Clinical Studies
Intravenous Dofetilide, a Class III Antiarrhythmic Agent, for the Termination of Sustained Atrial Fibrillation or Flutter

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Abstract

Objectives. This study sought to determine the safety and efficacy of a single bolus of intravenous dofetilide, a pure class III antiarrhythmic agent, for the termination of sustained atrial fibrillation or flutter.

Background. Dofetilide is a highly selective blocker of the rapid component of the delayed rectifier current causing action potential prolongation. These effects, and preliminary clinical data, suggest that it may be effective in the treatment of atrial fibrillation and flutter.

Methods. Ninety-one patients with sustained atrial fibrillation (75 patients) or flutter (16 patients) were entered into a double-blind, randomized multicenter study of one of two doses of dofetilide (4 or 8 μg/kg body weight) or placebo.

Results. Dofetilide effectively terminated the arrhythmia in 31% of patients receiving 8 μg/kg, a statistically significant difference from those receiving 4 μg/kg (conversion rate 12.5%, p < 0.05) or placebo (no conversion, p < 0.01). Patients with atrial flutter had a greater response to dofetilide (54% conversion rate) than those with atrial fibrillation (14.5% conversion rate, p < 0.001).

Conclusions. Intravenous dofetilide can convert sustained atrial fibrillation or flutter to sinus rhythm. However, its efficacy is greater in flutter—a response that contrasts with the poorer response seen with class I agents. This finding potentially represents an important advance in the pharmacologic termination of atrial flutter.

(J Am Coll Cardiol 1997;29:385–90)

Abbreviations

ANOVA
analysis of variance
CI
confidence interval
ECG
electrocardiogram, electrocardiographic
IKr
delayed inward rectifier current
QTc
corrected QT interval

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A list of the Intravenous Dofetilide Investigators appears in the AppendixAppendix A.