Long-term administration of enteric-coated mycophenolate sodium in kidney transplant patients

A large-scale, controlled clinical study has shown that enteric-coated mycophenolate sodium (EC-MPS) is therapeutically equivalent to mycophenolate mofetil (MMF) in de novo renal transplant patients. Safety and efficacy outcomes from an open-label extension of this core study (n = 122) were compared to those of the MMF arm of two well-controlled randomized studies (RAD B251, n = 141, and RAD B201, n = 150) for the 12- to 36-month posttransplant period. During this period, 33 (27%) EC-MPS patients experienced one or more drug-related adverse event. Sixteen patients (13%) discontinued the extension study due to adverse events. The incidence of all safety parameters was similar in the EC-MPS patients and the MMF-treated patients in the RAD B201 and RAD B251 studies during the 12- to 36-month posttransplant period, as was the frequency of adverse events, infections, malignancies, and hematological abnormalities. During the 24 months of the EC-MPS extension study, four patients died and two lost their graft. Biopsy-proven acute rejection (BPAR) occurred in four patients (3.3%). BPAR, graft loss, and death occurred in a similar proportion of MMF-treated patients in the RAD B201 and RAD B251 studies during months 12 to 36 posttransplant. These findings confirm the safety and efficacy of EC-MPS in maintenance transplant patients at least 1 year posttransplant and suggest that outcomes with EC-MPS are comparable to MMF in this population when used in combination with CsA-ME and steroids.