| Title | A preliminary study for the development of a cyclosporine pharmacokinetic model in renal transplant recipients | |
| Authors | Paraskevi F. Katsakiori¹, Dimitrios S. Goumenos², George C. Nikiforidis³ and Christodoulos S. Flordellis¹
1. Department of Pharmacology, School of Medicine, University of Patras 2. Department of Internal Medicine-Nephrology, University Hospital, Patras 3. Department of Medical Physics, School of Medicine, University of Patras, Patra, Greece |
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| Citation | Katsakiori, P.F., Goumenos, D.S., Nikiforidis, G.C., Flordellis, Ch.C.: A preliminary study for the development of a cyclosporine pharmacokinetic model in renal transplant recipients, Epitheorese Klin. Farmakol. Farmakokinet. 20(2): 206-207 (2006) | |
| Publication Date | Accepted for publication: 19-20 May 2006 | |
| Full Text Language | English | |
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| Keywords | Cyclosporine, neoral, population kinetics, pharmacokinetic analysis. | |
| Other Terms | review article | |
| Summary | Cyclosporine (CsA) is an immunosuppressive agent and its use is impeded by high intra- and inter- individual variability as well as narrow therapeutic index. In order to overcome these problems, therapeutic drug monitoring and dose individualization are necessary. The trial-and-error method, which is used today to estimate the appropriate dosing regimen, is time-consuming and may lead to treatment failure. The aim of our study was to formulate a population pharmacokinetic model for CsA in patients with kidney transplantation. In this direction, we estimated the pharmacokinetic factors that describe its kinetics. For this purpose, fifteen kidney transplant patients were enrolled in the study and analysis of their data was performed with Monte Carlo Markov Chain methodology. Compartmental analysis with one-compartment, first-order absorption model was used throughout the analysis. The values estimated for population kinetic parameters of CsA in renal transplant patients were Clearance/Bioavailability=0.16±0.0012 ml h-1 gr-1, Volume of Distribution/Bioavailability=0.079±0.001 ml gr-1 and (Absorption rate constant- Elimination rate constant)/Bioavailability=3.46±0.13 h-1. These preliminary data shows that the proposed method- ology can lead to more appropriate dosage individualization. The optimization of the model parameters requires more data as well as additional covariates (e.g. hepatic and renal function). Using these additional data, the next step will be the validation of the model in order to estimate its predictability. | |
| References | 1. Belitsky P.: Neoral use in the renal transplant recipient. Transplant. Proc. 32 (Suppl 3a): 10S-19S (2000)
2. Keown P.A., D.R.Primmett D.R.: Cyclosporine: The Principal immunosuppresant for renal transplantation. Transplant. Proc. 30: 1712-1715 (1998) 3. Tett S.E., et al.: Population Pharmacokinetics and Pharmacodynamics: An underutilized resource. Drug Information J. 32: 693-710 (1998) 4. Hochhaus G., Derendorf D. (Eds): Handbook of Pharmacokinetic/Pharmacodynamic correlation. Chapt. 4 5. Sheiner L., Wakefield J.: Population modelling in drug development. Statist. Meth. Med. Res. 8: 183-193 (1999) 6. Gilks W.R., Richardson S., Spiiegelhalter D.J. (Eds): Markov Chain Monte Carlo in Practice 7. Markov Chain Monte Carlo (MCMC), Gibbs sampling, Metropolis Algorithms and Simulated Annealing’, 2001 Bioinformatics Course Supplement, SNU Biointelligence Lab (http://bi.snu.ac.krl) 8. Markov Chain Monte Carlo in Practice: A roundtable discussion’, The American Statistician, Vol 52, No 2 (May 1998) 9. Ruggeri A., et al.: A program for the optimization of cyclosporine therapy using population kinetics modeling. Comput. Methods Programs Biomed. 61: 61-69 (2000) 10. Baraldo M., et al.: Pharmacokinetics of two oral cyclosporine A formulations in clinically stable heart-transplant patients. Pharmacol. Res. 43 (No 6), 2001 |
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Online ISSN 1011-6575
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Articles published in this Journal are Indexed or Abstracted in: • Chemical Abstracts • Elsevier’s Bibliographic Databases: Scopus, EMBASE, EMBiology, Elsevier BIOBASE SCImago Journal and Country Rank Factor
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