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dc.contributor.authorEkberg, Henrik
dc.contributor.authorTedesco-Silva, Helio
dc.contributor.authorDemirbas, Alper
dc.contributor.authorVitko, Stefan
dc.contributor.authorNashan, Bjorn
dc.contributor.authorGuerkan, Alp
dc.contributor.authorMargreiter, Raimund
dc.contributor.authorHugo, Christian
dc.contributor.authorGrinyo, Josep M.
dc.contributor.authorFrei, Ulrich
dc.contributor.authorVanrenterghem, Yves
dc.contributor.authorDaloze, Pierre
dc.contributor.authorHalloran, Philip F.
dc.contributor.authorELITE Symphony Study
dc.identifier.citationNew England Journal of Medicine. Waltham: Massachusetts Medical Soc, v. 357, n. 25, p. 2562-2575, 2007.
dc.description.abstractBackground: Immunosuppressive regimens with the fewest possible toxic effects are desirable for transplant recipients. This study evaluated the efficacy and relative toxic effects of four immunosuppressive regimens.Methods: We randomly assigned 1645 renal-transplant recipients to receive standard-dose cyclosporine, mycophenolate mofetil, and corticosteroids, or daclizumab induction, mycophenolate mofetil, and corticosteroids in combination with low-dose cyclosporine, low-dose tacrolimus, or low-dose sirolimus. the primary end point was the estimated glomerular filtration rate (GFR), as calculated by the Cockcroft-Gault formula, 12 months after transplantation. Secondary end points included acute rejection and allograft survival.Results: the mean calculated GFR was higher in patients receiving low-dose tacrolimus (65.4 ml per minute) than in the other three groups (range, 56.7 to 59.4 ml per minute). the rate of biopsy-proven acute rejection was lower in patients receiving low-dose tacrolimus (12.3%) than in those receiving standard-dose cyclosporine (25.8%), low-dose cyclosporine (24.0%), or low-dose sirolimus (37.2%). Allograft survival differed significantly among the four groups (P=0.02) and was highest in the low-dose tacrolimus group (94.2%), followed by the low-dose cyclosporine group (93.1%), the standard-dose cyclosporine group (89.3%), and the low-dose sirolimus group (89.3%). Serious adverse events were more common in the low-dose sirolimus group than in the other groups (53.2% vs. a range of 43.4 to 44.3%), although a similar proportion of patients in each group had at least one adverse event during treatment (86.3 to 90.5%).Conclusions: A regimen of daclizumab, mycophenolate mofetil, and corticosteroids in combination with low-dose tacrolimus may be advantageous for renal function, allograft survival, and acute rejection rates, as compared with regimens containing daclizumab induction plus either low-dose cyclosporine or low-dose sirolimus or with standard-dose cyclosporine without induction. ( number, NCT00231764.).en
dc.publisherMassachusetts Medical Soc
dc.relation.ispartofNew England Journal of Medicine
dc.rightsAcesso restrito
dc.titleReduced exposure to calcineurin inhibitors in renal transplantationen
dc.contributor.institutionLund Univ
dc.contributor.institutionUniversidade Federal de São Paulo (UNIFESP)
dc.contributor.institutionAkdeniz Univ
dc.contributor.institutionInst Klin & Expt Med
dc.contributor.institutionHannover Med Sch
dc.contributor.institutionSB Tepecik Hosp
dc.contributor.institutionUniv Klin
dc.contributor.institutionUniv Hosp
dc.contributor.institutionCiutat Univ Bellvitge
dc.contributor.institutionFree Univ Berlin
dc.contributor.institutionKatholieke Univ Leuven
dc.contributor.institutionCHU Montpellier
dc.contributor.institutionUniv Alberta
dc.description.affiliationLund Univ, Malmo, Sweden
dc.description.affiliationUniversidade Federal de São Paulo, São Paulo, Brazil
dc.description.affiliationAkdeniz Univ, Antalya, Turkey
dc.description.affiliationInst Klin & Expt Med, Prague, Czech Republic
dc.description.affiliationHannover Med Sch, D-30623 Hannover, Germany
dc.description.affiliationSB Tepecik Hosp, Izmir, Turkey
dc.description.affiliationUniv Klin, Innsbruck, Austria
dc.description.affiliationUniv Hosp, Erlangen, Germany
dc.description.affiliationCiutat Univ Bellvitge, Barcelona, Spain
dc.description.affiliationFree Univ Berlin, Klinikum Rudolf Virchow, Charite, D-1000 Berlin, Germany
dc.description.affiliationKatholieke Univ Leuven, Louvain, Belgium
dc.description.affiliationCHU Montpellier, Notre Dame Hosp, Montreal, PQ, Canada
dc.description.affiliationUniv Alberta, Edmonton, AB, Canada
dc.description.affiliationUnifespUniversidade Federal de São Paulo, São Paulo, Brazil
dc.description.sourceWeb of Science

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