Assessing proarrhythmic potential of drugs when optimal studies are infeasible

Assessing the potential for a new drug to cause life-threatening arrhythmias is now an integral component of premarketing safety assessment. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Guideline (ICH) E14 recommends the “Thoro...

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Veröffentlicht in:	The American heart journal 2009-05, Vol.157 (5), p.827-836.e1
Hauptverfasser:	Rock, Edwin P., MD, PhD, Finkle, John, MD, Fingert, Howard J., MD, Booth, Brian P., PhD, Garnett, Christine E., PharmD, Grant, Stephen, MD, Justice, Robert L., MD, Kovacs, Richard J., MD, Kowey, Peter R., MD, Rodriguez, Ignacio, MD, Sanhai, Wendy R., PhD, Strnadova, Colette, PhD, Targum, Shari L., MD, Tsong, Yi, PhD, Uhl, Kathleen, MD, Stockbridge, Norman, MD, PhD
Format:	Artikel
Sprache:	eng
Schlagworte:	Animals Biological and medical sciences Cardiac arrhythmia Cardiology. Vascular system Cardiovascular Controlled Clinical Trials as Topic - methods Critical path Disease Drug Approval - organization & administration Drug Evaluation, Preclinical - methods Drugs, Investigational - adverse effects Electrocardiography Electrocardiography - drug effects Federal regulation Heart rate Humans International Cooperation Long QT Syndrome - chemically induced Long QT Syndrome - physiopathology Medical sciences Mortality Pharmaceuticals Potassium Product safety Risk assessment Studies
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Zusammenfassung:	Assessing the potential for a new drug to cause life-threatening arrhythmias is now an integral component of premarketing safety assessment. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Guideline (ICH) E14 recommends the “Thorough QT Study” (TQT) to assess clinical QT risk. Such a study calls for careful evaluation of drug effects on the electrocardiographic QT interval at multiples of therapeutic exposure and with a positive control to confirm assay sensitivity. Yet for some drugs and diseases, elements of the TQT Study may be impractical or unethical. In these instances, alternative approaches to QT risk assessment must be considered. This article presents points to consider for evaluation of QT risk when alternative approaches are needed.
ISSN:	0002-8703 1097-6744
DOI:	10.1016/j.ahj.2009.02.020