Is a standard fixed dose of mycophenolate mofetil ideal for all patients?

Nephrology Dialysis Transplantation

Volumn 22, Issue 12, 2007, Pages 3638-3645

  Yau, Wai Ping ^a   Vathsala, Anantharaman ^b   Lou, Huei Xin ^b   Chan, Eli ^a  

^a NATIONAL UNIVERSITY OF SINGAPORE   (Singapore)

^b SINGAPORE GENERAL HOSPITAL   (Singapore)

Author keywords

Asian; Cyclosporine; Mycophenolic acid; Pharmacokinetics; Renal transplant; Weight adjusted dosing

Indexed keywords

COTRIMOXAZOLE; CYCLOSPORIN A; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; PREDNISOLONE;

ADULT; AREA UNDER THE CURVE; ARTICLE; BLOOD SAMPLING; CHINESE; CONTROLLED STUDY; CORRELATION ANALYSIS; FEMALE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; INDIAN; KIDNEY GRAFT REJECTION; KIDNEY TRANSPLANTATION; MAJOR CLINICAL STUDY; MALAYSIA; MALE; PRIORITY JOURNAL; STATISTICAL SIGNIFICANCE;

ADRENAL CORTEX HORMONES; ASIAN CONTINENTAL ANCESTRY GROUP; BODY WEIGHT; CYCLOSPORINE; FEMALE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; KIDNEY TRANSPLANTATION; MALE; MYCOPHENOLIC ACID; PROSPECTIVE STUDIES;

EID: 35549013341     PISSN: 09310509     EISSN: 14602385     Source Type: Journal    
DOI: 10.1093/ndt/gfm468     Document Type: Article

References (39)

1. European Mycophenolate Mofetil Co-operative Study Group. Placebo-controlled study of mycophenolate mofetil combined with cyclosporin and corticosteroids for prevention of acute rejection. Lancet 1995; 345: 1321-1325
2. Sollinger HW. Mycophenolate mofetil for the prevention of acute rejection in primary cadaveric renal allograft recipients. U.S. Renal Transplant Mycophenolate Mofetil Study Group. Transplantation 1995; 60: 225-232
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. Shapiro R, Jordan ML, Scantlebury VP et al. A prospective, randomized trial of tacrolimus/prednisone versus tacrolimus/prednisone/ mycophenolate mofetil in renal transplant recipients. Transplantation 1999; 67: 411-415
5. Miller J, Mendez R, Pirsch JD, Jensik SC. Safety and efficacy of tacrolimus in combination with mycophenolate mofetil (MMF) in cadaveric renal transplant recipients. FK506/MMF Dose-Ranging Kidney Transplant Study Group. Transplantation 2000; 69: 875-880
6. Johnson C, Ahsan N, Gonwa T et al. Randomized trial of tacrolimus (Prograf) in combination with azathioprine or mycophenolate mofetil versus cyclosporine (Neoral) with mycophenolate mofetil after cadaveric kidney transplantation. Transplantation 2000; 69: 834-841
7. Jain A, Kashyap R, Dodson F et al. A prospective randomized trial of tacrolimus and prednisone versus tacrolimus, prednisone and mycophenolate mofetil in primary adult liver transplantation: a single center report. Transplantation 2001; 72: 1091-1097
8. Kreis H, Cisterne JM, Land W et al. Sirolimus in association with mycophenolate mofetil induction for the prevention of acute graft rejection in renal allograft recipients. Transplantation 2000; 69: 1252-1260
9. Flechner SM, Kurian SM, Solez K et al. De novo kidney transplantation without use of calcineurin inhibitors preserves renal structure and function at two years. Am J Transplant 2004; 4: 1776-1785
10. Lo A, Egidi MF, Gaber LW et al. Comparison of sirolimus-based calcineurin inhibitor-sparing and calcineurin inhibitor-free regimens in cadaveric renal transplantation. Transplantation 2004; 77: 1228-1235
11. Hamdy AF, El-Agroudy AE, Bakr MA et al. Comparison of sirolimus with low-dose tacrolimus versus sirolimus-based calcineurin inhibitor-free regimen in live donor renal transplantation. Am J Transplant 2005; 5: 2531-2538
12. Larson TS, Dean PG, Stegall MD et al. Complete avoidance of calcineurin inhibitors in renal transplantation: a randomized trial comparing sirolimus and tacrolimus. Am J Transplant 2006; 6: 514-522
13. Neylan JF. Immunosuppressive therapy in high-risk transplant patients: dose-dependent efficacy of mycophenolate mofetil in African-American renal allograft recipients. U.S. Renal Transplant Mycophenolate Mofetil Study Group. Transplantation 1997; 64: 1277-1282
14. Krumme B, Wollenberg K, Kirste G, Schollmeyer P. Drug monitoring of mycophenolic acid in the early period after renal transplantation. Transplant Proc 1998; 30: 1773-1774
15. Hale MD, Nicholls AJ, Bullingham RE et al. The pharmacokinetic-pharmacodynamic relationship for mycophenolate mofetil in renal transplantation. Clin Pharmacol Ther 1998; 64: 672-683
16. 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: 759-768
17. Lu YP, Lin B, Liang MZ et al. Correlation of mycophenolic acid pharmacokinetic parameters with side effects in Chinese kidney transplant recipients treated with mycophenolate mofetil. Transplant Proc 2004; 36: 2079-2081
18. Smak Gregoor PJH, Hesse CJ, van Gelder T et al. Relation of mycophenolic acid trough levels and adverse events in kidney allograft recipients. Transplant Proc 1998; 30: 1192-1193
19. Hübner GI, Eismann R, Sziegoleit W. Relationship between mycophenolate mofetil side effects and mycophenolic acid plasma trough levels in renal transplant patients. Arzneimittelforschung 2000; 50: 936-940
20. Mourad M, Malaise J, Chaib Eddour D et al. Correlation of mycophenolic acid pharmacokinetic parameters with side effects in kidney transplant patients treated with mycophenolate mofetil. Clin Chem 2001; 47: 88-94
21. Mourad M, Malaise J, Chaib Eddour D et al. Pharmacokinetic basis for the efficient and safe use of low-dose mycophenolate mofetil in combination with tacrolimus in kidney transplantation. Clin Chem 2001; 47: 1241-1248
22. Kuypers DR, Claes K, Evenepoel P, Maes B, Vanrenterghem Y. 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: 434-447
23. Weber LT, Shipkova M, Lamersdorf T et al. Pharmacokinetics of mycophenolic acid (MPA) and determinants of MPA free fraction in pediatric and adult renal transplant recipients. J Am Soc Nephrol 1998; 9: 1511-1520
24. Suhail SM, Vathsala A, Lou HX, Woo KT. Safety and efficacy of mycophenolate mofetil for prophylaxis in Asian renal transplant recipients. Transplant Proc 2000; 32: 1757-1758
25. Tsang WK, Tong KL, Yeung S, Lee W, Chan HW. Efficacy and safety of mycophenolate mofetil in different dosages in Asian renal allograft recipients. Transplant Proc 2000; 32: 1755-1756
26. Wang X, Tang X, Xu D. Immunosuppressive effect of mycophenolate mofetil with two different dosages in cadaveric renal transplantation: a short study. Transplant Proc 1998; 30: 3573-3574
27. Julasareekul W, Eiam-Ong S, Bejraputra O, Seublinvong T. Pharmacokinetics of mycophenolic acid in kidney transplant recipients treated with a low dose (1 gram/day) of mycophenolate mofetil. J Med Assoc Thai 2003; 86: 766-771
28. Jirasiritham S, Sumethkul V, Mavichak V, Na-Bangchang K. The pharmacokinetics of mycophenolate mofetil in Thai kidney transplant recipients. Transplant Proc 2004; 36: 2076-2078
29. Cho EK, Han DJ, Kim SC, Burchart GJ, Venkataramanan R, Oh JM. Pharmacokinetic study of mycophenolic acid in Korean kidney transplant patients. J Clin Pharmacol 2004; 44: 743-750
30. Naito T, Shinno K, Maeda T et al. Effects of calcineurin inhibitors on pharmacokinetics of mycophenolic acid and its glucuronide metabolite during the maintenance period following renal transplantation. Biol Pharm Bull 2006; 29: 275-280
31. Satoh S, Tada H, Murakami M et al. The influence of mycophenolate mofetil versus azathioprine and mycophenolic acid pharmacokinetics on the incidence of acute rejection and infectious complications after renal transplantation. Transplant Proc 2005; 37: 1751-1753
32. Sugioka N, Sasaki T, Kokuhu T et al. Clinical pharmacokinetics of mycophenolate mofetil in Japanese renal transplant recipients: a retrospective cohort study in a single center. Biol Pharm Bull 2006; 29: 2099-2105
33. Satoh S, Tada H, Murakami M et al. Circadian pharmacokinetics of mycophenolic acid and implication of genetic polymorphisms for early clinical events in renal transplant recipients. Transplantation 2006; 82: 486-493
34. Vathsala A, Lu YM. Abbreviated cyclosporine pharmacokinetic profiling in clinical renal transplantation: from principles to practice. Transplant Proc 2001; 33: 3137-3139
35. Yau WP, Vathsala A, Lou HX, Chan E. Simple reversed-phase ion-pair liquid chromatography assay for the simultaneous determination of mycophenolic acid and its glucuronide metabolite in human plasma and urine. J Chromatogr B Analyt Technol Biomed Life Sci 2004; 805: 101-112
36. Pöge U, Gerhardt T, Palmedo H, Klehr H-U, Sauerbruch T, Woitas RP. MDRD equations for estimation of GFR in renal transplant recipients. Am J Transplant 2005; 5: 1306-1311
37. Shaw LM, Holt DW, Oellerich M, Meiser B, van Gelder T. Current issues in therapeutic drug monitoring of mycophenolic acid: report of a roundtable discussion. Ther Drug Monit 2001; 23: 305-315
38. Brunet M, Martorell J, Oppenheimer F et al. Pharmacokinetics and pharmacodynamics of mycophenolic acid in stable renal transplant recipients treated with low doses of mycophenolate mofetil. Transpl Int 2000; 13 [Suppl 1]: S301-S305
39. Behrend M, Lueck R, Pichlmayr R. Mycophenolic acid and mycophenolic acid glucuronide trough levels after renal transplantation. Transplant Proc 1997; 29: 2936-2938