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Conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium in stable maintenance renal transplant
F Pietruck1, M Abbud-Filho, A Vathsala
1University Hospital Essen, Department of Nephrology, Essen, Germany. frank.pietruck@uni-essen.de
Background:
Mycophenolate mofetil (MMF) is effective in renal transplant patients but concerns remain over its gastrointestinal (GI) tolerability. Enteric-coated mycophenolate sodium (EC-MPS; myfortic) has been developed with the intention of improving mycophenolic acid-related GI tolerability.
Methods:
Data were pooled in a planned analysis of three subprotocols of the myfortic Prospective Multicenter Study (myPROMS). In a 6-month study, efficacy and safety of converting stable renal transplant recipients from MMF to a bioequivalent dose of EC-MPS for mycophenolic acid exposure were evaluated. Treatment efficacy was recorded and graft function was assessed by measuring serum creatinine and estimating creatinine clearance. Adverse events (AEs) and infections were monitored and the incidence of EC-MPS dose changes was recorded.
Results:
A total of 588 patients were recruited, 564 (96%) of whom completed the study. The rate of treatment failure (defined as biopsy-proven acute rejection, graft loss, or death) was 1.9%, with no episodes of graft loss and only one death reported during the study. Renal function remained stable throughout the trial. EC-MPS was well tolerated; the majority of AEs were mild or moderate in severity. Dose reductions or interruptions were required by 6.3% and 1.9% of patients, respectively. Gastrointestinal AEs occurred in 138 patients (23.5%). The rate of dose adjustment as a result of a GI AE was 2.2%.
Conclusions:
Equimolar conversion from MMF to EC-MPS in maintenance renal transplant patients was safe and maintained efficacy.
Insights
Converting renal transplant patients from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS) is safe and maintains efficacy. This switch improved gastrointestinal tolerability in stable patients.
Area of Science:
- Nephrology
- Immunosuppression
- Transplantation
Background:
- Mycophenolate mofetil (MMF) is a common immunosuppressant for renal transplant recipients.
- Gastrointestinal (GI) tolerability is a significant concern with MMF therapy.
- Enteric-coated mycophenolate sodium (EC-MPS) was developed to mitigate MMF-associated GI issues.
Purpose of the Study:
- To evaluate the safety and efficacy of switching stable renal transplant patients from MMF to EC-MPS.
- To assess the gastrointestinal tolerability of EC-MPS compared to MMF.
- To determine if EC-MPS maintains mycophenolic acid exposure and graft function.
Main Methods:
- A planned analysis of three subprotocols from the myfortic Prospective Multicenter Study (myPROMS).
- Stable renal transplant recipients were converted from MMF to an equimolar dose of EC-MPS.
- Efficacy, graft function (serum creatinine, creatinine clearance), adverse events (AEs), and infections were monitored over 6 months.
Main Results:
- 564 out of 588 patients completed the 6-month study.
- Treatment failure rate was low at 1.9% (no graft loss, one death).
- Renal function remained stable; EC-MPS was well tolerated with mild/moderate AEs. GI AEs occurred in 23.5% of patients, with 2.2% requiring dose adjustment.
Conclusions:
- Equimolar conversion from MMF to EC-MPS is safe in maintenance renal transplant patients.
- The switch to EC-MPS effectively maintained the efficacy of immunosuppression.
- EC-MPS demonstrates acceptable GI tolerability in this patient population.
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