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Evaluation of antiarrhythmic drug efficacy in patients with an ICD: Unlimited potential or replete with complexity and problems?

Lookup NU author(s): Dr Sushma Saksena


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There are a number of novel ways in which implantable cardioverter defibrillator (ICD) endpoints can be used in clinical trials to evaluate antiarrhythmic drugs. The advances in ICD technology (storage, retrieval, and accurate interpretation of ICD electrograms) expand the potential to include the use of an ICD endpoint as a clinical surrogate for sudden death. The ICD also provides the necessary safety net to test new drugs. The frequent need for antiarrhythmic drugs in patients already fitted with an ICD (e.g., for atrial fibrillation) necessitates knowledge of the drugs' effect an defibrillator threshold. There are interpretative problems and challenges associated with all types of ICD trials, A particular difficult issue is the degree to which the results of data on antiarrhythmic drug efficacy and safety acquired in the context of an ICD endpoint trial might be extrapolated to patient populations in which the device is not used. These and other challenging issues are discussed, with the goal of enhancing the design and interpretation of clinical trials featuring ICD endpoints.

Publication metadata

Author(s): Saksena S; Pratt CM; Camm AJ; Bigger JT; Breithardt G; Campbell RWF; Epstein AE; Kappenberger LJ; Kuck KH; Pocock S; Waldo AL

Publication type: Conference Proceedings (inc. Abstract)

Publication status: Published

Conference Name: Cardio-Renal Drugs Advisory Board Meeting of the Food-and-Drug-Administration

Year of Conference: 1999

Pages: 1534-1549

ISSN: 1045-3873

Publisher: Wiley-Blackwell Publishing, Inc.


DOI: 10.1111/j.1540-8167.1999.tb00212.x

Library holdings: Search Newcastle University Library for this item

Series Title: Journal of Cardiovascular Electrophysiology