J Clin Pharmacol
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0091270009337944v1
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METHODS

Comparison of Semiautomated and Fully Automated Methods for QT Measurement During a Thorough QT/QTc Study: Variability and Sample Size Considerations

Benoît Tyl, MD, Meriam Kabbaj, PharmD, PhD, Basmah Fassi, BS, Patrick De Jode, MD and William Wheeler, MD, FACC

From MDS Pharma Services, Centralized Cardiac Services, Baillet-en-France, France (Dr Tyl, Mr Fassi, Dr De Jode, Dr Wheeler) and MDS Pharma Services, PK/PD, Zurich, Switzerland (Dr Kabbaj).

This study compares the ability of 2 semiautomated methods with a fully automated method for QT measurement to minimize the sample size required to detect a moxifloxacin effect and exclude a placebo effect in a thorough QT/QTc study. The fully automated and 1 of 2 semiautomated methods used a global QT measurement in 12 leads, whereas the other semiautomated method used a tangent method on single lead raw complexes. Mean QTcF intervals were greater when measured on a global QT electrocardiogram than on raw complexes, but the mean magnitudes of {Delta}QTcF were similar for all methods. The 3 methods detected a statistically significant increase in QTcF for moxifloxacin compared to placebo and were able to exclude a placebo effect on QTcF in all 62 participants. However, due to a smaller variability, the semiautomated methods allowed these detections with fewer than 20 participants, whereas the fully automated required at least 27 participants.

Key Words: QT interval • thorough QT/QTc study • repolarization • drug safety • QT prolongation

Address for reprints: Benoît Tyl, MD, MDS Pharma Services, 1-3, avenue du Bosquet, 95560 Baillet en France; e-mail: benoit.tyl{at}mdsinc.com.


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