Efficacy of Prolonged- and Immediate-release Tacrolimus in Kidney Transplantation: A Pooled Analysis of Two Large, Randomized, Controlled Trials

Efficacy of Prolonged- and Immediate-release Tacrolimus in Kidney Transplantation: A Pooled Analysis of Two Large, Randomized, Controlled Trials

Author Kraemer, B. K. Google Scholar
Albano, L. Google Scholar
Banas, B. Google Scholar
Charpentier, B. Google Scholar
Backman, L. Google Scholar
Tedesco-Silva, H., Jr. Autor UNIFESP Google Scholar
Lehner, F. Google Scholar
Mondragon-Ramirez, G. A. Google Scholar
Glyda, M. Google Scholar
Cassuto-Viguier, E. Google Scholar
Viklicky, O. Google Scholar
Mourad, G. Google Scholar
Rigotti, P. Google Scholar
Schleibner, S. Google Scholar
Kamar, N. Google Scholar
Abstract Background. 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.
xmlui.dri2xhtml.METS-1.0.item-coverage New York
Language English
Sponsor Astellas Pharma Europe Ltd
Date 2017
Published in Transplantation Proceedings. New York, v. 49, n. 9, p. 2040-2049, 2017.
ISSN 0041-1345 (Sherpa/Romeo, impact factor)
Publisher Elsevier Science Inc
Extent 2040-2049
Origin http://dx.doi.org/10.1016/j.transproceed.2017.07.011
Access rights Open access Open Access
Type Article
Web of Science ID WOS:000416202300013
URI https://repositorio.unifesp.br/handle/11600/58264

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