AUTHOR=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 

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 Study

JOURNAL=Transplant International

VOLUME=Volume 37 - 2024

YEAR=2024

URL=https://www.frontierspartnerships.org/journals/transplant-international/articles/10.3389/ti.2024.11571

DOI=10.3389/ti.2024.11571

ISSN=1432-2277

ABSTRACT=Once-daily extended-release tacrolimus (Envarsus®; 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 from IR-TAC/PR-TAC to LCPT. We conducted a non-interventional, 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. Among 221 patients switching to LCPT, mean (95% confidence interval) TETRAS scores were 10.60 (9.61, 11.58) at Day 0 (D0), 6.81 (5.96, 7.67) at Month 1, and 5.94 (5.79, 6.79) at Month 3 (M3); the mean decrease over time was statistically significant (p<0.0001 vs baseline). Although the mean daily LCPT dose decreased at each visit, mean tacrolimus trough concentrations increased significantly from 7.04 ng/mL at D0 to 7.59 ng/mL at M3 (p=0.0006). Other neurologic symptoms tended to improve, and the SF-12 mental component summary score improved significantly. No new safety concerns were evident. Switching to LCPT improved tremor and patient QoL.