Cited by 200Atrial Fibrillation Management and OutcomesCardiac Arrhythmias and TreatmentsCardiac electrophysiology and arrhythmias

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

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Vos, M A, Golitsyn, S R, Stangl, K, Ruda, M Y, Van Wijk, L, Harry, J D, Perry, K T, Touboul, P, Steinbeck, G, Wellens, H J J·1998·Heart

DOI 10.1136/hrt.79.6.568PMC PMC1728725

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Abstract

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. DESIGN: Double blind, randomised study. SETTING: 43 European hospitals. PATIENTS: 308 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 MEASURE: Successful conversion of atrial fibrillation or flutter, defined as termination of arrhythmia within one hour of treatment. RESULTS: Both 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. CONCLUSION: Ibutilide (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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ACC/AHA/ESC guidelines for the management of patients with atrial fibrillation31This document was approved by the American College of Cardiology Board of Trustees in August 2001, the American Heart Association Science Advisory and Coordinating Committee in August 2001, and the European Society of Cardiology Board and Committee for Practice Guidelines and Policy Conferences in August 2001.32When citing this document, the American College of Cardiology, the American Heart Association, and the European Society of Cardiology would appreciate the following citation format: Fuster V, Rydén LE, Asinger RW, Cannom DS, Crijns HJ, Frye RL, Halperin JL, Kay GN, Klein WW, Lévy S, McNamara RL, Prystowsky EN, Wann LS, Wyse DG. ACC/AHA/ESC guidelines for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines and Policy Conferences (Committee to Develop Guidelines for the Management of Patients With Atrial Fibrillation). J Am Coll Cardiol 2001;38:XX-XX.33This document is available on the World Wide Web sites of the American College of Cardiology (www.acc.org), the American Heart Association (www.americanheart.org), the European Society of Cardiology (www.escardio.org), and the North American Society of Pacing and Electrophysiology (www.naspe.org). Single reprints of this document (the complete Guidelines) to be published in the mid-October issue of the European Heart Journal are available by calling +44.207.424.4200 or +44.207.424.4389, faxing +44.207.424.4433, or writing Harcourt Publishers Ltd, European Heart Journal, ESC Guidelines – Reprints, 32 Jamestown Road, London, NW1 7BY, United Kingdom. Single reprints of the shorter version (Executive Summary and Summary of Recommendations) published in the October issue of the Journal of the American College of Cardiology and the October issue of Circulation, are available for $5.00 each by calling 800-253-4636 (US only) or by writing the Resource Center, American College of Cardiology, 9111 Old Georgetown Road, Bethesda, Maryland 20814. To purchase bulk reprints specify version and reprint number (Executive Summary 71-0208; full text 71-0209) up to 999 copies, call 800-611-6083 (US only) or fax 413-665-2671; 1000 or more copies, call 214-706-1466, fax 214-691-6342; or E-mail: pubauth@heart.org.
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Authors: Vos, M. A., Golitsyn, S. R., Stangl, K., Ruda, M. Y., Van Wijk, L., Harry, J. D., Perry, K. T., Touboul, P., Steinbeck, G., & Wellens, H. J. J.
Affiliations: Refaja Ziekenhuis (NL)
aUniversity Hospital, Maastricht, Netherlands, bCardiology Research Centre, Moscow, Russia, cHumholdt University, Berlin, Germany, dSt Chr Ziekenhuis Refaja, Stadskanaal, Netherlands, ePharmacia & Upjohn, Crawley, West Sussex, UK, fPharmacia & Upjohn, Kalamazoo, Michigan, USA, gHospitaux de Lyon, Lyon, France, hKlinikum Grosehadern of the University of Munich, Germany
Corresponding author: Vos, M A
ORCID: Vos, M A
Stangl, K
Steinbeck, G
Venue: Heart
Publisher: BMJ
Published: 1998-06-01
Volume: 79
Issue: 6
Pages: 568-575
ISSN: 1355-6037 (ISSN-L)
1468-201X
DOI: 10.1136/hrt.79.6.568
PMC: PMC1728725
OpenAlex: W2129291556
Cited by: 200
References: 39
Citations by year: 2026: 1 · 2025: 4 · 2024: 4 · 2023: 6 · 2022: 6 · 2021: 3 · 2020: 6 · 2019: 5 · 2018: 2 · 2017: 9 · 2016: 8 · 2015: 6 · 2014: 5 · 2013: 4 · 2012: 4
FWCI: 7.84
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: Heart (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac Arrhythmias and Treatments
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac electrophysiology and arrhythmias
Keywords: class III antiarrhythmic agents, atrial fibrillation, atrial flutter, drug safety, bradycardia, hypotension, QTc prolongation, digitalis, nifedipine
MeSH terms: Adult, Aged, Aged, 80 and over, Analysis of Variance, Anti-Arrhythmia Agents, Arrhythmias, Cardiac, Atrial Fibrillation, Atrial Flutter, Double-Blind Method, Drug Administration Schedule, Female, Humans, Infusions, Intravenous, Male, Middle Aged, Prospective Studies, Sotalol, Sulfonamides, Time Factors

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

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