Key result
The potential for ventricular arrhythmias causing sudden death is the most pressing cardiovascular safety concern during the development of new drugs.
Highlights the importance of QT prolongation as a safety biomarker for ventricular arrhythmias and sudden death in drug development.
Emphasizes proarrhythmic risk evaluation in drug development; supports QT prolongation as key biomarker yet leaves optimal predictors open.
The cardiovascular safety of new drugs is an overarching concern for all stakeholders: the pharmaceutical industry and the US Food and Drug Administration (FDA) prior to approval and doctors and patients during postrelease drug use. Of the many cardiac safety concerns that accompany development of new drugs--including those related to vasculature and valvular tissue, the potential for myopathies, and the possibility of other electrophysiologic perturbations--the most pressing concern is the potential for ventricular arrhythmias causing sudden death.
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Whellan et al. (2009) conducted a review in Cardiovascular safety in drug development. New drugs was evaluated. The potential for ventricular arrhythmias causing sudden death is the most pressing cardiovascular safety concern during the development of new drugs.
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