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; Karel Allegaert

doi:10.1007/s40264-023-01335-y

The QT_c-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, Karel Allegaert^*

^*Corresponding author for this work

Pharmacy

Research output: Contribution to journal › Article › Academic › peer-review

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Abstract

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).

Original language	English
Pages (from-to)	897-904
Number of pages	8
Journal	Drug Safety
Volume	46
Issue number	9
Early online date	28 Jul 2023
DOIs	https://doi.org/10.1007/s40264-023-01335-y
Publication status	Published - Sept 2023

Bibliographical note

Funding Information:
TS is supported by the Frans Van de Werf Fund for Clinical Cardiovascular Research for his research fellowship (2022 recipient), and V.Z.W. ‘De Kleine Hartjes’ and F.W.O. Vlaanderen. The PREMATCH study was supported by the Agency for Innovation by Science and Technology in Flanders (IWT) through the SAFE-PEDRUG project [IWT/SBO 130033]. KU Leuven Internal Funds (STG-18–00379) supported the Research Unit Hypertension and Cardiovascular Epidemiology, Department of Cardiovascular Sciences, Leuven. The research activities of AS are supported by the Clinical Research and Education Council of the University Hospitals, Leuven.

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© 2023, The Author(s).

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Vanthienen, J., Petrov, M. V., Luu, T. M., Cloutier, A., Raaijmakers, A., Staessen, J. A., Zhang, Z., Salaets, T., Laenen, A., Smits, A., Nuyt, A. M., Flahault, A., & Allegaert, K. (2023). The QT_c-Bazett Interval in Former Very Preterm Infants in Adolescence and Young Adulthood is Not Different from Term-Born Controls. Drug Safety, 46(9), 897-904. https://doi.org/10.1007/s40264-023-01335-y

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

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 < 0.01 for 5 and 10 ms, respectively). In the full dataset, females had a significantly longer QTc-Bazett than males (415 vs. 401 ms; p < 0.0001). Conclusions: QTc-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).",

author = "Jill Vanthienen and Petrov, {Marine Vassilev} and Luu, {Thuy Mai} and Anik Cloutier and Anke Raaijmakers and Staessen, {Jan A.} and Zhenyu Zhang and Thomas Salaets and Annouschka Laenen and Anne Smits and Nuyt, {Anne Monique} and Adrien Flahault and Karel Allegaert",

note = "Funding Information: TS is supported by the Frans Van de Werf Fund for Clinical Cardiovascular Research for his research fellowship (2022 recipient), and V.Z.W. {\textquoteleft}De Kleine Hartjes{\textquoteright} and F.W.O. Vlaanderen. The PREMATCH study was supported by the Agency for Innovation by Science and Technology in Flanders (IWT) through the SAFE-PEDRUG project [IWT/SBO 130033]. KU Leuven Internal Funds (STG-18–00379) supported the Research Unit Hypertension and Cardiovascular Epidemiology, Department of Cardiovascular Sciences, Leuven. The research activities of AS are supported by the Clinical Research and Education Council of the University Hospitals, Leuven. Publisher Copyright: {\textcopyright} 2023, The Author(s).",

year = "2023",

month = sep,

doi = "10.1007/s40264-023-01335-y",

language = "English",

volume = "46",

pages = "897--904",

journal = "Drug Safety",

issn = "0114-5916",

publisher = "Adis",

number = "9",

}

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 2023, 'The QT_c-Bazett Interval in Former Very Preterm Infants in Adolescence and Young Adulthood is Not Different from Term-Born Controls', Drug Safety, vol. 46, no. 9, pp. 897-904. https://doi.org/10.1007/s40264-023-01335-y

TY - JOUR

T1 - The QTc-Bazett Interval in Former Very Preterm Infants in Adolescence and Young Adulthood is Not Different from Term-Born Controls

AU - Vanthienen, Jill

AU - Petrov, Marine Vassilev

AU - Luu, Thuy Mai

AU - Cloutier, Anik

AU - Raaijmakers, Anke

AU - Staessen, Jan A.

AU - Zhang, Zhenyu

AU - Salaets, Thomas

AU - Laenen, Annouschka

AU - Smits, Anne

AU - Nuyt, Anne Monique

AU - Flahault, Adrien

AU - Allegaert, Karel

N1 - Funding Information: TS is supported by the Frans Van de Werf Fund for Clinical Cardiovascular Research for his research fellowship (2022 recipient), and V.Z.W. ‘De Kleine Hartjes’ and F.W.O. Vlaanderen. The PREMATCH study was supported by the Agency for Innovation by Science and Technology in Flanders (IWT) through the SAFE-PEDRUG project [IWT/SBO 130033]. KU Leuven Internal Funds (STG-18–00379) supported the Research Unit Hypertension and Cardiovascular Epidemiology, Department of Cardiovascular Sciences, Leuven. The research activities of AS are supported by the Clinical Research and Education Council of the University Hospitals, Leuven. Publisher Copyright: © 2023, The Author(s).

PY - 2023/9

Y1 - 2023/9

N2 - 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 < 0.01 for 5 and 10 ms, respectively). In the full dataset, females had a significantly longer QTc-Bazett than males (415 vs. 401 ms; p < 0.0001). Conclusions: QTc-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).

AB - 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 < 0.01 for 5 and 10 ms, respectively). In the full dataset, females had a significantly longer QTc-Bazett than males (415 vs. 401 ms; p < 0.0001). Conclusions: QTc-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).

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DO - 10.1007/s40264-023-01335-y

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SN - 0114-5916

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JO - Drug Safety

JF - Drug Safety

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ER -

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

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