Cargando…

A Multi-Centre Non-Interventional Study to Assess the Tolerability and Effectiveness of Extended-Release Tacrolimus (LCPT) in De Novo Liver Transplant Patients

Background: Available tacrolimus formulations exhibit substantial inter- and intra-individual variability in absorption and metabolism. The present non-interventional cohort study aimed to assess the tolerability and effectiveness of the once-daily tacrolimus formulation, LCPT, in hepatic allograft...

Descripción completa

Detalles Bibliográficos
Autores principales: Soliman, Thomas, Gyoeri, Georg, Salat, Andreas, Mejzlík, Vladimír, Berlakovich, Gabriela
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10094891/
https://www.ncbi.nlm.nih.gov/pubmed/37048621
http://dx.doi.org/10.3390/jcm12072537
_version_ 1785023949908738048
author Soliman, Thomas
Gyoeri, Georg
Salat, Andreas
Mejzlík, Vladimír
Berlakovich, Gabriela
author_facet Soliman, Thomas
Gyoeri, Georg
Salat, Andreas
Mejzlík, Vladimír
Berlakovich, Gabriela
author_sort Soliman, Thomas
collection PubMed
description Background: Available tacrolimus formulations exhibit substantial inter- and intra-individual variability in absorption and metabolism. The present non-interventional cohort study aimed to assess the tolerability and effectiveness of the once-daily tacrolimus formulation, LCPT, in hepatic allograft recipients in real life. Materials and methods: This study was conducted in Austria and the Czech Republic between July 2016 and August 2019. Patients aged ≥ 18 years old received LCPT per the approved label and local clinical routine. All the participants provided informed consent. Patients newly treated with tacrolimus (de novo) directly after transplantation were observed for six months. The relevant clinical variables were tacrolimus trough level (TL), total daily dose (TDD), number of dose adjustments, kidney and liver function, and tolerability. Results: Of the 70 analyzed patients, 72.9% were male and 85.7% were aged < 65 years old. The mean (SD) time to achieve tacrolimus target TL was 6.4 (4.6) days after 4.4 (4.0) dose adjustments; thereafter, TL remained stable throughout observation at approximately 8 ng/mL. The LCPT TDD at initiation was 8 mg and decreased by a median of 41.4% to 5 mg at 6 months. Liver function continuously improved, and kidney function remained stable. LCPT was well tolerated with 24 adverse events in eight patients (17 related to immunosuppression, mostly mild renal insufficiency, and hematological adverse events); two serious unrelated adverse events were reported (atrial flutter and liver dysfunction). Conclusions: TL was rapidly attained with few dose adaptations after LCPT initiation in de novo liver transplant patients. Liver function rapidly improved, whereas kidney function remained normal. LCPT was well-tolerated in this population.
format Online
Article
Text
id pubmed-10094891
institution National Center for Biotechnology Information
language English
publishDate 2023
publisher MDPI
record_format MEDLINE/PubMed
spelling pubmed-100948912023-04-13 A Multi-Centre Non-Interventional Study to Assess the Tolerability and Effectiveness of Extended-Release Tacrolimus (LCPT) in De Novo Liver Transplant Patients Soliman, Thomas Gyoeri, Georg Salat, Andreas Mejzlík, Vladimír Berlakovich, Gabriela J Clin Med Article Background: Available tacrolimus formulations exhibit substantial inter- and intra-individual variability in absorption and metabolism. The present non-interventional cohort study aimed to assess the tolerability and effectiveness of the once-daily tacrolimus formulation, LCPT, in hepatic allograft recipients in real life. Materials and methods: This study was conducted in Austria and the Czech Republic between July 2016 and August 2019. Patients aged ≥ 18 years old received LCPT per the approved label and local clinical routine. All the participants provided informed consent. Patients newly treated with tacrolimus (de novo) directly after transplantation were observed for six months. The relevant clinical variables were tacrolimus trough level (TL), total daily dose (TDD), number of dose adjustments, kidney and liver function, and tolerability. Results: Of the 70 analyzed patients, 72.9% were male and 85.7% were aged < 65 years old. The mean (SD) time to achieve tacrolimus target TL was 6.4 (4.6) days after 4.4 (4.0) dose adjustments; thereafter, TL remained stable throughout observation at approximately 8 ng/mL. The LCPT TDD at initiation was 8 mg and decreased by a median of 41.4% to 5 mg at 6 months. Liver function continuously improved, and kidney function remained stable. LCPT was well tolerated with 24 adverse events in eight patients (17 related to immunosuppression, mostly mild renal insufficiency, and hematological adverse events); two serious unrelated adverse events were reported (atrial flutter and liver dysfunction). Conclusions: TL was rapidly attained with few dose adaptations after LCPT initiation in de novo liver transplant patients. Liver function rapidly improved, whereas kidney function remained normal. LCPT was well-tolerated in this population. MDPI 2023-03-28 /pmc/articles/PMC10094891/ /pubmed/37048621 http://dx.doi.org/10.3390/jcm12072537 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Soliman, Thomas
Gyoeri, Georg
Salat, Andreas
Mejzlík, Vladimír
Berlakovich, Gabriela
A Multi-Centre Non-Interventional Study to Assess the Tolerability and Effectiveness of Extended-Release Tacrolimus (LCPT) in De Novo Liver Transplant Patients
title A Multi-Centre Non-Interventional Study to Assess the Tolerability and Effectiveness of Extended-Release Tacrolimus (LCPT) in De Novo Liver Transplant Patients
title_full A Multi-Centre Non-Interventional Study to Assess the Tolerability and Effectiveness of Extended-Release Tacrolimus (LCPT) in De Novo Liver Transplant Patients
title_fullStr A Multi-Centre Non-Interventional Study to Assess the Tolerability and Effectiveness of Extended-Release Tacrolimus (LCPT) in De Novo Liver Transplant Patients
title_full_unstemmed A Multi-Centre Non-Interventional Study to Assess the Tolerability and Effectiveness of Extended-Release Tacrolimus (LCPT) in De Novo Liver Transplant Patients
title_short A Multi-Centre Non-Interventional Study to Assess the Tolerability and Effectiveness of Extended-Release Tacrolimus (LCPT) in De Novo Liver Transplant Patients
title_sort multi-centre non-interventional study to assess the tolerability and effectiveness of extended-release tacrolimus (lcpt) in de novo liver transplant patients
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10094891/
https://www.ncbi.nlm.nih.gov/pubmed/37048621
http://dx.doi.org/10.3390/jcm12072537
work_keys_str_mv AT solimanthomas amulticentrenoninterventionalstudytoassessthetolerabilityandeffectivenessofextendedreleasetacrolimuslcptindenovolivertransplantpatients
AT gyoerigeorg amulticentrenoninterventionalstudytoassessthetolerabilityandeffectivenessofextendedreleasetacrolimuslcptindenovolivertransplantpatients
AT salatandreas amulticentrenoninterventionalstudytoassessthetolerabilityandeffectivenessofextendedreleasetacrolimuslcptindenovolivertransplantpatients
AT mejzlikvladimir amulticentrenoninterventionalstudytoassessthetolerabilityandeffectivenessofextendedreleasetacrolimuslcptindenovolivertransplantpatients
AT berlakovichgabriela amulticentrenoninterventionalstudytoassessthetolerabilityandeffectivenessofextendedreleasetacrolimuslcptindenovolivertransplantpatients
AT solimanthomas multicentrenoninterventionalstudytoassessthetolerabilityandeffectivenessofextendedreleasetacrolimuslcptindenovolivertransplantpatients
AT gyoerigeorg multicentrenoninterventionalstudytoassessthetolerabilityandeffectivenessofextendedreleasetacrolimuslcptindenovolivertransplantpatients
AT salatandreas multicentrenoninterventionalstudytoassessthetolerabilityandeffectivenessofextendedreleasetacrolimuslcptindenovolivertransplantpatients
AT mejzlikvladimir multicentrenoninterventionalstudytoassessthetolerabilityandeffectivenessofextendedreleasetacrolimuslcptindenovolivertransplantpatients
AT berlakovichgabriela multicentrenoninterventionalstudytoassessthetolerabilityandeffectivenessofextendedreleasetacrolimuslcptindenovolivertransplantpatients