Systematic and quantitative assessment of the effect of chronic kidney disease on CYP2D6 and CYP3A4/5
Abstract
Recent reviews suggest that chronic kidney disease (CKD) can affect the pharmacokinetics of nonrenally eliminated drugs, but the impact of CKD on individual elimination pathways has not been systematically evaluated. In this study we developed a comprehensive dataset of the effect of CKD on the pharmacokinetics of CYP2D6- and CYP3A4/5-metabolized drugs. Drugs for evaluation were selected based on clinical drug–drug interaction (CYP3A4/5 and CYP2D6) and pharmacogenetic (CYP2D6) studies. Information from dedicated CKD studies was available for 13 and 18 of the CYP2D6 and CYP3A4/5 model drugs, respectively. Analysis of these data suggested that CYP2D6-mediated clearance is generally decreased in parallel with the severity of CKD. There was no apparent relationship between the severity of CKD and CYP3A4/5-mediated clearance. The observed elimination-route dependency in CKD effects between CYP2D6 and CYP3A4/5 may inform the need to conduct clinical CKD studies with nonrenally eliminated drugs for optimal use of drugs in patients with CKD.
- Authors:
-
- U.S. Food and Drug Administration (FDA), Silver Spring, MD (United States). Center for Drug Evaluation and Research. Office of Translational Sciences. Office of Clinical Pharmacology
- U.S. Food and Drug Administration (FDA), Silver Spring, MD (United States). Center for Drug Evaluation and Research. Office of Translational Sciences. Office of Clinical Pharmacology; Shanghai Jiao Tong Univ. (China). School of Medicine. Shanghai General Hospital. Dept. of Pharmacy
- Univ. of Pittsburgh, PA (United States). Schools of Pharmacy and Medicine. Dept. of Medicine Renal-Electrolyte Division. Dept. of Pharmacy and Therapeutics. Center for Clinical Pharmaceutical Sciences
- Univ. of Manchester (United Kingdom). Manchester Pharmacy School. Centre for Applied Pharmaceutical Research; Simcyp (a Certara Company), Sheffield (United Kingdom)
- Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring Maryland USA
- Publication Date:
- Research Org.:
- Oak Ridge Institute for Science and Education (ORISE), Oak Ridge, TN (United States)
- Sponsoring Org.:
- USDOE Office of Science (SC)
- OSTI Identifier:
- 1623522
- Grant/Contract Number:
- SC0014664
- Resource Type:
- Accepted Manuscript
- Journal Name:
- Clinical Pharmacology and Therapeutics
- Additional Journal Information:
- Journal Volume: 100; Journal Issue: 1; Journal ID: ISSN 0009-9236
- Publisher:
- American Society for Clinical Pharmacology & Therapeutics - Wiley
- Country of Publication:
- United States
- Language:
- English
- Subject:
- 60 APPLIED LIFE SCIENCES; Pharmacology & Pharmacy
Citation Formats
Yoshida, K., Sun, B., Zhang, L., Zhao, P., Abernethy, DR, Nolin, TD, Rostami-Hodjegan, A., Zineh, I., and Huang, S-M. Systematic and quantitative assessment of the effect of chronic kidney disease on CYP2D6 and CYP3A4/5. United States: N. p., 2016.
Web. doi:10.1002/cpt.337.
Yoshida, K., Sun, B., Zhang, L., Zhao, P., Abernethy, DR, Nolin, TD, Rostami-Hodjegan, A., Zineh, I., & Huang, S-M. Systematic and quantitative assessment of the effect of chronic kidney disease on CYP2D6 and CYP3A4/5. United States. https://doi.org/10.1002/cpt.337
Yoshida, K., Sun, B., Zhang, L., Zhao, P., Abernethy, DR, Nolin, TD, Rostami-Hodjegan, A., Zineh, I., and Huang, S-M. Mon .
"Systematic and quantitative assessment of the effect of chronic kidney disease on CYP2D6 and CYP3A4/5". United States. https://doi.org/10.1002/cpt.337. https://www.osti.gov/servlets/purl/1623522.
@article{osti_1623522,
title = {Systematic and quantitative assessment of the effect of chronic kidney disease on CYP2D6 and CYP3A4/5},
author = {Yoshida, K. and Sun, B. and Zhang, L. and Zhao, P. and Abernethy, DR and Nolin, TD and Rostami-Hodjegan, A. and Zineh, I. and Huang, S-M},
abstractNote = {Recent reviews suggest that chronic kidney disease (CKD) can affect the pharmacokinetics of nonrenally eliminated drugs, but the impact of CKD on individual elimination pathways has not been systematically evaluated. In this study we developed a comprehensive dataset of the effect of CKD on the pharmacokinetics of CYP2D6- and CYP3A4/5-metabolized drugs. Drugs for evaluation were selected based on clinical drug–drug interaction (CYP3A4/5 and CYP2D6) and pharmacogenetic (CYP2D6) studies. Information from dedicated CKD studies was available for 13 and 18 of the CYP2D6 and CYP3A4/5 model drugs, respectively. Analysis of these data suggested that CYP2D6-mediated clearance is generally decreased in parallel with the severity of CKD. There was no apparent relationship between the severity of CKD and CYP3A4/5-mediated clearance. The observed elimination-route dependency in CKD effects between CYP2D6 and CYP3A4/5 may inform the need to conduct clinical CKD studies with nonrenally eliminated drugs for optimal use of drugs in patients with CKD.},
doi = {10.1002/cpt.337},
journal = {Clinical Pharmacology and Therapeutics},
number = 1,
volume = 100,
place = {United States},
year = {Mon Mar 07 00:00:00 EST 2016},
month = {Mon Mar 07 00:00:00 EST 2016}
}
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Figures / Tables:
Figure 1: Overview of the workflow of clinical CKD data collection for CYP2D6 and CYP3A4/5 model drugs. AUCR, area under the concentration-time curve ratio; AUCRliver, AUCR attributable to the inhibition of hepatic CYP3A4/5; CKD, chronic kidney disease; CYP, cytochrome P450; DDI, drug-drug interaction; DIDB, The University of Washington Metabolism andmore »
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