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

Transplantation Proceedings

Volumn 41, Issue 9, 2009, Pages 3683-3689

  Bilodeau, J F ^a   Montambault, P ^a   Wolff, J L ^a   Lemire, J ^a   Masse, M ^a  

^a CHUS ^*

Author keywords

[No Author keywords available]

Indexed keywords

CREATININE; CYCLOSPORIN; MYCOPHENOLIC ACID; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; TACROLIMUS;

ACUTE GRAFT REJECTION; ADULT; ARTICLE; CLINICAL ARTICLE; CLINICAL EVALUATION; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DIARRHEA; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; DRUG SUBSTITUTION; DRUG TOLERABILITY; DRUG WITHDRAWAL; ENTERIC COATED TABLET; EVENING DOSAGE; FEMALE; GASTROINTESTINAL SYMPTOM; GRAFT RECIPIENT; HUMAN; IMMUNOSUPPRESSIVE TREATMENT; KIDNEY TRANSPLANTATION; MAINTENANCE DRUG DOSE; MALE; MULTICENTER STUDY; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; RATING SCALE; TREATMENT DURATION;

ADULT; AGED; CYCLOSPORINE; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG TOLERANCE; FEMALE; GASTROINTESTINAL DISEASES; HUMANS; IMMUNOSUPPRESSIVE AGENTS; KIDNEY TRANSPLANTATION; MALE; MIDDLE AGED; MYCOPHENOLIC ACID; PROSPECTIVE STUDIES; SAFETY; TABLETS, ENTERIC-COATED; TACROLIMUS;

EID: 72049092687     PISSN: 00411345     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.transproceed.2009.06.183     Document Type: Article

References (38)

1. ®. 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 345 (1995) 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 61 (1996) 1029
4. Miller J., Mendez R., Pirsch J.D., 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 69 (2000) 875
5. Shapiro R., Jordan M.L., Scantlebury V.P., et al. A prospective, randomized trial of tacrolimus/prednisone versus tacrolimus/prednisone/mycophenolate mofetil in renal transplant recipients. Transplantation 67 (1999) 411
6. Sollinger H.W. Mycophenolate mofetil for the prevention of acute rejection in primary cadaveric renal allograft recipients. U.S. Renal Transplant Mycophenolate Mofetil Study Group. Transplantation 60 (1995) 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 63 (1997) 39
8. Hale M.D., Nicholls A.J., Bullingham R.E., et al. The pharmacokinetic-pharmacodynamic relationship for mycophenolate mofetil in renal transplantation. Clin Pharmacol Ther 64 (1998) 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 7 (2007) 2496
10. van Gelder T., Hilbrands L.B., 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 68 (1999) 261
11. Neri L., Rocca Rey L.A., Pinsky B.W., et al. Increased risk of graft failure in kidney transplant recipients after a diagnosis of dyspepsia or gastroesophageal reflux disease. Transplantation 85 (2008) 344
12. Bunnapradist S., Lentine K.L., Burroughs T.E., et al. Mycophenolate mofetil dose reductions and discontinuations after gastrointestinal complications are associated with renal transplant graft failure. Transplantation 82 (2006) 102
13. Machnicki G., Ricci J.F., Brennan D.C., et al. Economic impact and long-term graft outcomes of mycophenolate mofetil dosage modifications following gastrointestinal complications in renal transplant recipients. Pharmacoeconomics 26 (2008) 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 86 (2008) 371
15. Pelletier R.P., Akin B., Henry M.L., et al. The impact of mycophenolate mofetil dosing patterns on clinical outcome after renal transplantation. Clin Transplant 17 (2003) 200
16. Takemoto S.K., Pinsky B.W., Schnitzler M.A., et al. A retrospective analysis of immunosuppression compliance, dose reduction and discontinuation in kidney transplant recipients. Am J Transplant 7 (2007) 2704
17. Tierce J.C., Porterfield-Baxa J., Petrilla A.A., 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 19 (2005) 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 33 (2001) 3238
19. Bolin P., Tanriover B., Zibari G.B., 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 84 (2007) 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 81 (2006) 1290
21. Darji P., Vijayaraghavan R., Thiagarajan C.M., et al. Conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium in renal transplant recipients with gastrointestinal tract disorders. Transplant Proc 40 (2008) 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 4 (2004) 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 4 (2004) 237
24. Sollinger H. Enteric-coated mycophenolate sodium: therapeutic equivalence to mycophenolate mofetil in de novo renal transplant patients. Transplant Proc 36 (2004) 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 66 (2006) 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 37 (2005) 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 38 (2006) 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 39 (2007) 103
29. Meneses Rde P., and Kotsifas C.H. Benefits of conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium in pediatric renal transplant patients with stable graft function. Pediatr Transplant 13 (2009) 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 12 (2008) 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 15 (2006) 1223
32. de Winter B.C., 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 47 (2008) 827
33. Knoll G.A., MacDonald I., Khan A., et al. Mycophenolate mofetil dose reduction and the risk of acute rejection after renal transplantation. J Am Soc Nephrol 14 (2003) 2381
34. van Gelder T., Silva H.T., de Fijter J.W., et al. Comparing mycophenolate mofetil regimens for de novo renal transplant recipients: the fixed-dose concentration-controlled trial. Transplantation 86 (2008) 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 B.J., Borrows R.J., Fung C.L., et al. The natural history of chronic allograft nephropathy. N Engl J Med 349 (2003) 2326
37. Ojo A.O., Held P.J., Port F.K., et al. Chronic renal failure after transplantation of a nonrenal organ. N Engl J Med 349 (2003) 931
38. Kuypers D.R., 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 30 (2008) 673