Medizinische Universität Graz - Research portal
Selected Publication:
SHR Neuro Cancer Cardio Lipid Metab Microb
Salvadori, M; Holzer, H; Civati, G; Sollinger, H; Lien, B; Tomlanovich, S; Bertoni, E; Seifu, Y; Marrast, AC; ERL B301 Study Group.
Long-term administration of enteric-coated mycophenolate sodium (EC-MPS; myfortic) is safe in kidney transplant patients.
Clin Nephrol. 2006; 66(2):112-119
Web of Science
PubMed
- Co-authors Med Uni Graz
- Holzer Herwig
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- Abstract:
- Background: To date, there are no data on long-term use of enteric-coated mycophenolate sodium (EC-MPS; myfortic(R)) from time of renal transplantation. We report the first long-term safety and efficacy data on EC-MPS when administered for up to 3 years post transplant. Methods: De novo renal transplant recipients completing 1 year of treatment in a multicenter, randomized, double-blind trial of EC-MPS versus mycophenolate mofetil (MMF) were invited to take part in an open-label extension during which all patients received EC-MPS 720 mg b.i.d. Results from the period 12-36 months post transplant were compared to comparable data from MMF-treated patients taking part in two studies of everolimus versus MMF (RAD 201 and RAD 251). Results: Of 367 patients completing the blinded core study, 247(62%) entered the open-label extension phase. During the first 24 months of the extension, the incidence, type and severity of adverse events were comparable between the newly-exposed and long-term EC-MPS patients. There were 2 deaths in the newly-exposed group and 4 among long-term EC-MPS patients, with 1 and 2 graft losses, respectively. Six patients (5%) in the newly-exposed group and 4 (3%) in the long-term EC-MPS group experienced biopsy-proven acute rejection. Cross-study comparisons indicated that the tolerability profile of EC-MPS was similar to MMF, including the incidence of adverse events, infections and malignancies, as was the incidence of efficacy events. Conclusion: These results demonstrate that EC-MPS with cyclosporine and steroids provides good long-term efficacy and tolerability, and confirm the safety of converting renal transplant patients from MMF to EC-MPS.
- Find related publications in this database (using NLM MeSH Indexing)
- Adolescent -
- Adult -
- Aged -
- Double-Blind Method -
- Female -
- Humans -
- Immunosuppressive Agents - administration & dosage
- Kidney Transplantation -
- Male -
- Middle Aged -
- Mycophenolic Acid - administration & dosage
- Prospective Studies -
- Safety -
- Tablets, Enteric-Coated -
- Time Factors -
- Find related publications in this database (Keywords)
- mycophenolate mofetil
- mycophenolate sodium
- myfortic (R)
- conversion
- renal transplantation