Maximum a posteriori bayesian estimation of mycophenolic acid area under the concentration-time curve: Is this clinically useful for dosage prediction yet?

Clinical Pharmacokinetics

Volumn 50, Issue 12, 2011, Pages 759-772

  Staatz, Christine E ^a   Tett, Susan E ^a  

^a UNIVERSITY OF QUEENSLAND   (Australia)

Author keywords

Dose prediction; Drug monitoring; Immunosuppressants; Mycophenolate mofetil; Mycophenolic acid; Organ transplant; Pharmacokinetic modelling; Pharmacokinetics; Renal transplant

Indexed keywords

CORTICOSTEROID; CYCLOSPORIN A; MYCOPHENOLIC ACID; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; RAPAMYCIN; TACROLIMUS;

AREA UNDER THE CURVE; AUTOIMMUNE DISEASE; BAYES THEOREM; CLINICAL PRACTICE; CORTICOSTEROID THERAPY; DRUG EXPOSURE; DRUG FORMULATION; ENTERIC COATED TABLET; FORECASTING; GLOMERULONEPHRITIS; GRAFT RECIPIENT; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HUMAN; IDIOPATHIC DISEASE; KIDNEY GRAFT; MEDLINE; NEPHROTIC SYNDROME; PREDICTION; PRIORITY JOURNAL; REVIEW; SYSTEMIC LUPUS ERYTHEMATOSUS;

ANTIBIOTICS, ANTINEOPLASTIC; AREA UNDER CURVE; BAYES THEOREM; DOSE-RESPONSE RELATIONSHIP, DRUG; HUMANS; MYCOPHENOLIC ACID;

EID: 81255189102     PISSN: 03125963     EISSN: 11791926     Source Type: Journal    
DOI: 10.2165/11596380-000000000-00000     Document Type: Review

References (63)

1. Staatz CE, Tett SE. Clinical pharmacokinetics and pharmacodynamics of mycophenolate in solid organ transplant recipients. Clin Pharmacokinet 2007; 46 (1): 13-58 (Pubitemid 46091591)
2. van Hest R, Mathot R, Vulto A, et al. Predicting the usefulness of therapeutic drug monitoring of mycophenolic acid: a computer simulation. Ther Drug Monit 2005 Apr; 27 (2): 163-7 (Pubitemid 40463643)
3. 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 Jul; 9 (7): 1607-19
4. 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 Nov; 7 (11): 2496-503 (Pubitemid 47566324)
5. Kuypers DR, Le Meur Y, Cantarovich M, et al. Consensus report on therapeutic drug monitoring of mycophenolic acid in solid organ transplantation. Clin J Am Soc Nephrol 2010 Feb; 5 (2): 341-58
6. Barraclough KA, Staatz CE, Isbel NM, et al. Therapeutic monitoring of mycophenolate in transplantation: is it justified? Curr Drug Metab 2009 Feb; 10 (2): 179-87
7. Pelletier RP, Akin B, Henry ML, et al. The impact of mycophenolate mofetil dosing patterns on clinical outcome after renal transplantation. Clin Transplant 2003 Jun; 17 (3): 200-5 (Pubitemid 36748465)
8. Knoll GA, MacDonald I, Khan A, et al. Mycophenolate mofetil dose reduction and the risk of acute rejection after renal transplantation. J Am Soc Nephrol 2003 Sep; 14 (9): 2381-6 (Pubitemid 37052386)
9. Knight SR, Morris PJ. Does the evidence support the use of mycophenolate mofetil therapeutic drug monitoring in clinical practice? A systematic review. Transplantation 2008 Jun 27; 85 (12): 1675-85
10. 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 Jul; 4 (7): 1079-83 (Pubitemid 38868597)
11. Zuk DM, Pearson GJ. Monitoring of mycophenolate mofetil in orthotopic heart transplant recipients: a systematic review. Transplant Rev (Orlando) 2009 Jul; 23 (3): 171-7
12. Sagcal-Gironella AC, Fukuda T, Wiers K, et al. Pharmacokinetics and pharmacodynamics of mycophenolic acid and their relation to response to therapy of childhood-onset systemic lupus erythematosus. Semin Arthritis Rheum 2011 Feb; 40 (4): 307-13
13. Djabarouti S, Breilh D, Duffau P, et al. Steady-state mycophenolate mofetil pharmacokinetic parameters enable prediction of systemic lupus erythematosus clinical flares: an observational cohort study [published erratum appears in Arthritis Res Ther 2011; 13 (2): 401].
14. Arthritis Res Ther 2010; 12 (6): R217
15. Hao C, Anwei M, Bing C, et al. Monitoring mycophenolic acid pharmacokinetic parameters in liver transplant recipients: prediction of occurrence of leukopenia. Liver Transpl 2008 Aug; 14 (8): 1165-73
16. Roland M, Barbet C, PaintaudG, et al. Mycophenolate mofetil in patients with systemic lupus erythematosus: a prospective pharmacokinetic study. Lupus 2009 Apr; 18 (5): 441-7
17. Zahr N, Arnaud L, Marquet P, et al. Mycophenolic acid area under the curve correlates with disease activity in lupus patients treated with mycophenolate mofetil. Arthritis Rheum 2010 Jul; 62 (7): 2047-54
18. van der Meer AF, Marcus MA, Touw DJ, et al. Optimal sampling strategy development methodology using maximum a posteriori Bayesian estimation. Ther Drug Monit 2011 Apr; 33 (2): 133-46
19. Sherwin CM, Fukuda T, Brunner HI, et al. The evolution of population pharmacokinetic models to describe the enterohepatic recycling of mycophenolic acid in solid organ transplantation and autoimmune disease. Clin Pharmacokinet 2011 Jan 1; 50 (1): 1-24
20. 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 Oct 27; 82 (8): 1004-12 (Pubitemid 44632114)
21. 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 Mar; 17 (3): 871-80
22. de Winter BC, Mathot RA, Sombogaard F, et al. Differences in clearance of mycophenolic acid among renal transplant recipients, hematopoietic stem cell transplant recipients, and patients with autoimmune disease. Ther Drug Monit 2010 Oct; 32 (5): 606-14
23. van Gelder T, Silva HT, de Fijter JW, et al. Comparing mycophenolate mofetil regimens for de novo renal transplant recipients: the Fixed-Dose Concentration-Controlled trial. Transplantation 2008 Oct 27; 86 (8): 1043-51
24. Byrne R, Yost SE, Kaplan B. Mycophenolate mofetil monitoring: is there evidence that it can improve outcomes? Clin Pharmacol Ther 2011 Aug; 90 (2): 204-6
25. van Gelder T. Therapeutic drug monitoring for mycophenolic acid is value for (little) money. Clin Pharmacol Ther 2011 Aug; 90 (2): 203-4
26. Kuypers DR. Immunosuppressive drug monitoring: what to use in clinical practice today to improve renal graft outcome. Transpl Int 2005 Feb; 18 (2): 140-50 (Pubitemid 41743303)
27. Barraclough KA, Isbel NM, Staatz CE. Evaluation of the mycophenolic acid exposure estimation methods used in the APOMYGERE, FDCC, and Opticept trials. Transplantation 2010 Jul 15; 90 (1): 44-51
28. Dosch AO, Ehlermann P, Koch A, et al. A comparison of measured trough levels and abbreviated AUC estimation by limited sampling strategies for monitoring mycophenolic acid exposure in stable heart transplant patients receiving cyclosporin A-containing and cyclosporin A-free immunosuppressive regimens. Clin Ther 2006 Jun; 28 (6): 893-905 (Pubitemid 44062701)
29. 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 Oct; 29 (5): 600-6 (Pubitemid 47494058)
30. Tett SE, Saint-Marcoux F, Staatz CE, et al. Mycophenolate, clinical pharmacokinetics, formulations, and methods for assessing drug exposure. Transplant Rev (Orlando) 2011 Apr; 25 (2): 47-57
31. van Hest RM, Mathot RA, Vulto AG, et al. Within-patient variability of mycophenolic acid exposure: therapeutic drug monitoring from a clinical point of view. Ther Drug Monit 2006 Feb; 28 (1): 31-4 (Pubitemid 44391690)
32. Barraclough KA, Isbel NM, Franklin ME, et al. Evaluation of limited sampling strategies for mycophenolic acid after mycophenolate mofetil intake in adult kidney transplant recipients. Ther Drug Monit 2010 Dec; 32 (6): 723-33
33. Ting LS, Villeneuve E, Ensom MH. Beyond cyclosporine: a systematic review of limited sampling strategies for other immunosuppressants. Ther Drug Monit 2006 Jun; 28 (3): 419-30 (Pubitemid 44314932)
34. Saint-Marcoux F, Vandierdonck S, Premaud A, et al. Large scale analysis of routine dose adjustments of mycophenolate mofetil based on global exposure in renal transplant patients. Ther Drug Monit 2011; 33 (3): 285-94
35. 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 DrugMonit 2005 Jun; 27 (3): 354-61 (Pubitemid 40770993)
36. 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 Aug; 30 (4): 445-55
37. Sheiner LB, Rosenberg B, Melmon KL. Modelling of individual pharmacokinetics for computer-aided drug dosage. Comput Biomed Res 1972 Oct; 5 (5): 411-59
38. Bruchet NK, Ensom MH. Limited sampling strategies for mycophenolic acid in solid organ transplantation: a systematic review. Expert Opin Drug Metab Toxicol 2009 Sep; 5 (9): 1079-97
39. Saint-Marcoux F, Guigonis V, Decramer S, et al. Development of a Bayesian estimator for the therapeutic drug monitoring of mycophenolate mofetil in children with idiopathic nephrotic syndrome. Pharmacol Res 2011 May; 63 (5): 423-31
40. Thomson AH, Whiting B. Bayesian parameter estimation and population pharmacokinetics. Clin Pharmacokinet 1992 Jun; 22 (6): 447-67
41. Ludden TM, Beal SL, Sheiner LB. Comparison of the Akaike information criterion, the Schwarz criterion and the F test as guides to model selection. J Pharmacokinet Biopharm 1994 Oct; 22 (5): 431-45
42. 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 Sep; 60 (3): 249-56 (Pubitemid 41224132)
43. van Hest RM, van Gelder T, Bouw R, et al. Time-dependent clearance of mycophenolic acid in renal transplant recipients. Br J Clin Pharmacol 2007 Jun; 63 (6): 741-52 (Pubitemid 46753575)
44. Kuypers DR, Claes K, Evenepoel P, et al. Long-term changes in mycophenolic acid exposure in combination with tacrolimus and corticosteroids are dose dependent and not reflected by trough plasma concentration: a prospective study in 100 de novo renal allograft recipients. J Clin Pharmacol 2003 Aug; 43 (8): 866-80 (Pubitemid 36886107)
45. de Winter BC, Mathot RA, Sombogaard F, et al. Nonlinear relationship between mycophenolate mofetil dose and mycophenolic acid exposure: implications for therapeutic drug monitoring. Clin J AmSoc Nephrol 2011 Mar; 6 (3): 656-63
46. Premaud A, Rousseau A, Le Meur Y, et al. Feasibility of, and critical paths for mycophenolate mofetil Bayesian dose adjustment: pharmacological reappraisal of a concentration-controlled versus fixed-dose trial in renal transplant recipients. Pharmacol Res 2010 Feb; 61 (2): 167-74
47. Musuamba FT, Rousseau A, Bosmans JL, et al. 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. Clin Pharmacokinet 2009; 48 (11): 745-58
48. 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 (4): 253-66 (Pubitemid 38429305)
49. Hulin A, Blanchet B, Audard V, et al. Comparison of 3 estimation methods of mycophenolic acid AUC based on a limited sampling strategy in renal transplant patients. Ther Drug Monit 2009 Apr; 31 (2): 224-32
50. Premaud A, Weber LT, Tonshoff B, et al. Population pharmacokinetics of mycophenolic acid in pediatric renal transplant patients using parametric and nonparametric approaches. Pharmacol Res 2011 Mar; 63 (3): 216-24
51. Payen S, Zhang D, Maisin A, et al. Population pharmacokinetics of mycophenolic acid in kidney transplant pediatric and adolescent patients. Ther Drug Monit 2005 Jun; 27 (3): 378-88 (Pubitemid 40770997)
52. Monchaud C, De Winter B, Premaud A, et al. Bayesian estimation of mycophenolate mofetil (MMF) in lung transplantation using a population pharmacokinetic model developed in renal and lung transplant recipients [abstract]. Fundam Clin Pharmacol 2011; 25 Suppl. 1: 46
53. de Winter BC, Neumann I, van Hest RM, et al. Limited sampling strategies for therapeutic drug monitoring of mycophenolate mofetil therapy in patients with autoimmune disease. Ther Drug Monit 2009 Jun; 31 (3): 382-90
54. Sam WJ, Joy MS. Population pharmacokinetics of mycophenolic acid and metabolites in patients with glomerulonephritis. Ther Drug Monit 2010 Oct; 32 (5): 594-605
55. Zahr N, Amoura Z, Debord J, et al. Pharmacokinetic study of mycophenolate mofetil in patients with systemic lupus erythematosus and design of Bayesian estimator using limited sampling strategies. Clin Pharmacokinet 2008; 47 (4): 277-84 (Pubitemid 351367437)
56. Saint-Marcoux F, Royer B, Debord J, et al. Pharmacokinetic modelling and development of Bayesian estimators for therapeutic drug monitoring of mycophenolate mofetil in reduced-intensity haematopoietic stem cell transplantation. Clin Pharmacokinet 2009; 48 (10): 667-75
57. ZhaoW, Elie V, Baudouin V, et al. Population pharmacokinetics and Bayesian estimator of mycophenolic acid in children with idiopathic nephrotic syndrome. Br J Clin Pharmacol 2010 Apr; 69 (4): 358-66
58. Beal S, Sheiner LB, Boeckmann A, et al.NONMEMuser's guides (1989-2011). Ellicott City (MD): Icon Development Solutions, 2011
59. Fleming DH, Mathew BS, Prasanna S, et al. A possible simplification for the estimation of area under the curve (AUC) of enteric-coated mycophenolate sodium in renal transplant patients receiving tacrolimus. Ther Drug Monit 2011 Apr; 33 (2): 165-70
60. Barraclough KA, Lee KJ, Staatz CE. Pharmacogenetic influences on mycophenolate therapy. Pharmacogenomics 2010 Mar; 11 (3): 369-90
61. Picard N, Marquet P. The influence of pharmacogenetics and cofactors on clinical outcomes in kidney transplantation. Expert Opin Drug Metab Toxicol 2011 Jun; 7 (6): 731-43
62. Raggi MC, Siebert SB, Steimer W, et al. Customized mycophenolate dosing based on measuring inosine-monophosphate dehydrogenase activity significantly improves patients' outcomes after renal transplantation. Transplantation 2010 Dec 27; 90 (12): 1536-41
63. van Gelder T. Mycophenolate blood level monitoring: recent progress. Am J Transplant 2009 Jul; 9 (7): 1495-9