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

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

Research output: Contribution to journalArticle

249 Citations (Scopus)

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
Externally publishedYes

Fingerprint

Mycophenolic Acid
Transplants
Kidney
Biopsy
Graft Rejection
Cyclosporine
Incidence
Safety
Double-Blind Method
Adrenal Cortex Hormones

Keywords

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

ASJC Scopus subject areas

  • Immunology

Cite this

Enteric-Coated Mycophenolate Sodium is Therapeutically Equivalent to Mycophenolate Mofetil in de novo Renal Transplant Patients. / Salvadori, Maurizio; Holzer, Herwig; DeMattos, Angelo M; Sollinger, Hans; Arns, Wolfgang; Oppenheimer, Federico; Maca, Jeff; Hall, Michael.

In: American Journal of Transplantation, Vol. 4, No. 2, 02.2004, p. 231-236.

Research output: Contribution to journalArticle

Salvadori, Maurizio ; Holzer, Herwig ; DeMattos, Angelo M ; Sollinger, Hans ; Arns, Wolfgang ; Oppenheimer, Federico ; Maca, Jeff ; Hall, Michael. / Enteric-Coated Mycophenolate Sodium is Therapeutically Equivalent to Mycophenolate Mofetil in de novo Renal Transplant Patients. In: American Journal of Transplantation. 2004 ; Vol. 4, No. 2. pp. 231-236.
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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{\circledR}) 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{\circledR}) 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.",
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