Long-term administration of enteric-coated mycophenolate sodium (EC-MPS; myfortic®) is safe in kidney transplant patients

M. Salvadori, H. Holzer, G. Civati, H. Sollinger, B. Lien, S. Tomlanovich, E. Bertoni, Y. Seifu, A. C. Marrast, Angelo de Mattos, William Bennett, Mysore Kumar, Raymond Margreiter, Ferdinand Muehlbacher, Karoly Kalmar-Nagy, Martin Wilkie, Kenneth Brayman, Clyde Barker, F. Perner, Miguel Gentil & 15 others Miguel Gonzalez Molina, David Russell, Heide Sperschneider, A. Barama, Serder Yilmaz, P. Szenohradszky, L. Asztalos, Dietmar Abendroth, Domingo del Castillo, Bernhard Krämer, Wolfgang Arns, Viken Douzdijan, Igor Bajjoka, Yodit Seifu, Anne Claire Marrast

Research output: Contribution to journalArticle

25 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)112-119
Number of pages8
JournalClinical Nephrology
Volume66
Issue number2
Publication statusPublished - Aug 2006

Fingerprint

Mycophenolic Acid
Transplants
Kidney
Incidence
Safety
Kidney Transplantation
Cyclosporine
Steroids
Biopsy
Infection

Keywords

  • Conversion
  • Mycophenolate mofetil
  • Mycophenolate sodium
  • Myfortic®
  • Renal transplantation

ASJC Scopus subject areas

  • Nephrology

Cite this

Salvadori, M., Holzer, H., Civati, G., Sollinger, H., Lien, B., Tomlanovich, S., ... Marrast, A. C. (2006). Long-term administration of enteric-coated mycophenolate sodium (EC-MPS; myfortic®) is safe in kidney transplant patients. Clinical Nephrology, 66(2), 112-119.

Long-term administration of enteric-coated mycophenolate sodium (EC-MPS; myfortic®) is safe in kidney transplant patients. / Salvadori, M.; Holzer, H.; Civati, G.; Sollinger, H.; Lien, B.; Tomlanovich, S.; Bertoni, E.; Seifu, Y.; Marrast, A. C.; de Mattos, Angelo; Bennett, William; Kumar, Mysore; Margreiter, Raymond; Muehlbacher, Ferdinand; Kalmar-Nagy, Karoly; Wilkie, Martin; Brayman, Kenneth; Barker, Clyde; Perner, F.; Gentil, Miguel; Gonzalez Molina, Miguel; Russell, David; Sperschneider, Heide; Barama, A.; Yilmaz, Serder; Szenohradszky, P.; Asztalos, L.; Abendroth, Dietmar; del Castillo, Domingo; Krämer, Bernhard; Arns, Wolfgang; Douzdijan, Viken; Bajjoka, Igor; Seifu, Yodit; Marrast, Anne Claire.

In: Clinical Nephrology, Vol. 66, No. 2, 08.2006, p. 112-119.

Research output: Contribution to journalArticle

Salvadori, M, Holzer, H, Civati, G, Sollinger, H, Lien, B, Tomlanovich, S, Bertoni, E, Seifu, Y, Marrast, AC, de Mattos, A, Bennett, W, Kumar, M, Margreiter, R, Muehlbacher, F, Kalmar-Nagy, K, Wilkie, M, Brayman, K, Barker, C, Perner, F, Gentil, M, Gonzalez Molina, M, Russell, D, Sperschneider, H, Barama, A, Yilmaz, S, Szenohradszky, P, Asztalos, L, Abendroth, D, del Castillo, D, Krämer, B, Arns, W, Douzdijan, V, Bajjoka, I, Seifu, Y & Marrast, AC 2006, 'Long-term administration of enteric-coated mycophenolate sodium (EC-MPS; myfortic®) is safe in kidney transplant patients', Clinical Nephrology, vol. 66, no. 2, pp. 112-119.
Salvadori M, Holzer H, Civati G, Sollinger H, Lien B, Tomlanovich S et al. Long-term administration of enteric-coated mycophenolate sodium (EC-MPS; myfortic®) is safe in kidney transplant patients. Clinical Nephrology. 2006 Aug;66(2):112-119.
Salvadori, M. ; Holzer, H. ; Civati, G. ; Sollinger, H. ; Lien, B. ; Tomlanovich, S. ; Bertoni, E. ; Seifu, Y. ; Marrast, A. C. ; de Mattos, Angelo ; Bennett, William ; Kumar, Mysore ; Margreiter, Raymond ; Muehlbacher, Ferdinand ; Kalmar-Nagy, Karoly ; Wilkie, Martin ; Brayman, Kenneth ; Barker, Clyde ; Perner, F. ; Gentil, Miguel ; Gonzalez Molina, Miguel ; Russell, David ; Sperschneider, Heide ; Barama, A. ; Yilmaz, Serder ; Szenohradszky, P. ; Asztalos, L. ; Abendroth, Dietmar ; del Castillo, Domingo ; Krämer, Bernhard ; Arns, Wolfgang ; Douzdijan, Viken ; Bajjoka, Igor ; Seifu, Yodit ; Marrast, Anne Claire. / Long-term administration of enteric-coated mycophenolate sodium (EC-MPS; myfortic®) is safe in kidney transplant patients. In: Clinical Nephrology. 2006 ; Vol. 66, No. 2. pp. 112-119.
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abstract = "Background: To date, there are no data on long-term use of enteric-coated mycophenolate sodium (EC-MPS; myfortic{\circledR}) 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.",
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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, F.

AU - Gentil, Miguel

AU - Gonzalez Molina, Miguel

AU - Russell, David

AU - Sperschneider, Heide

AU - Barama, A.

AU - Yilmaz, Serder

AU - Szenohradszky, P.

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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