A Proof-of-Concept Evaluation of JTPc and Tp-Tec as Proarrhythmia Biomarkers in Preclinical Species: A Retrospective Analysis by an HESI-Sponsored Consortium Article Swipe
Emmanuel Boulay
,
Matthew M. Abernathy
,
Ray W. Chui
,
Gregory S. Friedrichs
,
Nicolas Gendron-Parra
,
Andrea Greiter‐Wilke
,
Jean‐Michel Guillon
,
John Koerner
,
Ariane Menard
,
Jill Steidl‐Nichols
,
Jennifer Pierson
,
Michael K. Pugsley
,
Eric I. Rossman
,
David G. Strauss
,
Éric Troncy
,
Jean‐Pierre Valentin
,
Todd Wisialowski
,
Simon Authier
·
YOU?
·
· 2018
· Open Access
·
· DOI: https://doi.org/10.1177/1091581818813601
YOU?
·
· 2018
· Open Access
·
· DOI: https://doi.org/10.1177/1091581818813601
Introduction: Based on the ICH S7B and E14 guidance documents, QT interval (QTc) is used as the primary in vivo biomarker to assess the risk of drug-induced torsades de pointes (TdP). Clinical and nonclinical data suggest that drugs that prolong the corrected QTc with balanced multiple ion channel inhibition (most importantly the l-type calcium, Cav1.2, and persistent or late inward sodium current, Nav1.5, in addition to human Ether-à-go-go-Related Gene [hERG] I Kr or Kv11.1) may have limited proarrhythmic liability. The heart rate-corrected J to T-peak (JTpc) measurement in particular may be considered to discriminate selective hERG blockers from multi-ion channel blockers. Methods: Telemetry data from Beagle dogs given dofetilide (0.3 mg/kg), sotalol (32 mg/kg), and verapamil (30 mg/kg) orally and Cynomolgus monkeys given medetomidine (0.4 mg/kg) orally were retrospectively analyzed for effects on QTca, JTpca, and T-peak to T-end covariate adjusted (Tpeca) interval using individual rate correction and super intervals (calculated from 0-6, 6-12, 12-18, and 18-24 hours postdose). Results: Dofetilide and cisapride (I Kr or Kv11.1 blockers) were associated with significant increases in QTca and JTpca, while sotalol was associated with significant increases in QTca, JTpca, and Tpeca. Verapamil (a Kv11.1 and Cav1.2 blocker) resulted in a reduction in QTca and JTpca, however, and increased Tpeca. Medetomidine was associated with a reduction in Tpeca and increase in JTpca. Discussion: Results from this limited retrospective electrocardiogram analysis suggest that JTpca and Tpeca may discriminate selective I Kr blockers and multichannel blockers and could be considered in the context of an integrated comprehensive proarrhythmic risk assessment.
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- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1177/1091581818813601
- https://journals.sagepub.com/doi/pdf/10.1177/1091581818813601
- OA Status
- bronze
- Cited By
- 14
- References
- 34
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W2905707403
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
-
https://openalex.org/W2905707403Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1177/1091581818813601Digital Object Identifier
- Title
-
A Proof-of-Concept Evaluation of JTPc and Tp-Tec as Proarrhythmia Biomarkers in Preclinical Species: A Retrospective Analysis by an HESI-Sponsored ConsortiumWork title
- Type
-
articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2018Year of publication
- Publication date
-
2018-12-19Full publication date if available
- Authors
-
Emmanuel Boulay, Matthew M. Abernathy, Ray W. Chui, Gregory S. Friedrichs, Nicolas Gendron-Parra, Andrea Greiter‐Wilke, Jean‐Michel Guillon, John Koerner, Ariane Menard, Jill Steidl‐Nichols, Jennifer Pierson, Michael K. Pugsley, Eric I. Rossman, David G. Strauss, Éric Troncy, Jean‐Pierre Valentin, Todd Wisialowski, Simon AuthierList of authors in order
- Landing page
-
https://doi.org/10.1177/1091581818813601Publisher landing page
- PDF URL
-
https://journals.sagepub.com/doi/pdf/10.1177/1091581818813601Direct link to full text PDF
- Open access
-
YesWhether a free full text is available
- OA status
-
bronzeOpen access status per OpenAlex
- OA URL
-
https://journals.sagepub.com/doi/pdf/10.1177/1091581818813601Direct OA link when available
- Concepts
-
Dofetilide, hERG, Torsades de pointes, QT interval, Proarrhythmia, Sotalol, Pharmacology, Potassium channel blocker, Verapamil, Ranolazine, Medicine, Quinidine, Sodium channel blocker, Internal medicine, Potassium channel, Chemistry, Sodium channel, Sodium, Calcium, Organic chemistry, Atrial fibrillationTop concepts (fields/topics) attached by OpenAlex
- Cited by
-
14Total citation count in OpenAlex
- Citations by year (recent)
-
2024: 2, 2023: 1, 2022: 2, 2021: 1, 2020: 5Per-year citation counts (last 5 years)
- References (count)
-
34Number of works referenced by this work
- Related works (count)
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10Other works algorithmically related by OpenAlex
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