Enteric Coated Mycophenolate Sodium is Therapeutically Equivalent to Mycophenolate Mofetil in de novoRenal Transplant Patients

Abstract

sThe introduction of mycophenolate mofetil (MMF) represented a major advance in transplant medicine, although optimal use may be limited by gastrointestinal (GI) side effects. An enteric coated formulation of mycophenolate sodium (EC MPS; myfortic®) has been developed with the aim of improving the upper GI tolerability of mycophenolic acid. Therapeutic equivalence of EC MPS (720 mg b.i.d.) and MMF (1000 mg MMF b.i.d.), with concomitant cyclosporine microemulsion (Neoral®) and corticosteroids, was assessed in 423 de novokidney transplant patients recruited to a 12 month, double blind study. Efficacy failure (biopsy proven acute rejection [BPAR], graft loss, death or loss to follow up) at 6 months (EC MPS 25.8% vs. MMF 26.2%; 95% CI: [−8.7, +8.0]) demonstrated therapeutic equivalence. At 12 months, the incidence of BPAR, graft loss or death was 26.3% and 28.1%, and of BPAR alone was 22.5% and 24.3% for EC MPS and MMF, respectively. Among those with BPAR, the incidence of severe acute rejection was 2.1% with EC MPS and 9.8% with MMF (p = ns). The safety profile and incidence of GI adverse events were similar for both groups. Within 12 months, 15.0% of EC MPS patients and 19.5% of MMF patients required dose changes for GI adverse events (p = ns). Enteric coated MPS 720 mg b.i.d. is therapeutically equivalent to MMF 1000 mg b.i.d. with a comparable safety profile.