Proc Natl Acad Sci USA. 1976;73:2501-2504.
26. Kappas A, Anderson KE, Conney AH, Alvares AP. Influence of dietary protein and carbohydrate on antipyrine and theophylline metabolism in man. Clin Pharmacol Ther. 1976;20:643-653.
27. Anderson KE, Conney AH, Kappas A. Nutrition and oxidative drug metabolism in man: relative influence of dietary lipids, carbohydrate, and protein. Clin Pharmacol Ther. 1979;26:493-501.
28. Fagan TC, Walle T, Oexmann MJ, et al. Increased clearance of propranolol and theophylline by high-protein compared with high-carbohydrate diet. Clin Pharmacol Ther. 1987;41:402-406.
29. Juan D, Worwag EM, Schoeller DA, Kotake AN, Hughes RL, Frederiksen MC. Effects of dietary protein on theophylline pharmacokinetics and caffeine and aminopyrine breath tests. Clin Pharmacol Ther. 1986;40:187-194.
30. Dunn TE, Ludwig EA, Slaughter RL, Camara DS, Jusko WJ. Pharmacokinetics and pharmacodynamics of methylprednisolone in obesity. Clin Pharmacol Ther. 1991;49:536-549.
31. Kong AN, Ludwig EA, Slaughter RL, et al. Pharmacokinetics and pharmacodynamic modeling of direct suppression effects of methylprednisolone on serum cortisol and blood histamine in human subjects. Clin Pharmacol Ther. 1989;46:616-628.
32. Lew KH, Ludwig EA, Milad MA, et al. Gender-based effects on methylprednisolone pharmacokinetics and pharmacodynamics. Clin Pharmacol Ther. 1993;54:402-414.
33. Reiss WG, Slaughter RL, Ludwig EA, Middleton E Jr, Jusko WJ. Steroid dose sparing: pharmacodynamic responses to single versus divided doses of methylprednisolone in man. J Allergy Clin Immunol. 1990;85:1058-1066.
34. Wong M, Balleine RL, Collins M, Liddle C, Clarke CL, Gurney H. CYP3A5 genotype and midazolam clearance in Australian patients receiving chemotherapy. Clin Pharmacol Ther. 2004;75:529-538.
35. Goh BC, Lee SC, Wang LZ, et al. Explaining interindividual variability of docetaxel pharmacokinetics and pharmacodynamics in Asians through phenotyping and genotyping strategies. J Clin Oncol. 2002;20:3683-3690.
36. Shih PS, Huang JD. Pharmacokinetics of midazolam and 1′- hydroxymidazolam in Chinese with different CYP3A5 genotypes. Drug Metab Dispos. 2002;30:1491-1496.
37. Floyd MD, Gervasini G, Masica AL, et al. Genotype-phenotype associations for common CYP3A4 and CYP3A5 variants in the basal and induced metabolism of midazolam in European- and African-American men and women. Pharmacogenetics. 2003;13:595-606.
38. Yu KS, Cho JY, Jang IJ, et al. Effect of the CYP3A5 genotype on the pharmacokinetics of intravenous midazolam during inhibited and induced metabolic states. Clin Pharmacol Ther. 2004;76:104-112.
39. Fukuda T, Onishi S, Fukuen S, et al. CYP3A5 genotype did not impact on nifedipine disposition in healthy volunteers. Pharmacogenomics J. 2004;4:34-39.
40. Hesselink DA, van Schaik RH, van der Heiden IP, et al. Genetic polymorphisms of the CYP3A4, CYP3A5, and MDR-1 genes and pharmacokinetics of the calcineurin inhibitors cyclosporine and tacrolimus. Clin Pharmacol Ther. 2003;74:245-254.
41. Zheng H, Webber S, Zeevi A, et al. Tacrolimus dosing in pediatric heart transplant patients is related to CYP3A5 and MDR1 gene polymorphisms. Am J Transplant. 2003;3:477-483.
42. Goto M, Masuda S, Kiuchi T, et al. CYP3A5*1-carrying graft liver reduces the concentration/oral dose ratio of tacrolimus in recipients of living-donor liver transplantation. Pharmacogenetics. 2004;14:471-478.
43. 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;5:595-603.
44. Thervet E, Anglicheau D, King B, et al. Impact of cytochrome p450 3A5 genetic polymorphism on tacrolimus doses and concentration-to-dose ratio in renal transplant recipients. Transplantation. 2003;76:1233-1235.
45. Anglicheau D, Thervet E, Etienne I, et al. CYP3A5 and MDR1 genetic polymorphisms and cyclosporine pharmacokinetics after renal transplantation. Clin Pharmacol Ther. 2004;75:422-433.
46. Anglicheau D, Verstuyft C, Laurent-Puig P, 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. 2003;14:1889-1896.
47. Macphee IA, Fredericks S, Tai T, et al. Tacrolimus pharmacogenetics: polymorphisms associated with expression of cytochrome p4503A5 and P-glycoprotein correlate with dose requirement. Transplantation. 2002;74:1486-1489.
48. von Ahsen N, Richter M, Grupp C, Ringe B, Oellerich M, Armstrong VW. No influence of the MDR-1 C3435T polymorphism or a CYP3A4 promoter polymorphism (CYP3A4-V allele) on dose-adjusted cyclosporin A trough concentrations or rejection incidence in stable renal transplant recipients. Clin Chem. 2001;47:1048-1052.
49. Chowbay B, Cumaraswamy S, Cheung YB, Zhou Q, Lee EJ. Genetic polymorphisms in MDR1 and CYP3A4 genes in Asians and the influence of MDR1 haplotypes on cyclosporin disposition in heart transplant recipients. Pharmacogenetics. 2003;13:89-95.
50. Mai I, Stormer E, Goldammer M, et al. MDR1 haplotypes do not affect the steady-state pharmacokinetics of cyclosporine in renal transplant patients. J Clin Pharmacol. 2003;43:1101-1107.
51. Saitoh H, Hatakeyama M, Eguchi O,Oda M, Takada M. Involvement of intestinal P-glycoprotein in the restricted absorption of methylprednisolone from rat small intestine. J Pharm Sci 1998;87:73-75.
52. Oka A, Oda M, Saitoh H, Nakayama A, Takada M, Aungst BJ. Secretory transport of methylprednisolone possibly mediated by P-glycoprotein in Caco-2 cells. Biol Pharm Bull. 2002;25:393-396.
53. Yates CR, Chang C, Kearbey JD, et al. Structural determinants of P-glycoprotein-mediated transport of glucocorticoids. Pharm Res. 2003;20:1794-1803.
54. Lin JH. Drug-drug interaction mediated by inhibition and induction of P-glycoprotein. Adv Drug Deliv Rev. 2003;55:53-81.
55. Westlind-Johnsson A, Malmebo S, Johansson A, et al. Comparative analysis of CYP3A expression in human liver suggests only a minor role for CYP3A5 in drug metabolism. Drug Metab Dispos. 2003;31:755-761.
56. Patki KC, Von Moltke LL, Greenblatt DJ. In vitro metabolism of midazolam, triazolam, nifedipine, and testosterone by human liver microsomes and recombinant cytochromes p450: role of cyp3a4 and cyp3a5. Drug Metab Dispos. 2003;31:938-944.
57. Huang W, Lin YS, McConn DJ, et al. Evidence of significant contribution from CYP3A5 to hepatic drug metabolism. Drug Metab Dispos. 2004;32:1434-1445.
58. Hsieh KP, Lin YY, Cheng CL, et al. Novel mutations of CYP3A4 in Chinese. Drug Metab Dispos. 2001;29:268-273.
59. Lamba JK, Lin YS, Thummel K, et al. Common allelic variants of cytochrome P4503A4 and their prevalence in different populations. Pharmacogenetics. 2002;12:121-132.
60. Garcia-Martin E, Martinez C, Pizarro RM, et al. CYP3A4 variant alleles in white individuals with low CYP3A4 enzyme activity. Clin Pharmacol Ther. 2002;71:196-204.
61. Vree TB, Lagerwerf AJ, Verwey-van Wissen CP, Jongen PJ. High-performance liquid chromatography analysis, preliminary pharmacokinetics, metabolism and renal excretion of methylprednisolone with its C6 and C20 hydroxy metabolites in multiple sclerosis patients receiving high-dose pulse therapy. J Chromatogr B Biomed Sci Appl. 1999;732:337-348.
62. Fukushima-Uesaka H, Saito Y, Watanabe H, et al. Haplotypes of CYP3A4 and their close linkage with CYP3A5 haplotypes in a Japanese population. Hum Mutat. 2004;23:100.
63. Jounaidi Y, Hyrailles V, Gervot L, Maurel P. Detection of CYP3A5 allelic variant: a candidate for the polymorphic expression of the protein? Biochem Biophys Res Commun. 1996;221:466-470.
64. Chou FC, Tzeng SJ, Huang JD. Genetic polymorphism of cytochrome P450 3A5 in Chinese. Drug Metab Dispos. 2001;29:1205-1209.