Enteric-Coated Mycophenolate Sodium is Therapeutically Equivalent to Mycophenolate Mofetil in de novo Renal Transplant Patients

Maurizio Salvadori, Herwig Holzer, Angelo De Mattos, Hans Sollinger, Wolfgang Arns, Federico Oppenheimer, Jeff Maca, Michael Hall

Research output: Contribution to journalArticlepeer-review

257 Scopus citations

Abstract

The 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 novo kidney 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, + 8.01) 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 2 2.5% 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.

Original languageEnglish (US)
Pages (from-to)231-236
Number of pages6
JournalAmerican Journal of Transplantation
Volume4
Issue number2
DOIs
StatePublished - Feb 2004

Keywords

  • EC-MPS
  • Efficacy
  • Enteric-coated mycophenolate sodium
  • Immunosuppression
  • MMF
  • MPA
  • Mycophenolate mofetil
  • Mycophenolic acid
  • Myfortic®
  • Renal transplant

ASJC Scopus subject areas

  • Immunology and Allergy
  • Transplantation
  • Pharmacology (medical)

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