Investigation of parameters highlighting drug induced small changes of the T-wave's morphology for drug safety studies

Tobias Baas; Ksenija Gräfe; Antoun Khawaja; Olaf Dössel

doi:10.1109/IEMBS.2011.6090769

Investigation of parameters highlighting drug induced small changes of the T-wave's morphology for drug safety studies

Tobias Baas, Ksenija Gräfe, Antoun Khawaja, Olaf Dössel

Abstract

In guideline E14, the American Food and Drug Administration (FDA) requests for clinical studies to investigate the prolongation of the heart rate corrected QT-interval (QTc) of the ECG. As drug induced QT-prolongation can be caused by changes in the repolarisation of the ventricles, it is so far a thorough ECG biomarker of risk for ventricular tachyarrhyth-mias and Torsade de Pointes (TdP). Ventricular repolarisation changes not only change QT but also influence the morphology of the T-wave. In a (400 mg single dose) Moxifloxacin positive control study both, QTc and several descriptors describing the T-wave morphology have been measured. Moxifloxacin is changing two shape dependent descriptors significantly (P≤0.05) about 3 to 4 hours after a 400 mg oral single dose of Moxifloxacin.

Original language	German
Title of host publication	Proceedings of the 33rd IEEE conference on Engineering in Medicine and Biology Society
Publication date	2011
ISBN (Print)	978-1-4244-4121-1
ISBN (Electronic)	978-1-4577-1589-1
DOIs	https://doi.org/10.1109/IEMBS.2011.6090769
Publication status	Published - 2011
Externally published	Yes

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10.1109/IEMBS.2011.6090769

Cite this

@inproceedings{a74427025a3d4c4e9cf9e2f5419cef32,

title = "Investigation of parameters highlighting drug induced small changes of the T-wave's morphology for drug safety studies",

abstract = "In guideline E14, the American Food and Drug Administration (FDA) requests for clinical studies to investigate the prolongation of the heart rate corrected QT-interval (QTc) of the ECG. As drug induced QT-prolongation can be caused by changes in the repolarisation of the ventricles, it is so far a thorough ECG biomarker of risk for ventricular tachyarrhyth-mias and Torsade de Pointes (TdP). Ventricular repolarisation changes not only change QT but also influence the morphology of the T-wave. In a (400 mg single dose) Moxifloxacin positive control study both, QTc and several descriptors describing the T-wave morphology have been measured. Moxifloxacin is changing two shape dependent descriptors significantly (P≤0.05) about 3 to 4 hours after a 400 mg oral single dose of Moxifloxacin.",

author = "Tobias Baas and Ksenija Gr{\"a}fe and Antoun Khawaja and Olaf D{\"o}ssel",

year = "2011",

doi = "10.1109/IEMBS.2011.6090769",

language = "Deutsch",

isbn = "978-1-4244-4121-1 ",

booktitle = "Proceedings of the 33rd IEEE conference on Engineering in Medicine and Biology Society",

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Investigation of parameters highlighting drug induced small changes of the T-wave's morphology for drug safety studies. / Baas, Tobias; Gräfe, Ksenija; Khawaja, Antoun et al.
Proceedings of the 33rd IEEE conference on Engineering in Medicine and Biology Society. 2011.

Research output: Chapters in Books/Reports/Conference Proceedings › Conference contribution › peer-review

TY - GEN

T1 - Investigation of parameters highlighting drug induced small changes of the T-wave's morphology for drug safety studies

AU - Baas, Tobias

AU - Gräfe, Ksenija

AU - Khawaja, Antoun

AU - Dössel, Olaf

PY - 2011

Y1 - 2011

N2 - In guideline E14, the American Food and Drug Administration (FDA) requests for clinical studies to investigate the prolongation of the heart rate corrected QT-interval (QTc) of the ECG. As drug induced QT-prolongation can be caused by changes in the repolarisation of the ventricles, it is so far a thorough ECG biomarker of risk for ventricular tachyarrhyth-mias and Torsade de Pointes (TdP). Ventricular repolarisation changes not only change QT but also influence the morphology of the T-wave. In a (400 mg single dose) Moxifloxacin positive control study both, QTc and several descriptors describing the T-wave morphology have been measured. Moxifloxacin is changing two shape dependent descriptors significantly (P≤0.05) about 3 to 4 hours after a 400 mg oral single dose of Moxifloxacin.

AB - In guideline E14, the American Food and Drug Administration (FDA) requests for clinical studies to investigate the prolongation of the heart rate corrected QT-interval (QTc) of the ECG. As drug induced QT-prolongation can be caused by changes in the repolarisation of the ventricles, it is so far a thorough ECG biomarker of risk for ventricular tachyarrhyth-mias and Torsade de Pointes (TdP). Ventricular repolarisation changes not only change QT but also influence the morphology of the T-wave. In a (400 mg single dose) Moxifloxacin positive control study both, QTc and several descriptors describing the T-wave morphology have been measured. Moxifloxacin is changing two shape dependent descriptors significantly (P≤0.05) about 3 to 4 hours after a 400 mg oral single dose of Moxifloxacin.

U2 - 10.1109/IEMBS.2011.6090769

DO - 10.1109/IEMBS.2011.6090769

M3 - Konferenzbeitrag

SN - 978-1-4244-4121-1

BT - Proceedings of the 33rd IEEE conference on Engineering in Medicine and Biology Society

ER -