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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

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Published:25th Mar 2020
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.>

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