title: 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.
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.
authors.affiliation: Department of Transplant Surgery, Thomas Jefferson University Hospital, Philadelphia, PA 19107-5563, USA. cataldo.doria@jefferson.edu
authors.forename: Cataldo
authors.initials: C
authors.lastname: Doria
authors.forename: Stuart
authors.initials: S
authors.lastname: Greenstein
authors.forename: Mohanram
authors.initials: M
authors.lastname: Narayanan
authors.forename: Kimi
authors.initials: K
authors.lastname: Ueda
authors.forename: Anne
authors.initials: A
authors.lastname: Wiland
authors.forename: Kevin
authors.initials: K
authors.lastname: McCague
authors.forename: Bashir
authors.initials: B
authors.lastname: Sankari
authors.forename: Laurence
authors.initials: L
authors.lastname: Chan
mesh_terms: D000903:Antibiotics, Antineoplastic / Q000627:therapeutic use; D005260:Female; D005500:Follow-Up Studies; D005919:Glomerular Filtration Rate; D006084:Graft Rejection / Q000517:prevention & control*; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007674:Kidney Diseases / Q000601:surgery*; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000627:therapeutic use*; D011183:Postoperative Complications / Q000517:prevention & control*; D011446:Prospective Studies; D012449:Safety; D016559:Tacrolimus / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000903:Antibiotics, Antineoplastic; D007166:Immunosuppressive Agents; D009173:Mycophenolic Acid; D016559:Tacrolimus