Heart 1998;79:568-575 ( June )

Superiority of ibutilide (a new class III agent) over DL-sotalol in converting atrial flutter and atrial fibrillation

M A Vos,^a S R Golitsyn,^b K Stangl,^c M Y Ruda,^b L Van Wijk,^d J D Harry,^e K T Perry,^f P Touboul,^g G Steinbeck,^h H J J Wellens^a, for the Ibutilide/Sotalol Comparator Study Group

^a University Hospital, Maastricht, Netherlands, ^b Cardiology Research Centre, Moscow, Russia, ^c Humholdt University, Berlin, Germany, ^d St Chr Ziekenhuis Refaja, Stadskanaal, Netherlands, ^e Pharmacia & Upjohn, Crawley, West Sussex, UK, ^f Pharmacia & Upjohn, Kalamazoo, Michigan, USA, ^g Hospitaux de Lyon, Lyon, France, ^h Klinikum Grosehadern of the University of Munich, Germany

Correspondence to: Dr M A Vos, Department of Cardiology, Cardiovascular Research Institute Maastricht, University Hospital Maastricht, PO Box 5800, 6202 AZ Maastricht, Netherlands.

Accepted for publication 24 November 1997

ObjectiveTo compare the efficacy and safety of a single dose of ibutilide, a new class III antiarrhythmic drug, with that of DL-sotalol in terminating chronic atrial fibrillation or flutter in haemodynamically stable patients.
DesignDouble blind, randomised study.
Setting43 European hospitals.
Patients308 patients (mean age 60 years, 70% men, 48% with heart disease) with sustained atrial fibrillation (n = 251) or atrial flutter (n = 57) (duration three hours to 45 days) were randomised to three groups to receive a 10 minute infusion of 1 mg ibutilide (n = 99), 2 mg ibutilide (n = 106), or 1.5 mg/kg DL-sotalol (n = 103). Infusion was discontinued at termination of the arrhythmia.
Main outcome measureSuccessful conversion of atrial fibrillation or flutter, defined as termination of arrhythmia within one hour of treatment.
ResultsBoth drugs were more effective against atrial flutter than against atrial fibrillation. Ibutilide was superior to DL-sotalol for treating atrial flutter (70% and 56% v 19%), while the high dose of ibutilide was more effective for treating atrial fibrillation than DL-sotalol (44% v 11%) and the lower dose of ibutilide (44% v 20%, p < 0.01). The mean (SD) time to arrhythmia termination was 13 (7) minutes with 2 mg ibutilide, 19 (15) minutes with 1 mg ibutilide, and 25 (17) minutes with DL-sotalol. In all patients, the duration of arrhythmia before treatment was a predictor of arrhythmia termination, although this was less obvious in the group that received 2 mg ibutilide. This dose converted almost 48% of atrial fibrillation that was present for more than 30 days. Concomitant use of digitalis or nifedipine and prolongation of the QTc interval were not predictive of arrhythmia termination. Bradycardia (6.5%) and hypotension (3.7%) were more common side effects with DL-sotalol. Of 211 patients given ibutilide, two (0.9%) who received the higher dose developed polymorphic ventricular tachycardia, one of whom required direct current cardioversion.
ConclusionIbutilide (given in 1 or 2 mg doses over 10 minutes) is highly effective for rapidly terminating persistent atrial fibrillation or atrial flutter. This new class III drug, under monitored conditions, is a potential alternative to currently available cardioversion options.

Keywords: atrial fibrillation;  atrial flutter;  antiarrhythmic agents;  ibutilide;  sotalol

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© 1998 by Heart
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