Early outcomes associated with de novo once‐daily extended‐release versus twice‐daily immediate‐release tacrolimus in a predominantly African American kidney transplant population: A single‐center observational study

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Autores principales: Margaret M. Romine, David B. Leeser, Karen Kennamer, Catherine Nguyen, Heather Jones, Kristel McLawhorn, Scott Kendrick, William Irish
Formato: Artículo Open Access
Publicado: Wiley 2024
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author Margaret M. Romine
David B. Leeser
Karen Kennamer
Catherine Nguyen
Heather Jones
Kristel McLawhorn
Scott Kendrick
William Irish
author_facet Margaret M. Romine
David B. Leeser
Karen Kennamer
Catherine Nguyen
Heather Jones
Kristel McLawhorn
Scott Kendrick
William Irish
Margaret M. Romine
David B. Leeser
Karen Kennamer
Catherine Nguyen
Heather Jones
Kristel McLawhorn
Scott Kendrick
William Irish
collection Wiley Open Access
contents Early outcomes associated with de novo once‐daily extended‐release versus twice‐daily immediate‐release tacrolimus in a predominantly African American kidney transplant population: A single‐center observational study Margaret M. Romine David B. Leeser Karen Kennamer Catherine Nguyen Heather Jones Kristel McLawhorn Scott Kendrick William Irish Clinical Transplantation AbstractIntroductionThe purpose of this study was to compare early outcomes of de novo LCPT (once‐daily extended‐release tacrolimus) to IR TAC (twice‐daily immediate‐release tacrolimus) in a predominantly African American (AA) adult kidney transplant population.MethodsThis is a single center, retrospective cohort study. Patients were divided into two cohorts: IR TAC (administered between January 1, 2017, and January 31, 2019) and LCPT (administered between February 1, 2019, and May 31, 2020). Primary endpoints were changes in tacrolimus trough levels (ng/mL) and estimated glomerular filtration rate up to 12 months post‐transplantation. Clinical endpoints included graft survival, delayed graft function, biopsy‐proven rejection, CMV viremia, and BK. A propensity score weighted generalized linear mixed effects model was used for analysis.ResultsThe rate of change in tacrolimus levels was significantly higher in the LCPT cohort compared to the IR TAC cohort at 14 days post‐discharge (.2455 ng/mL per day vs. .1073 ng/mL, respectively; p < .001). Subsequently, the LCPT cohort had a slightly higher rate of decline (–.015 ng/mL per day vs. –.010 ng/mL with IR TAC; p = .0894) up to 12 months post‐discharge. Although eGFR was similar between the two cohorts at 12 months post‐transplant, the rate of increase was slower in the LCPT cohort (.1371 mL/min per day vs. .1852 mL/min per day, p = .0314). No significant differences were found in graft survival, DGF, BPAR, CMV, or BK infection.ConclusionThis study demonstrates that despite higher early trough levels with immediate post‐transplant LCPT use, clinical outcomes are comparable to IR TAC at one‐year post‐transplant. Notably, LCPT use does not increase the incidence of DGF and that this formulation of CNI can be used as first line therapy post‐transplant. 10.1111/ctr.15268 http://creativecommons.org/licenses/by-nc/4.0/
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spellingShingle Early outcomes associated with de novo once‐daily extended‐release versus twice‐daily immediate‐release tacrolimus in a predominantly African American kidney transplant population: A single‐center observational study
Margaret M. Romine
David B. Leeser
Karen Kennamer
Catherine Nguyen
Heather Jones
Kristel McLawhorn
Scott Kendrick
William Irish
Clinical Transplantation
Early outcomes associated with de novo once‐daily extended‐release versus twice‐daily immediate‐release tacrolimus in a predominantly African American kidney transplant population: A single‐center observational study Margaret M. Romine David B. Leeser Karen Kennamer Catherine Nguyen Heather Jones Kristel McLawhorn Scott Kendrick William Irish Clinical Transplantation AbstractIntroductionThe purpose of this study was to compare early outcomes of de novo LCPT (once‐daily extended‐release tacrolimus) to IR TAC (twice‐daily immediate‐release tacrolimus) in a predominantly African American (AA) adult kidney transplant population.MethodsThis is a single center, retrospective cohort study. Patients were divided into two cohorts: IR TAC (administered between January 1, 2017, and January 31, 2019) and LCPT (administered between February 1, 2019, and May 31, 2020). Primary endpoints were changes in tacrolimus trough levels (ng/mL) and estimated glomerular filtration rate up to 12 months post‐transplantation. Clinical endpoints included graft survival, delayed graft function, biopsy‐proven rejection, CMV viremia, and BK. A propensity score weighted generalized linear mixed effects model was used for analysis.ResultsThe rate of change in tacrolimus levels was significantly higher in the LCPT cohort compared to the IR TAC cohort at 14 days post‐discharge (.2455 ng/mL per day vs. .1073 ng/mL, respectively; p < .001). Subsequently, the LCPT cohort had a slightly higher rate of decline (–.015 ng/mL per day vs. –.010 ng/mL with IR TAC; p = .0894) up to 12 months post‐discharge. Although eGFR was similar between the two cohorts at 12 months post‐transplant, the rate of increase was slower in the LCPT cohort (.1371 mL/min per day vs. .1852 mL/min per day, p = .0314). No significant differences were found in graft survival, DGF, BPAR, CMV, or BK infection.ConclusionThis study demonstrates that despite higher early trough levels with immediate post‐transplant LCPT use, clinical outcomes are comparable to IR TAC at one‐year post‐transplant. Notably, LCPT use does not increase the incidence of DGF and that this formulation of CNI can be used as first line therapy post‐transplant. 10.1111/ctr.15268 http://creativecommons.org/licenses/by-nc/4.0/
title Early outcomes associated with de novo once‐daily extended‐release versus twice‐daily immediate‐release tacrolimus in a predominantly African American kidney transplant population: A single‐center observational study
topic Clinical Transplantation
url https://onlinelibrary.wiley.com/doi/10.1111/ctr.15268