title: QT interval prolongation as a biomarker for torsades de pointes and sudden death in drug development.
abstract: Prolongation of the QT interval on the surface 12-lead electrocardiogram is widely accepted as a biomarker for the potential of a drug to produce torsades de pointes and/or sudden death. Detection of drug-induced prolongation of the QT interval in animals and man is frequently confounded by extrinsic and intrinsic factors that limit the ability to detect a true drug effect. In particular drugs that increase heart rate show an apparent increase in QT interval that confounds assessment of a true drug effect on cardiac ventricular repolarization. The basis for the use of the QT interval as a biomarker will be examined.
mesh_terms: D000818:Animals; D015415:Biomarkers; D016757:Death, Sudden, Cardiac / Q000209:etiology*; D015195:Drug Design; D004562:Electrocardiography / Q000187:drug effects*; D005260:Female; D006801:Humans; D008297:Male; D012737:Sex Factors; D016171:Torsades de Pointes / Q000139:chemically induced*
chemical_list: D015415:Biomarkers