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Heart 1998;79:568-575 ( June )
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
Objective
To 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.
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