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Association of mycophenolic acid dose with efficacy and safety events in kidney transplant patients receiving tacrolimus: an analysis of the Mycophenolic acid Observational REnal transplant registry
Author(s) -
Doria Cataldo,
Greenstein Stuart,
Narayanan Mohanram,
Ueda Kimi,
Wiland Anne,
McCague Kevin,
Sankari Bashir,
Chan Laurence
Publication year - 2012
Publication title -
clinical transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 76
eISSN - 1399-0012
pISSN - 0902-0063
DOI - 10.1111/ctr.12035
Subject(s) - medicine , mycophenolic acid , tacrolimus , discontinuation , adverse effect , urology , kidney transplantation , mycophenolate , transplantation , gastroenterology , immunosuppression , surgery
Background Dose‐finding studies for mycophenolic acid ( MPA ) in tacrolimus‐treated kidney transplant patients are lacking. Methods Data from 901 de novo kidney transplant recipients enrolled in the prospective, non‐interventional Mycophenolic acid Observational REnal (MORE) transplant registry were analyzed according to baseline daily MPA dose (<2000, 2000 or >2000 mg). Results The proportion of patients receiving 2000 and <2000 mg was 77.6% and 19.9% at baseline, 74.5% and 23.3% at month 1, 62.4% and 35.5% at month 3, 48.5% and 50.2% at month 6, and 44.1% and 55.2% at month 12. More patients were maintained on 2000 mg with enteric‐coated mycophenolate sodium ( EC ‐ MPS ) vs. mycophenolate mofetil (month 6, 52.7% vs. 43.0% [p = 0.02]; month 12, 47.3% vs. 39.4% [p = 0.08]). Multivariate modeling showed no significant effect of baseline MPA dose on 12‐month risk of biopsy‐proven acute rejection, graft loss or estimated GFR , or on safety events including MPA discontinuation other than a higher rate of gastrointestinal adverse events in patients with an initial MPA dose >2000 mg (p = 0.029) vs. 2000 mg. Conclusions These findings suggest that an initial MPA dose of <2000 mg does not compromise 12‐month efficacy in tacrolimus‐treated kidney transplants, but controlled trials are required and the lower threshold for MPA dose remains to be defined.