Kraemer, B. K. and Albano, L. and Banas, B. and Charpentier, B. and Backman, L. and Tedesco-Silva, H. and Lehner, F. and Mondragon-Ramirez, G. A. and Glyda, M. and Cassuto-Viguier, E. and Viklicky, O. and Mourad, G. and Rigotti, P. and Schleibner, S. and Kamar, N. (2017) Efficacy of Prolonged- and Immediate-release Tacrolimus in Kidney Transplantation: A Pooled Analysis of Two Large, Randomized, Controlled Trials. TRANSPLANTATION PROCEEDINGS, 49 (9). pp. 2040-2049. ISSN 0041-1345, 1873-2623
Full text not available from this repository. (Request a copy)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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | WITHIN-PATIENT VARIABILITY; ONCE-DAILY TACROLIMUS; TWICE-DAILY PROGRAF; OPEN-LABEL TRIAL; RENAL-TRANSPLANTATION; LIVER-TRANSPLANTATION; GRAFT LOSS; RECIPIENTS; CONVERSION; EXPOSURE; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Abteilung für Nephrologie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 14 Dec 2018 13:19 |
| Last Modified: | 19 Feb 2019 12:57 |
| URI: | https://pred.uni-regensburg.de/id/eprint/1913 |
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