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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.

Authors :
Vanthienen J
Petrov MV
Luu TM
Cloutier A
Raaijmakers A
Staessen JA
Zhang Z
Salaets T
Laenen A
Smits A
Nuyt AM
Flahault A
Allegaert K
Source :
Drug safety [Drug Saf] 2023 Sep; Vol. 46 (9), pp. 897-904. Date of Electronic Publication: 2023 Jul 28.
Publication Year :
2023

Abstract

Introduction: Although relevant for precision pharmacovigilance, there are conflicting data on whether former preterm birth is associated with QT <subscript>c-Bazett</subscript> prolongation in later life.<br />Methods: To explore QT <subscript>c-Bazett</subscript> 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 <subscript>c-Bazett</subscript> difference, a non-inferiority approach was applied (one-sided, upper limit of the 95% confidence interval [CI] mean QT <subscript>c-Bazett</subscript> difference, 5 and 10 ms). We also investigated the impact of characteristics, either perinatal or at assessment, on QT <subscript>c-Bazett</subscript> in the full dataset (cases and controls). Data were reported as median and range.<br />Results: The pooled dataset contained 164 former preterm and/or ELBW (cases) and 140 controls born full-term from three studies. The median QT <subscript>c-Bazett</subscript> intervals were 409 (335-490) and 410 (318-480) ms in cases and controls. The mean QT <subscript>c-Bazett</subscript> 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 <subscript>c-Bazett</subscript> than males (415 vs. 401 ms; p < 0.0001).<br />Conclusions: QT <subscript>c-Bazett</subscript> 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).<br /> (© 2023. The Author(s).)

Details

Language :
English
ISSN :
1179-1942
Volume :
46
Issue :
9
Database :
MEDLINE
Journal :
Drug safety
Publication Type :
Academic Journal
Accession number :
37505401
Full Text :
https://doi.org/10.1007/s40264-023-01335-y