Evidence map›Paper›PMID 36748725›Full record

ArticlePharmacology research & perspectives2023

Testing the nonclinical Comprehensive In Vitro Proarrhythmia Assay (CiPA) paradigm with an established anti-seizure medication: Levetiracetam case study.

Annie Delaunois, François-Xavier Mathy, Miranda Cornet, Vitalina Gryshkova, Chloé Korlowski, François Bonfitto, Juliane Koch, Anne-Françoise Schlit, Simon Hebeisen, Elisa Passini and 2 more

Open access · goldAbstract read
In one paragraph

Article in Pharmacology research & perspectives, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.9field-weighted citation impact, top 25% 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

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. 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

12 authors at 4 institutions in 4 countries.

Annie DelaunoisDevelopment Sciences, UCB Biopharma SRL, Braine-l'Alleud, Belgium.ORCID 0000-0001-6345-7989
François-Xavier MathyDevelopment Sciences, UCB Biopharma SRL, Braine-l'Alleud, Belgium.
Miranda CornetDevelopment Sciences, UCB Biopharma SRL, Braine-l'Alleud, Belgium.
Vitalina GryshkovaDevelopment Sciences, UCB Biopharma SRL, Braine-l'Alleud, Belgium.
Chloé KorlowskiDevelopment Sciences, UCB Biopharma SRL, Braine-l'Alleud, Belgium.
François BonfittoPatient Safety, UCB Biopharma SRL, Braine-l'Alleud, Belgium.
Juliane KochPatient Safety, UCB Biosciences GmbH, Monheim, Germany.
Anne-Françoise SchlitPatient Safety, UCB Biopharma SRL, Braine-l'Alleud, Belgium.
Simon HebeisenB'SYS GmbH, Witterswil, Switzerland.
Elisa PassiniDepartment of Computer Science, University of Oxford, Oxford, UK.
Blanca RodriguezDepartment of Computer Science, University of Oxford, Oxford, UK.
Jean-Pierre ValentinDevelopment Sciences, UCB Biopharma SRL, Braine-l'Alleud, Belgium.
UCB Pharma (Belgium) · BEUniversity of Oxford · GBTwitter (United States) · USUCB Pharma (Germany) · DE

Funding

Wellcome Trust
6 · The paper itself

Abstract

Levetiracetam (LEV), a well-established anti-seizure medication (ASM), was launched before the original ICH S7B nonclinical guidance assessing QT prolongation potential and the introduction of the Comprehensive In Vitro Proarrhythmia Assay (CiPA) paradigm. No information was available on its effects on cardiac channels. The goal of this work was to "pressure test" the CiPA approach with LEV and check the concordance of nonclinical core and follow-up S7B assays with clinical and post-marketing data. The following experiments were conducted with LEV (0.25-7.5 mM): patch clamp assays on hERG (acute or trafficking effects), Na

Indexed as

Induced Pluripotent Stem CellsLong QT SyndromeAnimalsDogsHumansLevetiracetamMyocytes, CardiacLevetiracetamcardiac safetyCiPAICH S7BlevetiracetamnonclinicalQT prolongationtorsade de pointes

Identifiers

PMID36748725
PMCPMC9903303
OpenAlexW4319334041

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.