Multicentre randomized trial of sotalol vs amiodarone for chronic malignant ventricular tachyarrhythmias. Amiodarone vs Sotalol Study Group.

Sotalol was compared with amiodarone in this open randomized multicentre study of patients with ventricular tachycardia or fibrillation not associated with acute myocardial infarction refractory to or intolerant of Class I drugs. 16 of 30 patients treated with amiodarone completed 12 months on therapy, five were withdrawn because of recurrent ventricular tachycardia and nine because of presumed adverse drug reactions, compliance problems or protocol violation. Four of those who were withdrawn died within 12 months. Sixteen of 29 patients completed 12 months on sotalol, one was withdrawn because of ventricular tachycardia and nine because of presumed adverse drug reactions, poor compliance or the need for coronary artery surgery. Three died on treatment and two after withdrawal but within 12 months of entering the study. When the results are analysed by intention to treat there was no significant difference in antiarrhythmic efficacy or in the incidence of side-effects severe enough to warrant withdrawal from the trial. There was an increase in left ventricular ejection fraction in those treated with sotalol, which, because of its pharmacokinetics, is an attractive alternative to amiodarone for patients with malignant ventricular arrhythmias who can tolerate beta-adrenergic blockade.