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FTY720 versus MMF with Cyclosporine in de novo Renal Transplantation: A 1‐Year, Randomized Controlled Trial in Europe and Australasia

Salvadori, M. ; Budde, K. ; Charpentier, B. ; Klempnauer, J. ; Nashan, B. ; Pallardo, L. M. ; Eris, J. ; Schena, F. P. ; Eisenberger, U. ; Rostaing, L. ; Hmissi, A. ; Aradhye, S.

American journal of transplantation, 2006-12, Vol.6 (12), p.2912-2921 [Periódico revisado por pares]

Oxford, UK: Blackwell Publishing Ltd

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Título:
FTY720 versus MMF with Cyclosporine in de novo Renal Transplantation: A 1‐Year, Randomized Controlled Trial in Europe and Australasia
Autor: Salvadori, M. ; Budde, K. ; Charpentier, B. ; Klempnauer, J. ; Nashan, B. ; Pallardo, L. M. ; Eris, J. ; Schena, F. P. ; Eisenberger, U. ; Rostaing, L. ; Hmissi, A. ; Aradhye, S.
Assuntos: Adult ; Antibiotics. Antiinfectious agents. Antiparasitic agents ; Antiviral agents ; Australasia ; Biological and medical sciences ; Creatinine - metabolism ; Cyclosporine ; Cyclosporine - therapeutic use ; Cytomegalovirus ; Drug Therapy, Combination ; efficacy ; Europe ; Fingolimod Hydrochloride ; FTY720 ; Graft Survival - immunology ; Graft Survival - physiology ; Histocompatibility Testing ; Humans ; Kidney Transplantation - immunology ; Liver Function Tests ; Medical sciences ; Miscellaneous ; mycophenolate mofetil ; Mycophenolic Acid - analogs & derivatives ; Mycophenolic Acid - pharmacokinetics ; Mycophenolic Acid - therapeutic use ; Pharmacology. Drug treatments ; Propylene Glycols - therapeutic use ; Public health. Hygiene ; Public health. Hygiene-occupational medicine ; renal transplantation ; Safety ; Sphingosine - analogs & derivatives ; Sphingosine - therapeutic use ; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases ; Surgery of the urinary system
É parte de: American journal of transplantation, 2006-12, Vol.6 (12), p.2912-2921
Notas: ObjectType-Article-1
SourceType-Scholarly Journals-1
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Descrição: FTY720 is a novel immunomodulator investigated in de novo renal transplantation and other therapeutic areas including multiple sclerosis. This 1‐year multicenter, randomized, phase III study in 668 de novo renal transplant patients compared FTY720 2.5 mg plus full‐dose cyclosporine (FDC) or FTY720 5.0 mg plus reduced‐dose cyclosporine (RDC), with mycophenolate mofetil (MMF) plus FDC. The primary efficacy endpoint was the composite incidence of first treated biopsy‐proven acute rejection (BPAR), graft loss, death or premature study discontinuation at month 12. Primary efficacy with FTY720 2.5 mg and MMF (32.4% and 30.2%; p = NS), plus mortality and BPAR incidence, were comparable. Patients receiving FTY720 5.0 mg plus RDC were discontinued from treatment due to increased risk of acute rejection (primary endpoint incidence 47.3%). FTY720 was associated with lower creatinine clearance (month 12: 53.1, 56.0 vs. 65.1 mL/min; p < 0.001) and more macular edema cases (2.2% and 1.3% vs. 0%), whereas cytomegalovirus infections were higher with MMF (6.2% and 10.6% vs. 18.1% p < 0.0001 and p = 0.0139, respectively). FTY720 2.5 mg provided comparable rejection prophylaxis over 12 months versus MMF; however, FTY720 5.0 mg did not support a 50% reduction in cyclosporine exposure. The cause of macular edema cases and lower creatinine clearance with FTY720 in de novo transplantation needs further investigation. This 12‐month phase III study in de novo renal transplant recipients demonstrated that although FTY720 2.5 mg plus full‐dose cyclosporine (FDC) provided rejection prophylaxis compared to mycophenolate mofetil plus FDC, FTY720 5.0 mg plus reduction in cyclosporine exposure resulted in an excess of rejection episodes.
Editor: Oxford, UK: Blackwell Publishing Ltd
Idioma: Inglês

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FTY720 versus MMF with Cyclosporine in de novo Renal Transplantation: A 1‐Year, Randomized Controlled Trial in Europe and Australasia

Salvadori, M. ; Budde, K. ; Charpentier, B. ; Klempnauer, J. ; Nashan, B. ; Pallardo, L. M. ; Eris, J. ; Schena, F. P. ; Eisenberger, U. ; Rostaing, L. ; Hmissi, A. ; Aradhye, S.

Oxford, UK: Blackwell Publishing Ltd

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