Long-term antiarrhythmic efficacy and safety of d-sotalol in patients with ventricular tachycardia and a low ejection fraction

Summary

Since in patients with ventricular tachycardia (VT) and compromised left ventricular function, antiarrhythmic therapy poses a particular problem, an open-label safety study of d-sotalol, a new class III antiarrhythmic agent, was performed. Thirteen patients with defined VT and a low left ventricular ejection fraction (LVEF) were treated with orally administered d-sotalol, 100 mg bid, and in a few patients 100 mg tid, in an open study. Patients were followed up for 35±11 months, with the longest follow-up amounting to 51 months. The data obtained suggest that d-sotalol was moderately effective as an antiarrhythmic agent, in particular with respect to premature ventricular contractions (PVCs) and coupled and repetitive PVCs. The beneficial effect appeared to persist on long-term treatment. d-Sotalol was well tolerated and no subjective or objective adverse reactions were observed. There were no signs of worsening of congestive heart failure, proarrhythmogenic activity, or torsades de pointes, although QT-prolongation was observed. There were no dropouts in the study. Two patients died: One patient with idiopathic dilated cardiomyopathy (with LVEF=11%) died suddenly after 38 months of follow-up and one patient after 17 months from recurrent myocardial infarction. Neither of these had shown recurrence of VT on 24 hour ambulatory ECG recordings. In conclusion, in this small group of patients d-sotalol appeared to be safe and well tolerated during long-term treatment of patients with VT and poor left ventricular function. There were clear suggestions of antiarrhythmic activity, reflected by the suppression of complex ventricular arrhythmias and by the absence of recurrent VT on long-term follow-up in the majority of patients. These results would encourage a larger, formal trial on the use of d-sotalol in this type of patients,.