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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
Article first published online: 2 NOV 2012
© 2012 John Wiley & Sons A/S.
Volume 26, Issue 6, pages E602–E611, November/December 2012
How to Cite
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., , , , , , , .
Conflict of interest: CD and LC have received speaker's honoraria from Novartis. KU has received speaker's fees, advisory board honoraria, and research funding from Novartis. AW and KM are employees of Novartis Pharmaceuticals Corporation. SG, MN, and BS have no conflicts of interest to declare.
- Issue published online: 6 DEC 2012
- Article first published online: 2 NOV 2012
- Manuscript Accepted: 5 JUN 2012
- Novartis Pharmaceuticals Corporation
- kidney transplantation;
- mycophenolic acid;
Dose-finding studies for mycophenolic acid (MPA) in tacrolimus-treated kidney transplant patients are lacking.
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).
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.
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.