Evaluation of the genetic component of variability in CYP3A4 activity: A repeated drug administration method

Pharmacogenetics

Volumn 10, Issue 5, 2000, Pages 373-388

  Özdemir, Vural ^c   Kalow, Werner ^b   Tang, Bing Kou ^c   Paterson, Andrew D ^c   Walker, Scott E ^c   Endrenyi, Laszlo ^c   Kashuba, Angela D M ^a  

^a UNIVERSITY OF NORTH CAROLINA   (United States)

^b UNIVERSITY OF TORONTO   (Canada)

^c NONE

Author keywords

CYP3A4; Genetic component; Heritability

Indexed keywords

CYCLOSPORIN; CYTOCHROME P450 3A4; DOXORUBICIN; ERYTHROMYCIN; ETHINYLESTRADIOL; ETHYLMORPHINE; LIVER ENZYME; MIDAZOLAM; NIFEDIPINE; NITRENDIPINE; STEROID;

CIRCADIAN RHYTHM; DRUG METABOLISM; ENZYME ACTIVITY; HUMAN; HUMAN EXPERIMENT; MATHEMATICAL MODEL; MEDICAL LITERATURE; NORMAL HUMAN; PHARMACOGENETICS; PRIORITY JOURNAL; REVIEW;

ADOLESCENT; ADULT; AGED; CYTOCHROME P-450 ENZYME SYSTEM; DRUG ADMINISTRATION SCHEDULE; DRUG THERAPY; ENZYME ACTIVATION; FEMALE; GENE EXPRESSION REGULATION, ENZYMOLOGIC; HUMANS; INDIVIDUALITY; MALE; MEDLINE; MIDDLE AGED; MIXED FUNCTION OXYGENASES; PHARMACEUTICAL PREPARATIONS; SUBSTRATE SPECIFICITY; VARIATION (GENETICS);

EID: 0000783041     PISSN: 0960314X     EISSN: None     Source Type: Journal    
DOI: 10.1097/00008571-200007000-00001     Document Type: Review

References (73)

1. Bailey DG, Bend JR, Arnold JM, Tran LT, Spence JD. Erythromycin-felodipine interaction: magnitude, mechanism, and comparison with grapefruit juice. Clin Pharmacol Ther 1996; 60:25-33.
2. Bailey DG, Malcolm J, Arnold O, Spence JD. Grapefruit juice-drug interactions. Br J Clin Pharmacol 1998; 46:101-110.
3. Ball SE, Scatina J, Kao J, Ferron GM, Fruncillo R, Mayer P, et al. Population distribution and effects on drug metabolism of a genetic variant in the 5′ 162 promotor region of CYP3A4. Clin Pharmacol Ther 1999; 66:288-294.
4. Bruguerolle B. Chronopharmacokinetics. Current status. Clin Pharmacokinet 1998; 35:83-94.
5. Carol W, Klinger G, Jäger R, Kasch R, Michels W. Untersuchungen zur inter-und intraindividuellen variabilität pharmakokinetischer parameter für kontrazeptive steroide. Zent BI Gynäkol 1991; 113:783-787.
6. Eichelbaum M, Somogyi A. Inter-and intra-subject variation in the first-pass elimination of highly cleared drugs during chronic dosing studies with deuterated verapamil. Eur J Clin Pharmacol 1984; 26:47-53.
7. Eksborg S, Strandler HS, Edsmyr F, Naslund I, Tahvanainen P. Pharmacokinetic study of IV infusions of adriamycin. Eur J Clin Pharmacol 1985; 28:205-212.
8. Endrenyi L, Inaba T, Kalow W. Genetic studies of amobarbital elimination based on its kinetics in twins. Clin Pharmacol Ther 1976; 20:701-714.
9. Engel G, Hofmann U, Heidemann H, Cosme J, Eichelbaum M. Antipyrine as a probe for human oxidative drug metabolism: identification of the cytochrome P450 enzymes catalyzing 4-hydroxyantipyrine, 3-hydroxymethylantipyrine, and norantipyrine formation. Clin Pharmacol Ther 1996; 59:613-623.
10. Freund JE, Walpole RE. Mathematical statistics. 3rd edn. Englewood Cliffs, New Jersey: Prentice Hall; 1980, pp. 358.
11. Friedrich V, Motulsky AG. Human genetics: problems and approaches. 2nd edn. New York: Springer-Verlag; 1986, pp. 205-218.
12. Fromm MF, Busse D, Kroemer HK, Eichelbaum M. Differential induction of prehepatic and hepatic metabolism of verapamil by rifampin. Hepatology 1996; 24:796-801.
13. Gerdin E, Rane A. N-demethylation of ethylmorphine in pregnant and nonpregnant women and in men: an evaluation of the effects of sex steroids. Brit J Clin Pharmacol 1992; 34:250-255.
14. 14C N-methyl] erythromycin breath test in healthy male volunteers. J Clin Pharmacol 1998; 38:492-495.
15. Gil P, Favre R, Durand A, Iliadis A, Cano JP, Carcassonne Y. Time dependency of adriamycin and adriamycinol kinetics. Cancer Chemother Pharmacol 1983; 10:120-124.
16. Gonzalez FJ, Schmid BJ, Umeno M, Mcbride OW, Hardwick JP, Meyer UA, et al. Human P450PCN1: sequence, chromosome localization, and direct evidence through cDNA expression that P450PCN1 is nifedipine oxidase. DNA 1988; 7:79-86.
17. Gorski JC, Hall SD, Jones DR, VandenBranden M, Wrighton SA. Regioselective biotransformation of midazolam by members of the human cytochrome P450 3A (CYP3A) subfamily. Biochem Pharmacol 1994; 47:1643-1653.
18. Gotzkowsky SK, Kashuba ADM, Hall W, Kulaway RW, Beck DJ. Rocci ML, et al. Poor correlation between 24 h urinary 6β-hydroxy cortisol: cortisol molar ratios (CMR) and plasma midazolam clearance (MDZ CL) as measures of hepatic CYP3A activity [abstract]. Clin Pharmacol Ther 1999; 65:167.
19. Guengerich FP. Mechanism-based inactivation of human liver microsomal cytochrome P-450 IIIA4 by gestodene. Chem Res Toxicol 1990; 3:363-371.
20. Hall SD, Thummel KE, Watkins PB, Lown KS, Benet LZ, Paine MF, et al. Molecular and physical mechanisms of first-pass extraction. Drug Metab Dispos 1999; 27:161-166.
21. Inoue K, Inazawa J, Nakagawa H, Shimada T, Yamazaki H, Guengerich FP, et al. Assignment of the human cytochrome P-450 nifedipine oxidase gene (CYP3A4) to chromosome 7 at band q22.1 by fluorescence in-situ hybridization. Jpn J Hum Genet 1992; 37:133-138.
22. Jacquet JM, Bressolle F, Galtier M, Bourrier M, Donadio D, Jourdan J, et al. Doxorubicin and doxorubicinol: intra-and inter-individual variations of pharmacokinetic parameters. Cancer Chemother Pharmacol 1990; 27:219-225.
23. Jung-Hoffmann C, Kuhl H. Intra-and interindividual variations in contraceptive steroid levels during 12 treatment cycles: No relation to irregular bleedings. Contraception 1990; 42:423-436.
24. Kalow W. Pharmacogenetics: heredity and the response to drugs. Philadelphia: WB Saunders; 1962, pp. 1-231.
25. Kalow W. Pharmacogenetics in biological perspective. Pharmacol Rev 1997; 49:369-379.
26. Kalow W. Pharmacogenetic research: a revolutionary science. J Psychiatry Neurosci 1999; 24:139-140.
27. Kalow W, Tang BK, Endrenyi L. Hypothesis: comparisons of inter-and intra-individual variations can substitute for twin studies in drug research. Pharmacogenetics 1998; 8:283-289.
28. Kalow W, Endrenyi L, Tang BK. Repeat administration of drugs as a means to assess the genetic component in pharmacological variability. Pharmacology 1999a; 58:281-284.
29. Kalow W, Ozdemir V, Tang BK, Tothfalusi L, Endrenyi L. The science of pharmacological variability: an essay. Clin Pharmacol Ther 1999b; 66:445-447.
30. Karlsson MO, Sheiner LB. The importance of modeling interoccasion variability in population pharmacokinetic analyses. J Pharmacokinet Biopharm 1993; 21:735-750.
31. Kashuba AD, Nafziger AN. Physiological changes during the menstrual cycle and their effects on the pharmacokinetics and pharmacodynamics of drugs. Clin Pharmacokinet 1998; 34:203-218.
32. Kashuba ADM, Bertino JS, Rocci ML, Kulawy RW, Beck DJ, Nafziger AN. Quantification of 3-month intraindividual variability and the influence of sex and menstrual cycle phase on CYP3A activity as measured by phenotyping with intravenous midazolam. Clin Pharmacol Ther 1998; 64:269-277.
33. Kim RB, Wandel C, Leake B, Cvetkovic M, Fromm MF, Dempsey PJ, et al. Interrelationship between substrates and inhibitors of human CYP3A and P-glycoprotein. Pharm Res 1999; 16:408-414.
34. Kleyn PW, Vesell ES. Genetic variation as a guide to drug development. Science 1998; 281:1820-1821.
35. Kolars JC, Schmiedlin-Ren P, Schuetz JD, Fang C, Watkins PB. Identification of rifampin-inducible P450IIIA4 (CYP3A4) in human small bowel enterocytes. J Clin Invest 1992; 90:1871-1878.
36. Kolars JC, Lown KS, Schmiedlin-Ren P, Ghosh M, Fang C, Wrighton SA, et al. CYP3A gene expression in human gut epithelium. Pharmacogenetics 1994; 4:247-259.
37. Kovacs SJ, Martin DE, Everitt DE, Patterson SD, Jorkasky DK. Urinary excretion of 6β-hydroxycortisol as an in-vivo marker for CYP3A induction: applications and recommendations. Clin Pharmacol Ther 1998; 63:617-622.
38. Kuhnz W. Hümpel M, Schütt B, Louton T, Steinberg B, Gansau C. Relative bioavailability of ethinyl estradiol from two different oral contraceptive formulations after single oral administration to 18 women in an intraindividual cross-over design. Horm Res 1990; 33:40-44.
39. Lacroix D, Sonnier M, Moncion A, Cheron G, Cresteil T. Expression of CYP3A in the human liver - evidence that the shift between CYP3A7 and CYP3A4 occurs immediately after birth. Eur J Biochem 1997; 247:625-634.
40. Lindholm A, Henricsson S, Lind M, Dahlqvist R. Intraindividual variability in the relative systemic availability of cyclosporin after oral dosing. Eur J Clin Pharmacol 1988; 34:461-464.
41. Lindholm A. Factors influencing the pharmacokinetics of cyclosporine in man. Ther Drug Monit 1991; 13:465-477.
42. Lobo J, Jack DB, Kendall MJ. The intra-and inter-subject variability of nifedipine pharmacokinetics in young volunteers. Eur J Clin Pharmacol 1986; 30:57-60.
43. Lobo J, Jack DB, Kendall MJ. Inter-and intra-subject variability of nitrendipine and the effects of food. Eur J Clin Pharmacol 1987; 32:357-360.
44. Lown KS, Kolars JC, Thummel KE, Barnett JL, Kunze KL, Wrighton SA, et al. Interpatient heterogeneity in expression of CYP3A4 and CYP3A5 in small bowel. Lack of prediction by the erythromycin breath test. Drug Metab Dispos 1994; 22:947-955.
45. Lynch M, Walsh B. Genetic analysis of quantitative traits. 1st edn. Sunderland, Massachusetts: Sinauer Associates Inc., Publishers; 1998, pp. 1-980.
46. Meyer UA. Overview of enzymes of drug metabolism. J Pharmacokinet Biopharm 1996; 24:449-459.
47. Morgan ET, Sewer MB, Iber H, Gonzalez FJ, Lee YH, Tukey RH, et al. Physiological and pathophysiological regulation of cytochrome P450. Drug Metab Dispos 1998; 26:1232-1240.
48. Nelson DR, Koymans L, Kamataki T, Stegeman JJ, Feyereisen R, Waxman DJ, et al. P450 superfamily: update on new sequences, gene mapping, accession numbers and nomenclature. Pharmacogenetics 1996; 6:1-42.
49. Ohlman S, Lindholm A. Hägglund H, Säwe J, Kahan BD. On the intraindividual variability and chronobiology of cyclosporine pharmacokinetics in renal transplantation. Eur J Clin Pharmacol 1993; 44:265-269.
50. Penno MB, Dvorchik BH, Vesell ES. Genetic variation in rates of antipyrine metabolite formation: a study in uninduced twins. Proc Natl Acad Sci USA 1981; 78:5193-5196.
51. Rice JA. Mathematical statistics and data analysis. 2nd edn. Belmont, CA: Wadsworth Publishing Company: 1995, pp. 448.
52. Rosner B. Fundamentals of biostatistics. 3rd edn. Belmont, CA: Wadsworth Publishing Company; 1990, pp. 478.
53. Schellens JH, Soons PA, Breimer DD. Lack of bimodality in nifedipine plasma kinetics in a large population of healthy subjects. Biochem Pharmacol 1988; 37:2507-2510.
54. Schmider J, Greenblatt DJ, von Moltke LL, Shader RI. Relationship of in-vitro data on drug metabolism to in-vivo pharmacokinetics and drug interactions: implications for diazepam disposition in humans. J Clin Psychopharmacol 1996; 16:267-272.
55. Sheiner LB. The population approach to pharmacokinetic data analysis: rationale and standard data analysis methods. Drug Metab Rev 1984; 15:153-171.
56. Shimada T, Guengerich FP. Evidence for cytochrome P-450NF, the nifedipine oxidase, being the principal enzyme involved in the bioactivation of aflatoxins in human liver. Proc Natl Acad Sci USA 1989; 86:462-165.
57. Shimada T, Yamazaki H, Mimura M, Inui Y, Guengerich FP. Interindividual variations in human liver cytochrome P-450 enzymes involved in the oxidation of drugs, carcinogens and toxic chemicals: studies with liver microsomes of 30 Japanese and 30 Caucasians. J Pharmacol Exp Ther 1994; 270:414-423.
58. Soons PA, Schoemaker HC, Cohen AF, Breimer DD. Intraindividual variability in nifedipine pharmacokinetics and effects in healthy subjects. J Clin Pharmacol 1992; 32:324-331.
59. Tett SE, Holford NHG, McLachlan AJ. Population pharmacokinetics and pharmacodynamics: an underutilized resource. Drug Info J 1998; 32:693-710.
60. Thummel KE, Shen DD, Podoll TO, Kunze KL, Trager WF, Bacchi CE, et al. Use of midazolam as a human cytochrome P450 3 A probe: II. Characterization of inter-and intraindividual hepatic CYP3A variability after liver transplantation. J Pharmacol Exp Ther 1994; 271:557-566.
61. Vesell ES. Advances in pharmacogenetics. Prog Med Genet 1973; 9:291-367.
62. Vesell ES. Twin studies in pharmacogenetics. Hum Genet Suppl 1978; 1:19-30.
63. Vesell ES. Clinical pharmacology: a personal perspective. Clin Pharmacol Ther 1985; 38:603-612.
64. Vesell ES. Pharmacogenetic perspectives gained from twin and family studies. In: Kalow W, editor. Pharmacogenetics of drug metabolism. New York: Pergamon Press Inc.; 1992, pp. 843-863.
65. Vesell ES. Reflections from distant euvettes. Drug Metab Rev 1996; 28:493-511.
66. von Moltke LL, Greenblatt DJ, Schmider J, Harmatz JS, Shader RI. Metabolism of drugs by cytochrome P450 3A isoforms. Implications for drug interactions in psychopharmacology. Clin Pharmacokinet 1995; 29 (Suppl 1):33-43.
67. Wagner JG. Intrasubject variation in elimination half-lives of drugs which are appreciably metabolized. J Pharmacokinet Biopharm 1973; 1:165-173.
68. Watkins PB. Noninvasive tests of CYP3A enzymes. Pharmacogenetics 1994; 4:171-184.
69. Waxman DJ, Attisano C, Guengerich FP, Lapenson DP. Human liver microsomal steroid metabolism: identification of the major microsomal steroid hormone 6β-hydroxylase cytochrome P-450 enzyme. Arch Biochem Biophys 1988; 263:424-436.
70. Weber WW. Pharmacogenetics. New York: Oxford University Press; 1997, pp. 41-70.
71. Westlind A, Lofberg L, Tindberg N, Andersson TB. Ingelman-Sundberg M. Interindividual differences in hepatic expression of CYP3A4: relationship to genetic polymorphism in the 5′-upstream regulatory region. Biochem Biophys Res Commun 1999; 259:201-205.
72. Wilkinson GR, Shand DG. Commentary: a physiological approach to hepatic drug clearance. Clin Pharmacol Ther 1975; 18:377-390.
73. Wilkinson GR. Cytochrome P4503A (CYP3A) metabolism: prediction of in-vivo activity in humans. J Pharmacokinet Biopharm 1996; 24:475-490.