Limited-sampling strategy for mycophenolic acid in renal transplant recipients reciving enteric-coated mycophenolate sodium and tacrolimus

Therapeutic Drug Monitoring

Volumn 34, Issue 3, 2012, Pages 298-305

  Fructuoso, Ana I Sánchez ^a   Perez Flores, Isabel ^a   Calvo, Natividad ^a   Valero, Rosalia ^a   Matilla, Elisa ^a   Ortega, Dolores ^a   Del Dedo, Maria A ^a   Fernández Pérez, Cristina ^a   Barrientos, Alberto ^a  

^a HOSPITAL CLÍNICO SAN CARLOS   (Spain)

Author keywords

Limited sampling strategy; Mycophenolate sodium; Pharmacokinetics; Renal transplantation

Indexed keywords

CYCLOSPORIN; MYCOPHENOLIC ACID; TACROLIMUS;

ACCURACY; ADULT; AREA UNDER THE CURVE; ARTICLE; BLOOD SAMPLING; DRUG BLOOD LEVEL; ENTERIC COATED TABLET; ENZYME MULTIPLIED IMMUNOASSAY TECHNIQUE; FEMALE; GRAFT RECIPIENT; HUMAN; KIDNEY TRANSPLANTATION; LINEAR REGRESSION ANALYSIS; MAJOR CLINICAL STUDY; MALE; MEASUREMENT; PRIORITY JOURNAL; RELIABILITY; VALIDATION PROCESS;

ADULT; AREA UNDER CURVE; BLOOD SPECIMEN COLLECTION; FEMALE; HUMANS; KIDNEY TRANSPLANTATION; MALE; MIDDLE AGED; MYCOPHENOLIC ACID; TABLETS, ENTERIC-COATED; TACROLIMUS;

EID: 84861234638     PISSN: 01634356     EISSN: 15363694     Source Type: Journal    
DOI: 10.1097/FTD.0b013e318255cc15     Document Type: Article

References (33)

1. Meier-Kriesche HU, Li S, Gruessner RW, et al. Immunosuppression: evolution in practice and trends, 1994-2004. Am J Transplant. 2006;6: 1111-1131.
2. European Mycophenolate Mofetil Study Group. Placebo-controlled study of mycophenolate mofetil combined with cyclosporin and corticosteroid for prevention of acute rejection. Lancet. 1995;345:1321-1325.
3. The Tricontinental Mycophenolate Mofetil Renal Transplantation Study Group. A blinded, randomized clinical trial of mycophenolate mofetil for the prevention of acute rejection in cadaveric renal transplantation. Transplantation. 1996;61:1029-1037.
4. Sollinger HW, For the U.S. Renal Transplant Mycophenolate Mofetil Study Group. Mycophenolate mofetil for the prevention of acute rejection in primary cadaveric renal allograft recipients. Transplantation. 1995;60:225-232.
5. Salvadori M, Holzer H, de Mattos A, et al, and The ERL B301 Study Groups. Enteric-coated mycophenolate sodium is therapeutically equivalent to mycophenolate mofetil in de novo renal transplant patients. Am J Transplant. 2004;4:231-236. (Pubitemid 38248526)
6. Budde K, Curtis J, Knoll G, et al, and the ERL B302 Study Group. Enteric-coated mycophenolate sodium can be safely administered in maintenance renal transplant patients: results of a 1-year study. Am J Transplant. 2004;4:237-243. (Pubitemid 38248527)
7. Roche information. Available at http://www.gene.com/gene/products/ information/cellcept/pdf/pi.pdf.
8. Novartis information. Available at http://www.pharma.us.novartis.com/ product/pi/pdf/myfortic.pdf.
9. Shaw LM, Nicholls A, Hale M, et al. Therapeutic monitoring of mycophenolic acid. A consensus panel report. Clin Biochem. 1998;31: 317-322. (Pubitemid 28385228)
10. Cox VC, Ensom MH. Mycophenolate mofetil for solid organ transplantation: does the evidence support the need for clinical pharmacokinetic monitoring? Ther Drug Monit. 2003;25:137-157. (Pubitemid 36373421)
11. Shaw LM, Sollinger HW, Halloran P, et al. Mycophenolate mofetil: a report of the consensus panel. Ther Drug Monit. 1995;17:690-699.
12. Hale MD, Nicholls AJ, Bullingham RES, et al. The pharmacokinetic- pharmacodynamic relationship for mycophenolate mofetil in renal transplantation. Clin Pharmacol Ther. 1998;64:672-683. (Pubitemid 29011387)
13. Oellerich M, Shipkova M, Schutz E, et al. Pharmacokinetic and metabolic investigations of mycophenolic acid in pediatric renal transplant recipients: implications for therapeutic drug monitoring. German Study Group on Mycophenolate Mofetil Therapy in Pediatric Renal Transplant Recipients. Ther Drug Monit. 2000;22:20-26. (Pubitemid 30083090)
14. Shaw LM, Korecka M, DeNofrio D, et al. Pharmacokinetic, pharmacodynamic, and outcome investigations as the basis for mycophenolic acid therapeutic drug monitoring in renal transplant patients. Clin Biochem. 2001;34:17-22. (Pubitemid 32178501)
15. van Gelder T, Hilbrands L, 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. (Pubitemid 29360288)
16. Nicholls A. Opportunities for therapeutic monitoring of mycophenolate mofetil dose in renal transplantation suggested by the pharmacokineticspharmacodynamic relationship for mycophenolic acid and suppression of rejection. Clin Biochem. 1998;31:329-333. (Pubitemid 28385230)
17. Staatz CE, Tett SE. Clinical pharmacokinetics and pharmacodynamics of mycophenolate in solid organ transplant recipients. Clin Pharmacokinet. 2007;46:13-58. (Pubitemid 46091591)
18. Filler G, Mai J. Limited sampling strategy for mycophenolic acid area under the curve. Ther Drug Monit. 2000;22:169-173. (Pubitemid 30196820)
19. 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. (Pubitemid 34925784)
20. Miura M, Satoh S, Niioka T, et al. Early phase limited sampling strategy characterizing tacrolimus and mycophenolic acid pharmacokinetics adapted to the maintenance phase of renal transplant patients. Ther Drug Monit. 2009;31:467-474.
21. 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;32: 723-733.
22. Bruchet NK, Emson MHH. Limited sampling strategies for mycophenolic acid in solid transplantation: a systematic review. Expert Opin Drug Metab Toxicol. 2009;5:1079-1097.
23. de Winter BC, van Gelder T, Mathot RA, et al. Limited sampling strategies drawn within 3 hours postdose poorly predict mycophenolic acid area-under-the-curve after enteric-coated mycophenolate sodium. Ther Drug Monit. 2009;31:585-591.
24. Capone D, Tarantino G, Kadilli I, et al. Evalutation of mycophenolic acid systemic exposure by limited sampling strategy in kidney transplant recipients receiving enteric-coated mycophenolate sodium (EC-MPS) and cyclosporine. Nephrol Dial Transplant. 2011;26:3019-3025.
25. Sommerer C, Müller-Krebs S, Schaier M, et al. Pharmacokinetic and pharmacodynamic analysis of enteric-coated mycophenolate sodium: limited sampling strategies and clinical outcome in renal transplant patients. Br J Clin Pharmacol. 2010;69:346-357.
26. Emit 2000 Mycophenolic Acid Assay. Syva [package insert]. Newark, NJ: Siemens Healthcare Diagnostics; 2007.
27. Sheiner LB, Beal SL. Some suggestions for measuring predictive performance. J Pharmacokinet Biopharm. 1981;9:503-512.
28. Bland M, Altman DG. Statistical methods for assessing agreement between methods of clinical measurement. Lancet. 1986;1:307-310. (Pubitemid 16134762)
29. Arns W, Breuer S, Choudhury S, et al. Enteric-coated mycophenolate sodium delivers bioequivalent MPA exposure compared with mycophenolate mofetil. Clin Transplant. 2005;19:199-206. (Pubitemid 40424890)
30. Kuypers DRJ, 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;5:341-358.
31. 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)
32. Glanemann M, Klupp J, Langrehr JM, et al. Mycophenolate mofetil is superior in combination with tacrolimus compared to cyclosporine for immunosuppressive therapy after liver transplantation. Transplant Proc. 2001;33:1069-1070. (Pubitemid 32237750)
33. Kaplan B, Meier-Kriesche HU, Minnick P, et al. Randomized calcineurin inhibitor cross over study to measure the pharmacokinetics of co-administered enteric-coated mycophenolate sodium. Clin Transplant. 2005;19: 551-558. (Pubitemid 40990669)