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Objectives The goal of the present study was to assess the efficacy and safety of intravenous tedisamil, a new antiarrhythmic compound, for conversion of rece nt-onset atrial fibrillation (AF) or atrial flutter (AFL) to normal sinus rhyth m (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, randomi zed, 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 tw o-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 te disamil at 0.6mg/kg body weight or matching placebo. Treatments were given as si ngle intravenous infusions. The primary study end point consisted of the percent age 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 ob served in 41%(25/61) of the tedisamil 0.4mg/kg group, 51%(27 of 53) of the ted isamil 0.6mg/kg group, and 7%(4/59) of the placebo group (p< 0.001 for both ted isamil groups vs. placebo). Average time to conversion was 35 min in patients re ceiving tedisamil. There were two instances of selfterminating ventricular tachy cardia: one episode of torsade de pointes and one of monomorphic ventricular tac hycardia, 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.
Objectives The goal of the present study was to assess the efficacy and safety of intravenous tedisamil, a new antiarrhythmic compound, for conversion of rece nt-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, randomi zed, placebo-controlled, sequential ascending A total of 201 patients with symptomatic AF or AFL of 3 to 48 h duration were enrolled in a tw o-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 te disamil at 0.6 mg / kg body weight or matching placebo. Treatments were given as si ngle intravenous infusions. The primary study end point consisted of the percent of of patients of converting to NSR for at Results Of 175 patients representing the intention-to-treat sample, conversion to NSR was ob served in 41% (25/61) of the tedisamil 0.4 mg / kg group, 51% (27 of 53) of the ted isamil 0.6 mg / kg group, and 7% (4/59) of the placebo group (p <0.001 for both ted isamil groups vs. placebo). Average time to conversion was 35 min in patients re ceiving tedisamil. There were two instances of selfterminating ventricular tachy cardia: one episode of torsade de pointes and one of monomorphic ventricular tac hycardia, 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.