Enteric-coated mycophenolate sodium versus mycophenolate mofetil maintenance immunosuppression: outcomes analysis of the United Network for Organ Sharing/Organ Procurement and Transplantation Network database.
BACKGROUND
A large, retrospective database analysis was conducted to evaluate the long-term outcomes of patients who received enteric-coated mycophenolate sodium (EC-MPS) versus mycophenolate mofetil (MMF) maintenance immunosuppression at the time of discharge.


METHODS
All primary kidney transplant patients who received either EC-MPS or MMF at time of discharge in the United Network for Organ Sharing/Organ Procurement and Transplantation Network database from 2004 to 2007 were included. Patients were excluded if they had received a previous kidney transplant, multiple organs, or combination therapy with everolimus at the time of discharge. Outcomes included graft failure, death-censored graft failure, and death with functioning graft, biopsy-proven acute rejection (BPAR), new-onset diabetes mellitus, and renal function. The propensity score method was used to adjust for nonrandomized treatment selection. A total of 48,458 patients were included in the analysis.


RESULTS
At time of discharge, 10.4% of patients received EC-MPS (n=5057) and 89.6% received MMF (n=43,401). Propensity score-adjusted regression analysis showed that patients who received EC-MPS were at increased risk of BPAR (hazards ratio, 1.167; 95% confidence interval, 1.056-1.129; P=0.002).


CONCLUSIONS
The adjusted BPAR rate difference at 3 years posttransplantation was less than 2% (13.6% vs. 11.7%); statistically significant because of the large number of patients included in the analysis, but a difference that may not be clinically meaningful. No differences in graft survival, new-onset diabetes mellitus, or renal function were observed between the treatment groups.
Irish
William
W
CTI, Clinical Trial and Consulting Services, Raleigh, NC 27615, USA. wirish@ctifacts.com
Arcona
Stephen
S
Gifford
Ryan J
RJ
Baillie
G Mark
GM
Cooper
Matthew
M
D019992:Databases as Topic; D004359:Drug Therapy, Combination; D000068338:Everolimus; D006084:Graft Rejection / Q000453:epidemiology; D006085:Graft Survival / Q000187:drug effects; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007677:Kidney Function Tests; D016030:Kidney Transplantation / Q000276:immunology*; D008727:Methotrexate / Q000627:therapeutic use; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000009:adverse effects* / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010351:Patient Discharge; D018579:Patient Selection; D012189:Retrospective Studies; D012307:Risk Factors; D020123:Sirolimus / Q000031:analogs & derivatives / Q000627:therapeutic use; D013608:Tablets, Enteric-Coated; D018183:Transplantation Chimera; D014184:Transplantation, Homologous / Q000276:immunology / Q000473:pathology; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D013608:Tablets, Enteric-Coated; D000068338:Everolimus; D009173:Mycophenolic Acid; D020123:Sirolimus; D008727:Methotrexate