title: Comparing outcomes associated with dose manipulations of enteric-coated mycophenolate sodium versus mycophenolate mofetil in renal transplant recipients.
abstract: BACKGROUND
  This study assessed the incidence of reported gastrointestinal (GI) complications in patients treated with enteric-coated mycophenolate sodium (EC-MPS) versus mycophenolate mofetil (MMF) and to examine the impact of dose manipulations on biopsy-proven acute rejection (BPAR).
  
  
  METHODS
  A retrospective study was conducted in 379 renal transplant recipients initiated on EC-MPS or MMF through 3-months posttransplant between the years of 2001 to 2007. Descriptive univariate analyses were used for comparisons of baseline characteristics and outcome measures between the cohorts. A Cox proportional hazards model was used to evaluate the time to a first BPAR event.
  
  
  RESULTS
  GI complications occurred at an incidence of 52.8% and 48.9% in the EC-MPS and MMF cohorts, respectively (NS). Patients requiring dose manipulations due to GI complications were 19.7% with EC-MPS and 25.3% with MMF (NS). The mean equimolar dose reduction below 2000 mg was 930+/-292.13 mg with EC-MPS and 933+/-173.95 mg with MMF (NS). Patients treated with EC-MPS experienced significantly fewer BPAR episodes than those treated with MMF (14% EC-MPS vs. 23.1% MMF; P =0.0221).
  
  
  CONCLUSIONS
  In this study, EC-MPS had a similar incidence of GI complications and dose manipulations compared with MMF. Despite similar GI complication rates and dose manipulations, treatment with EC-MPS seemed to result in a lower incidence of BPAR. Based on these observations, more studies need to be conducted to evaluate risks for BPAR relating to mycophenolic acid product.
authors.affiliation: Division of Transplantation, University of Maryland School of Medicine, Baltimore, MD 21201, USA. mcooper@smail.umaryland.edu
authors.forename: Matthew
authors.initials: M
authors.lastname: Cooper
authors.forename: Kathleen L
authors.initials: KL
authors.lastname: Deering
authors.forename: Douglas P
authors.initials: DP
authors.lastname: Slakey
authors.forename: Qing
authors.initials: Q
authors.lastname: Harshaw
authors.forename: Stephen
authors.initials: S
authors.lastname: Arcona
authors.forename: Erin L
authors.initials: EL
authors.lastname: McCann
authors.forename: Flavia A
authors.initials: FA
authors.lastname: Rasetto
authors.forename: Sander S
authors.initials: SS
authors.lastname: Florman
mesh_terms: D000368:Aged; D015331:Cohort Studies; D004305:Dose-Response Relationship, Drug; D005260:Female; D041981:Gastrointestinal Tract / Q000187:drug effects; D006084:Graft Rejection / Q000188:drug therapy / Q000517:prevention & control; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D016030:Kidney Transplantation / Q000276:immunology*; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*; D016016:Proportional Hazards Models; D012189:Retrospective Studies; D012307:Risk Factors; D013608:Tablets, Enteric-Coated
chemical_list: D007166:Immunosuppressive Agents; D013608:Tablets, Enteric-Coated; D009173:Mycophenolic Acid