Enteric-coated mycophenolate sodium

Expert Opin Drug Saf. 2010 Nov;9(6):981-94. doi: 10.1517/14740338.2010.513379.

Abstract

Importance of the field: Mycophenolic acid (MPA) therapy is a fundamental component of most post-transplant immunosuppressive regimens. Side effects, however, are common and frequently necessitate dose reductions or discontinuations.

Areas covered in this review: Enteric-coated mycophenolate sodium (EC-MPS) is designed to improve the gastrointestinal (GI) tolerability of MPA. This review assesses the pharmacology, efficacy and safety of EC-MPS.

What the reader will gain: An understanding of the use of EC-MPS in solid organ transplantation and the key trials examining the GI impact of EC-MPS versus the immediate-release mycophenolate mofetil (MMF) formulation. The article also addresses the possible impact of proton pump inhibitor therapy, and the optimal MPA dose with different concomitant immunosuppressants.

Take home message: Evidence from blinded trials using standard reporting measures or patient-reported outcomes has not confirmed a significant improvement in the GI symptom burden using EC-MPS. Several open-label studies, however, have consistently shown an improvement in GI tolerability with EC-MPS, which can permit restoration of the optimal MPA dose. EC-MPS has equal efficacy and possibly a different tolerability profile to MMF, thus offering a choice to physicians and their patients, particularly those experiencing MMF-related GI symptoms, diabetic patients or those in whom an MPA dose reduction is required.

Publication types

  • Review

MeSH terms

  • Dose-Response Relationship, Drug
  • Drug Monitoring
  • Enzyme Inhibitors / administration & dosage
  • Enzyme Inhibitors / adverse effects
  • Enzyme Inhibitors / pharmacokinetics*
  • Enzyme Inhibitors / pharmacology*
  • Humans
  • Immunosuppressive Agents / administration & dosage
  • Immunosuppressive Agents / adverse effects
  • Kidney Transplantation
  • Mycophenolic Acid / administration & dosage
  • Mycophenolic Acid / adverse effects
  • Mycophenolic Acid / analogs & derivatives*
  • Mycophenolic Acid / pharmacokinetics*
  • Mycophenolic Acid / pharmacology*
  • Randomized Controlled Trials as Topic
  • Tablets, Enteric-Coated / administration & dosage
  • Tablets, Enteric-Coated / adverse effects
  • Tablets, Enteric-Coated / pharmacokinetics
  • Tablets, Enteric-Coated / pharmacology
  • Treatment Outcome

Substances

  • Enzyme Inhibitors
  • Immunosuppressive Agents
  • Tablets, Enteric-Coated
  • Mycophenolic Acid