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

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.

Enteric-coated mycophenolate sodium given in combination with tacrolimus has a lower incidence of serious infections in Asian renal-transplant recipients compared with mycophenolate mofetil

“…Fortunately, EC‐MPS provides an alternative to MMF in renal‐transplant patients receiving MMF maintenance immunosuppressive therapy who have GI symptoms. Previous studies have shown that patients selected for GI intolerance associated with MMF treatment have reductions in GI symptoms when they are switched to EC‐MPS . The results of this study, as described above, observed no difference in the overall incidence of GI AEs between EC‐MPS and MMF.…”

Is Conversion from Mycophenolate Mofetil to Enteric-Coated Mycophenolate Sodium Justifiable for Gastrointestinal Quality of Life?

“…Indiscriminate study group allocation by random sequence generation was performed in five studies [18, 19, 36, 39, 44]. In each case, satisfactory allocation concealment was used [18, 19, 36, 39, 44]. Two further studies randomised their treatment arms; however, the method for allocation concealment was either not discussed or considered unsatisfactory [24, 40].…”

“…This ensured that all participants, outcome assessors and healthcare providers were blinded to the intervention allocations. A further two studies reported successful blinding of their participants; however, as the two forms of mycophenolate appear quite different, it is unclear as to whether a lack of a dummy control affected study performance and detection bias [24, 44]. The remaining 24 studies did not blind their participants, outcomes assessors or healthcare providers [20–23, 25–43, 45, 46].…”

“…In the majority of cases, primary outcomes and associated statistics were only partially reported. Another five studies had some degree of selective reporting, but the influence on conclusions were unclear [20, 21, 27, 29, 44]. Ten studies reported all primary and secondary outcomes with reported conclusions reflecting the results obtained [18, 19, 23–25, 28, 32, 36, 42, 43].…”

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“…1 Therefore, it can reduce rejection and improve graft and recipient survival. 2,3 However, even when administrated at its recommended dose, some patients have more serious adverse effects, including diarrhea, abdominal pain, bone marrow toxicities, and infection, [4][5][6] which can vary. 7 At present, a large number of clinical investigations have shown that gene polymorphism is one of the important factors leading to MMF differences among individuals, [8][9][10] with individualized medication regimens based on different genotypes of patients effectively increasing the therapeutic efficacy and reducing adverse effects, as well as reducing the cost of treatment.…”