Modifying Tacrolimus-related Toxicity After Liver Transplantation Comparing Life Cycle Pharma Tacrolimus Versus Extended-released Tacrolimus: A Multicenter, Randomized Controlled Trial

Midas B. Mulder*, Bart van Hoek, Wojtek G. Polak, Ian P.J. Alwayn, Brenda C.M. de Winter, Sarwa Darwish Murad, Elke Verhey-Hart, Lara Elshove, Nicole S. Erler, Dennis A. Hesselink, Caroline M. den Hoed, Herold J. Metselaar

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

10 Downloads (Pure)

Abstract

Background:

The aim of this open-label, multicenter, randomized controlled study was to investigate whether the life cycle pharma (LCP)-tacrolimus compared with the extended-release (ER)-tacrolimus formulation results in a difference in the prevalence of posttransplant diabetes, hypertension and chronic kidney disease (CKD) at 12 mo after liver transplantation.

Methods:

Patients were 1:1 randomized to either of the 2 tacrolimus formulations. The primary endpoint was defined as a composite endpoint of any of 3 events: sustained (>3 mo postrandomization) posttransplant diabetes, new-onset hypertension, and/or CKD, defined as estimated glomerular filtration rate <60 mL/min/1.73 m2 for >3 m during the follow-up.

Results:

In total, 105 patients were included. In the intention-to-treat analysis, a statistically significant lower proportion of liver transplant recipients in the LCP-tacrolimus group reached the composite primary endpoint at 12 mo compared with the ER-tacrolimus group (50.9% [27/53], 95% confidence interval [CI], 37.9%-63.9% versus 71.2% [37/52], 95% CI, 57.7%-81.7%; risk difference: 0.202; 95% CI, 0.002-0.382; P = 0.046). No significant difference was found in the per protocol analysis. In the intention-to-treat and per protocol population, fewer liver transplant recipients in the LCP-tacrolimus group developed CKD and new-onset hypertension compared with the ER-tacrolimus group. No differences in rejection rate, graft and patient survival were found. 

Conclusions:

A statistically significant and clinically relevant reduction in the prevalence of the composite primary endpoint was found in the LCP-tacrolimus group compared with the ER-tacrolimus group in the first year after liver transplantation with comparable efficacy.

Original languageEnglish
Article numberE1612
JournalTransplantation Direct
Volume10
Issue number4
DOIs
Publication statusPublished - 12 Mar 2024

Bibliographical note

Publisher Copyright:
© 2024 Wolters Kluwer Health. All rights reserved.

Fingerprint

Dive into the research topics of 'Modifying Tacrolimus-related Toxicity After Liver Transplantation Comparing Life Cycle Pharma Tacrolimus Versus Extended-released Tacrolimus: A Multicenter, Randomized Controlled Trial'. Together they form a unique fingerprint.

Cite this