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

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023001%3A_____%2F17%3A00076204" target="_blank" >RIV/00023001:_____/17:00076204 - isvavai.cz</a>

Result on the web

<a href="http://www.transplantation-proceedings.org/article/S0041-1345(17)30692-9/pdf" target="_blank" >http://www.transplantation-proceedings.org/article/S0041-1345(17)30692-9/pdf</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.transproceed.2017.07.011" target="_blank" >10.1016/j.transproceed.2017.07.011</a>

Result language

angličtina

Original language name

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

Original language description

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 &lt; .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.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

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OECD FORD branch

30213 - Transplantation

Project

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Continuities

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Publication year

2017

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Transplantation proceedings

ISSN

0041-1345

e-ISSN

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Volume of the periodical

49

Issue of the periodical within the volume

9

Country of publishing house

US - UNITED STATES

Number of pages

10

Pages from-to

2040-2049

UT code for WoS article

000416202300013

EID of the result in the Scopus database

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