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CLINICAL RESEARCH: ELECTROPHYSIOLOGY

Safety and efficacy of intravenously administered tedisamil for rapid conversion of recent-onset atrial fibrillation or atrial flutter

Stefan H. Hohnloser, MD^*,*, Paul Dorian, MD, Matthias Straub, MD, Katrin Beckmann and Peter Kowey, MD

^* J. W. Goethe University, Frankfurt, Germany
St. Michel's Hospital, Toronto, Canada
Solvay Pharmaceuticals GmbH, Hannover, Germany
Lankenau Hospital and the Main Line Health System, Wynnewood, Pennsylvania, USA

Manuscript received December 1, 2003; revised manuscript received February 10, 2004, accepted March 16, 2004.

^* Reprint requests and correspondence: Dr. Stefan H. Hohnloser, J. W. Goethe University, Department of Cardiology, Division of Electrophysiology, Theodor-Stern-Kai 7, 60596 Frankfurt/Main, Germany.
hohnloser{at}em.uni-frankfurt.de

OBJECTIVES: The goal of the present study was to assess the efficacy and safety of intravenous tedisamil, a new antiarrhythmic compound, for conversion of recent-onset atrial fibrillation (AF) or atrial flutter (AFL) to normal sinus rhythm (NSR).

BACKGROUND: Tedisamil is a novel antiarrhythmic drug with predominantly class III activity. Its efficacy and safety for conversion of recent onset AF or AFL to NSR is not known.

METHODS: This was a multicenter, double-blind, randomized, placebo-controlled, sequential ascending dose-group trial. A total of 201 patients with symptomatic AF or AFL of 3 to 48 h duration were enrolled in a two-stage study. During stage 1, patients were randomized to receive tedisamil at 0.4 mg/kg body weight or matching placebo; during stage 2, patients received tedisamil at 0.6 mg/kg body weight or matching placebo. Treatments were given as single intravenous infusions. The primary study end point consisted of the percentage of patients converting to NSR for at least 60 s within 2.5 h.

RESULTS: Of 175 patients representing the intention-to-treat sample, conversion to NSR was observed in 41% (25/61) of the tedisamil 0.4 mg/kg group, 51% (27 of 53) of the tedisamil 0.6 mg/kg group, and 7% (4/59) of the placebo group (p < 0.001 for both tedisamil groups vs. placebo). Average time to conversion was 35 min in patients receiving tedisamil. There were two instances of self-terminating ventricular tachycardia: one episode of torsade de pointes and one of monomorphic ventricular tachycardia, both in patients receiving 0.6 mg/kg tedisamil.

CONCLUSIONS: Tedisamil at dosages of 0.4 and 0.6 mg/kg was superior to placebo in converting AF or AFL. Tedisamil has a rapid onset of action leading to conversion within 30 to 40 min in the majority of responders.

Abbreviations and Acronyms   AF = atrial fibrillation   AFL = atrial flutter   ECG = electrocardiogram/electrocardiographic   NSR = normal sinus rhythm

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