Comparisons of oral propafenone and sotalol as an initial treatment in patients with symptomatic paroxysmal atrial fibrillation.

The main goal of this study is to evaluate the safety and efficacy of propafenone versus sotalol as an initial choice of treatment in patients with symptomatic paroxysmal atrial fibrillation (AF), according to a double-blind randomized system. In the oral propafenone group (n = 41), 2 patients (5%) discontinued therapy because of gastrointestinal discomfort in 1 and dizziness in the other. Thirty-one (79%) of the 39 patients who continued the treatment had effective response to oral propafenone (>75% reduction of symptomatic arrhythmic attacks) on a mean dose of 663 +/- 99 mg/day with a decrease in attack frequency from 10 +/- 3 to 2 +/- 1 times per week. In the oral sotalol group (n = 38), 4 patients (11%) discontinued treatment because of dizziness in 2 and symptomatic bradycardia in 2. Twenty-six of the 34 patients (76%) who continued the treatment had effective response to oral sotalol on a mean dose of 200 +/- 57 mg/day with a decrease in attack frequency from 11 +/- 3 to 2 +/- 1 times per week. Comparisons of the results between propafenone and sotalol groups showed a similar incidence of intolerable (2 of 41 vs 4 of 38, p = 0.42) and tolerable side effects (10 of 39 vs 8 of 34, p = 1.0). The attack frequency at baseline (11 +/- 3 vs 10 +/- 4 times per week, p = 0.23) and after treatment (3 +/- 1 vs 3 +/- 2 times per week, p = 0.85) did not differ significantly between the 2 groups. The incidence of effective response to drugs was also similar (31 of 39 vs 26 of 34, p = 0.78). Furthermore, the decrease of symptom scores (-32 +/- 8% vs -29 +/- 7%, p = 0.18) and percentage decrease of ventricular rate (-15 +/- 4% vs -18 +/- 4%, p = 0.10) during AF were also similar between the 2 groups. In conclusion, oral propafenone and sotalol are equally effective and safe in preventing attacks and alleviating symptoms of paroxysmal AF.

RCT Entities:   Population Interventions Outcomes