Enteric-coated mycophenolate sodium can be safely administered in maintenance renal transplant patients: Results of a 1-year study

With the objective of enhancing upper gastrointestinal (GI) tolerability, enteric-coated mycophenolate sodium (EC-MPS, myfortic(R), Novartis Pharma AG, Basel, Switzerland) has been developed. This double-blinded, 12-month study investigated whether renal transplant patients taking mycophenolate mofetil (MMF) can be safely converted to EC-MPS. Stable kidney transplant patients were randomized to receive EC-MPS (720 mg b. i. d.; n = 159) or continue receiving MMF (1000 mg b. i. d.; n = = 163). The incidence of GI adverse events (AEs) was similar at 3 months (primary endpoint: EC-MPS 26.4%; MMF 20.9%; p = NS) and at 12 months (EC-MPS 29.6%; MMF 24.5%; p = NS). The increase from baseline in mean GI AE severity score, adjusted for duration, tended to be lower in EC-MPS patients (3 months: 0.15 vs. 0.20; 12 months: 0.23 vs. 0.47; p = NS). Neutropenia ( < 1500 cells/mm(3)) within the first 3 months (coprimary endpoint) was low in both groups(EC-MPS 0.6%; MMF 3.1%; p = NS). Although the overall incidence of infections was similar, the number of serious infections was significantly lower in EC-MPS patients (8.8% vs. 16.0%; p < 0.05). Similar rates of efficacy failure (EC-MPS 2.5%; MMF 6.1%; p = NS), biopsy-proven acute rejection (EC-MPS 1.3%; MMF 3.1%; p = NS) and biopsy-proven chronic rejection (EC-MPS 3.8%; MMF 4.9%; p = NS) were observed in both groups. In conclusion, renal maintenance patients can be converted from MMF to EC-MPS without compromising the safety and efficacy profile associated with MMF.