Effect of CYP3A5*3 genotype on the pharmacokinetics and pharmacodynamics of alprazolam in healthy subjects

Clinical Pharmacology and Therapeutics

Volumn 79, Issue 6, 2006, Pages 590-599

  Park, Ji Young ^a,b,c   Kim, Kyoung Ah ^a,b,c   Park, Pil Whan ^a,b,c   Lee, Ock Je ^a,b,c   Kang, Dong Kyun ^a,b,c   Shon, Ji Hong ^a,b,c   Liu, Kwang Hyun ^a,b,c   Shin, Jae Gook ^a,b,c  

^a Korea University College of Medicine   (South Korea)

^b Gachon University   (South Korea)

^c Inje University College of Medicine   (South Korea)

Author keywords

[No Author keywords available]

Indexed keywords

ALPRAZOLAM; CYTOCHROME P450 3A5; ANXIOLYTIC AGENT; CYTOCHROME P450 3A; DNA; PRIMER DNA;

ADULT; ALLELE; AREA UNDER THE CURVE; ARTICLE; CONTROLLED STUDY; DIGIT SYMBOL SUBSTITUTION TEST; DOSE TIME EFFECT RELATION; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISPOSITION; DRUG EFFECT; FUNCTIONAL ASSESSMENT; GENETIC POLYMORPHISM; GENOTYPE; HUMAN; HUMAN EXPERIMENT; MALE; MEASUREMENT; NORMAL HUMAN; PHARMACODYNAMICS; PHARMACOGENETICS; PRIORITY JOURNAL; PSYCHOMOTOR ACTIVITY; RESPONSE TIME; SCORING SYSTEM; SINGLE DRUG DOSE; STATISTICAL SIGNIFICANCE; VOLUNTEER; ASIAN; BLOOD; CLINICAL TRIAL; GENETICS; KOREA; ORAL DRUG ADMINISTRATION; POLYMERASE CHAIN REACTION; REFERENCE VALUE;

ADMINISTRATION, ORAL; ADULT; ALPRAZOLAM; ANTI-ANXIETY AGENTS; AREA UNDER CURVE; ASIAN CONTINENTAL ANCESTRY GROUP; CYTOCHROME P-450 CYP3A; DNA; DNA PRIMERS; GENOTYPE; HUMANS; KOREA; MALE; POLYMERASE CHAIN REACTION; POLYMORPHISM, GENETIC; REFERENCE VALUES;

EID: 33744537737     PISSN: 00099236     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.clpt.2006.02.008     Document Type: Article

References (47)

1. Evans W.E., and Relling M.V. Pharmacogenomics. translating functional genomics into rational therapeutics. Science 286 (1999) 487-491
2. Nelson D.R., Koymans L., Kamataki T., Stegeman J.J., Feyereisen R., Waxman D.J., et al. P450 superfamily. update on new sequences, gene mapping, accession numbers and nomenclature. Pharmacogenetics 6 (1996) 1-42
3. Shimada T., Yamazaki H., Mimura M., Inui Y., and Guengerich F.P. 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 270 (1994) 414-423
4. Aoyama T., Yamano S., Waxman D.J., Lapenson D.P., Meyer U.A., Fischer V., et al. Cytochrome P-450 hPCN3, a novel cytochrome P-450 IIIA gene product that is differentially expressed in adult human liver. cDNA and deduced amino acid sequence and distinct specificities of cDNA-expressed hPCN1 and hPCN3 for the metabolism of steroid hormones and cyclosporine. J Biol Chem 264 (1989) 10388-10395
5. Wrighton S.A., Ring B.J., Watkins P.B., and VandenBranden M. Identification of a polymorphically expressed member of the human cytochrome P-450III family. Mol Pharmacol 36 (1989) 97-105
6. Kuehl P., Zhang J., Lin Y., Lamba J., Assem M., Schuetz J., et al. Sequence diversity in CYP3A promoters and characterization of the genetic basis of polymorphic CYP3A5 expression. Nat Genet 27 (2001) 383-391
7. Hustert E., Haberl M., Burk O., Wolbold R., He Y.Q., Klein K., et al. The genetic determinants of the CYP3A5 polymorphism. Pharmacogenetics 11 (2001) 773-779
8. Lin Y.S., Dowling A.L., Quigley S.D., Farin F.M., Zhang J., Lamba J., et al. Co-regulation of CYP3A4 and CYP3A5 and contribution to hepatic and intestinal midazolam metabolism. Mol Pharmacol 62 (2002) 162-172
9. Lamba J.K., Lin Y.S., Schuetz E.G., and Thummel K.E. Genetic contribution to variable human CYP3A-mediated metabolism. Adv Drug Deliv Rev 54 (2002) 1271-1294
10. Xie H.G., Wood A.J., Kim R.B., Stein C.M., and Wilkinson G.R. Genetic variability in CYP3A5 and its possible consequences. Pharmacogenomics 5 (2004) 243-272
11. Greenblatt D.J., and Wright C.E. Clinical pharmacokinetics of alprazolam. Therapeutic implications. Clin Pharmacokinet 24 (1993) 453-471
12. Williams J.A., Ring B.J., Cantrell V.E., Jones D.R., Eckstein J., Ruterbories K., et al. Comparative metabolic capabilities of CYP3A4, CYP3A5, and CYP3A7. Drug Metab Dispos 30 (2002) 883-891
13. Hirota N., Ito K., Iwatsubo T., Green C.E., Tyson C.A., Shimada N., et al. In vitro/in vivo scaling of alprazolam metabolism by CYP3A4 and CYP3A5 in humans. Biopharm Drug Dispos 22 (2001) 53-71
14. Yu K.S., Cho J.Y., Jang I.J., Hong K.S., Chung J.Y., Kim J.R., et al. Effect of the CYP3A5 genotype on the pharmacokinetics of intravenous midazolam during inhibited and induced metabolic states. Clin Pharmacol Ther 76 (2004) 104-112
15. Toyo'oka T., Kumaki Y., Kanbori M., Kato M., and Nakahara Y. Determination of hypnotic benzodiazepines (alprazolam, estazolam, and midazolam) and their metabolites in rat hair and plasma by reversed-phase liquid-chromatography with electrospray ionization mass spectrometry. J Pharm Biomed Anal 30 (2003) 1773-1787
16. Crouch D.J., Rollins D.E., Canfield D.V., Andrenyak D.M., and Schulties J.E. Quantitation of alprazolam and alpha-hydroxyalprazolam in human plasma using liquid chromatography electrospray ionization MS-MS. J Anal Toxicol 23 (1999) 479-485
17. Greenblatt D.J., Harmatz J.S., von Moltke L.L., Wright C.E., Durol A.L., Harrel-Joseph L.M., et al. Comparative kinetics and response to the benzodiazepine agonists triazolam and zolpidem. evaluation of sex-dependent differences. J Pharmacol Exp Ther 293 (2000) 435-443
18. Macphee I.A., Fredericks S., Mohamed M., Moreton M., Carter N.D., Johnston A., et al. Tacrolimus pharmacogenetics. the CYP3A5*1 allele predicts low dose-normalized tacrolimus blood concentrations in whites and South Asians. Transplantation 79 (2005) 499-502
19. Macphee I., Fredericks S., Tai T., Syrris P., Carter N., Johnston A., et al. Tacrolimus pharmacogenetics. polymorphisms associated with expression of cytochrome P4503A5 and P-glycoprotein correlate with dose requirement. Transplantation 74 (2002) 1486-1489
20. Zheng H., Webber S., Zeevi A., Schuetz E., Zhang J., Bowman P., et al. Tacrolimus dosing in pediatric heart transplant patients is related to CYP3A5 and MDR1 gene polymorphisms. Am J Transplant 3 (2003) 477-483
21. Hesselink D.A., van Schaik R.H., van der Heiden I.P., van der Werf M., Gregoor P.J., Lindemans J., et al. Genetic polymorphisms of the CYP3A4, CYP3A5, and MDR-1 genes and pharmacokinetics of the calcineurin inhibitors cyclosporine and tacrolimus. Clin Pharmacol Ther 74 (2003) 245-254
22. Min D.I., Ellingrod V.L., Marsh S., and McLeod H. CYP3A5 polymorphism and the ethnic differences in cyclosporine pharmacokinetics in healthy subjects. Ther Drug Monit 26 (2004) 524-528
23. Yates C.R., Zhang W., Song P., Li S., Gaber A.O., Kotb M., et al. The effect of CYP3A5 and MDR1 polymorphic expression on cyclosporine oral disposition in renal transplant patients. J Clin Pharmacol 43 (2003) 555-564
24. Frohlich M., Hoffmann M.M., Burhenne J., Mikus G., Weiss J., and Haefeli W.E. Association of the CYP3A5 A6986G (CYP3A5*3) polymorphism with saquinavir pharmacokinetics. Br J Clin Pharmacol 58 (2004) 443-444
25. Katz D.A., Grimm D.R., Cassar S.C., Gentile M.C., Ye X., Rieser M.J., et al. CYP3A5 genotype has a dose-dependent effect on ABT-773 plasma levels. Clin Pharmacol Ther 75 (2004) 516-528
26. Goh B.C., Lee S.C., Wang L.Z., Fan L., Guo J.Y., Lamba J., et al. Explaining interindividual variability of docetaxel pharmacokinetics and pharmacodynamics in Asians through phenotyping and genotyping strategies. J Clin Oncol 20 (2002) 3683-3690
27. Floyd M., Gervasini G., Masica A., Mayo G., George A., Bhat K., 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 13 (2003) 595-606
28. Fukuda T., Onishi S., Fukuen S., Ikenaga Y., Ohno M., Hoshino K., et al. CYP3A5 genotype did not impact on nifedipine disposition in healthy volunteers. Pharmacogenomics J 4 (2004) 34-39
29. Yamamoto T., Kubota T., Ozeki T., Sawada M., Yokota S.I., Yamada Y., et al. Effects of the CYP3A5 genetic polymorphism on the pharmacokinetics of diltiazem. Clin Chim Acta 362 (2005) 147-154
30. He P., Court M.H., Greenblatt D.J., and Von Moltke L.L. Genotype-phenotype associations of cytochrome P450 3A4 and 3A5 polymorphism with midazolam clearance in vivo. Clin Pharmacol Ther 77 (2005) 373-387
31. Eap C.B., Buclin T., Hustert E., Bleiber G., Golay K.P., Aubert A.C., et al. Pharmacokinetics of midazolam in CYP3A4- and CYP3A5-genotyped subjects. Eur J Clin Pharmacol 60 (2004) 231-236
32. Wong M., Balleine R.L., Collins M., Liddle C., Clarke C.L., and Gurney H. CYP3A5 genotype and midazolam clearance in Australian patients receiving chemotherapy. Clin Pharmacol Ther 75 (2004) 529-538
33. Shih P.-S., and Huang J.-D. Pharmacokinetics of midazolam and 1'-hydroxymidazolam in Chinese with different CYP3A5 genotypes. Drug Metab Dispos 30 (2002) 1491-1496
34. Haehner B.D., Gorski J.C., Vandenbranden M., Wrighton S.A., Janardan S.K., Watkins P.B., et al. Bimodal distribution of renal cytochrome P450 3A activity in humans. Mol Pharmacol 50 (1996) 52-59
35. Givens R.C., Lin Y.S., Dowling A.L., Thummel K.E., Lamba J.K., Schuetz E.G., et al. CYP3A5 genotype predicts renal CYP3A activity and blood pressure in healthy adults. J Appl Physiol 95 (2003) 1297-1300
36. Wennerholm A., Allqvist A., Svensson J.O., Gustafsson L.L., Mirghani R.A., and Bertilsson L. Alprazolam as a probe for CYP3A using a single blood sample. pharmacokinetics of parent drug, and of alpha- and 4-hydroxy metabolites in healthy subjects. Eur J Clin Pharmacol 61 (2005) 113-118
37. Markowitz J.S., Devane C.L., Chavin K.D., Taylor R.M., Ruan Y., and Donovan J.L. Effects of garlic (Allium sativum L.) supplementation on cytochrome P450 2D6 and 3A4 activity in healthy volunteers. Clin Pharmacol Ther 74 (2003) 170-177
38. Masica A.L., Mayo G., and Wilkinson G.R. In vivo comparisons of constitutive cytochrome P450 3A activity assessed by alprazolam, triazolam, and midazolam. Clin Pharmacol Ther 76 (2004) 341-349
39. Fraser A.D., Bryan W., and Isner A.F. Urinary screening for alprazolam and its major metabolites by the Abbott ADx and TDx analyzers with confirmation by GC/MS. J Anal Toxicol 15 (1991) 25-29
40. Shipkova M., and Wieland E. Glucuronidation in therapeutic drug monitoring. Clin Chim Acta 358 (2005) 2-23
41. Lamba J.K., Lin Y.S., Schuetz E.G., and Thummel K.E. Genetic contribution to variable human CYP3A-mediated metabolism. Adv Drug Deliv Rev 54 (2002) 1271-1294
42. CYP3A4 allele nomenclature. Human Cytochrome P450 (CYP) Allele Nomenclature Committee Web site. Available from URL:http://www.imm.ki.se/CYPalleles/cyp3a4.htm. Accessed September 17, 2005.
43. Wacher V.J., Wu C.Y., and Benet L.Z. Overlapping substrate specificities and tissue distribution of cytochrome P450 3A and P-glycoprotein. implications for drug delivery and activity in cancer chemotherapy. Mol Carcinog 13 (1995) 129-134
44. Watkins P.B. The barrier function of CYP3A4 and P-glycoprotein in the small bowel. Adv Drug Deliv Rev 27; (1997) 161-170
45. Benet L.Z., Izumi T., Zhang Y., Silverman J.A., and Wacher V.J. Intestinal MDR transport proteins and P-450 enzymes as barriers to oral drug delivery. J Control Release 62 (1999) 25-31
46. Kaplan G.B., Greenblatt D.J., Ehrenberg B.L., Goddard J.E., Harmatz J.S., and Shader R.I. Single-dose pharmacokinetics and pharmacodynamics of alprazolam in elderly and young subjects. J Clin Pharmacol 38 (1998) 14-21
47. Greenblatt D.J., Wright C.E., von Moltke L.L., Harmatz J.S., Ehrenberg B.L., Harrel L.M., et al. Ketoconazole inhibition of triazolam and alprazolam clearance. differential kinetic and dynamic consequences. Clin Pharmacol Ther 64 (1998) 237-247