A randomized, double-blind, placebo-controlled evaluation of the efficacy and safety of intravenously administered dofetilide in patients with Wolff-Parkinson-White syndrome.

Pharmacological conversion of arrhythmias in Wolff-Parkinson-White (WPW) syndrome is often frequently undertaken. Current antiarrhythmic drugs used for conversion can be associated with significant side effects and variable efficacy. Fifteen male patients (mean age 34, range 18-63 years) with WPW syndrome and atrial fibrillation or AVRT induced in the electrophysiology laboratory were enrolled in a prospective, randomized, placebo-controlled crossover study. Patients were randomized to one of two doses of intravenous dofetilide or placebo. Patients who failed to respond to this initial infusion received a second higher dose infusion of dofetilide. With the initial infusion, six of ten dofetilide patients converted to sinus rhythm compared to one of five placebo patients. After a second infusion of dofetilide for placebo patients and higher dose dofetilide for low dose dofetilide patients, the overall conversion rate was 71% with dofetilide compared with 20% for placebo (P = 0.046). Atrial fibrillation converted to sinus rhythm in 82% of patients who received dofetilide. Intravenous dofetilide was safe and effective at converting induced atrial fibrillation in patients with WPW syndrome.