Impact of Switching From Immediate- or Prolonged-Release to Once-Daily Extended-Release Tacrolimus (LCPT) on Tremor in Stable Kidney Transplant Recipients: The Observational ELIT Study Article Swipe
Magali Giral
,
Philippe Grimbert
,
Baptiste Morin
,
Nicolas Bouvier
,
Matthias Büchler
,
Jacques Dantal
,
Valérie Garrigue
,
Dominique Bertrand
,
Nassim Kamar
,
Paolo Malvezzi
,
Karine Moreau
,
Yoni Athea
,
Yannick Le Meur
·
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.3389/ti.2024.11571
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.3389/ti.2024.11571
Once-daily extended-release tacrolimus (LCPT) exhibits increased bioavailability versus immediate-release (IR-TAC) and prolonged release (PR-TAC) tacrolimus. Improvements in tremor were previously reported in a limited number of kidney transplant patients who switched to LCPT. We conducted a non-interventional, non-randomized, uncontrolled, longitudinal, prospective, multicenter study to assess the impact of switching to LCPT on tremor and quality of life (QoL) in a larger population of stable kidney transplant patients. The primary endpoint was change in The Essential Tremor Rating Assessment Scale (TETRAS) score; secondary endpoints included 12-item Short Form Survey (SF-12) scores, tacrolimus trough concentrations, neurologic symptoms, and safety assessments. Subgroup analyses were conducted to assess change in TETRAS score and tacrolimus trough concentration/dose (C 0 /D) ratio by prior tacrolimus formulation and tacrolimus metabolizer status. Among 221 patients, the mean decrease of TETRAS score after switch to LCPT was statistically significant ( p < 0.0001 vs. baseline). There was no statistically significant difference in change in TETRAS score after switch to LCPT between patients who had received IR-TAC and those who had received PR-TAC before switch, or between fast and slow metabolizers of tacrolimus. The overall increase of C 0 /D ratio post-switch to LCPT was statistically significant ( p < 0.0001) and from baseline to either M1 or M3 (both p < 0.0001) in the mITT population and in all subgroups. In the fast metabolizers group, the C 0 /D ratio crossed over the threshold of 1.05 ng/mL/mg after the switch to LCPT. Other neurologic symptoms tended to improve, and the SF-12 mental component summary score improved significantly. No new safety concerns were evident. In this observational study, all patients had a significant improvement of tremor, QoL and C 0 /D ratio post-switch to LCPT irrespective of the previous tacrolimus formulation administered (IR-TAC or PR-TAC) and irrespective from their metabolism status (fast or slow metabolizers).
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Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.3389/ti.2024.11571
- https://www.frontierspartnerships.org/articles/10.3389/ti.2024.11571/pdf
- OA Status
- gold
- Cited By
- 6
- References
- 38
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4394889119
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
-
https://openalex.org/W4394889119Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.3389/ti.2024.11571Digital Object Identifier
- Title
-
Impact of Switching From Immediate- or Prolonged-Release to Once-Daily Extended-Release Tacrolimus (LCPT) on Tremor in Stable Kidney Transplant Recipients: The Observational ELIT StudyWork title
- Type
-
articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2024Year of publication
- Publication date
-
2024-04-17Full publication date if available
- Authors
-
Magali Giral, Philippe Grimbert, Baptiste Morin, Nicolas Bouvier, Matthias Büchler, Jacques Dantal, Valérie Garrigue, Dominique Bertrand, Nassim Kamar, Paolo Malvezzi, Karine Moreau, Yoni Athea, Yannick Le MeurList of authors in order
- Landing page
-
https://doi.org/10.3389/ti.2024.11571Publisher landing page
- PDF URL
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https://www.frontierspartnerships.org/articles/10.3389/ti.2024.11571/pdfDirect link to full text PDF
- Open access
-
YesWhether a free full text is available
- OA status
-
goldOpen access status per OpenAlex
- OA URL
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https://www.frontierspartnerships.org/articles/10.3389/ti.2024.11571/pdfDirect OA link when available
- Concepts
-
Medicine, Tacrolimus, Observational study, Kidney transplant, Calcineurin, Internal medicine, Kidney transplantation, Nephrology, Kidney, Urology, TransplantationTop concepts (fields/topics) attached by OpenAlex
- Cited by
-
6Total citation count in OpenAlex
- Citations by year (recent)
-
2025: 5, 2024: 1Per-year citation counts (last 5 years)
- References (count)
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38Number of works referenced by this work
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-
10Other works algorithmically related by OpenAlex
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