Evidence map›Paper›PMID 37048621›Full record

ArticleJournal of clinical medicine2023

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

Thomas Soliman, Georg Gyoeri, Andreas Salat, Vladimír Mejzlík, Gabriela Berlakovich

Open access · goldAbstract read
In one paragraph

Article in Journal of clinical medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
1.2field-weighted citation impact, top 21% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Early Conversion to Once-Daily MeltDoseJournal of clinical medicine · 2025
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 2 countries.

Thomas SolimanDepartment of Surgery, Division of Transplantation, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria.ORCID 0000-0001-6871-9343
Georg GyoeriDepartment of Surgery, Division of Transplantation, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria.ORCID 0000-0002-0863-2876
Andreas SalatDepartment of Surgery, Division of Transplantation, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria.ORCID 0000-0001-7647-215X
Vladimír MejzlíkCenter for Cardiovascular and Transplantation Surgery, 602 00 Brno, Czech Republic.
Gabriela BerlakovichDepartment of Surgery, Division of Transplantation, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria.ORCID 0000-0001-8850-7874
Medical University of Vienna · ATCentrum kardiovaskulární a transplantační chirurgie · CZ

Funding

Chiesi (Italy) : NIS005377
6 · The paper itself

Abstract

backgroundAvailable 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

methodsThis 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.

resultsOf 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).

conclusionsTL 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.

Indexed as

extended-release tacrolimusgraft rejectionLCPTliver functionliver transplantreal-world evidencesafetytrough level

Identifiers

PMID37048621
PMCPMC10094891
OpenAlexW4361216073

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.