Pharmacokinetic modelling of the plasma protein binding of mycophenolic acid in renal transplant recipients

Clinical Pharmacokinetics

Volumn 48, Issue 7, 2009, Pages 463-476

  Van Hest, Reinier M ^a   Van Gelder, Teun ^a   Vulto, Arnold G ^a   Shaw, Leslie M ^b   Mathot, Ron A A ^a  

^a ERASMUS MEDICAL CENTER   (Netherlands)

^b UNIVERSITY OF PENNSYLVANIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CORTICOSTEROID; CREATININE; CYCLOSPORIN; IMMUNOSUPPRESSIVE AGENT; MYCOPHENOLIC ACID; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; MYCOPHENOLIC ACID BETA D GLUCURONIDE; SERUM ALBUMIN; UNCLASSIFIED DRUG;

ADULT; AGED; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATININE CLEARANCE; DRUG BINDING; DRUG BIOAVAILABILITY; DRUG DOSE REDUCTION; DRUG MECHANISM; FEMALE; GLUCURONIDATION; GRAFT RECIPIENT; HUMAN; KIDNEY FUNCTION; KIDNEY GRAFT; KIDNEY GRAFT REJECTION; KIDNEY TRANSPLANTATION; MAJOR CLINICAL STUDY; MALE; PLASMA PROTEIN BINDING; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL;

ADULT; AGED; BAYES THEOREM; BLOOD PROTEINS; COMPUTER SIMULATION; CREATININE; DRUG DOSAGE CALCULATIONS; DRUG THERAPY, COMBINATION; FEMALE; GLUCURONIDES; HUMANS; IMMUNOSUPPRESSIVE AGENTS; KIDNEY; KIDNEY FUNCTION TESTS; KIDNEY TRANSPLANTATION; MALE; METABOLIC CLEARANCE RATE; MIDDLE AGED; MODELS, BIOLOGICAL; MYCOPHENOLIC ACID; PROTEIN BINDING; SERUM ALBUMIN; YOUNG ADULT;

EID: 68949205021     PISSN: 03125963     EISSN: 11791926     Source Type: Journal    
DOI: 10.2165/11312600-000000000-00000     Document Type: Article

References (36)

1. Kaufman DB, Shapiro R, Lucey MR, et al. Immunosuppression: practice and trends. Am J Transplant 2004; 4 Suppl. 9: 38-53
2. Bullingham RE, Nicholls AJ, Kamm BR. Clinical pharmacokinetics of mycophenolate mofetil. Clin Pharmacokinet 1998; 34: 429-55
3. Nowak I, Shaw LM. Mycophenolic acid binding to human serum albumin: characterization and relation to pharmacodynamics. Clin Chem 1995; 41: 1011-7
4. Shipkova M, Strassburg CP, Braun F, et al. Glucuronide and glucoside conjugation of mycophenohc acid by human hver, kidney and intestinal microsomes. Br J Pharmacol 2001; 132: 1027-34
5. Picard N, Ratanasavanh D, Premaud A, et al. Identification of the UDP-glucuronosyltransferase isoforms involved in mycophenolic acid phase II metabolism. Drug Metab Dispos 2005; 33: 139-46
6. Wilkinson GR, Shand DC. Commentary: a physiological approach to hepatic drug clearance. Clin Pharmacol Ther 1975; 18: 377-90
7. Van Hest RM, Mathot RA, Pescovitz MD, et al. Explaining variability in mycophenolic acid exposure to optimize mycophenolate mofetil dosing: a population pharmacokinetic meta-analysis of mycophenolic acid in renal transplant recipients. J Am Soc Nephrol 2006; 17: 871-80
8. Van Hest RM, Van Gelder T, Vulto AG, et al. Population pharmacokinetics of mycophenolic acid in renal transplant recipients. Clin Pharmacokinet 2005; 44: 1083-96
9. Shaw LM, Korecka M, Aradbye S, et al. Mycopbenolic acid area under the curve values in African American and Caucasian renal transplant patients are comparable. J Clin Pharmacol 2000; 40: 624-33
10. Johnson AG, Rigby RJ, Taylor PJ, et al. The kinetics of mycophenolic acid and its glucuronide metabolite in adult kidney transplant recipients. Clin Pharmacol Ther 1999; 66: 492-500
11. Benet LZ, Hoener BA. Changes in plasma protein binding have little clinical relevance. Clin Pharmacol Ther 2002; 71: 115-21
12. Kaplan B, Meier-Kriesche HU, Friedman G, et al. The effect of renal insufficiency on mycophenolic acid protein binding. J Clin Pharmacol 1999; 39: 715-20
13. Weber LT, Shipkova M, Lamersdorf T, et al. Pharmacokinetics of mycophenolic acid (MPA) and determinants of MPA free fraction in pediatric and adult renal transplant recipients. German Study group on Mycophenolate Mofetil Therapy in Pediatric Renal Transplant Recipients. J Am Soc Nephrol 1998; 9: 1511-20
14. Kuypers DR, Vanrenterghem Y, Squifflet JP, et al. Twelve-month evaluation of the clinical pharmacokinetics of total and free mycophenolic acid and its glucuronide metabolite in renal transplant recipients on low dose tacrolimus in combination with mycophenolate mofetil. Ther Drug Monit 2003; 25: 609-22
15. Shaw LM, Mick R, Nowak I, et al. Pharmacokinetics of mycophenolic acid in renal transplant recipients with delayed graft function. J Clin Pharmacol 1998; 38: 268-75
16. Van Gelder T, Hilbrands LB, Vanrenterghem Y, et al. A randomized double blind, multicenter plasma concentration study of the safety and efficacy of oral mycophenolate mofetil for the prevention of acute rejection after kidney transplantation. Transplantation 1999; 68: 261-6
17. Hale MD, Nicholls AJ, Bullingham RE, et al. The pharmacokinetic- pharmacodynamic relationship for mycophenolate mofetil in renal transplantation. Clin Pharmacol Ther 1998; 64: 672-83
18. Tsina I, Chu F, Hama K, et al. Manual and automated (robotic) high-performance liquid chromatography methods for the determination of mycophenolic acid and its glucuronide conjugate in human plasma. J Chrom B Biomed Appl 1996; 675: 119-29
19. Karlsson MO, Sheiner LB. The importance of modeling interoccasion variabililty in population pharmacokinetic analyses. J Pharmacokinet Biopharm 1993; 21: 735-50
20. Henningsson A, Sparreboom A, Sandstrom M, et al. Population pharmacokinetic modelling of unbound and total plasma concentrations of paclitaxel in cancer patients. Eur J Cancer 2003; 39: 1105-14
21. Sheiner LB, Beal SL. Evaluation of methods for estimating population pharmacokinetic parameters: III. Monoexponential model: routine clinical pharmacokinetic data. J Pharmacokinet Biopharm 1983; 11: 303-19
22. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976; 16: 31-41
23. Mandema JW, Verotta D, Sheiner LB. Building population pharmacokinetic pharmacodynamic models: I. Models for covariate effects. J Pharmacokinet Biopharm 1992; 20: 511-28
24. Beal SL, Sheiner LB. NONMEM Project Group. NONMEM user's guides. San Fransisco (CA): University of California at San Fransisco, 1998
25. Ette E, Ludden T. Population pharmacokinetic modeling: the importance of informative graphics. Pharm Res 1995; 12: 1845-55
26. Jadhav PR, Gobburu JV. A new equivalence based metric for predictive check to qualify mixed-effects models. AAPS J 2005; 7 (3): E523-31
27. Hesselink DA, Van Hest RM, Mathot RA, et al. Cyclosporine interacts with mycophenolic acid by inhibiting the multidrug resistance-associated protein 2. Am J Transplant 2005; 5: 987-94
28. Van Gelder T, Klupp J, Barten MJ, et al. Comparison of the effects of tacrolimus and cyclosporine on the pharmacokinetics of mycophenolic acid. Ther Drug Monit 2001; 23: 119-28
29. Weber LT, Lamersdorf T, Shipkova M, et al. Area under the plasma concentration time curve for total, but not for free, mycophenolic acid increases in the stable phase after renal transplantation: a longitudinal study in pediatric patients. German Study Group on Mycophenolate Mofetil Therapy in Pediatric Renal Transplant Recipients. Ther Drug Monit 1999; 21: 498-506
30. Kaplan B, Gruber SA, Nallamathou R, et al. Decreased protein binding of mycophenolic acid associated with leukopenia in a pancreas transplant recipient with renal failure. Transplantation 1998; 65: 1127-9
31. Mudge DW, Atcheson BA, Taylor PJ, et al. Severe toxicity associated with a markedly elevated mycophenolic acid free fraction in a renal transplant recipient. Ther Drug Monit 2004; 26: 453-5
32. Weber LT, Shipkova M, Armstrong VW, et al. The pharmacokinetic- pharmacodynamic relationship for total and free mycophenolic acid in pediatric renal transplant recipients: a report from the German study group on mycophenolate mofetil therapy. J Am Soc Nephrol 2002; 13: 759-68
33. Atcheson BA, Taylor PJ, Mudge DW, et al. Mycophenolic acid pharmacokinetics and related outcomes early after renal transplant. Br J Clin Pharmacol 2005; 59: 271-80
34. Atcheson BA, Taylor PJ, Kirkpatrick CM, et al. Free mycophenolic acid should be monitored in renal transplant recipients with hypoalbuminemia. Ther Drug Monit 2004; 26: 284-6
35. Kiberd BA, Lawen J, Fraser AD, et al. Early adequate mycophenolic acid exposure is asociated with less rejection in kidney transplantation. Am J Transplant 2004; 4: 1079-83
36. Higaki K, Yamashita S, Amidon GL. Time-dependent oral absorption models. J Pharmacokin Pharmacodyn 2001; 28: 109-28