TY - JOUR
T1 - Long-term administration of enteric-coated mycophenolate sodium (EC-MPS; myfortic®) is safe in kidney transplant patients
AU - Salvadori, M.
AU - Holzer, H.
AU - Civati, G.
AU - Sollinger, H.
AU - Lien, B.
AU - Tomlanovich, S.
AU - Bertoni, E.
AU - Seifu, Y.
AU - Marrast, A. C.
AU - de Mattos, Angelo
AU - Bennett, William
AU - Kumar, Mysore
AU - Margreiter, Raymond
AU - Muehlbacher, Ferdinand
AU - Kalmar-Nagy, Karoly
AU - Wilkie, Martin
AU - Brayman, Kenneth
AU - Barker, Clyde
AU - Perner, Ferenc
AU - Gentil, Miguel
AU - Gonzalez Molina, Miguel
AU - Russell, David
AU - Sperschneider, Heide
AU - Barama, A.
AU - Yilmaz, Serder
AU - Szenohradszky, Pal
AU - Asztalos, L.
AU - Abendroth, Dietmar
AU - del Castillo, Domingo
AU - Krämer, Bernhard
AU - Arns, Wolfgang
AU - Douzdijan, Viken
AU - Bajjoka, Igor
AU - Seifu, Yodit
AU - Marrast, Anne Claire
PY - 2006/8
Y1 - 2006/8
N2 - Background: To date, there are no data on long-term use of enteric-coated mycophenolate sodium (EC-MPS; myfortic®) 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.
AB - Background: To date, there are no data on long-term use of enteric-coated mycophenolate sodium (EC-MPS; myfortic®) 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.
KW - Conversion
KW - Mycophenolate mofetil
KW - Mycophenolate sodium
KW - Myfortic®
KW - Renal transplantation
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M3 - Article
C2 - 16939067
AN - SCOPUS:33747104149
SN - 0301-0430
VL - 66
SP - 112
EP - 119
JO - Clinical Nephrology
JF - Clinical Nephrology
IS - 2
ER -