Limited sampling models and bayesian estimation for mycophenolic acid area under the curve prediction in stable renal transplant patients co-medicated with ciclosporin or sirolimus

Clinical Pharmacokinetics

Volumn 48, Issue 11, 2009, Pages 745-758

  Musuamba, Flora T ^a   Rousseau, Annick ^b   Bosmans, Jean Louis ^c   Senessael, Jean Jacques ^d   Cumps, Jean ^a   Marquet, Pierre ^b   Wallemacq, Pierre ^e   Verbeeck, Roger K ^a  

^a UNIVERSITÉ CATHOLIQUE DE LOUVAIN   (Belgium)

^b INSERM U850   (Belgium)

^c ANTWERP UNIVERSITY HOSPITAL   (Belgium)

^d UNIVERSITY HOSPITAL BRUSSELS   (Belgium)

^e CLINIQUES UNIVERSITAIRES SAINT LUC   (Belgium)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; CYCLOSPORIN A; GLUCURONIDE; MYCOPHENOLIC ACID; MYCOPHENOLIC ACID BETA D GLUCURONIDE; PREDNISOLONE; RAPAMYCIN; UNCLASSIFIED DRUG;

ADULT; AGED; ANALYTICAL ERROR; AREA UNDER THE CURVE; ARTICLE; BAYES THEOREM; CLINICAL ARTICLE; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG DOSE REDUCTION; DRUG DOSE REGIMEN; DRUG GLUCURONIDATION; DRUG SUBSTITUTION; DRUG URINE LEVEL; DRUG WITHDRAWAL; ENTEROHEPATIC CIRCULATION; FEMALE; GLOMERULUS FILTRATION RATE; GRAFT RECIPIENT; HUMAN; KIDNEY GRAFT REJECTION; KIDNEY TRANSPLANTATION; MALE; MAXIMUM PLASMA CONCENTRATION; PLASMA CONCENTRATION-TIME CURVE; POSTOPERATIVE PERIOD; PRIORITY JOURNAL; RECOMMENDED DRUG DOSE; TIME TO MAXIMUM PLASMA CONCENTRATION;

ADULT; AGED; AREA UNDER CURVE; BAYES THEOREM; BIOLOGICAL AVAILABILITY; CYCLOSPORINE; DRUG DOSAGE CALCULATIONS; DRUG MONITORING; DRUG THERAPY, COMBINATION; FEMALE; GLOMERULAR FILTRATION RATE; GLUCURONIDES; HUMANS; IMMUNOSUPPRESSIVE AGENTS; KIDNEY TRANSPLANTATION; LINEAR MODELS; LIVER FUNCTION TESTS; MALE; MIDDLE AGED; MYCOPHENOLIC ACID; NONLINEAR DYNAMICS; PREDICTIVE VALUE OF TESTS; PRODRUGS; SIROLIMUS; YOUNG ADULT;

EID: 70349976689     PISSN: 03125963     EISSN: 11791926     Source Type: Journal    
DOI: 10.2165/11318060-000000000-00000     Document Type: Article

References (39)

1. European Mycophenolate Mofetil Corporate Study Group. Placebo-controlled study of mycophenolate mofetil combined with cyclosporine and corticosteroids for prevention of acute rejection. Lancet 1995; 345: 1321-1325
2. Langman LJ, LeGatt DF, Yatscoff R. Pharmacodynamic assessment of mycophenolic acid-induced immunosuppression by measuring IMP dehy-drogenase activity. Clin Chem 1995; 41: 295-299
3. Allison AC, Eugui EM. The design and development of an immunosuppressive drug, mycophenolate mofetil. Semin Immunopathol 1993; 14: 353-380
4. Hale MD, Nicholls AJ, Bullingham RES, et al. The pharmacokinetic- pharmacodynamic relationship for mycophenolate mofetil in renal transplantation. Clin Pharmacol Ther 1999; 64: 672-683
5. Staatz CE, Tett SE. Clinical pharmacokinetics and pharmacodynamics of mycophenolate in solid organ transplant recipients. Clin Pharmacokinet 2007; 46: 13-58
6. van Gelder T, Hilbrands LB, Vanrenterghem Y, et al. A randomized double-blind, multicenter plasma concentration controlled study of the safety and efficacy of oral mycophenolate mofetil for the prevention of acute rejection after kidney transplantation. Transplantation 1999; 68: 261-266
7. Cellcept (mycophenolate mofetil) 500mg powder: summary of product char-acteristics, Welwyn Garden City: Roche Products Limited, 2009 Jun 8 [online], http://emc.medicines.org.uk/medicine/1681/SPC/ Cellcept+500mg+Powder/ [Accessed 2009 Sep 11]
8. Shaw LM, Sollinger HW, Halloran P, et al. Mycophenolate mofetil: a report of the consensus panel. Ther Drug Monit 1995; 17: 690-699
9. Johnson AG, Rigby RJ, Taylor PJ, et al. The kinetics ofmycophenolic acid and its glucuronide metabolite in adult kidney transplant recipients. Clin Pharmacol Ther 1999; 66: 492-500
10. Bullingham R, Monroe S, Nicholls AJ, et al. Pharmacokinetics and bioavail-ability of mycophenolate mofetil in healthy subjects after single oral and intravenous administration. J Clin Pharm 1996; 36: 315-324
11. Wollenberg K, Krumme B, Schollmeyer P, et al. Pharmacokinetics of myco-phenolic acid after renal transplantation. Transplant Proc 1998; 30: 2237-2239
12. Mourad M, Malaise J, Chaib Eddour D, et al. Correlation of mycophenolic acid pharmacokinetic parameters with side effects in kidney transplant patients treated with mycophenolate mofetil. Clin Chem 2000; 47: 88-94
13. Sennesael JJ, Bosmans JL, Bogers JP, et al. Conversion from cyclosporine to sirolimusinstable renal transplant recipients. Transplantation 2005; 80: 1578-1585
14. Pawinski T, Hale MD, Korecka M, et al. Limited sampling strategy for the estimation of mycophenolic acid area under the curve in adult renal transplant patients treated with concomitant tacrolimus. Clin Chem 2002; 48: 1497-1504
15. Lindbom L, Pihlgrem P, Jonsson EN. PsN-toolkit: a collection of computer intensive statistical methods for non-linear mixed effect modeling using NONMEM. Comput Methods Programs Biomed 2005; 79: 241-257
16. Jonsson EN, Karlsson MO. Xpose: an S-Plus based population pharmaco-kinetic/pharmacodynamic building aid for NONMEM. Comput Methods Programs Biomed 1999; 58: 51-64
17. Hu TM, Hayton WL. Allometric scaling of xenobiotic clearance: uncertainty versus universality. AAPS Pharm Sci 2001; 3: 1-15
18. Hooker AC, Staatz CE, Karlsson MO. Conditional weighted residuals (CWRES): a model diagnostic for the FOCE method. Pharm Res 2007; 24: 2187-2197
19. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976; 16: 31-41
20. Nankivell BJ, Gruenewald SM, Allen RD, et al. Predicting glomerular filtra-tion rate after kidney transplantation. Transplantation 1995; 59: 1683-1689
21. Premaud A, Le Meur Y, Debord J, et al. Maximum a posteriori Bayesian estimation of mycophenolic acid pharmacokinetics in renal transplant recipients at different postgrafting periods. Ther Drug Monit 2005; 27: 354-361
22. Le Guellec C, Bourgoin H, Buchler M, et al. Population pharmacokinetics and Bayesian estimation of mycophenolic acid concentrations in stable renal transplant patients. Clin Pharmacokinet 2004; 43: 253-266
23. Sheiner LB, Beal SL. Some suggestions for measuring predictive performance. J Pharmacokinet Biopharm 1981; 9: 503-512
24. Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986; I: 307-310
25. Willis C, Taylor PJ, Salm P, et al. Evaluation of limited sampling strategies for estimation of 12-hour mycophenolic acid area under the plasma concentration-time curvein adult renal transplant patients. Ther Drug Monit 2000; 22: 549-554
26. Yeung S, Tong KL, Tsang WK, et al. Determination of mycophenolate area under the curve bylimited sampling strategy. Transplant Proc 2001; 33: 1052-1053
27. Zicheng Y, Xianghui W, Peijun Z, et al. Evaluation of the practicability of limited sampling strategies for the estimation of mycophenolic acid exposure in Chinese adult renal recipients. Ther Drug Monit 2007; 29: 600-606
28. Filler G, Mai I. Limited sampling strategy for mycophenolic acid area under the curve. Ther Drug Monit 2000; 22: 169-173
29. Figurski MJ, Nawrocki A, Pescovitz MD, et al. Development of a predictive limited sampling strategy for estimation of mycophenolic acid area under the concentration time curve in patients receiving concomitant sirolimus or cyclosporine. Ther Drug Monit 2008; 30: 445-455
30. Shum B, Duffull SB, Taylor PJ, et al. Population pharmacokinetic analysis of mycophenolic acid in renal transplant recipients following oral administration of mycophenolate mofetil. Br J Clin Pharmacol 2003; 56: 188-197
31. Jiao Z, Ding JJ, Shen J, et al. Population pharmacokinetic modelling for en-terohepatic circulation of mycophenolic acid in healthy Chinese and influence of polymorphism in UGT1A9. Br J Clin Pharmacol 2008; 65: 893-907
32. Cremers S, Schoemaker R, Scholten E, et al. Characterizing the role of enterohepatic recycling in the interactions between mycophenolate mofetil and calcineurin inhibitors in renal transplant patients by pharmacokinetic modelling. Br J Clin Pharmacol 2007; 10: 249-256
33. van Hest RM, Mathot RAA, 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: 871-880
34. Staatz CE, Dufull SB, Kiberd D, et al. Population pharmacokinetics of mycophenolic acid during the first week after transplantation. Eur J Clin Pharmacol 2005; 61: 507-516
35. van Hest RM, van Gelder T, Vulto AG, et al. Population pharmacokinetics of mycophenolic acid in renal transplant recipients. Clin Pharmacokinet 2005; 44: 1083-1096
36. Kuypers DR, Verleden G, Naesens M, et al. Drug interaction between myco-phenolate mofetil and rifampin: possible induction of uridine diphosphate glucurosyl-transferase. Clin Pharmacol Ther 2005; 78: 81-88
37. Hesselink DA, Van Hest RM, Mathot RAA, et al. Cyclosporine interacts with mycophenolate mofetil by inhibiting the multidrug resistance-associated protein 2. Am J Transplant 2005; 5: 987-994
38. van Gelder T, Klupp J, Barten MJ, et al. Comparison of the effects of tacro-limus and cyclosporine on the pharmacokinetics of mycophenolic acid. Ther Drug Monit 2001; 23: 119-128
39. Le Meur Y, Buchler M, Thierry A, et al. Individualized mycophenolate mofetil dosing based on drug exposure significantly improves patient outcomes after renal transplantation. Am J Transplant 2007; 7: 2496-2503