Evaluation of the mycophenolic acid exposure estimation Methods used in the APOMYGERE, FDCC, and opticept trials

Transplantation

Volumn 90, Issue 1, 2010, Pages 44-51

  Barraclough, Katherine A ^a   Isbel, Nicole M ^a   Staatz, Christine E ^a  

^a UNIVERSITY OF QUEENSLAND   (Australia)

Author keywords

Bayesian estimation; Limited sampling strategies; Mycophenolate mofetil; Therapeutic drug monitoring.

Indexed keywords

CYCLOSPORIN; CYCLOSPORIN A; DILTIAZEM; MYCOPHENOLIC ACID; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; PREDNISOLONE; TACROLIMUS;

ACCURACY; ACUTE GRAFT REJECTION; ADULT; AREA UNDER THE CURVE; ARTICLE; BAYES THEOREM; CLINICAL ARTICLE; COHORT ANALYSIS; CONTROLLED STUDY; CORRELATION ANALYSIS; DRUG BLOOD LEVEL; DRUG EXPOSURE; DRUG MONITORING; FEMALE; GRAFT RECIPIENT; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; IMMUNOSUPPRESSIVE TREATMENT; KIDNEY GRAFT REJECTION; KIDNEY TRANSPLANTATION; MALE; MULTIPLE REGRESSION; PREDICTION AND FORECASTING; PRIORITY JOURNAL; TANDEM MASS SPECTROMETRY;

ADULT; ANTI-BACTERIAL AGENTS; AREA UNDER CURVE; BAYES THEOREM; CADAVER; CYCLOSPORINE; DRUG MONITORING; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; KIDNEY TRANSPLANTATION; LIVING DONORS; MALE; MIDDLE AGED; MYCOPHENOLIC ACID; PREDICTIVE VALUE OF TESTS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SAMPLING STUDIES; TISSUE DONORS;

EID: 77954625082     PISSN: 00411337     EISSN: None     Source Type: Journal    
DOI: 10.1097/TP.0b013e3181e06584     Document Type: Article

References (36)

1. U.S. Organ Procurement and Transplantation Network and the Scientific Registry of Transplant Recipients. Available at: http://www. ustransplant.org/annual-reports/current/. Accessed August 18, 2009.
2. Shaw LM, Kaplan B, DeNofrio D, et al. Pharmacokinetics and concentration-control investigations of mycophenolic acid in adults after transplantation. Ther Drug Monitor 2000; 22: 14.
3. van Gelder T, Silva H, de Fijter H, et al. Comparing mycophenolate mofetil regimens for de novo renal transplant recipients: The fixed-dose concentration-controlled trial. Transplantation 2008; 86: 1043.
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; 7: 2496.
5. van Gelder T, Hilbrands LB, Vanrenterghem Y, et al. A randomized double-blind, multicenter plasma concentration controlled study of the safety and efficacy oforal mycophenolate mofetil for the prevention of acute rejection after kidney transplantation. Transplantation 1999; 68: 261.
6. 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 of the German study group on mycophenolate mofetil therapy. J Am Soc Nephrol 2002; 13: 759.
7. 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.
8. Kuypers DR, Claes K, Evenepoel P, et al. Clinical efficacy and toxicity profile of tacrolimus and mycophenolic acid in relation to combined long-term pharmacokinetics in de novo renal allograft recipients. Clin Pharmacol Ther 2004; 75: 434.
9. Ather tcheson BA, Taylor PJ, Mudge DW, et al. Mycophenolic acid pharmacokinetics and related outcomes early after renal transplant. Br J Clin Pharmacol, 2005; 59: 271.
10. Gaston RS, Kaplan B, Shah T, et al. Fixed-or controlled-dose myco-phenolate mofetil with standard-or reduced-dose calcineurin inhibitors: The opticept trial. Am J Transplant 2009; 9: 1607.
11. 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.
12. van Gelder T, Shaw LM. The rationale for and limitations of therapeutic drug monitoring for mycophenolate mofetil in transplantation. Transplantation 2005; 80(2 suppl): S244.
13. van Gelder T, Le Meur Y, Shaw LM, et al. Therapeutic drug monitoring of mycophenolate mofetil in transplantation. Ther Drug Monitor 2006; 28: 145.
14. van Gelder T. Mycophenolate blood level monitoring: Recent progress. Am J Transplant, 2009; 9: 1495.
15. Barraclough KA, Staatz CE, Isbel NM, et al. Therapeutic monitoring of mycophenolate in transplantation: Is it justified Curr Drug Metabol 2009; 10: 179.
16. Nicholls AJ. Opportunities for therapeutic monitoring of mycopheno-late mofetil dose in renal transplantation suggested by the pharmaco-kinetic/ pharmacodynamic relationship for mycophenolic acid and suppression of rejection. Clin Biochem 1998; 31: 329.
17. Oellerich M, Shipkova M, Schutz E, et al. Pharmacokinetic and metabolic investigations of mycophenolic acid in pediatric patients after renal transplantation: Implications for therapeutic drug monitoring. German Study Group on mycophenolate mofetil therapy in pediatric renal transplant recipients. Ther Drug Monitor 2000; 22: 20.
18. Pawinski T, Durlik M, Szlaska I, et al. Comparison of mycophenolic acid pharmacokinetic parameters in kidney transplant patients within the first 3 months post-transplant. J Clin Pharm Ther 2006; 31: 27.
19. Lu YP, Lin B, Liang MZ, et al. Correlation of mycophenolic acid phar-macokinetic parameters with side effects in Chinese kidney transplant recipients treated with mycophenolate mofetil. Transplantation Proc 2004; 36: 2079.
20. Krumme B, Wollenberg K, Kirste G, et al. Drug monitoring of myco-phenolic acid in the early period after renal transplantation. Transplant Proc 1998; 30: 1773.
21. Hazzan M, Labalette M, Copin MC, et al. Predictive factors of acute rejection after early cyclosporine withdrawal in renal transplant recipients who receive mycophenolate mofetil: Results from a prospective, randomized trial. J Am Soc Nephrol 2005; 16: 2509.
22. 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.
23. Okamoto M, Wakabayashi Y, Higuchi A, et al. Therapeutic drug monitoring of mycophenolic acid in renal transplant recipients. Transplant Proc 2005; 37: 859.
24. Kuypers DR, Vanrenterghem Y, Squifflet JP, et al. Twelve-month evaluation of the clinical pharmacokinetics of total and free mycophenolic acid and its glucuronide metabolites in renal allograft recipients on low dose tacrolimus in combination with mycophenolate mofetil. Ther Drug Monitor 2003; 25: 609.
25. 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; 43: 866.
26. Pillans PI, Rigby RJ, Kubler P, et al. A retrospective analysis of myco-phenolic acid and cyclosporin concentrations with acute rejection in renal transplant recipients. Clin Biochem 2001; 34: 77.
27. Barbari A, Stephan A, Masri MA, et al. Mycophenolic acid plasma trough level: Correlation with clinical outcome. Exp Clin Transplant 2005; 3: 355.
28. Premaud A, Le Meur Y, Debord J, et al. Maximumaposteriori bayesian estimation of mycophenolic acid pharmacokinetics in renal transplant recipients at different postgrafting periods. Ther Drug Monitor 2005; 27: 354.
29. Premaud A, Debord J, Rousseau A, et al. A double absorption-phase model adequately describes mycophenolic acid plasma profiles in de novo renal transplant recipients given oral mycophenolate mofetil. Clin Pharmacokinet 2005; 44: 837.
30. Scholten EM, Cremers SC, Schoemaker RC, et al. AUC-guided dosing of tacrolimus prevents progressive systemic overexposure in renal transplant recipients. Kidney Int 2005; 67: 2440.
31. Ting LS, Villeneuve E, Ensom MH. Beyond cyclosporine: A systematic review of limited sampling strategies for other immunosuppressants. Ther Drug Monitor 2006; 28: 419.
32. Jones CE, Taylor PJ, Johnson AG. High-performance liquid chromatogra-phy determination of mycophenolic acid and its glucuronide metabolite in human plasma. J Chromatogr B Biomed Sci Appl 1998; 708: 229.
33. Le Meur Y, Buchler M, Lavaud S, et al. Concentration-controlled versus fixed dose of MMF in kidney transplant recipients: Preliminary results of a French Multicenter Randomized Study [abstract]. Presented at American Congress of Transplantation, Seattle, WA; 2005.
34. Pawinski T, Hale M, Korecka M, Fitzsimmons WE, Shaw LM. 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.
35. Sheiner LB, Beal SL. Some suggestions for measuring predictive performance. J Pharmacokinet Biopharm 1981; 9: 503.
36. Coresh J, Stevens LA. Kidney function estimating equations: Where do we stand Curr Opin Nephrol Hyperten 2006; 15: 276.