Superiority of ibutilide (a new class III agent) overdl-sotalol in converting atrial flutter and atrial fibrillation
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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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Dofetilide and ibutilide, pure class III AADs, are very effective for interrupting AFL intravenously, while class Ia and Ic drugs have little or no effect.
“Dofetilide and ibutilide, pure class III AADs, are very effective for interrupting AFL in intravenous administration, while Class Ia and Ic drugs have little or no effect.138 -142,149”
From European Heart Rhythm Association (EHRA) consensus document on the management of supraventricular arrhythmias, endorsed by Heart Rhythm Society (HRS), Asia-Pacific Heart Rhythm Society (APHRS), and Sociedad Latinoamericana de Estimulacion Cardiaca y Electrofisiologia (SOLAECE) (2017) · cites this paper as [142]
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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
- Venue
- Heart
- Publisher
- BMJ
- Published
- 1998-06-01
- Volume
- 79
- Issue
- 6
- Pages
- 568-575
- ISSN
- 1355-6037 (ISSN-L)
- 1468-201X
- 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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