Comparison of highly-automatic versus FDA-submitted QT measurements for the detection of moxifloxacin induced prolongation of the QTc interval

In this study, we investigated the ability of a QT algorithm to detect small drug-induced QT interval prolongation by adopting a ldquohighly-automatizedrdquo approach. In a set of 8,911 digital ECGs, we analyzed the drug-concentration profile of computerized QTc to the measurements submitted to the Food and Drug Administration (FDA) by pharmaceutical companies. The RR and QT intervals were measured using lead II based on a QT algorithm included in the COMPAS software package developed at University of Rochester Medical Center, NY. When comparing the time-dependent effect of the drug on the QTc interval the automatic technique produced results similar to the measurements reported by contract research organizations to the Agency (FDA).