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FDA Seeks Alternatives To QT Interval For Assessing Risk Of Torsade de Pointes

 
• By Cathy Dombrowski

A clinical study funded by the Critical Path Initiative is looking at the change in a number of electrocardiogram parameters in patients given drugs known to prolong the QT interval and with varying risks for the abnormal heart rhythm.

A clinical study conducted under the Critical Path Initiative could provide drug developers with a means to differentiate harmful from benign QT prolongation and allow an earlier determination of whether a compound poses a risk of causing Torsade de Pointes, a potentially fatal abnormal heart rhythm.

The goal is to find other electrocardiographic parameters that indicate when QT prolongation is likely to lead to Torsade. FDA...

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