Limited sampling model for advanced mycophenolic acid therapeutic drug monitoring after liver transplantation

Therapeutic Drug Monitoring

Volumn 36, Issue 2, 2014, Pages 141-147

  Langers, Pieter ^a   Press, Rogier R ^a   Inderson, Akin ^a   Cremers, Serge C L M ^b   Den Hartigh, Jan ^a   Baranski, Andrzej G ^a   Van Hoek, Bart ^a  

^a LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^b Departments of Clinical Pharmacy and Toxicology Leiden University Medical Center ^*  (United States)

Author keywords

Limited sampling models; Mycophenolate mofetil; Mycophenolic acid; Orthotopic liver transplantation; Therapeutic drug monitoring

Indexed keywords

ALBUMIN; CYCLOSPORIN; GLUCOCORTICOID; MYCOPHENOLIC ACID; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; PREDNISONE; RAPAMYCIN; TACROLIMUS; CREATININE; IMMUNOSUPPRESSIVE AGENT; SERUM ALBUMIN;

ADULT; AGED; ALBUMIN BLOOD LEVEL; AREA UNDER THE CURVE; ARTICLE; BAYESIAN LEARNING; CORRELATION ANALYSIS; CREATININE CLEARANCE; DRUG BIOAVAILABILITY; DRUG CLEARANCE; DRUG DOSE INCREASE; DRUG MONITORING; HUMAN; KIDNEY FUNCTION; LIVER TRANSPLANTATION; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; PLASMA CLEARANCE; PRIORITY JOURNAL; YOUNG ADULT; ADOLESCENT; ANALOGS AND DERIVATIVES; BAYES THEOREM; BLOOD; DOSE RESPONSE; DRUG INTERACTION; FEMALE; KIDNEY FUNCTION TEST; METABOLISM; PROCEDURES;

ADOLESCENT; ADULT; AGED; AREA UNDER CURVE; BAYES THEOREM; CREATININE; CYCLOSPORINE; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG INTERACTIONS; DRUG MONITORING; FEMALE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; KIDNEY FUNCTION TESTS; LIVER TRANSPLANTATION; MALE; MIDDLE AGED; MYCOPHENOLIC ACID; SERUM ALBUMIN; TACROLIMUS; YOUNG ADULT;

EID: 84897057847     PISSN: 01634356     EISSN: 15363694     Source Type: Journal    
DOI: 10.1097/FTD.0b013e3182a37a1e     Document Type: Article

References (49)

1. Allison AC, Eugui EM. The design and development of an immunosuppressive drug, mycophenolate mofetil. Springer Semin Immunopathol. 1993;14:353-380
2. Reich DJ, Clavien PA, Hodge EE. Mycophenolate mofetil for renal dysfunction in liver transplant recipients on cyclosporine or tacrolimus: Randomized, prospective, multicenter pilot study results. Transplantation. 2005;80:18-25
3. Kiberd BA, Lawen J, Fraser AD, et al. Early adequate mycophenolic acid exposure is associated with less rejection in kidney transplantation. Am J Transplant. 2004;4:1079-1083
4. Pillans PI, Rigby RJ, Kubler P, et al. A retrospective analysis of mycophenolic acid and cyclosporin concentrations with acute rejection in renal transplant recipients. Clin Biochem. 2001;34:77-81
5. DeNofrio D, Loh E, Kao A, et al. Mycophenolic acid concentrations are associated with cardiac allograft rejection. J Heart Lung Transplant. 2000;19:1071-1076
6. Yamani MH, Starling RC, Goormastic M, et al. The impact of routine mycophenolate mofetil drug monitoring on the treatment of cardiac allograft rejection. Transplantation. 2000;69:2326-2330
7. Tredger JM, Brown NW, Adams J, et al. Monitoring mycophenolate in liver transplant recipients: Toward a therapeutic range. Liver Transpl. 2004;10:492-502
8. Zicheng Y, Weixia Z, Hao C, et al. Limited sampling strategy for the estimation of mycophenolic acid area under the plasma concentration-Time curve in adult patients undergoing liver transplant. Ther Drug Monit. 2007; 29:207-214
9. Wiesner R, Rabkin J, Klintmalm G, et al. A randomized double-blind comparative study of mycophenolate mofetil and azathioprine in combination with cyclosporine and corticosteroids in primary liver transplant recipients. Liver Transpl. 2001;7:442-450
10. Bilbao I, Castells L, Rojas L, et al. Immunosuppression based on mycophenolate mofetil in stable liver transplanted patients. Int Immunopharmacol. 2006;6:1977-1983
11. Moreno Planas JM, Cuervas-Mons Martinez V, Rubio Gonzalez E, et al. Mycophenolate mofetil can be used as monotherapy late after liver transplantation. Am J Transplant. 2004;4:1650-1655
12. Fairbanks KD, Thuluvath PJ. Mycophenolate mofetil monotherapy in liver transplantation: A single center experience. Liver Transpl. 2004; 10:1189-1194
13. van Gelder T, Hilbrands LB, Vanrenterghem Y, et al. A randomized doubleblind, 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
14. Le Meur Y, Büchler 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
15. van Gelder T, Le Meur Y, Shaw LM, et al. Therapeutic drug monitoring of mycophenolate mofetil in transplantation. Ther Drug Monit. 2006;28: 145-154
16. Arns W, Cibrik DM, Walker RG, et al. Therapeutic drug monitoring of mycophenolic acid in solid organ transplant patients treated with mycophenolate mofetil: Review of the literature. Transplantation. 2006;82:1004-1012
17. Kaplan B. Mycophenolic acid trough level monitoring in solid organ transplant recipients treated with mycophenolate mofetil: Association with clinical outcome. Curr Med Res Opin. 2006;22:2355-2364
18. Pawinski T, Hale M, 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
19. Shaw LM, Holt DW, Oellerich M, et al. Current issues in therapeutic drug monitoring of mycophenolic acid: Report of a roundtable discussion. Ther Drug Monit. 2001;23:305-315
20. Filler G. Abbreviated mycophenolic acid AUC from C0, C1, C2, and C4 is preferable in children after renal transplantation on mycophenolate mofetil and tacrolimus therapy. Transpl Int. 2004;17:120-125
21. Le Guellec C, Bourgoin H, Büchler M, et al. Population pharmacokinetics and Bayesian estimation of mycophenolic acid concentrations in stable renal transplant patients. Clin Pharmacokinet. 2004;43:253-266
22. Filler G, Mai I. Limited sampling strategy for mycophenolic acid area under the curve. Ther Drug Monit. 2000;22:169-173
23. Mardigyan V, Tchervenkov J, Metrakos P. Best single time points as surrogates to the tacrolimus and mycophenolic acid area under the curve in adult liver transplant patients beyond 12 months of transplantation. Clin Ther. 2005;27:463-469
24. Behrend M. Mycophenolate mofetil: Suggested guidelines for use in kidney transplantation. BioDrugs. 2001;15:37-53
25. 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. 2005;60:249-256
26. Proost JH. Adaptive control of drug dosage regimens using maximum a posteriori probability Bayesian fitting. Int J Clin Pharmacol Ther. 1995;33:531-536
27. Bullingham RE, Nicholls AJ, Kamm BR. Clinical pharmacokinetics of mycophenolate mofetil. Clin Pharmacokinet. 1998;34:429-455
28. Sheiner LB, Beal SL. Some suggestions for measuring predictive performance. J Pharmacokinet Biopharm. 1981;9:503-512
29. de Winter BCM, van Gelder T, Sombogaard F, et al. Pharmacokinetic role of protein binding of mycophenolic acid and its glucuronide metabolite in renal transplant recipients. J Pharmacokinet Pharmacodyn. 2009; 36:541-564
30. 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
31. Langers P, Cremers SC, den Hartigh J, et al. Easy-To-use, accurate and flexible individualized Bayesian limited sampling method without fixed time points for ciclosporin monitoring after liver transplantation. Aliment Pharmacol Ther. 2005;21:549-557
32. Langers P, Press RR, den Hartigh J, et al. Flexible limited sampling model for monitoring tacrolimus in stable patients having undergone liver transplantation with samples 4 to 6 hours after dosing is superior to trough concentration. Ther Drug Monit. 2008;30:456-461
33. Borrows R, Chusney G, James A, et al. Determinants of mycophenolic acid levels after renal transplantation. Ther Drug Monit. 2005;27:442-450
34. Yau WP, Vathsala A, Lou HX, et al. Is a standard fixed dose of mycophenolate mofetil ideal for all patients? Nephrol Dial Transplant. 2007; 22:3638-3645
35. Borrows R, Chusney G, Loucaidou M, et al. Mycophenolic acid 12-h trough level monitoring in renal transplantation: Association with acute rejection and toxicity. Am J Transplant. 2006;6:121-128
36. 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
37. Kuriata-Kordek M, Boratynska M, Falkiewicz K, et al. The influence of calcineurin inhibitors on mycophenolic acid pharmacokinetics. Transplant Proc. 2003;35:2369-2371
38. Cattaneo D, Gaspari F, Ferrari S, et al. Pharmacokinetics help optimizing mycophenolate mofetil dosing in kidney transplant patients. Clin Transplant. 2001;15:402-409
39. Gaston RS, Kaplan B, Shah T, et al. Fixed- or controlled-dose mycophenolate mofetil with standard- or reduced-dose calcineurin inhibitors: The Opticept trial. Am J Transplant. 2009;9:1607-1619
40. Flechner SM. Minimizing calcineurin inhibitor drugs in renal transplantation. Transplant Proc. 2003;35:118S-121S.
41. Créput C, Blandin F, Deroure B, et al. Long-Term effects of calcineurin inhibitor conversion to mycophenolate mofetil on renal function after liver transplantation. Liver Transpl. 2007;13:1004-1010
42. Pfitzmann R, Klupp J, Langrehr JM, et al. Mycophenolatemofetil for immunosuppression after liver transplantation: A follow-up study of 191 patients. Transplantation. 2003;76:130-136
43. 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;23:119-128
44. Smak Gregoor PJ, van Gelder T, Hesse CJ, et al. Mycophenolic acid plasma concentrations in kidney allograft recipients with or without cyclosporin: A cross-sectional study. Nephrol Dial Transplant. 1999; 14:706-708
45. Filler G, Zimmering M, Mai I. Pharmacokinetics of mycophenolate mofetil are influenced by concomitant immunosuppression. Pediatr Nephrol. 2000; 14:100-104
46. Patel CG, Harmon M, Gohh RY, et al. Concentrations of mycophenolic acid and glucuronide metabolites under concomitant therapy with cyclosporine or tacrolimus. Ther Drug Monit. 2007;29:87-95
47. 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;5:987-994
48. Langers P, Cremers SC, den Hartigh J, et al. Individualized population pharmacokinetic model with limited sampling for cyclosporine monitoring after liver transplantation in clinical practice. Aliment Pharmacol Ther. 2007;26:1447-1454
49. Mourer JS, den Hartigh J, van Zwet EW, et al. Randomized trial comparing late concentration-controlled calcineurin inhibitor or mycophenolate mofetil withdrawal. Transplantation. 2012;93:887-894.