Abstract
The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Guideline E14 recommends ‘Thorough QT Study’ as a standard assessment of drug-induced QT interval prolongation. At the same time, the value of drug-induced QTc prolongation as a surrogate marker for risk of life-threatening polymorphic ventricular tachycardia known as torsades des pointes remains controversial. Beat-to-beat variability of QT interval was recently proposed as an alternative metric. The following review addresses mechanisms of beat-to-beat QT variability, methods of QT interval variability measurements, and its prognostic value in clinical studies.
Original language | English (US) |
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Pages (from-to) | 245-251 |
Number of pages | 7 |
Journal | Therapeutic Advances in Drug Safety |
Volume | 2 |
Issue number | 6 |
DOIs | |
State | Published - Dec 2011 |
Externally published | Yes |
Keywords
- QT interval
- QT variability
- drug safety
- ventricular tachyarrhythmias
ASJC Scopus subject areas
- Pharmacology (medical)