# Tremors and Health-Related Quality of Life in Liver Transplant Recipients: Post-hoc Analysis of a Multicenter, Randomized, Controlled Trial Comparing a Life Cycle Pharma-Tacrolimus Regimen and Extended-Release Tacrolimus Regimen

## TL;DR

This study compared two tacrolimus regimens in liver transplant patients and found no significant differences in tremors or quality of life.

## Contribution

The study provides evidence on the equivalence of two tacrolimus regimens regarding tremors and HRQoL in liver transplant recipients.

## Key findings

- 25% of LCP-tacrolimus patients experienced tremors compared to 30.4% in the ER-tacrolimus group at 12 months.
- No statistically significant differences in HRQoL were observed between the two tacrolimus regimens.
- Risk difference for tremors was not statistically significant (p = 0.63).

## Abstract

We investigated whether life cycle pharma (LCP)-tacrolimus compared to extended-release (ER)-tacrolimus results in a difference in severity of tremors and HRQoL. In this multi-center, open-label, randomized, controlled trial, 108 patients were randomized in a 1:1 ratio to either LCP-tacrolimus regimen or ER-tacrolimus regimen after transplantation. HRQoL was assessed with the EQ-5D-5L and SF-36 questionnaire (two generic HRQoL instruments) and the quality of life in essential tremor (QUEST) questionnaire (domain specific HRQoL instrument). The EQ-5D-5L scores were translated to the societal values. We examined the HRQoL over the course of the study by fitting generalized mixed effect models. In total, 105 patients were included, 53 to the LCP- and 52 to the ER-tacrolimus regimen. Baseline questionnaires were available for every LT recipient. At 12 months 25% [10/40], 95% confidence interval (CI) 14.2%–40.2% of the LT recipients in the LCP-tacrolimus regimen group experienced tremors compared to 30.4% [14/46], 95%-CI 19.1%–44.8% of the LT recipients in the ER-tacrolimus regimen group; risk difference: 0.054; 95%-CI −0.151–0.249; p = 0.63. No statistically significant differences in HRQoL were seen between the two regimens. We could not demonstrate differences in the HRQoL or occurrence of tremors between LCP-tacrolimus and ER-tacrolimus regimens