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Superior efficacy of enteric-coated mycophenolate vs mycophenolate mofetil in de novo transplant recipients: pooled
M Salvadori1, E Bertoni, K Budde
1Renal Unit, Careggi University Hospital, Florence, Italy.
Abstract:
Dose reduction and discontinuation of mycophenolate mofetil (MMF) therapy because of gastrointestinal complications has been associated with increased risk of acute rejection episodes and graft loss. Enteric-coated mycophenolate sodium (EC-MPS) delays release of mycophenolic acid (MPA), and was designed to reduce MPA-related gastrointestinal adverse events. Data comparing the efficacy of EC-MPS vs MMF in de novo renal transplant (RTx) recipients from large prospective studies are limited. Therefore, a pooled data analysis was performed based on 1891 de novo RTx recipients receiving EC-MPS (n = 1289) or MMF (n = 602) plus cyclosporine and steroid therapy in 4 prospective multicenter studies with similar entry criteria. In all trials, the initial dose of EC-MPS was 1440 mg/d, and of MMF was 2000 mg/d; both dosages deliver equimolar amounts of MPA. Induction therapy was permitted in 2 studies per center practice. Multivariate logistic regression analysis was performed, adjusting other potential explanatory variables including recipient age, sex, and race/ethnicity; induction therapy; and diabetes mellitus at baseline. In addition, propensity scores were used to explain potential bias. Mean (SD) MPA dose (EC-MPS dosage was converted to MMF equivalent) during months 0 to 12 was similar: EC-MPS, 1820 (370) mg/d, vs MMF, 1860 (290) mg/d. However, at univariate and multivariate analyses, the rates of treatment failure, biopsy-proved acute rejection episodes, and graft loss were significantly lower with EC-MPS compared with MMF at month 12. In conclusion, this pooled analysis documents a substantial improvement in efficacy in de novo RTx recipients receiving EC-MPS vs MMF with concomitant cyclosporine and steroid therapy.
Insights
Enteric-coated mycophenolate sodium (EC-MPS) shows improved efficacy over mycophenolate mofetil (MMF) in de novo kidney transplant recipients. This analysis found lower rates of rejection and graft loss with EC-MPS, suggesting better outcomes for transplant patients.
Area of Science:
- Nephrology
- Immunosuppression Therapy
- Transplant Medicine
Background:
- Gastrointestinal complications from mycophenolate mofetil (MMF) can lead to dose reduction or discontinuation, increasing risks of acute rejection and graft loss in renal transplant (RTx) recipients.
- Enteric-coated mycophenolate sodium (EC-MPS) was developed to mitigate MMF-related gastrointestinal adverse events by delaying mycophenolic acid (MPA) release.
Purpose of the Study:
- To compare the efficacy of EC-MPS versus MMF in de novo RTx recipients using a pooled data analysis from multiple prospective studies.
- To evaluate treatment failure, acute rejection episodes, and graft loss rates between EC-MPS and MMF treatment groups.
Main Methods:
- A pooled analysis of 1891 de novo RTx recipients (EC-MPS n=1289; MMF n=602) receiving concomitant cyclosporine and steroid therapy.
- Standardized initial dosing (EC-MPS 1440 mg/d, MMF 2000 mg/d, equimolar MPA) across 4 prospective multicenter studies.
- Multivariate logistic regression and propensity score analysis were employed, adjusting for baseline characteristics and induction therapy.
Main Results:
- Mean MPA doses were similar between EC-MPS and MMF groups over 12 months.
- Univariate and multivariate analyses revealed significantly lower rates of treatment failure, biopsy-proved acute rejection, and graft loss with EC-MPS compared to MMF at 12 months post-transplant.
Conclusions:
- This pooled analysis demonstrates superior efficacy of EC-MPS compared to MMF in de novo RTx recipients when used with cyclosporine and steroids.
- EC-MPS offers a potential therapeutic advantage by reducing adverse events and improving long-term graft outcomes.
