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Digital 12-Lead Holter vs Standard Resting Supine Electrocardiogram for the Assessment of Drug-Induced QTc Prolongation

Assessment by Different Recording and Measurement Methods

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Cardiac Safety of Noncardiac Drugs

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Abstract

Ever since it was introduced in routine clinical cardiology practice (1), the continuous ambulatory electrocardiogram (Holter ECG) has been routinely used for diagnostic assessment of patients with different types of heart disease like cardiac arrhythmias, transient ischemic episodes and silent myocardial ischemia. The incidence of cardiac arrhythmia and myocardial ischemia, as well as the assessment of heart rate variability on Holter ECG acquired continuously over 24 h or longer have been useful for predicting clinical disease outcomes (2–5). Likewise, Holter ECG is often used in clinical drug research for the monitoring of general cardiac safety of novel drugs under development, particularly during the early phase I trials. In contrast, Holter ECG has only rarely been used in drug development for the formal assessment of drug-induced effects on cardiac repolarization, and the experience of central ECG laboratories in measuring ECG intervals on Holter is limited. Pharmaceutical sponsors and patients alike would benefit if reliable QT/QTc assessment were possible by Holter ECG, whereby the continuous ambulatory digital 12-lead ECG would be used to substitute for standard resting supine 12-lead ECGs in the assessment of drug-induced QT/QTc prolongation.

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Authors and Affiliations

  1. Clinical Pharmacology, La Jolla Laboratories, Pfizer Inc., San Diego, CA, USA

    Nenad Sarapa MD (Director)

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  1. Nenad Sarapa MD
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Editors and Affiliations

  1. eResearchTechnology Inc., Philadelphia, PA, USA

    Joel Morganroth MD (Chief Scientist, Clinical Professor of Medicine) (Chief Scientist, Clinical Professor of Medicine)

  2. University of Pennsylvania School of Medicine, Philadelphia, PA, USA

    Joel Morganroth MD (Chief Scientist, Clinical Professor of Medicine) (Chief Scientist, Clinical Professor of Medicine)

  3. Global Medical Affairs, eResearchTechnology Inc., Bridgewater, NJ

    Ihor Gussak MD, PhD, FACC (Vice President, Clinical Associate Professor of Medicine, Associate Editor) (Vice President, Clinical Associate Professor of Medicine, Associate Editor)

  4. UMDNJ-Robert Wood Johnson Medical School, New Brunswick, NJ

    Ihor Gussak MD, PhD, FACC (Vice President, Clinical Associate Professor of Medicine, Associate Editor) (Vice President, Clinical Associate Professor of Medicine, Associate Editor)

  5. Journal of Electrocardiology, Bridgewater, NJ, USA

    Ihor Gussak MD, PhD, FACC (Vice President, Clinical Associate Professor of Medicine, Associate Editor) (Vice President, Clinical Associate Professor of Medicine, Associate Editor)

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© 2005 Humana Press Inc., Totowa, NJ

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Sarapa, N. (2005). Digital 12-Lead Holter vs Standard Resting Supine Electrocardiogram for the Assessment of Drug-Induced QTc Prolongation. In: Morganroth, J., Gussak, I. (eds) Cardiac Safety of Noncardiac Drugs. Humana Press. https://doi.org/10.1007/978-1-59259-884-7_8

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