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...
Gespeichert in:
| 1. Verfasser: | |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
November 2017
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| In: |
Transplantation proceedings
Year: 2017, Jahrgang: 49, Heft: 9, Pages: 2040-2049 |
| ISSN: | 1873-2623 |
| DOI: | 10.1016/j.transproceed.2017.07.011 |
| Online-Zugang: | 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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| Verfasserangaben: | 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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| 245 | 1 | 0 | |a Efficacy of prolonged- and immediate-release tacrolimus in kidney transplantation |b a pooled analysis of two large, randomized, controlled trials |c 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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| 520 | |a 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. | ||
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