Conversion from Mycophenolate Mofetil to Enteric-Coated Mycophenolate Sodium in Stable Maintenance Renal Transplant Patients: Pooled Results from Three International, Multicenter Studies

Abstract

Background. Mycophenolate mofetil (MMF) is effective in renal transplant patients but concerns remain over its gastrointestinal (GI) tolerability. Enteric-coated mycophenolate sodium (EC-MPS; myfortic) has been developed with the intention of improving mycophenolic acid-related GI tolerability. Methods. Data were pooled in a planned analysis of three subprotocols of the myfortic Prospective Multicenter Study (n7yPROMS). In a 6-month study, efficacy and safety of converting stable renal transplant recipients from MMF to a bioequivalent dose of EC-MPS for mycophenolic acid exposure were evaluated. Treatment efficacy was recorded and graft function was assessed by measuring serum creatinine and estimating creatinine clearance . Adverse events (AEs) and infections were monitored and the incidence of EC-MPS dose changes was recorded. Results. A total of 588 patients were recruited, 564 (96%) of whom completed the study. The rate of treatment failure (defined as biopsy- proven acute rejection, graft loss, or death) was 1.9%, with no episodes of graft loss and only one death reported during the study. Renal function remained stable throughout the trial. EC- MPS was well tolerated; the majority of AEs were mild or moderate in severity. Dose reductions or interruptions were required by 6.3% and 1.9% of patients, respectively. Gastrointestinal AEs occurred in 138 patients( 23.5%). The rate of dose adjustment as a result of a GI AE was 2.2%. Conclusions. Equimolar conversion from MMF to EC- MPS in maintenance renal transplant patients was safe and maintained efficacy.