Transplantation Proceedings
Volume 41, Issue 9 , Pages 3683-3689 , November 2009

Evaluation of Tolerability and Ability to Increase Immunosuppression in Renal Transplant Patients Converted From Mycophenolate Mofetil to Enteric-Coated Mycophenolate Sodium

References 

  1. CellCept®. Hoffmann La-Roche Ltd, 2008
  2. European Mycophenolate Mofetil Cooperative Study Group. Placebo-controlled study of mycophenolate mofetil combined with cyclosporin and corticosteroids for prevention of acute rejection. Lancet. 1995;345:1321
  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
  4. Miller J, Mendez R, Pirsch JD, et al. 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
  5. 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
  6. 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
  7. Halloran P, Mathew T, Tomlanovich S, et al. Mycophenolate mofetil in renal allograft recipients: a pooled efficacy analysis of three randomized, double-blind, clinical studies in prevention of rejection (The International Mycophenolate Mofetil Renal Transplant Study Groups). Transplantation. 1997;63:39
  8. Hale MD, Nicholls AJ, Bullingham RE, et al. The pharmacokinetic-pharmacodynamic relationship for mycophenolate mofetil in renal transplantation. Clin Pharmacol Ther. 1998;64:672
  9. 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
  10. van Gelder T, Hilbrands LB, 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
  11. Neri L, Rocca Rey LA, Pinsky BW, et al. Increased risk of graft failure in kidney transplant recipients after a diagnosis of dyspepsia or gastroesophageal reflux disease. Transplantation. 2008;85:344
  12. Bunnapradist S, Lentine KL, Burroughs TE, et al. Mycophenolate mofetil dose reductions and discontinuations after gastrointestinal complications are associated with renal transplant graft failure. Transplantation. 2006;82:102
  13. Machnicki G, Ricci JF, Brennan DC, et al. Economic impact and long-term graft outcomes of mycophenolate mofetil dosage modifications following gastrointestinal complications in renal transplant recipients. Pharmacoeconomics. 2008;26:951
  14. Opelz G, Dohler B, et al. Effect on kidney graft survival of reducing or discontinuing maintenance immunosuppression after the first year posttransplant. Transplantation. 2008;86:371
  15. Pelletier RP, Akin B, Henry ML, et al. The impact of mycophenolate mofetil dosing patterns on clinical outcome after renal transplantation. Clin Transplant. 2003;17:200
  16. Takemoto SK, Pinsky BW, Schnitzler MA, et al. A retrospective analysis of immunosuppression compliance, dose reduction and discontinuation in kidney transplant recipients. Am J Transplant. 2007;7:2704
  17. Tierce JC, Porterfield-Baxa J, Petrilla AA, et al. Impact of mycophenolate mofetil (MMF)-related gastrointestinal complications and MMF dose alterations on transplant outcomes and healthcare costs in renal transplant recipients. Clin Transplant. 2005;19:779
  18. Bjarnason I. Enteric coating of mycophenolate sodium: a rational approach to limit topical gastrointestinal lesions and extend the therapeutic index of mycophenolate. Transplant Proc. 2001;33:3238
  19. Bolin P, Tanriover B, Zibari GB, et al. Improvement in 3-month patient-reported gastrointestinal symptoms after conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium in renal transplant patients. Transplantation. 2007;84:1443
  20. Chan L, Mulgaonkar S, Walker R, et al. Patient-reported gastrointestinal symptom burden and health-related quality of life following conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium. Transplantation. 2006;81:1290
  21. Darji P, Vijayaraghavan R, Thiagarajan CM, et al. Conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium in renal transplant recipients with gastrointestinal tract disorders. Transplant Proc. 2008;40:2262
  22. 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. 2004;4:231
  23. 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. 2004;4:237
  24. Sollinger H. Enteric-coated mycophenolate sodium: therapeutic equivalence to mycophenolate mofetil in de novo renal transplant patients. Transplant Proc. 2004;36:517S
  25. Budde K, Knoll G, Curtis J, et al. Long-term safety and efficacy after conversion of maintenance renal transplant recipients from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPA, myfortic). Clin Nephrol. 2006;66:103
  26. Budde K, Knoll G, Curtis J, et al. Safety and efficacy after conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium: results of a 1-year extension study. Transplant Proc. 2005;37:912
  27. Nashan B, Suwelack B, Ivens K, et al. Conversion to enteric-coated mycophenolate sodium from various doses of mycophenolate mofetil: results of a prospective international multicenter trial in maintenance renal transplant patients receiving cyclosporine. Transplant Proc. 2006;38:2856
  28. Pietruck F, Abbud-Filho M, Vathsala A, et al. Conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium in stable maintenance renal transplant patients: pooled results from three international, multicenter studies. Transplant Proc. 2007;39:103
  29. Meneses Rde P, Kotsifas CH. Benefits of conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium in pediatric renal transplant patients with stable graft function. Pediatr Transplant. 2009;13:188
  30. Pape L, Ahlenstiel T, Kreuzer M, et al. Improved gastrointestinal symptom burden after conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium in kidney transplanted children. Pediatr Transplant. 2008;12:640
  31. Kleinman L, Kilburg A, Machnicki G, et al. Using GI-specific patient outcome measures in renal transplant patients: validation of the GSRS and GIQLI. Qual Life Res. 2006;15:1223
  32. 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
  33. 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;14:2381
  34. 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;86:1043
  35. Shehata M, Bhandari S, Venkat-Raman G, et al. Effect of conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium on maximum tolerated dose and gastrointestinal symptoms following kidney transplantation. Transpl Int. 2009;Apr 7 [Epub ahead of print]
  36. Nankivell BJ, Borrows RJ, Fung CL, et al. The natural history of chronic allograft nephropathy. N Engl J Med. 2003;349:2326
  37. Ojo AO, Held PJ, Port FK, et al. Chronic renal failure after transplantation of a nonrenal organ. N Engl J Med. 2003;349:931
  38. Kuypers DR, de Jonge H, Naesens M, et al. Current target ranges of mycophenolic acid exposure and drug-related adverse events: a 5-year, open-label, prospective, clinical follow-up study in renal allograft recipients. Clin Ther. 2008;30:673

 This study was sponsored by a grant from Novartis Canada.

PII: S0041-1345(09)01311-6

doi: 10.1016/j.transproceed.2009.06.183

Transplantation Proceedings
Volume 41, Issue 9 , Pages 3683-3689 , November 2009

Article Tools

* Image Usage & Resolution