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

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-int...

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Veröffentlicht in:Transplant international Jg. 37; S. 11571
Hauptverfasser: Giral, Magali, Grimbert, Philippe, Morin, Baptiste, Bouvier, Nicolas, Buchler, Matthias, Dantal, Jacques, Garrigue, Valérie, Bertrand, Dominique, Kamar, Nassim, Malvezzi, Paolo, Moreau, Karine, Athea, Yoni, Le Meur, Yannick
Format: Journal Article
Sprache:Englisch
Veröffentlicht: Switzerland Frontiers Media SA 17.04.2024
Frontiers Media
Frontiers Media S.A
Schlagworte:
Adult
Aged
Bioavailability
Blood
C0/D ratio
Delayed-Action Preparations
Drug Administration Schedule
Drug dosages
extended-release tacrolimus
Female
Health Archive
Humans
Immunology
immunosuppression
Immunosuppressive Agents
Immunosuppressive Agents - administration & dosage
Immunosuppressive Agents - pharmacokinetics
Kidney Transplantation
Kidney transplants
Kidneys
LCPT
Life Sciences
Longitudinal Studies
Male
Middle Aged
Non-pharmacological intervention
Observational studies
Patients
Prospective Studies
Quality of Life
Statistical analysis
Subgroups
Tacrolimus
Tacrolimus - administration & dosage
Tacrolimus - pharmacokinetics
Transplant Recipients
Tremor
Tremor (Muscular contraction)
Tremor - drug therapy
Tremors
fast metabolizer
tremor
C0/D ratio
kidney transplantation
LCPT
extended-release tacrolimus
immunosuppression
quality of life
ISSN:1432-2277, 0934-0874, 1432-2277
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Zusammenfassung: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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PMCID: PMC11061389
These authors have contributed equally to this work
ISSN:1432-2277
0934-0874
1432-2277
DOI:10.3389/ti.2024.11571