Cardiovascular medicine
Low dose amiodarone and sotalol in the treatment of recurrent,
symptomatic atrial fibrillation: a comparative, placebo controlled
study
G E Kochiadakis, N E Igoumenidis, M E Marketou, M D Kaleboubas, E N Simantirakis, P E Vardas
Cardiology
Department, University Hospital of Heraklion, PO Box 1352, Heraklion,
Crete, Greece
Correspondence to: Professor P E Vardas email: cardio{at}med.uoc.gr
Accepted 10 April 2000
OBJECTIVE
To assess and compare the
safety and efficacy of amiodarone and sotalol in the treatment of
patients with recurrent symptomatic atrial fibrillation.
DESIGN
Prospective, randomised,
single blind, placebo controlled study.
SETTING
Tertiary cardiac referral centre.
PATIENTS
186 consecutive patients (97 men, 89 women; mean (SD) age, 63 (10) years) with recurrent,
symptomatic 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 160-480 mg daily, as tolerated.
MAIN OUTCOME MEASURES
Recurrence of
atrial fibrillation or side effects.
RESULTS
In the amiodarone group, 31 of the 65 patients developed atrial fibrillation after an average of
six months, while 15 (11 in sinus rhythm and four in atrial
fibrillation) experienced significant side effects after an average of
16 months. In the sotalol group, relapse to atrial fibrillation
occurred in 47 of the 61 patients after an average of eight months;
three experienced side effects during the titration phase. In the
placebo group, 53 of the 60 patients developed atrial fibrillation
after an average of four months (p < 0.001 for amiodarone and
sotalol v placebo; p < 0.001 for amiodarone
v sotalol).
CONCLUSIONS
Both amiodarone and
sotalol can be used for the maintenance of normal sinus rhythm in
patients with symptomatic atrial fibrillation. Amiodarone is more
effective but causes more side effects.
Keywords: amiodarone; sotalol; atrial fibrillation
© 2000 by Heart
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