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Evaluation of Antiarrhythmic Drug Efficacy in Patients with an ICD:
Author(s) -
PRATT CRAIG M.,
CAMM A. JOHN,
BIGGER J. THOMAS,
BREITHARDT GÜNTER,
CAMPBELL RONALD W.F.,
EPSTEIN ANDREW E.,
KAPPENBERGER LUKAS J.,
KUCK KARLHEINZ,
POCOCK STUART,
SAKSENA SANJEEV,
WALDO ALBERT L.
Publication year - 1999
Publication title -
journal of cardiovascular electrophysiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.193
H-Index - 138
eISSN - 1540-8167
pISSN - 1045-3873
DOI - 10.1111/j.1540-8167.1999.tb00212.x
Subject(s) - medicine , clinical trial , context (archaeology) , intensive care medicine , implantable cardioverter defibrillator , ventricular fibrillation , sudden cardiac death , surrogate endpoint , clinical endpoint , efficacy , drug , sudden death , drug trial , pharmacology , paleontology , biology
Antiarrhythmic Drug Efficacy in Patients with an ICD. There are a number of novel ways in which implantable cardioverter defibrillator (ICD) endpoints can he 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 on 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 he 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.