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The QT(c-Bazett) Interval in Former Very Preterm Infants in Adolescence and Young Adulthood is Not Different from Term-Born Controls

INTRODUCTION: Although relevant for precision pharmacovigilance, there are conflicting data on whether former preterm birth is associated with QT(c-Bazett) prolongation in later life. METHODS: To explore QT(c-Bazett) interval differences between former preterm and/or extremely low birth weight (ELBW...

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Autores principales: Vanthienen, Jill, Petrov, Marine Vassilev, Luu, Thuy Mai, Cloutier, Anik, Raaijmakers, Anke, Staessen, Jan A., Zhang, Zhenyu, Salaets, Thomas, Laenen, Annouschka, Smits, Anne, Nuyt, Anne-Monique, Flahault, Adrien, Allegaert, Karel
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10442256/
https://www.ncbi.nlm.nih.gov/pubmed/37505401
http://dx.doi.org/10.1007/s40264-023-01335-y
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author Vanthienen, Jill
Petrov, Marine Vassilev
Luu, Thuy Mai
Cloutier, Anik
Raaijmakers, Anke
Staessen, Jan A.
Zhang, Zhenyu
Salaets, Thomas
Laenen, Annouschka
Smits, Anne
Nuyt, Anne-Monique
Flahault, Adrien
Allegaert, Karel
author_facet Vanthienen, Jill
Petrov, Marine Vassilev
Luu, Thuy Mai
Cloutier, Anik
Raaijmakers, Anke
Staessen, Jan A.
Zhang, Zhenyu
Salaets, Thomas
Laenen, Annouschka
Smits, Anne
Nuyt, Anne-Monique
Flahault, Adrien
Allegaert, Karel
author_sort Vanthienen, Jill
collection PubMed
description INTRODUCTION: Although relevant for precision pharmacovigilance, there are conflicting data on whether former preterm birth is associated with QT(c-Bazett) prolongation in later life. METHODS: To explore QT(c-Bazett) interval differences between former preterm and/or extremely low birth weight (ELBW) cases and term-born controls in adolescence and young adulthood, we analyzed pooled individual data after a structured search on published cohorts. To test the absence of a QT(c-Bazett) difference, a non-inferiority approach was applied (one-sided, upper limit of the 95% confidence interval [CI] mean QT(c-Bazett) difference, 5 and 10 ms). We also investigated the impact of characteristics, either perinatal or at assessment, on QT(c-Bazett) in the full dataset (cases and controls). Data were reported as median and range. RESULTS: The pooled dataset contained 164 former preterm and/or ELBW (cases) and 140 controls born full-term from three studies. The median QT(c-Bazett) intervals were 409 (335–490) and 410 (318–480) ms in cases and controls. The mean QT(c-Bazett) difference was 1 ms, with an upper 95% CI of 6 ms (p > 0.05 and p < 0.01 for 5 and 10 ms, respectively). In the full dataset, females had a significantly longer QT(c-Bazett) than males (415 vs. 401 ms; p < 0.0001). CONCLUSIONS: QT(c-Bazett) intervals are not significantly different between former preterm and/or ELBW cases and term-born controls, and we rejected a potential prolongation > 10 ms in cases. When prescribing QTc-prolonging drugs, pharmacovigilance practices in this subpopulation should be similar to the general public (NCT05243537). SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40264-023-01335-y.
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spelling pubmed-104422562023-08-23 The QT(c-Bazett) Interval in Former Very Preterm Infants in Adolescence and Young Adulthood is Not Different from Term-Born Controls Vanthienen, Jill Petrov, Marine Vassilev Luu, Thuy Mai Cloutier, Anik Raaijmakers, Anke Staessen, Jan A. Zhang, Zhenyu Salaets, Thomas Laenen, Annouschka Smits, Anne Nuyt, Anne-Monique Flahault, Adrien Allegaert, Karel Drug Saf Original Research Article INTRODUCTION: Although relevant for precision pharmacovigilance, there are conflicting data on whether former preterm birth is associated with QT(c-Bazett) prolongation in later life. METHODS: To explore QT(c-Bazett) interval differences between former preterm and/or extremely low birth weight (ELBW) cases and term-born controls in adolescence and young adulthood, we analyzed pooled individual data after a structured search on published cohorts. To test the absence of a QT(c-Bazett) difference, a non-inferiority approach was applied (one-sided, upper limit of the 95% confidence interval [CI] mean QT(c-Bazett) difference, 5 and 10 ms). We also investigated the impact of characteristics, either perinatal or at assessment, on QT(c-Bazett) in the full dataset (cases and controls). Data were reported as median and range. RESULTS: The pooled dataset contained 164 former preterm and/or ELBW (cases) and 140 controls born full-term from three studies. The median QT(c-Bazett) intervals were 409 (335–490) and 410 (318–480) ms in cases and controls. The mean QT(c-Bazett) difference was 1 ms, with an upper 95% CI of 6 ms (p > 0.05 and p < 0.01 for 5 and 10 ms, respectively). In the full dataset, females had a significantly longer QT(c-Bazett) than males (415 vs. 401 ms; p < 0.0001). CONCLUSIONS: QT(c-Bazett) intervals are not significantly different between former preterm and/or ELBW cases and term-born controls, and we rejected a potential prolongation > 10 ms in cases. When prescribing QTc-prolonging drugs, pharmacovigilance practices in this subpopulation should be similar to the general public (NCT05243537). SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40264-023-01335-y. Springer International Publishing 2023-07-28 2023 /pmc/articles/PMC10442256/ /pubmed/37505401 http://dx.doi.org/10.1007/s40264-023-01335-y Text en © The Author(s) 2023 https://creativecommons.org/licenses/by-nc/4.0/Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Original Research Article
Vanthienen, Jill
Petrov, Marine Vassilev
Luu, Thuy Mai
Cloutier, Anik
Raaijmakers, Anke
Staessen, Jan A.
Zhang, Zhenyu
Salaets, Thomas
Laenen, Annouschka
Smits, Anne
Nuyt, Anne-Monique
Flahault, Adrien
Allegaert, Karel
The QT(c-Bazett) Interval in Former Very Preterm Infants in Adolescence and Young Adulthood is Not Different from Term-Born Controls
title The QT(c-Bazett) Interval in Former Very Preterm Infants in Adolescence and Young Adulthood is Not Different from Term-Born Controls
title_full The QT(c-Bazett) Interval in Former Very Preterm Infants in Adolescence and Young Adulthood is Not Different from Term-Born Controls
title_fullStr The QT(c-Bazett) Interval in Former Very Preterm Infants in Adolescence and Young Adulthood is Not Different from Term-Born Controls
title_full_unstemmed The QT(c-Bazett) Interval in Former Very Preterm Infants in Adolescence and Young Adulthood is Not Different from Term-Born Controls
title_short The QT(c-Bazett) Interval in Former Very Preterm Infants in Adolescence and Young Adulthood is Not Different from Term-Born Controls
title_sort qt(c-bazett) interval in former very preterm infants in adolescence and young adulthood is not different from term-born controls
topic Original Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10442256/
https://www.ncbi.nlm.nih.gov/pubmed/37505401
http://dx.doi.org/10.1007/s40264-023-01335-y
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