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Efficacy of Prolong...
Efficacy of Prolonged- and Immediate-release Tacrolimus in Kidney Transplantation : A Pooled Analysis of Two Large, Randomized, Controlled Trials
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- Kraemer, B. K. (author)
- Heidelberg Univ, Univ Med Ctr Mannheim, Dept Med 5, Theodor Kutzer Ufer 1-3, D-68167 Mannheim, Germany
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- Albano, L. (author)
- Nice Univ Hosp, Dept Nephrol, Nice, France
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- Banas, B. (author)
- Univ Med Ctr Regensburg, Dept Nephrol, Regensburg, Germany
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- Charpentier, B. (author)
- Univ Paris Sud 11, INSERM, UMR 1197, Villejuif, France;Univ Hosp Bicetre, Le Kremlin Bicetre, France
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- Bäckman, Lars (author)
- Uppsala universitet,Transplantationskirurgi,Uppsala Univ Hosp, Dept Transplantat, Uppsala, Sweden
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- Tedesco-Silva, H., Jr. (author)
- Univ Fed Sao Paulo, Hosp Rim, Div Nephrol, Sao Paulo, Brazil
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- Lehner, F. (author)
- Hannover Med Sch, Gen Visceral & Transplantat Surg, Hannover, Germany
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- Mondragon-Ramirez, G. A. (author)
- Mexican Inst Transplants, Transplant Surg Dept, Morelos, Mexico
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- Glyda, M. (author)
- Dist Publ Hosp, Dept Transplantol & Gen Surg, Poznan, Poland
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- Cassuto-Viguier, E. (author)
- Pasteur 2 Nice Univ Hosp, Renal Transplant Unit, Nice, France
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- Viklicky, O. (author)
- Inst Clin & Expt Med, Dept Nephrol, Prague, Czech Republic
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- Mourad, G. (author)
- Montpellier Univ Hosp, Lapeyronie Hosp, Dept Nephrol Dialysis & Transplantat, Montpellier, France
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- Rigotti, P. (author)
- Padua Univ Hosp, Kidney & Pancreas Transplant Unit, Padua, Italy
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- Schleibner, S. (author)
- Astellas Pharma GmbH, Formerly Med Affairs, Munich, Germany
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- Kamar, N. (author)
- Paul Sabatier Univ, CHU Rangueil, Dept Nephrol & Organ Transplantat, Toulouse, France
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(creator_code:org_t)
- Elsevier BV, 2017
- 2017
- English.
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In: Transplantation Proceedings. - : Elsevier BV. - 0041-1345 .- 1873-2623. ; 49:9, s. 2040-2049
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Abstract
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- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kirurgi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Surgery (hsv//eng)
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- ref (subject category)
- art (subject category)
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- By the author/editor
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Kraemer, B. K.
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Albano, L.
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Banas, B.
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Charpentier, B.
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Bäckman, Lars
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Tedesco-Silva, H ...
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Lehner, F.
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Mondragon-Ramire ...
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Glyda, M.
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Cassuto-Viguier, ...
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Viklicky, O.
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Mourad, G.
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Rigotti, P.
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Schleibner, S.
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Kamar, N.
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Surgery
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Transplantation ...
- By the university
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Uppsala University