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European Heart Journal 2000 21(15):1265-1273; doi:10.1053/euhj.1999.2039
Copyright © 2000 by the European Society of Cardiology.
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Comparison of intravenously administered dofetilide versus amiodarone in the acute termination of atrial fibrillation and flutter. A multicentre, randomized, double-blind, placebo-controlled study

L Bianconia,f1, A Castroa, M Dinellib, P Albonib, A Pappalardoc, E Richiardid and M Santinia

a Division of Cardiology, San Filippo Neri Hospital, Rome, Italy
b Division of Cardiology, Santissima Annunziata Hospital, Cento, Italy
c Cardiology Service—ICU, Policlinico Casilino, Rome, Italy
d Division of Cardiology, General Hospital, Asti, Italy

revised December 6, 1999; accepted December 18, 1999

Abstract

Aims This study compared the efficacy and safety of intravenous dofetilide with amiodarone and placebo in converting atrial fibrillation or flutter to sinus rhythm.

Methods and Results One hundred and fifty patients with atrial fibrillation or flutter (duration range 2h–6 months) were given 15-min intravenous infusions of 8µg.kg–1of dofetilide (n=48), 5mg.kg–1of amiodarone (n=50), or placebo (n=52) and monitored continuously for 3h. Sinus rhythm was restored in 35%, 4%, and 4% of patients, respectively (P<0·001, dofetilide vs placebo;P=ns, amiodarone versus placebo). Dofetilide was more effective in atrial flutter than in atrial fibrillation (cardioversion rates 75% and 22%, respectively;P=0·004). The mean time to conversion with dofetilide was 55±15min. Dofetilide prolonged the QTc interval (+16% at 20min). Amiodarone substantially decreased the ventricular rate in non-converters (–18beats.min–1at 30min). Two patients given dofetilide (4%) had non-sustained ventricular tachycardias, and four (8%) had torsade de pointes, in one case requiring electrical cardioversion.

Conclusion Intravenous dofetilide is significantly more effective than amiodarone or placebo in restoring sinus rhythm in patients with atrial fibrillation or flutter. However, when infused intravenously at this dose and rate, dofetilide causes a significant incidence of torsade de pointes.

Key Words: dofetilide, amiodarone, antiarrhythmic drugs, atrial fibrillation, atrial flutter, cardioversion

f1 Correspondence: Dr Leopoldo Bianconi, Via San Sotero 12, 00165 Rome, Italy. Email:kofler@opbg.net


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