JSM 2005 - Toronto

Abstract #304541

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Legend: = Applied Session, = Theme Session, = Presenter
Activity Number: 138
Type: Contributed
Date/Time: Monday, August 8, 2005 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #304541
Title: Impact of QT Correction Methods on the Assessment of QT Prolongation Potential of Drugs
Author(s): Navdeep Boparai*+ and Genming Shi and Ferdous Gheyas
Companies: Schering-Plough and Schering-Plough and Schering-Plough
Address: 2015 Galloping Hill Road, Kenilworth, NJ, 07033, United States
Keywords: QT ; Torsade ; Correction ; Regression ; Bazett ; Fridericia
Abstract:

In recent years, several marketed drugs have been found to cause severe cardiac adverse events. Torsade de Pointes (TdP), a particularly dangerous form of arrhythmia, may result in sudden death. Regulatory agencies are now requiring that all noncardiac drugs be tested for cardiac safety. QT prolongation is thought to be correlated with drug-induced torsade and is the focus of cardiac safety assessment efforts. Evaluation of QT prolongation for assessing the cardiac safety of new drugs has now come to the forefront and guidance documents are being written on this by the regulatory agencies. One of the key issues being debated is the correction of QT for heart rate. In this presentation, various commonly used correction methods will be discussed. The impact of correction method on our ability to detect QT prolongation will be considered. If the relationship between QT and heart rate is the same for placebo and the treated group, regression-based correction methods are appropriate. If the relationships are different for the placebo and the treated group, the commonly used correction methods could lead to misleading results.

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Revised March 2005