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dc.contributor.authorKraemer, B. K.
dc.contributor.authorAlbano, L.
dc.contributor.authorBanas, B.
dc.contributor.authorCharpentier, B.
dc.contributor.authorBackman, L.
dc.contributor.authorTedesco-Silva, H., Jr. [UNIFESP]
dc.contributor.authorLehner, F.
dc.contributor.authorMondragon-Ramirez, G. A.
dc.contributor.authorGlyda, M.
dc.contributor.authorCassuto-Viguier, E.
dc.contributor.authorViklicky, O.
dc.contributor.authorMourad, G.
dc.contributor.authorRigotti, P.
dc.contributor.authorSchleibner, S.
dc.contributor.authorKamar, N.
dc.date.accessioned2020-09-01T13:21:27Z
dc.date.available2020-09-01T13:21:27Z
dc.date.issued2017
dc.identifierhttp://dx.doi.org/10.1016/j.transproceed.2017.07.011
dc.identifier.citationTransplantation Proceedings. New York, v. 49, n. 9, p. 2040-2049, 2017.
dc.identifier.issn0041-1345
dc.identifier.urihttps://repositorio.unifesp.br/handle/11600/58264
dc.description.abstractBackground. Two large, prospective studies (12-03; OSAKA) compared the efficacy and tolerability of prolonged-release versus immediate-release tacrolimus in kidney transplant patients also receiving mycophenolate mofetil and low-dose corticosteroids (without induction therapy). Methods. Data were combined into one database to compare results over 24 weeks using 3 alternative endpoints: biopsy-confirmed acute rejection (BCAR); the Food and Drug Administration composite endpoint (graft loss, SCAR, and loss to follow-up), and the European Medicines Agency composite endpoint (graft loss, BCAR, and graft dysfunction). The 95% confidence intervals were calculated (10% noninferiority margin). Results. Overall, 633 patients received prolonged-release tacrolimus (12-03, n = 331; OSAKA, n = 302) and 645 received immediate-release tacrolimus (n = 336; n = 309). Baseline characteristics were comparable. Proportionately more patients receiving prolonged-release tacrolimus had trough levels of 5-15 ng/mL on day 1 (60.8%) and 2 (56.6%) versus immediate-release tacrolimus (42.5% and 43.9%, respectively, both P < .001). Efficacy of prolonged-release and immediate-release tacrolimus were similar as assessed by BCAR (13.9% vs 14.1%, respectively), European Medicines Agency composite endpoint (40.3% vs 38.3%) and US Food and Drug Administration composite endpoint (21.5% vs 19.8%). Conclusions. Novel efficacy endpoints as required by the European Medicines Agency and US Food and Drug Administration demonstrate noninferiority of prolonged-release versus immediate-release tacrolimus. Significantly more patients treated with prolonged release tacrolimus versus immediate-release tacrolimus achieved trough levels of 5 to 15 ng/mL early after transplantation.en
dc.description.sponsorshipAstellas Pharma Europe Ltd
dc.format.extent2040-2049
dc.language.isoeng
dc.publisherElsevier Science Inc
dc.relation.ispartofTransplantation Proceedings
dc.rightsAcesso aberto
dc.titleEfficacy of Prolonged- and Immediate-release Tacrolimus in Kidney Transplantation: A Pooled Analysis of Two Large, Randomized, Controlled Trialsen
dc.typeArtigo
dc.description.affiliationHeidelberg Univ, Univ Med Ctr Mannheim, Dept Med 5, Theodor Kutzer Ufer 1-3, D-68167 Mannheim, Germany
dc.description.affiliationNice Univ Hosp, Dept Nephrol, Nice, France
dc.description.affiliationUniv Med Ctr Regensburg, Dept Nephrol, Regensburg, Germany
dc.description.affiliationUniv Hosp Bicetre, Le Kremlin Bicetre, France
dc.description.affiliationUniv Paris Sud 11, INSERM, UMR 1197, Villejuif, France
dc.description.affiliationUppsala Univ Hosp, Dept Transplantat, Uppsala, Sweden
dc.description.affiliationUniv Fed Sao Paulo, Hosp Rim, Div Nephrol, Sao Paulo, Brazil
dc.description.affiliationHannover Med Sch, Gen Visceral & Transplantat Surg, Hannover, Germany
dc.description.affiliationMexican Inst Transplants, Transplant Surg Dept, Morelos, Mexico
dc.description.affiliationDist Publ Hosp, Dept Transplantol & Gen Surg, Poznan, Poland
dc.description.affiliationPasteur 2 Nice Univ Hosp, Renal Transplant Unit, Nice, France
dc.description.affiliationInst Clin & Expt Med, Dept Nephrol, Prague, Czech Republic
dc.description.affiliationMontpellier Univ Hosp, Lapeyronie Hosp, Dept Nephrol Dialysis & Transplantat, Montpellier, France
dc.description.affiliationPadua Univ Hosp, Kidney & Pancreas Transplant Unit, Padua, Italy
dc.description.affiliationAstellas Pharma GmbH, Formerly Med Affairs, Munich, Germany
dc.description.affiliationPaul Sabatier Univ, CHU Rangueil, Dept Nephrol & Organ Transplantat, Toulouse, France
dc.description.affiliationUnifespUniv Fed Sao Paulo, Hosp Rim, Div Nephrol, Sao Paulo, Brazil
dc.identifier.fileWOS000416202300013.pdf
dc.identifier.doi10.1016/j.transproceed.2017.07.011
dc.description.sourceWeb of Science
dc.identifier.wosWOS:000416202300013
dc.coverageNew York
dc.citation.volume49
dc.citation.issue9


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