Conversion from Mycophenolate Mofetil to Mycophenolate Sodium in maintenance renal transplant recipients: a multicenter retrospective analysis

Abstract

Mycophenolate mofetil (MMF) is an effective immunosuppressive agent but its benefits can be jeopardized if dose reductions/discontinuations are required due to adverse events (AE). An enteric-coated formulation of mycophenolate sodium (EC-MPS) has been designed to reduce AEs in the upper gastrointestinal (GI) tract. Purpose: The aim of this retrospective analysis was to evaluate the reasons of conversion from any immunosuppressive adjuvant therapy to EC-MPS in adult renal transplant recipients and in addition to study the outcome of this group of patients. Casuistic and Method: One hundred and nine renal transplant recipients converted from any immunosuppressive adjuvant drug to EC-MPS, were evaluated in 12 transplant centers from Brazil. The recipients were predominantly male (62%), 71% Caucasian, with a mean age of 43 ± 13 years and 53% of them were recipients of living related donors. After a follow up time of 13 ± 10 months, patients were converted to EC-MPS mostly (35%) due to gastrointestinal adverse events (GI-AEs). Results: Most of the patients (n=83; 76%) were switched from MMF therapy and in 36 (33%) the conversion was exclusively due to GI-AE of which diarrhea was the most frequent reported GI-AE (83%). One month after the conversion from MMF to EC-MPS 57% and 13% of the patients with GI symptoms reported resolution of the symptoms (RS) or partial improvement (Pl), respectively. After a mean time of follow-up of 10 months, 62% and 5% of the patients reported resolution or PI, respectively. Changes of drug dosage pre- and post-switch were 83% and 14%, respectively. The mean serum creatinine, weight and hematological parameters did not change significantly before and after conversion. Conclusion: The main reasons reported by centers to switch patients to EC-MPS were electiveness and GI adverse events. Conversion of patients with GI AEs from MMF to EC-MPS is clinically safe and provided resolution or partial improvement of GI symptoms in 67% of these patients