Enteric-coated Mycophenolate Sodium (myfortic??): An Overview of Current and Future Use in Transplantation

Abstract

Mycophenolic acid (MPA) exerts a potent immunosuppressive effect via a number of distinct mechanisms. Use of the mycophenolate mofetil (MMF) formulation is associated with significant efficacy benefits, but gastrointestinal adverse events frequently necessitate dose reductions, interruptions or discontinuation. Enteric-coated mycophenolate sodium (EC-MPS) delays the release of MPA until the small intestine. Pivotal trials in renal transplant patients have demonstrated equivalent efficacy and safety of EC-MPS and MMF. The myfortic® Prospective Multicenter Study (myPROMS) is an international clinical trial of EC-MPS, with 14 subprotocols and 1700 patients, in de novo and maintenance renal transplant patients receiving cyclosporine, with or without corticosteroids. Results from three myPROMS studies have confirmed that maintenance patients can be safely converted from MMF to EC-MPS. Evidence from the US and European myPROMS studies have shown that EC-MPS and cyclosporine provide good efficacy with a favorable safety profile (including gastrointestinal tolerability) regardless of whether higher or lower cyclosporine C2 targets are used. In terms of quality of life, interim results from the Patient Reported Outcomes in renal transplant patients with or without GastroIntestinal Symptoms (PROGIS) study suggest that the conversion of MMF-treated patients with gastrointestinal complaints to EC-MPS may be associated with a significant improvement in gastrointestinal burden, health-related quality of life and psychological well-being. However these data will need to be confirmed in a true controlled trial. Only limited data from clinical trials of EC-MPS in non-renal transplantation are currently available.