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Is Conversion from Mycophenolate Mofetil to Enteric-Coated Mycophenolate Sodium Justifiable for Gastrointestinal

Kyle M Gardiner1,2, Susan E Tett3, Christine E Staatz3

  • 1School of Pharmacy, University of Queensland, Brisbane, QLD, 4102, Australia. kyle.gardiner@qut.edu.au.

Drugs in R&D
|November 15, 2018
PubMed
Abstract

Insights

Enteric-coated mycophenolate sodium (EC-MPS) is replacing mycophenolate mofetil (MMF) for improved gastrointestinal (GI) quality of life. However, a review found high bias in studies, with low-bias studies showing no significant GI benefit from EC-MPS over MMF.

Area of Science:

  • Transplantation and immunology
  • Pharmacology
  • Gastroenterology

Background:

  • Enteric-coated mycophenolate sodium (EC-MPS) is increasingly used as a replacement for mycophenolate mofetil (MMF) in immunosuppressive therapy.
  • The primary driver for this switch is the claimed enhancement of gastrointestinal (GI) quality of life.

Purpose of the Study:

  • To critically evaluate the bias in existing studies comparing EC-MPS and MMF regarding GI outcomes.
  • To determine if current evidence supports the conversion from MMF to EC-MPS for GI benefit.

Main Methods:

  • A systematic literature search was performed following a pre-defined protocol.
  • Two independent reviewers assessed study quality using the Cochrane risk of bias tool.
  • Data extraction and analysis adhered to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.

Main Results:

  • Twenty-nine studies were analyzed for risk of bias; only three met criteria for low risk.
  • In these low-risk studies, no statistically significant differences were observed in GI adverse events or GI-related quality of life between EC-MPS and MMF groups.
  • The majority of studies exhibited a high risk of bias.

Conclusions:

  • A high risk of bias pervades studies examining the switch from MMF to EC-MPS for improved GI quality of life.
  • Evidence from low-bias studies does not support converting patients stable on MMF to EC-MPS.
  • Alternative strategies should be considered for managing GI adverse events before contemplating a switch to EC-MPS.

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