NDLI: Association of ABCB1, CYP3A4*18B and CYP3A5*3 genotypes with the pharmacokinetics of tacrolimus in healthy Chinese subjects: a population pharmacokinetic analysis.

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Association of ABCB1, CYP3A4*18B and CYP3A5*3 genotypes with the pharmacokinetics of tacrolimus in healthy Chinese subjects: a population pharmacokinetic analysis.

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Association of ABCB1, CYP3A418B and CYP3A53 genotypes with the pharmacokinetics of tacrolimus in healthy Chinese subjects: a population pharmacokinetic analysis.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Shi, X-J Geng, F. Jiao, Z. Cui, X-Y Qiu, X-Y Zhong, M-K
Description	Country affiliation: China Author Affiliation: Shi XJ ( Clinical Pharmacy Laboratory, Huashan Hospital, Fudan University, Shanghai, China.)
Abstract	WHAT IS KNOWN AND OBJECTIVE: Tacrolimus (TAC) is metabolized mainly by the CYP3A subfamily and extruded into the intestine by P-glycoprotein, which is encoded by the ABCB1 gene. Several studies have suggested that the CYP3A53 genotype influenced the pharmacokinetics (PK) of TAC. The CYP3A418B and CYP3A53 alleles are clinically important in Chinese subjects because of their relatively high frequency. The present study aimed at evaluating the effects of ABCB1 (C1236T-G2677T/A-C3435T), CYP3A418B and CYP3A53 genetic polymorphisms on TAC PK in healthy Chinese subjects. METHODS: Data were obtained from a comparative bioavailability study of oral TAC formulations (n = 22). TAC whole blood concentrations were measured by LC-MS/MS. Genetic polymorphisms were determined using a direct sequencing method. Nonlinear mixed-effects modelling (NONMEM) was performed to assess the effect of genotypes and demographics on TAC PKs. RESULTS AND DISCUSSION: Both CYP3A418B and CYP3A53 polymorphisms affected the TAC PK, whereas ABCB1 genetic polymorphisms and other demographic characteristics did not. The combined genotypes of CYP3A418B and CYP3A53 had a greater impact than either genotype alone, and they were estimated to account for 28·4% of the inter-subject variability of apparent clearance (CL/F) by NONMEM. The CL/F in subjects with CYP3A41/1-CYP3A53/3 was 10·3 L/h and was 48·5% in those not carrying CYP3A41/1-CYP3A53/3. WHAT IS NEW AND CONCLUSION: This is the first study to extensively explore the influence of CYP3A418B, CYP3A53 and ABCB1 genetic polymorphisms on TAC PK in healthy Chinese subjects. The results demonstrated that subjects with a combined genotype of CYP3A41/1-CYP3A53/*3 may require lower TAC doses to achieve target concentration levels and further investigation is needed in larger populations to confirm the clinical benefits.
File Format	HTM / HTML
ISSN	02694727
Issue Number	5
Volume Number	36
e-ISSN	13652710
Journal	Journal of Clinical Pharmacy and Therapeutics
Language	English
Publisher	Wiley-Blackwell
Publisher Date	2011-10-01
Publisher Place	Great Britain (UK)
Access Restriction	Subscribed
Subject Keyword	Discipline Therapeutics Discipline Pharmacology Cytochrome P-450 Cyp3a Genetics Genetics, Population Methods Immunosuppressive Agents Pharmacokinetics Kidney Transplantation P-glycoprotein Tacrolimus Adult Asian Continental Ancestry Group Cross-over Studies Metabolism Cytochrome P-450 Enzyme System Demography Female Gene Frequency Statistics & Numerical Data Humans Blood Pharmacology Kidney Physiopathology Male Models, Biological P-glycoproteins Polymorphism, Genetic Polymorphism, Single Nucleotide Random Allocation Reproducibility Of Results Young Adult Comparative Study Journal Article Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Pharmacology Pharmacology (medical)

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