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

Cataldo Doria, Stuart Greenstein, Mohanram Narayanan, Kimi Ueda, Anne Wiland, Kevin McCague, Bashir Sankari, Laurence Chan

Research output: Contribution to journalArticle

5 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)E602-E611
JournalClinical Transplantation
Volume26
Issue number6
DOIs
StatePublished - Nov 2012

Keywords

  • Immunosuppression
  • Kidney transplantation
  • Mycophenolic acid
  • Outcomes

ASJC Scopus subject areas

  • Transplantation

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