Copyright © 1989 by the European Society of Cardiology.
© 1989 The European Society of Cardiology
Multicentre randomized trial of sotalol vs amiodarone for chronic malignant ventricular tachyarrhythmias
AMIODARONE VS SOTALOL STUDY GROUPReceived 11 July 1988; revised 13 February 1989; .
Address for correspondence: J. H. N. Belt, Director of Cardiology, Royal Brisbane Hospital, Brisbane 4029 Australia
Abstract
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to or intolerant of Class I drugs. 16 of 30 patients treated with amiodarone completed 12 months on therapy, five were withdrawn because of recurrent ventricular tachycardia and nine because of presumed adverse drug reactions, compliance problems or protocol violation. Four of those who were withdrawn died within 12 months.
Sixteen of 29 patients completed 12 months on sotalol, one was withdrawn because of ventricular tachycardia and nine because of presumed adverse drug reactions, poor compliance or the need for coronary artery surgery.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 pharmacokine-tics, is an attractive alternative to amiodarone for patients with malignant ventricular arrhythmias who can tolerate ß-adrenergic blockade.
Key Words: Sotalol • amiodarone • ventricular tachycardia • ventricular fibrillation
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