Usefulness of propafenone for recurrent paroxysmal atrial fibrillation.

To evaluate the efficacy of propafenone for suppression of recurrent paroxysmal symptomatic atrial fibrillation (AF), patients with frequent episodes of AF entered an open-label, dose-ranging study to determine the maximal tolerated dose of propafenone and were subsequently randomized to alternate between propafenone and placebo every month for 4 months. Patients recorded each episode of AF in a diary and recorded a simultaneous electrocardiographic rhythm strip by means of a transtelephonic recorder and transmitter to validate the presence of AF. Eighteen patients were eligible for study. During dose ranging, 4 patients withdrew due to inadequate drug efficacy or poor compliance, 2 withdrew due to intolerable side effects and 1 died. The mean dose of propafenone at the end of dose ranging was 644 +/- 189 mg/day. During the crossover study, the percentage of days with an attack of AF was significantly reduced by propafenone compared with placebo (27 +/- 34 vs 51 +/- 34%, p less than 0.01). The rate of early crossover or withdrawal from the crossover study was 13.6% with propafenone and 45% with placebo (p = 0.056). Five patients went on to receive long-term propafenone and 4 continued treatment with suppression of AF for 12 to 21 months. During the crossover study there were 29 reported minor side effects with propafenone and 11 with placebo.

Randomized placebo-controlled trial of propafenone for treatment of atrial tachyarrhythmias after cardiac surgery.

Fourteen patients with atrial fibrillation or flutter and a ventricular rate of greater than or equal to 120 beats/min occurring after cardiac surgery entered a double-blind placebo-controlled conditional crossover trial of intravenous propafenone. Patients randomly received either propafenone (2 mg/kg body weight) or placebo during a 10 minute intravenous infusion. If 20 minutes after the initiation of this infusion there was no conversion to sinus rhythm, the patient received a second intravenous infusion over 10 minutes (either propafenone or placebo, whichever was not given first). The electrocardiogram was recorded continuously throughout the study. Fourteen patients received propafenone and 10 received placebo. No patient's rhythm converted to sinus rhythm after placebo. In six patients (43%) (p less than 0.001), the arrhythmia converted to sinus rhythm between 5 and 10 minutes after the end of the propafenone infusion. After propafenone, the ventricular response to atrial fibrillation or flutter decreased significantly from 141.6 +/- 15.2 to 116.0 +/- 15.5 beats/min. Ventricular rate did not change after placebo. The mean propafenone plasma concentration was 3.46 +/- 2.17 mg/liter. The only side effect of propafenone noted was a decrease in systolic blood pressure of 9 +/- 9 mm Hg. Propafenone was useful for management of atrial fibrillation after cardiac surgery both for control of rapid ventricular response and for conversion to sinus rhythm.