Limited sampling strategies drawn within 3 hours postdose poorly predict mycophenolic acid area-under-the-curve after enteric-coated mycophenolate sodium

Therapeutic Drug Monitoring

Volumn 31, Issue 5, 2009, Pages 585-591

  De Winter, Brenda C M ^a   Van Gelder, Teun ^a   Mathot, Ron A A ^a   Glander, Petra ^b   Tedesco Silva, Helio ^c   Hilbrands, Luuk ^d   Budde, Klemens ^b   Van Hest, Reinier M ^a  

^a ERASMUS UNIVERSITY ROTTERDAM   (Netherlands)

^b CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^c FEDERAL UNIVERSITY OF SÃO PAULO   (Brazil)

^d RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

Author keywords

Limited sampling strategy; Mycophenolic acid; Pharmacokinetics; Therapeutic drug monitoring

Indexed keywords

CYCLOSPORIN A; MYCOPHENOLIC ACID;

ADOLESCENT; ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; BLOOD SAMPLING; CONTROLLED STUDY; DRUG MONITORING; ENTERIC COATED TABLET; FEMALE; GRAFT RECIPIENT; HUMAN; KIDNEY GRAFT; KIDNEY TRANSPLANTATION; LIMITED SAMPLING STRATEGY; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; PLASMA CONCENTRATION-TIME CURVE; PRIORITY JOURNAL; TIME TO MAXIMUM PLASMA CONCENTRATION; VALIDATION STUDY;

ADOLESCENT; ADULT; AGED; AREA UNDER CURVE; BLOOD SPECIMEN COLLECTION; CYCLOSPORINE; DRUG INTERACTIONS; DRUG MONITORING; FEMALE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; MALE; MIDDLE AGED; MYCOPHENOLIC ACID; SAMPLING STUDIES; YOUNG ADULT;

EID: 70349677373     PISSN: 01634356     EISSN: 15363694     Source Type: Journal    
DOI: 10.1097/FTD.0b013e3181b8679a     Document Type: Article

References (34)

1. Budde K, Curtis J, Knoll G, et al. Enteric-coated mycophenolate sodium can be safely administered in maintenance renal transplant patients: results of a 1-year study. Am J Transplant. 2003;4:237-243.
2. Salvadori M, Holzer H, De Mattos A, et al. Enteric-coated mycophenolate sodium is therapeutically equivalent to mycophenolate mofetil in de novo renal transplant patients. Am J Transplant. 2003;4:2131-2136.
3. Kaufman DB, Shapiro R, Lucey MR, et al. Immunosuppression: practice and trends. Am J Transplant. 2004;4(Suppl 9):38-53.
4. Knoll G. Trends in kidney transplantation over the past decade. Drugs. 2008;68(Suppl 1):3-10.
5. Bullingham RE, Nicholls AJ, Kamm BR. Clinical pharmacokinetics of mycophenolate mofetil. Clin Pharmacokinet. 1998;34:429-455.
6. Shipkova M, Strassburg CP, Braun F, et al. Glucuronide and glucoside conjugation of mycophenolic acid by human liver, kidney and intestinal microsomes. Br J Pharmacol. 2001;132:1027-1034.
7. Picard N, Ratanasavanh D, Premaud A, et al. Identification of the UDPglucuronosyltransferase isoforms involved in mycophenolic acid phase II metabolism. Drug Metab Dispos. 2005;33:139-146.
8. Shaw LM, Korecka M, Venkataramanan R, et al. Mycophenolic acid pharmacodynamics and pharmacokinetics provide a basis for rational monitoring strategies. Am J Transplant. 2003;3:534-542.
9. Van Gelder T, Tedesco Silva H, De Fijter JW et al. Comparing mycophenolate mofetil regimens for de novo renal transplant recipients: the fixed dose concentration controlled trial. Transplantation. 2008;86: 1043-1051.
10. Le Meur Y, Büchler M, Thierry A, et al. Individualized mycophenolate mofetil dosing based on drug exposure significantly improved patient outcomes after renal transplantation. Am J Transplant. 2007;7:2496-2503.
11. Hale MD, Nicholls AJ, Bullingham RE, et al. The pharmacokineticpharmacodynamic relationship for mycophenolate mofetil in renal transplantation. Clin Pharmacol Ther. 1998;64:672-683.
12. Premaud A, Lemeur 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.
13. Pawinski T, Hale M, Korecka M, et al. Limited sampling strategy for the estimation of mycophenolic acid areau under the curve in adult renal transplant patients treated with concomitant tacrolimus. Clin Chem. 2002; 48:1497-1504.
14. Filler G, Mai I. Limited sampling strategy for mycophenolic acid area under the curve. Ther Drug Monit. 2000;22:169-173.
15. Weber LT, Hoecker B, Armstrong VW, et al. Validation of an abbreviated pharmacokinetic profile for the estimation of mycophenolic acid exposure in pediatric renal transplant recipients. Ther Drug Monit. 2006;28:623-631.
16. Kaplan B, Meier-Kriesche H-U, Minnick P, et al. Randomized calcineurin inhibitor cross over study to measure the pharmacokinetics of coadministered enteric-coated mycophenolate sodium. Clin Transplant. 2005;19:551-558.
17. De Winter BC, Van Gelder T, Glander P, et al. Population pharmacokinetics of mycophenolic acid: a comparison between enteric-coated mycophenolate sodium and mycophenolate mofetil in renal transplant recipients. Clin Pharmacokinet. 2008;47:827-838.
18. Budde K, Bauer S, Hambach P, et al. Pharmacokinetic and pharmacodynamic comparison of enteric-coated mycophenolate sodium and mycophenolate mofetil in maintenance renal transplant patients. Am J Transplant. 2007;7:888-898. (Pubitemid 46481185)
19. 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 curve in adult renal transplant patients. Ther Drug Monit. 2000;22:549-554.
20. Budde K, Tedesco-Silva H, Pestana JM, et al. Enteric-coated mycophenolate sodium provides higher mycophenolic acid predose levels compared with mycophenolate mofetil: implications for therapeutic drug monitoring. Ther Drug Monit. 2007;29:381-384.
21. Budde K, Glander P, Kramer BK, et al. Conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium in maintenance renal transplant recipients receiving tacrolimus: clinical, pharmacokinetic, and pharmacodynamic outcomes. Transplantation. 2007;83:417-424. (Pubitemid 46667845)
22. Budde K, Glander P, Schuhmann R, et al. Conversion from cyclosporine to everolimus leads to better renal function and profound changes in everolimus pharmacokinetics. Am J Transplant. 2006;6(S2):999. Abstract.
23. Arns W, Glander P, Schuhmann R, et al. Conversion from tacrolimus to everolimus does not influence the pharmacokinetics but increases pharmacodynamic response of mycophenolate sodium in renal transplant patients. Am J Transplant. 2006;6(S2):488. Abstract.
24. Tedesco-Silva H, Bastien MC, Choi L, et al. Mycophenolic acid metabolite profile in renal transplant patients receiving enteric-coated mycophenolate sodium or mycophenolate mofetil. Transplant Proc. 2005; 37:852-855.
25. de Winter BCM, van Hest RM, Hilbrands LB, et al. Measured mycophenolic acid concentrations after administration of mycophenolate sodium (Myfortic-) are higher with EMIT compared to HPLC [Abstract]. Br J Clin Pharmacol. 2005;60:671-672.
26. Sheiner LB, Beal SL. Some suggestions for measuring predictive performance. J Pharmacokinet Biopharm. 1981;9:503-512.
27. Bland M, Altman DG. Statistical methods for assessing agreement between methods of clinical measurement. Lancet. 1986;1:307-310.
28. 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.
29. Kuypers DRJ, 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;43:866-880.
30. Yeung S, Tong KL, Tsang WK, et al. Determination of mycophenolate area under the curve by limited sampling strategy. Transplant Proc. 2001; 33:1052-1053.
31. 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: 445-452.
32. van Hest RM, Mathot RA, Vulto AG, et al. Mycophenolic acid in diabetic renal transplant recipients: pharmacokinetics and application of a limited sampling strategy. Ther Drug Monit. 2004;26:620-625.
33. Cattaneo D, Cortinovis M, Baldelli S, et al. Pharmacokinetics of mycophenolate sodium and comparison with the mofetil formulation in stable kidney transplant recipients. Clin J Am Soc Nephrol. 2007;2: 1147-1155.
34. 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;63:741-752.