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

Jill Vanthienen, Marine Vassilev Petrov, Thuy Mai Luu, Anik Cloutier, Anke Raaijmakers, Jan A. Staessen, Zhenyu Zhang, Thomas Salaets, Annouschka Laenen, Anne Smits, Anne-Monique Nuyt, Adrien Flahault and Karel Allegaert ()
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Jill Vanthienen: KU Leuven
Marine Vassilev Petrov: KU Leuven
Thuy Mai Luu: University of Montreal
Anik Cloutier: University of Montreal
Anke Raaijmakers: KU Leuven
Jan A. Staessen: Non-Profit Research Institute Alliance for the Promotion of Preventive Medicine
Zhenyu Zhang: KU Leuven
Thomas Salaets: University Hospitals Leuven
Annouschka Laenen: KU Leuven
Anne Smits: KU Leuven
Anne-Monique Nuyt: University of Montreal
Adrien Flahault: University of Montreal
Karel Allegaert: KU Leuven

Drug Safety, 2023, vol. 46, issue 9, No 7, 897-904

Abstract: Abstract Introduction Although relevant for precision pharmacovigilance, there are conflicting data on whether former preterm birth is associated with QTc-Bazett prolongation in later life. Methods To explore QTc-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 QTc-Bazett difference, a non-inferiority approach was applied (one-sided, upper limit of the 95% confidence interval [CI] mean QTc-Bazett difference, 5 and 10 ms). We also investigated the impact of characteristics, either perinatal or at assessment, on QTc-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 QTc-Bazett intervals were 409 (335–490) and 410 (318–480) ms in cases and controls. The mean QTc-Bazett difference was 1 ms, with an upper 95% CI of 6 ms (p > 0.05 and p 10 ms in cases. When prescribing QTc-prolonging drugs, pharmacovigilance practices in this subpopulation should be similar to the general public (NCT05243537).

Date: 2023
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DOI: 10.1007/s40264-023-01335-y

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