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Cardiovascular Research 2000 47(2):219-233; doi:10.1016/S0008-6363(00)00119-X
© 2000 by European Society of Cardiology
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Copyright © 2000, European Society of Cardiology

The potential for QT prolongation and pro-arrhythmia by non-anti-arrhythmic drugs: Clinical and regulatory implications

Report on a Policy Conference of the European Society of Cardiology

Wilhelm Haverkamp*, Günter Breithardt*, A.John Camm, Michiel J Janse, Michael R Rosen, Charles Antzelevitch, Denis Escande, Michael Franz, Marek Malik, Arthur Moss and Rashmi ShahAppendix A

* Corresponding author. Tel.: +49-251-834-7617; fax: +49-251-834-7864 breithg@uni-muenster.de

Received 27 April 2000; accepted 28 April 2000

The first 150 words of the full text of this article appear below.


   1 Preamble1
 
The Policy Conference on The Potential for QT Prolongation and Pro-arrhythmia by Non-anti-arrhythmic Drugs. Clinical and Regulatory Implications was held at the European Heart House in Sophia Antipolis, France, on the initiative of Günter Breithardt, FESC, FACC, on June 24th and 25th, 1999 after formal approval by the Board of the European Society of Cardiology (ESC).

The conference was organised under the auspices of the ESC Committee for Scientific and Clinical Initiatives by Günter Breithardt and Wilhelm Haverkamp, Münster, Germany, with participation of representatives of the Working Group on Arrhythmias of the ESC, the American College of Cardiology, the American Heart Association, the World Heart Federation, the European Agency for the Evaluation of Medicinal Products, the Medicines Control Agency (UK), the Food and Drug Administration (USA), the National Heart, Lung and Blood Institute (USA), the Federal Institute for Drugs and Medical Devices (Germany), and the Medical Products Agency (Sweden).

The . . . [Full Text of this Article]


   2 The problem
 

   3 Mechanisms of QT prolongation and TdP
 

   4 Detecting drug-induced effects on repolarization
 
4.1 In vitro models
4.2 In-vivo animal models

   5 Clinical assessment of drug effects on repolarization
 
5.1 Phase I/II studies
5.2 Phase III studies
5.3 Post-marketing surveillance

   6 Regulatory perspectives
 

   7 Conclusions
 

   Appendix A
 

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