Gastrointestinal side effects in liver transplant recipients taking enteric-coated mycophenolate sodium vs. mycophenolate mofetil.
Lopez-Solis R, Devera M, Steel J, et al.Clinical transplantation [record in progress].
Aims
To compare the gastro-intestinal (GI) side-effects of enteric coated mycophenolate sodium (EC-MPS) with mycophenolate mofetil (MMF) in liver transplant recipients in two studies a de novo, and a conversion study.
Interventions
Participants were administered MMF (500 or 1000mg by mouth twice a day) or EC-MPS (360 or 720mg by mouth twice a day) for 12 weeks.
Participants
30 liver transplant recipients 18-80 years who were 1-6 months post transplant and taking a CNI with or without corticosteroids.
Outcomes
The primary outcomes included the incidence and severity of GI side effects, bone marrow suppression and incidence of CMV infection or disease. The secondary outcomes were the discontinuation of the drug following adverse effects and renal function assessed by creatinine levels.
Follow-up
12 weeks
CET Conclusions
The report describes two prospective studies namely a randomised, double-blinded trial and a prospective, non-random study. The review will only discuss the randomised trial. A small number of liver transplant recipients (n=30) who were 1-6 months posttransplant and taking a calcineurin inhibitor were randomised to MMF or EC-MPS. At 2, 6 and 12 weeks gastrointestinal side-effects were assessed using the validated Gastrointestinal Symptoms Rating Scale (GSRS). No differences between the two intervention arms were found for the total score on the GSRS or on any of its subscales (abdominal pain, reflux, indigestion, diarrhoea, constipation) at 12 weeks. There were also no differences between the arms for any of the other primary or secondary outcomes. No information was given regarding the randomisation and method of double-blinding, which make it difficult to assess the validity of the results.
Data analysis
Per protocol analysis
Trial registration
Not reported.