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Enteric-coated mycophenolate sodium

Klemens Budde1, Michael Dürr, Lutz Liefeldt

  • 1Clinical Transplant Programme and Department of Nephrology, Charité Universitätsmedizin Berlin, Campus Charité Mitte, Charitéplatz 1, Berlin, Germany. klemens.budde@charite.de

Expert Opinion on Drug Safety
|August 28, 2010
PubMed
Abstract

Insights

Enteric-coated mycophenolate sodium (EC-MPS) may improve gastrointestinal tolerability in transplant patients, though blinded trials show no significant symptom reduction. Open-label studies suggest EC-MPS offers a viable alternative to mycophenolate mofetil (MMF) for managing side effects.

Area of Science:

  • Immunosuppression in transplantation
  • Gastrointestinal tolerability of immunosuppressants
  • Pharmacology of mycophenolic acid derivatives

Background:

  • Mycophenolic acid (MPA) is crucial for post-transplant immunosuppression.
  • Gastrointestinal (GI) side effects frequently disrupt MPA therapy, leading to dose adjustments or cessation.
  • Improving GI tolerability is essential for optimizing immunosuppressive regimens.

Purpose of the Study:

  • To review the pharmacology, efficacy, and safety of enteric-coated mycophenolate sodium (EC-MPS).
  • To assess the GI impact of EC-MPS compared to mycophenolate mofetil (MMF).
  • To explore factors influencing MPA dosing, including proton pump inhibitors and concomitant immunosuppressants.

Main Methods:

  • Review of key clinical trials comparing EC-MPS and MMF formulations.
  • Analysis of data on gastrointestinal symptom burden and patient-reported outcomes.
  • Examination of pharmacological properties and tolerability profiles.

Main Results:

  • Blinded trials did not confirm significant GI symptom improvement with EC-MPS.
  • Open-label studies consistently reported enhanced GI tolerability with EC-MPS.
  • EC-MPS demonstrated comparable efficacy to MMF with a potentially different tolerability profile.

Conclusions:

  • EC-MPS offers an alternative to MMF, particularly for patients with MMF-related GI issues.
  • Improved GI tolerability with EC-MPS may allow for restoration of optimal MPA dosing.
  • This formulation provides a valuable option for transplant recipients requiring MPA therapy.

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