American College of Clinical Pharmacy
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  Poster Hall

Sun-88 - Assessment of cognitive function before and after conversion from immediate release tacrolimus to LCP-tacrolimus (Envarsus XR®) (ACOFTE)

Scientific Poster Session II - Original Research

Original Research
  Sunday, October 13, 2024
  12:45 PM–02:15 PM

Abstract

Introduction:

Tacrolimus (Tac-IR) is the backbone of immunosuppressive therapy for kidney transplant recipients (KTR) due to its superior outcomes. Its adverse effect profile includes neurotoxicity and cognitive impairment. Neurotoxicity from tacrolimus is documented in case reports, although there is minimal published clinical trial research. It is thought that these toxicities are primarily related to peak tacrolimus levels. LCP-tacrolimus (LCP-Tac) is a sustained release formulation of tacrolimus that has a significantly reduced peak. Use of LCP-Tac may help to maintain kidney function while reducing neurotoxicity.

Research Question or Hypothesis:

Conversion to LCP-Tac from Tac-IR significantly improves cognitive function in kidney transplant recipients using an objective measure of cognition.

Study Design:

This is a prospective clinical trial to assess cognitive function of KTR while on Tac-IR and at least 90 days after conversion to LCP-Tac using Montreal Cognitive Assessment (MoCA) and the NIH Toolbox Cognitive Domains.

Methods:

Adult KTR on Tac-IR for at least two months being converted to LCP-Tac underwent an initial cognitive evaluation and a second cognitive evaluation approximately 90 days after starting LCP-Tac. Patients were excluded if non-English speaking, had a history of stroke or dementia, and if they were unable to provide informed consent. Primary objective was to compare the uncorrected Cognition Fluid Composite score (CFC) before and after conversion to LCP-Tac. Secondary objectives included each individual test within the NIH Toolbox and the MoCA. Statistics were completed using GraphPad Prism. Descriptive statistics were used for demographic data. Paired t-test was used to compare normally distributed continuous data with a p<0.05 considered significant.

Results:

19 patients completed an initial and second cognitive assessment. The mean of differences of the CFC was 3.526 (p=0.0381). The mean of differences of the uncorrected Patten Comparison (PC) Test was 8.053 (p=0.0019).

Conclusion:

Patients had improvements in cognitive function when converted to LCP-Tac, driven primarily by the PC test, which measures processing speed.

Presenting Author

Elizabeth Cohen PharmD
Yale-New Haven Hospital

Authors

Kristen Belfield PharmD
Yale New Haven Hospital

Vincent Do PharmD
Yale New Haven Hospital

Richard N. Formica Jr. MD
Yale-New Haven Hospital