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Efficacy of prolonged- and immediate-release tacrolimus in kidney transplantation: a pooled analysis of two large, randomized, controlled trials

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 co...

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Bibliographic Details
Main Author: Krämer, Bernhard (Author)
Format: Article (Journal)
Language:English
Published: November 2017
In: Transplantation proceedings
Year: 2017, Volume: 49, Issue: 9, Pages: 2040-2049
ISSN:1873-2623
DOI:10.1016/j.transproceed.2017.07.011
Online Access:Verlag, Volltext: http://dx.doi.org/10.1016/j.transproceed.2017.07.011
Verlag, Volltext: http://www.sciencedirect.com/science/article/pii/S0041134517306929
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Author Notes:B.K. Krämer, L. Albano, B. Banas, B. Charpentier, L. Bäckman, H. Tedesco-Silva, F. Lehner, G.A. Mondragón-Ramírez, M. Glyda, E. Cassuto-Viguier, O. Viklický, G. Mourad, P. Rigotti, S. Schleibner, and N. Kamar
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Summary: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, BCAR, 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. ClinicalTrials.govNCT00189839; NCT00717470.
Item Description:Gesehen am 08.11.2018
Physical Description:Online Resource
ISSN:1873-2623
DOI:10.1016/j.transproceed.2017.07.011

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