Low dose amiodarone and sotalol in the treatment of recurrent, symptomaticatrial fibrillation: a comparative, placebo controlled study

Objective-To assess and compare the safety and efficacy of amiodarone and s otalol in the treatment of patients with recurrent symptomatic atrial fibri llation. Design-Prospective, randomised, single blind, placebo controlled s tudy. Setting-Tertiary cardiac referral centre. Patients-186 consecutive pa tients (97 men, 89 women; mean (SD) age, 63 (10) years) with recurrent, sym ptomatic atrial fibrillation. Interventions-65 patients were randomised to amiodarone, 61 to sotalol, and 60 to placebo. Patients receiving amiodarone were maintained at a dose of 200 mg/day after a 30 day loading phase. The sotalol dose was 160-4 80 mg daily, as tolerated. Main outcome measures-Rec urrence of atrial fibrillation or side effects. Results-In the amiodarone g roup, 3 1 of the 65 patients developed atrial fibrillation after an average of six months, while 15 (11 in sinus rhythm and four in atrial fibrillatio n) experienced significant side effects after an average of 16 months. In t he sotalol group, relapse to atrial fibrillation occurred in 47 of the 61 p atients after an average of eight months; three experienced side effects du ring the titration phase. In the placebo group, 53 of the 60 patients devel oped atrial fibrillation after an average of four months (p < 0.001 for ami odarone and sotalol v placebo; p < 0.001 for amiodarone v sotalol). Conclus ions-Both amiodarone and sotalol can be used for the maintenance of normal sinus rhythm in patients with symptomatic atrial fibrillation. Amiodarone i s more effective but causes more side effects. (Heart 2000;84:751-257)