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Gastrointestinal side effects in liver transplant recipients taking enteric-coated mycophenolate sodium vs.
Roberto Lopez-Solis1, Michael DeVera, Jennifer Steel
1Thomas E. Starzl Transplantation Institute, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
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.
Insights
Enteric-coated mycophenolate sodium (EC-MPS) showed improved gastrointestinal (GI) symptoms in liver transplant patients previously treated with mycophenolate mofetil (MMF). A de novo study found no significant difference in GI side effects between EC-MPS and MMF.
Area of Science:
- Immunology
- Pharmacology
- Transplantation Medicine
Background:
- Mycophenolate mofetil (MMF) is an immunosuppressant used in liver transplantation.
- Severe gastrointestinal (GI) side effects can limit MMF use.
- Enteric-coated mycophenolate sodium (EC-MPS) may offer better tolerability.
Purpose of the Study:
- To compare the GI side effects of EC-MPS and MMF in liver transplant recipients.
- To evaluate EC-MPS tolerability in de novo and conversion settings.
Main Methods:
- Two studies were conducted: a de novo randomized, prospective, double-blinded study (Study I) and a conversion study (Study II).
- Gastrointestinal Symptoms Rating Scale (GSRS) was used to assess GI symptoms (pain, reflux, indigestion, diarrhea, constipation).
- Study I compared 15 EC-MPS recipients to 15 MMF recipients; Study II involved 29 patients converting from MMF to EC-MPS.
Main Results:
- Study I revealed no significant difference in total GSRS scores or symptom subscores between EC-MPS and MMF (p > 0.05).
- Study II demonstrated significant improvement in all GI symptoms over time after conversion from MMF to EC-MPS (p < 0.001).
Conclusions:
- While de novo EC-MPS did not show superior GI tolerability compared to MMF in Study I, conversion to EC-MPS significantly improved GI symptoms in Study II.
- EC-MPS may be a viable option for liver transplant patients experiencing GI side effects with MMF.
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