Conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium in liver transplant patients presenting gastrointestinal disorders: A pilot study

Abstract

Gastrointestinal (GI) disorders are one of the main adverse events in patients treated by mycophenolic acid (MPA). The aim of this prospective study was to evaluate the effect of conversion from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS) in liver transplant patients presenting GI side-effects Since January 2003, stable liver transplant patients receiving MMF and presenting GI disorders, without evidence of other origin than MMF were enrolled. Conversion was performed without a washout period at an equimolar daily dosage. Thirty-six patients were included after a median delay of 45 months after liver transplantation (LT) (16 women and 20 men, median age of 47 years). Diarrhoea was the main clinical symptom (n ϭ 28, 77.7%). At the time of inclusion, patients were treated with MMF since 18 months (range 3-28) and GI disorders were known for 9 months (range 3-12). After a median follow-up of 12 months after conversion, GI disorders were resolved in 20 patients (55%), improved in 6 patients (17%) and not modified or worsened in 10 patients (28%). Our results strongly suggest that conversion from MMF to EC-MPS in liver transplant patients can improve gastrointestinal disorders in a majority of the patients, and therefore might be considered as the best therapeutic option.

Use of enteric‐coated mycophenolate sodium in liver transplant patients with intestinal intolerance caused by mycophenolate mofetil

“…Patients enrolled in this study were assessed at baseline and visit 2 (4–6 wk post‐baseline) with a series of questionnaires which showed a decrease in the intensity of the GI side‐effects and an improvement in the patients QoL. EC‐MPS has been shown to be safe in both adult and pediatric liver recipients converted away from MMF, but this study did not use QoL questionnaires to analyze the impact of the conversion (11).…”

“…Patients enrolled in this study were assessed at baseline and visit 2 (4-6 wk post-baseline) with a series of questionnaires which showed a decrease in the intensity of the GI side-effects and an improvement in the patients QoL. EC-MPS has been shown to be safe in both adult and pediatric liver recipients converted away from MMF, but this study did not use QoL questionnaires to analyze the impact of the conversion (11). In our single center, open label study, conversion from MMF to EC-MPS has shown a statistically significant improvement in GI-related QoL in recipients of OLT with GI intolerability, with the exception of the emotional subscale at months 3 and 12.…”

Comparison of a new enzymatic assay with a high-performance liquid chromatography/ ultraviolet detection method for therapeutic drug monitoring of mycophenolic acid in adult liver transplant recipients

“…Immunosuppressive regimens containing mycophenolate mofetil (MMF), a prodrug of mycophenolic acid (MPA), have shown efficacy in adult liver transplant recipients 1–3. Recently, enteric‐coated mycophenolate sodium (EC‐MPS), a new formulation of MPA, has shown a reduction of gastrointestinal disorders in comparison with MMF 4. MPA prevents the proliferation of both T and B lymphocytes by selectively and reversibly inhibiting type II inosine monophosphate dehydrogenase (IMPDH), a key enzyme in the de novo pathway of purine synthesis 5…”

Reply: MMF to EC-MPS conversion: What makes the difference?

“…1 We agree that many 1-way conversion trials have been reported to be initially successful, and subsequently, not to be confirmed. Nevertheless, results of pilot studies can be considered as the first step of scientific demonstration of the efficacy of a new therapeutic strategy.…”