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Tacrolimus predose concentrations do not predict the risk of acute rejection after renal transplantation: a pooled analysis from three randomized-controlled clinical trials(†).
Am J Transplant 2013; 13(5):1253-61AJ

Abstract

Therapeutic drug monitoring (TDM) for tacrolimus (Tac) is universally applied. However, the concentration-effect relationship for Tac is poorly defined. This study investigated whether Tac concentrations are associated with acute rejection in kidney transplant recipients. Data from three large trials were pooled. We used univariate and multivariate analysis to investigate the relationship between biopsy-proven acute rejection (BPAR) and Tac predose concentration at five time points (day 3, 10 and 14, and month 1 and 6 after transplantation). A total of 136/1304 patients experienced BPAR, giving an overall incidence of 10.4%. We did not find any significant correlations between Tac predose concentrations and the incidence of BPAR at the different time points. In the multivariate analysis, only delayed graft function (DGF) and the use of induction therapy were independently correlated with BPAR, with an odds ratio of 2.7 [95% CI: 1.8-4.0; p < 0.001] for DGF and 0.66 [95% CI: 0.44-0.99; p = 0.049] for induction therapy. The other variables, including the Tac predose concentrations, were not statistically significantly associated with BPAR. We did not find an association between the Tac predose concentrations measured at five time points after kidney transplantation and the incidence of acute rejection occurring thereafter. Based on this study it is not possible to define the optimal target concentrations for Tac.

Authors+Show Affiliations

Department of Hospital Pharmacy, Erasmus MC, Rotterdam, the Netherlands.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23480233

Citation

Bouamar, R, et al. "Tacrolimus Predose Concentrations Do Not Predict the Risk of Acute Rejection After Renal Transplantation: a Pooled Analysis From Three Randomized-controlled Clinical Trials(†)." American Journal of Transplantation : Official Journal of the American Society of Transplantation and the American Society of Transplant Surgeons, vol. 13, no. 5, 2013, pp. 1253-61.
Bouamar R, Shuker N, Hesselink DA, et al. Tacrolimus predose concentrations do not predict the risk of acute rejection after renal transplantation: a pooled analysis from three randomized-controlled clinical trials(†). Am J Transplant. 2013;13(5):1253-61.
Bouamar, R., Shuker, N., Hesselink, D. A., Weimar, W., Ekberg, H., Kaplan, B., ... van Gelder, T. (2013). Tacrolimus predose concentrations do not predict the risk of acute rejection after renal transplantation: a pooled analysis from three randomized-controlled clinical trials(†). American Journal of Transplantation : Official Journal of the American Society of Transplantation and the American Society of Transplant Surgeons, 13(5), pp. 1253-61. doi:10.1111/ajt.12191.
Bouamar R, et al. Tacrolimus Predose Concentrations Do Not Predict the Risk of Acute Rejection After Renal Transplantation: a Pooled Analysis From Three Randomized-controlled Clinical Trials(†). Am J Transplant. 2013;13(5):1253-61. PubMed PMID: 23480233.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Tacrolimus predose concentrations do not predict the risk of acute rejection after renal transplantation: a pooled analysis from three randomized-controlled clinical trials(†). AU - Bouamar,R, AU - Shuker,N, AU - Hesselink,D A, AU - Weimar,W, AU - Ekberg,H, AU - Kaplan,B, AU - Bernasconi,C, AU - van Gelder,T, Y1 - 2013/03/08/ PY - 2012/12/18/received PY - 2013/01/11/revised PY - 2013/01/14/accepted PY - 2013/3/14/entrez PY - 2013/3/14/pubmed PY - 2013/10/30/medline SP - 1253 EP - 61 JF - American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons JO - Am. J. Transplant. VL - 13 IS - 5 N2 - Therapeutic drug monitoring (TDM) for tacrolimus (Tac) is universally applied. However, the concentration-effect relationship for Tac is poorly defined. This study investigated whether Tac concentrations are associated with acute rejection in kidney transplant recipients. Data from three large trials were pooled. We used univariate and multivariate analysis to investigate the relationship between biopsy-proven acute rejection (BPAR) and Tac predose concentration at five time points (day 3, 10 and 14, and month 1 and 6 after transplantation). A total of 136/1304 patients experienced BPAR, giving an overall incidence of 10.4%. We did not find any significant correlations between Tac predose concentrations and the incidence of BPAR at the different time points. In the multivariate analysis, only delayed graft function (DGF) and the use of induction therapy were independently correlated with BPAR, with an odds ratio of 2.7 [95% CI: 1.8-4.0; p < 0.001] for DGF and 0.66 [95% CI: 0.44-0.99; p = 0.049] for induction therapy. The other variables, including the Tac predose concentrations, were not statistically significantly associated with BPAR. We did not find an association between the Tac predose concentrations measured at five time points after kidney transplantation and the incidence of acute rejection occurring thereafter. Based on this study it is not possible to define the optimal target concentrations for Tac. SN - 1600-6143 UR - https://www.unboundmedicine.com/medline/citation/23480233/Tacrolimus_Predose_Concentrations_Do_Not_Predict_the_Risk_of_Acute_Rejection_After_Renal_Transplantation:_A_Pooled_Analysis_From_Three_Randomized_Controlled_Clinical_Trials_†_ L2 - https://doi.org/10.1111/ajt.12191 DB - PRIME DP - Unbound Medicine ER -