Conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium in maintenance renal transplant patients: preliminary results from the myfortic prospective multicenter study.

Mycophenolate mofetil (MMF), in combination with cyclosporine and corticosteroids, improves long-term graft survival in renal transplant recipients. However, optimal MMF therapy may be limited by gastrointestinal (GI) intolerance, which may result in the need for MMF dose reduction, interruption, or discontinuation, leading to increased risk of acute rejection. Enteric-coated mycophenolate sodium (EC-MPS) is a new formulation delivering mycophenolic acid developed with the aim of improving upper GI tolerability. A large prospective, open-label, multicenter program (myPROMS: myfortic PROspective Multicenter Study) is underway to determine the efficacy and safety of EC-MPS, in combination with cyclosporine microemulsion (CsA; Neoral) in a large population of de novo and maintenance renal transplant recipients. myPROMS consists of one global protocol with 14 subprotocols. Each subprotocol is designed to address further specific objectives, such as specific patient populations, steroid regimens, and various CsA C2 targets. The preliminary data summarized here are from two subprotocols, which investigated the benefits of converting maintenance renal transplant patients receiving MMF to EC-MPS. The 3-month interim analyses suggest that the conversion from MMF to EC-MPS is well tolerated in maintenance renal transplant recipients.