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Enteric-coated mycophenolate sodium: safe conversion from mycophenolate mofetil in maintenance renal transplant
K Budde1, P Glander, F Diekmann
1University Hospital Charité, Berlin, Germany. klemens.budde@charite.de
Abstract:
Mycophenolate mofetil (MMF), in combination with cyclosporine and corticosteroids, improves long-term graft function and survival in renal transplant recipients. However, optimal MMF therapy may be limited by gastrointestinal (GI) intolerance, which may result in the need for MMF dose reduction, interruption, or discontinuation, leading to increased risk of acute rejection. Enteric-coated mycophenolate sodium (EC-MPS) is an advanced formulation delivering mycophenolic acid (MPA), developed with the objective of improving MPA-related upper GI adverse events. A pivotal, 12-month, phase III, randomized, multicenter, double-blind, double-dummy, parallel group study investigated whether stable renal transplant patients can be converted from MMF to EC-MPS therapy without compromising tolerability or efficacy. Stable renal transplant recipients received either MMF, 1000 mg b.i.d. (n=159), or EC-MPS, 720 mg b.i.d. (n=163), for 12 months. The incidence of GI adverse events was comparable between both treatment groups at 3 and 6 months, but there was a trend toward reduced severity of GI side effects in the EC-MPS group. There were fewer serious adverse events with EC-MPS and significantly fewer serious infections (P<.05). This comparable safety profile for EC-MPS and MMF also extended to elderly patients and patients with diabetes at baseline. For the composite efficacy variable of biopsy-proven acute rejection, graft loss, death, or loss to follow-up, EC-MPS had a lower 12-month efficacy failure rate (EC-MPS: 7.5% vs MMF: 12.3%; P=ns). These data demonstrate that stable renal transplant recipients receiving MMF can be converted to EC-MPS with no efficacy or tolerability compromise.
Insights
Switching from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS) is safe and effective for renal transplant patients. This conversion maintains graft function and survival while potentially reducing gastrointestinal side effects.
Area of Science:
- Nephrology
- Immunosuppression
- Pharmacology
Background:
- Mycophenolate mofetil (MMF) is a key immunosuppressant in renal transplantation, improving graft survival.
- Gastrointestinal (GI) intolerance is a significant limitation of MMF therapy, potentially leading to dose adjustments and increased rejection risk.
- Enteric-coated mycophenolate sodium (EC-MPS) is a novel formulation designed to mitigate MMF-related upper GI adverse events.
Purpose of the Study:
- To evaluate the safety and efficacy of converting stable renal transplant recipients from MMF to EC-MPS.
- To compare the incidence and severity of GI adverse events between MMF and EC-MPS therapies.
- To assess the impact of conversion on graft function, survival, and serious adverse events.
Main Methods:
- A 12-month, randomized, double-blind, double-dummy, parallel-group Phase III study.
- Stable renal transplant recipients were randomized to receive either MMF (1000 mg b.i.d.) or EC-MPS (720 mg b.i.d.).
- Efficacy was assessed by a composite endpoint including biopsy-proven acute rejection, graft loss, death, or loss to follow-up.
Main Results:
- GI adverse event incidence was comparable at 3 and 6 months, with a trend towards reduced severity in the EC-MPS group.
- EC-MPS demonstrated fewer serious adverse events and significantly fewer serious infections (P<.05).
- The 12-month efficacy failure rate was lower with EC-MPS (7.5%) compared to MMF (12.3%), though not statistically significant (P=ns).
Conclusions:
- Conversion from MMF to EC-MPS in stable renal transplant recipients is well-tolerated and effective.
- EC-MPS offers a comparable safety profile to MMF, with potential benefits in reducing GI side effects and serious infections.
- EC-MPS represents a viable alternative for patients experiencing GI intolerance with MMF, without compromising long-term outcomes.
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