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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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Detalles Bibliográficos
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
Descripción
Sumario: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.