Gastrointestinal side effects in liver transplant recipients taking enteric-coated mycophenolate sodium vs. mycophenolate mofetil

Clin Transplant. 2014 Jul;28(7):783-8. doi: 10.1111/ctr.12379. Epub 2014 Jun 1.

Abstract

In the setting of liver transplantation, mycophenolate mofetil (MMF) may be used as an adjuvant therapy for immunosuppression to prevent graft rejection; however, its use may be limited due to severe gastrointestinal (GI) side effects. In contrast, enteric-coated mycophenolate sodium (EC-MPS) may be associated with less severe side effects and hence better tolerability. We compared the side effects of EC-MPS to MMF in liver transplant patients in a de novo study (Study I-randomized, prospective, double-blinded) and a conversion study (Study II). In both studies, the severity of GI symptoms was assessed at various time points using the Gastrointestinal Symptoms Rating Scale (GSRS) survey, a validated survey of GI symptoms (abdominal pain, reflux, indigestion, diarrhea, and constipation). In Study I, the symptoms of 30 recipients receiving EC-MPS (n = 15) were compared to 15 recipients receiving MMF. A multivariate analysis of variance (MANOVA) of the total GSRS scores and symptom syndrome subscores revealed no significant difference (p > 0.05) between the two medications over time. A conversion study (Study II) with 29 participants, however, showed that over time, all GI symptoms improved significantly (p < 0.001) when the patients were treated with EC-MPS instead of MMF.

Keywords: Gastrointestinal Symptoms Rating Scale; enteric-coated; immunosuppression; liver transplantation; mycophenolate mofetil; mycophenolate sodium.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Gastrointestinal Diseases / chemically induced*
  • Graft Rejection / drug therapy*
  • Graft Rejection / etiology
  • Humans
  • Immunosuppressive Agents / adverse effects*
  • Immunosuppressive Agents / therapeutic use
  • Liver Diseases / surgery*
  • Liver Transplantation*
  • Male
  • Middle Aged
  • Mycophenolic Acid / adverse effects
  • Mycophenolic Acid / analogs & derivatives*
  • Mycophenolic Acid / therapeutic use
  • Prognosis
  • Prospective Studies
  • Quality of Life
  • Risk Factors
  • Surveys and Questionnaires
  • Tablets, Enteric-Coated
  • Transplant Recipients
  • Young Adult

Substances

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