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Cumulative Experience of Azimilide-Associated Torsades de Pointes Ventricular Tachycardia in the 19 Clinical Studies Comprising the Azimilide Database

Craig M. Pratt, MD, FACC^_*,_*, Hussein R. Al-Khalidi, PhD, Jose M. Brum, MD, Michael J. Holroyde, PhD, Peter J. Schwartz, MD, FACC, Stephen R. Marcello, MD, FACC, Martin Borggrefe, MD, FACC, Paul Dorian, MD, FACC^||, A. John Camm, MD, FACC^¶ on behalf of the Azimilide Trials Investigators

^_* Department of Cardiology, Methodist DeBakey Heart Center, Houston, Texas
Procter & Gamble Pharmaceuticals, Cincinnati, Ohio
Department of Cardiology, Policlinico S. Matteo, IRRCS, and University of Pavia, Pavia, Italy
Klinikum Mannheim, Universtatsklinikum, Mannheim, Germany
^|| Division of Cardiology, St. Michael's Hospital, Toronto, Ontario, Canada
^¶ Department of Cardiology, St. George's Hospital, London, England

View larger version (17K): [in a new window]   Figure 1 Time course of torsades de pointes (TdP) in double-blind (DB) atrial fibrillation (AF) trials, all of which required azimilide loading (17 cases), and in the open-label (OL) trials, only for those patients who were on placebo during the DB phase (7 cases) (A). Time course of TdP in the 39 cases without loading by treatment indication (17 AF OL, 15 ICD, 7 post-myocardial infarction [MI]) (B). Time course of TdP in patients with versus without loading in the DB trials (17 loaded, 14 not loaded) (C).

View larger version (26K): [in a new window]   Figure 2 Incidence of torsades de pointes (TdP) by gender at each azimilide dose (A). Frequency of TdP by gender and age distribution (B). Percent of patients with and without TdP across different QTc ranges (C). Distribution of patients by maximum QTc and the risk for TdP (D). Abbreviations as in Figure 1.