Clinical Experience with Extended-Release Tacrolimus in Older Adult Kidney Transplant Recipients: A Retrospective Cohort Study.

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Title: Clinical Experience with Extended-Release Tacrolimus in Older Adult Kidney Transplant Recipients: A Retrospective Cohort Study.
Authors: January, Spenser E., Hagopian, Jennifer C., Nesselhauf, Nicole M., Progar, Kristin, Horwedel, Timothy A., Santos, Rowena Delos
Source: Drugs & Aging; May2021, Vol. 38 Issue 5, p397-406, 10p
Subject Terms: ACQUISITION of data methodology, WORK, AGE distribution, KIDNEY transplantation, RETROSPECTIVE studies, RACE, REGRESSION analysis, EXPERIENTIAL learning, MEDICAL records, TACROLIMUS, TRANSPLANTATION of organs, tissues, etc., LONGITUDINAL method, REHABILITATION, OLD age
Abstract: Background: Extended-release tacrolimus (LCP-Tac) prescribing information states that there is insufficient data in older adult patients from which to make recommendations on use in this population. This study sought to provide information on de novo use of LCP-Tac in the older adult kidney transplant population. Methods: This single-center retrospective study had two distinct objectives; to determine if weight-based doses of LCP-Tac differ based on recipient age and to compare safety and efficacy between LCP-Tac and immediate-release tacrolimus (IR-Tac) in older adult transplant recipients. Data was obtained through electronic chart review up to 2 years after transplant with censoring for graft loss and death. Results: Weight-based doses were compared between patients aged ≥ 65 years (n = 84), 36–64 years (n = 64), and ≤35 years (n = 44). LCP-Tac weight-based doses were lower at all time points in patients ≥ 65 years of age. Both age and race significantly impacted required dose on linear regression. The doses required to achieve therapeutic tacrolimus troughs were significantly lower in all age groups compared with the current FDA de novo dosing recommendation. In the older adult population, graft outcomes and infectious and metabolic complications were compared between recipients of LCP-Tac (n = 84) and IR-Tac (n = 42). Within this cohort, there were no differences between LCP-Tac and IR-Tac on graft function, rejection, graft loss, death, cytomegalovirus viremia, BK viremia, hypertension, diabetes, alopecia, or tremor up to 2 years after transplant. Conclusions: Older adult recipients required significantly lower LCP-Tac doses compared with younger recipients and with the FDA-labeled starting dose. There were no differences in graft outcomes or adverse effects in older adult patients who received LCP-Tac versus IR-Tac. [ABSTRACT FROM AUTHOR]
Copyright of Drugs & Aging is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Data: Clinical Experience with Extended-Release Tacrolimus in Older Adult Kidney Transplant Recipients: A Retrospective Cohort Study.
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  Data: Drugs & Aging; May2021, Vol. 38 Issue 5, p397-406, 10p
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  Data: <searchLink fieldCode="DE" term="%22ACQUISITION+of+data+methodology%22">ACQUISITION of data methodology</searchLink><br /><searchLink fieldCode="DE" term="%22WORK%22">WORK</searchLink><br /><searchLink fieldCode="DE" term="%22AGE+distribution%22">AGE distribution</searchLink><br /><searchLink fieldCode="DE" term="%22KIDNEY+transplantation%22">KIDNEY transplantation</searchLink><br /><searchLink fieldCode="DE" term="%22RETROSPECTIVE+studies%22">RETROSPECTIVE studies</searchLink><br /><searchLink fieldCode="DE" term="%22RACE%22">RACE</searchLink><br /><searchLink fieldCode="DE" term="%22REGRESSION+analysis%22">REGRESSION analysis</searchLink><br /><searchLink fieldCode="DE" term="%22EXPERIENTIAL+learning%22">EXPERIENTIAL learning</searchLink><br /><searchLink fieldCode="DE" term="%22MEDICAL+records%22">MEDICAL records</searchLink><br /><searchLink fieldCode="DE" term="%22TACROLIMUS%22">TACROLIMUS</searchLink><br /><searchLink fieldCode="DE" term="%22TRANSPLANTATION+of+organs%2C+tissues%2C+etc%2E%22">TRANSPLANTATION of organs, tissues, etc.</searchLink><br /><searchLink fieldCode="DE" term="%22LONGITUDINAL+method%22">LONGITUDINAL method</searchLink><br /><searchLink fieldCode="DE" term="%22REHABILITATION%22">REHABILITATION</searchLink><br /><searchLink fieldCode="DE" term="%22OLD+age%22">OLD age</searchLink>
– Name: Abstract
  Label: Abstract
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  Data: Background: Extended-release tacrolimus (LCP-Tac) prescribing information states that there is insufficient data in older adult patients from which to make recommendations on use in this population. This study sought to provide information on de novo use of LCP-Tac in the older adult kidney transplant population. Methods: This single-center retrospective study had two distinct objectives; to determine if weight-based doses of LCP-Tac differ based on recipient age and to compare safety and efficacy between LCP-Tac and immediate-release tacrolimus (IR-Tac) in older adult transplant recipients. Data was obtained through electronic chart review up to 2 years after transplant with censoring for graft loss and death. Results: Weight-based doses were compared between patients aged ≥ 65 years (n = 84), 36–64 years (n = 64), and ≤35 years (n = 44). LCP-Tac weight-based doses were lower at all time points in patients ≥ 65 years of age. Both age and race significantly impacted required dose on linear regression. The doses required to achieve therapeutic tacrolimus troughs were significantly lower in all age groups compared with the current FDA de novo dosing recommendation. In the older adult population, graft outcomes and infectious and metabolic complications were compared between recipients of LCP-Tac (n = 84) and IR-Tac (n = 42). Within this cohort, there were no differences between LCP-Tac and IR-Tac on graft function, rejection, graft loss, death, cytomegalovirus viremia, BK viremia, hypertension, diabetes, alopecia, or tremor up to 2 years after transplant. Conclusions: Older adult recipients required significantly lower LCP-Tac doses compared with younger recipients and with the FDA-labeled starting dose. There were no differences in graft outcomes or adverse effects in older adult patients who received LCP-Tac versus IR-Tac. [ABSTRACT FROM AUTHOR]
– Name: Abstract
  Label:
  Group: Ab
  Data: <i>Copyright of Drugs & Aging is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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        Value: 10.1007/s40266-021-00842-w
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      – Code: eng
        Text: English
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        PageCount: 10
        StartPage: 397
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      – SubjectFull: ACQUISITION of data methodology
        Type: general
      – SubjectFull: WORK
        Type: general
      – SubjectFull: AGE distribution
        Type: general
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      – TitleFull: Clinical Experience with Extended-Release Tacrolimus in Older Adult Kidney Transplant Recipients: A Retrospective Cohort Study.
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              Text: May2021
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