Conversion efficacy and safety of intravenous ibutilide compared with intravenous procainamide in patients with atrial flutter or fibrillation

Annabelle S. Volgman, Peter A. Carberry, Bruce Stambler, William R Lewis, George H. Dunn, Kimberly T. Perry, James T. Vanderlugt, Peter R. Kowey

Research output: Contribution to journalArticle

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Abstract

Objectives. This multicenter study compared the efficacy and safety of ibutilide versus procainamide for conversion of recentonset atrial flutter or fibrillation. Background. Ibutilide fumarate is an intravenous (IV) class III antiarrhythmic agent that has been shown to be significantly more effective than placebo in the pharmacologic conversion of atrial flutter and fibrillation to sinus rhythm. Procainamide is commonly used for conversion of recent-onset atrial fibrillation to normal sinus rhythm. Methods. One hundred twenty-seven patients (age range 22 to 92 years) with atrial flutter or fibrillation of 3 h to 90 days' (mean 21 days) duration were randomized to receive either two 10-min IV infusions of 1 mg of ibutilide fumarate, separated by a 10-min infusion of 5% dextrose in sterile water, or three successive 10-min IV infusions of 400 mg of procainamide hydrochloride. Results. Of the 127 patients, 120 were evaluated for efficacy: 35 (58.3%) of 60 in the ibutilide group compared with 11 (18.3%) of 60 in the procainamide group had successful termination within 1.5 h of treatment (p < 0.0001). Seven patients were found to have violated the protocol and were not included in the final evaluation. In the patients with atrial flutter, ibutilide had a significantly higher success rate than procainamide (76% [13 of 17] vs. 14% [3 of 22], p = 0.001). Similarly, in the atrial fibrillation group, ibutilide had a significantly higher success rate than procainamide (51% [22 of 43] vs. 21% [8 of 38], p = 0.005). One patient who received ibutilide, which was found to be a protocol violation, had sustained polymorphic ventricular tachycardia requiring direct current cardioversion. Seven patients who received procainamide became hypotensive. Conclusions. This study establishes the superior efficacy of ibutilide over procainamide when administered to patients to convert either atrial fibrillation or atrial flutter to sinus rhythm. Hypotension was the major adverse effect seen with procainamide. A low incidence of serious proarrhythmia was seen with the administration of ibutilide occurring at the end of infusion.

Original languageEnglish (US)
Pages (from-to)1414-1419
Number of pages6
JournalJournal of the American College of Cardiology
Volume31
Issue number6
DOIs
StatePublished - May 1998

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Procainamide
Atrial Flutter
Atrial Fibrillation
Safety
Intravenous Infusions
ibutilide
Electric Countershock
Ventricular Tachycardia
Hypotension
Multicenter Studies
Placebos
Glucose

ASJC Scopus subject areas

  • Nursing(all)

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Conversion efficacy and safety of intravenous ibutilide compared with intravenous procainamide in patients with atrial flutter or fibrillation. / Volgman, Annabelle S.; Carberry, Peter A.; Stambler, Bruce; Lewis, William R; Dunn, George H.; Perry, Kimberly T.; Vanderlugt, James T.; Kowey, Peter R.

In: Journal of the American College of Cardiology, Vol. 31, No. 6, 05.1998, p. 1414-1419.

Research output: Contribution to journalArticle

Volgman, Annabelle S. ; Carberry, Peter A. ; Stambler, Bruce ; Lewis, William R ; Dunn, George H. ; Perry, Kimberly T. ; Vanderlugt, James T. ; Kowey, Peter R. / Conversion efficacy and safety of intravenous ibutilide compared with intravenous procainamide in patients with atrial flutter or fibrillation. In: Journal of the American College of Cardiology. 1998 ; Vol. 31, No. 6. pp. 1414-1419.
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abstract = "Objectives. This multicenter study compared the efficacy and safety of ibutilide versus procainamide for conversion of recentonset atrial flutter or fibrillation. Background. Ibutilide fumarate is an intravenous (IV) class III antiarrhythmic agent that has been shown to be significantly more effective than placebo in the pharmacologic conversion of atrial flutter and fibrillation to sinus rhythm. Procainamide is commonly used for conversion of recent-onset atrial fibrillation to normal sinus rhythm. Methods. One hundred twenty-seven patients (age range 22 to 92 years) with atrial flutter or fibrillation of 3 h to 90 days' (mean 21 days) duration were randomized to receive either two 10-min IV infusions of 1 mg of ibutilide fumarate, separated by a 10-min infusion of 5{\%} dextrose in sterile water, or three successive 10-min IV infusions of 400 mg of procainamide hydrochloride. Results. Of the 127 patients, 120 were evaluated for efficacy: 35 (58.3{\%}) of 60 in the ibutilide group compared with 11 (18.3{\%}) of 60 in the procainamide group had successful termination within 1.5 h of treatment (p < 0.0001). Seven patients were found to have violated the protocol and were not included in the final evaluation. In the patients with atrial flutter, ibutilide had a significantly higher success rate than procainamide (76{\%} [13 of 17] vs. 14{\%} [3 of 22], p = 0.001). Similarly, in the atrial fibrillation group, ibutilide had a significantly higher success rate than procainamide (51{\%} [22 of 43] vs. 21{\%} [8 of 38], p = 0.005). One patient who received ibutilide, which was found to be a protocol violation, had sustained polymorphic ventricular tachycardia requiring direct current cardioversion. Seven patients who received procainamide became hypotensive. Conclusions. This study establishes the superior efficacy of ibutilide over procainamide when administered to patients to convert either atrial fibrillation or atrial flutter to sinus rhythm. Hypotension was the major adverse effect seen with procainamide. A low incidence of serious proarrhythmia was seen with the administration of ibutilide occurring at the end of infusion.",
author = "Volgman, {Annabelle S.} and Carberry, {Peter A.} and Bruce Stambler and Lewis, {William R} and Dunn, {George H.} and Perry, {Kimberly T.} and Vanderlugt, {James T.} and Kowey, {Peter R.}",
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T1 - Conversion efficacy and safety of intravenous ibutilide compared with intravenous procainamide in patients with atrial flutter or fibrillation

AU - Volgman, Annabelle S.

AU - Carberry, Peter A.

AU - Stambler, Bruce

AU - Lewis, William R

AU - Dunn, George H.

AU - Perry, Kimberly T.

AU - Vanderlugt, James T.

AU - Kowey, Peter R.

PY - 1998/5

Y1 - 1998/5

N2 - Objectives. This multicenter study compared the efficacy and safety of ibutilide versus procainamide for conversion of recentonset atrial flutter or fibrillation. Background. Ibutilide fumarate is an intravenous (IV) class III antiarrhythmic agent that has been shown to be significantly more effective than placebo in the pharmacologic conversion of atrial flutter and fibrillation to sinus rhythm. Procainamide is commonly used for conversion of recent-onset atrial fibrillation to normal sinus rhythm. Methods. One hundred twenty-seven patients (age range 22 to 92 years) with atrial flutter or fibrillation of 3 h to 90 days' (mean 21 days) duration were randomized to receive either two 10-min IV infusions of 1 mg of ibutilide fumarate, separated by a 10-min infusion of 5% dextrose in sterile water, or three successive 10-min IV infusions of 400 mg of procainamide hydrochloride. Results. Of the 127 patients, 120 were evaluated for efficacy: 35 (58.3%) of 60 in the ibutilide group compared with 11 (18.3%) of 60 in the procainamide group had successful termination within 1.5 h of treatment (p < 0.0001). Seven patients were found to have violated the protocol and were not included in the final evaluation. In the patients with atrial flutter, ibutilide had a significantly higher success rate than procainamide (76% [13 of 17] vs. 14% [3 of 22], p = 0.001). Similarly, in the atrial fibrillation group, ibutilide had a significantly higher success rate than procainamide (51% [22 of 43] vs. 21% [8 of 38], p = 0.005). One patient who received ibutilide, which was found to be a protocol violation, had sustained polymorphic ventricular tachycardia requiring direct current cardioversion. Seven patients who received procainamide became hypotensive. Conclusions. This study establishes the superior efficacy of ibutilide over procainamide when administered to patients to convert either atrial fibrillation or atrial flutter to sinus rhythm. Hypotension was the major adverse effect seen with procainamide. A low incidence of serious proarrhythmia was seen with the administration of ibutilide occurring at the end of infusion.

AB - Objectives. This multicenter study compared the efficacy and safety of ibutilide versus procainamide for conversion of recentonset atrial flutter or fibrillation. Background. Ibutilide fumarate is an intravenous (IV) class III antiarrhythmic agent that has been shown to be significantly more effective than placebo in the pharmacologic conversion of atrial flutter and fibrillation to sinus rhythm. Procainamide is commonly used for conversion of recent-onset atrial fibrillation to normal sinus rhythm. Methods. One hundred twenty-seven patients (age range 22 to 92 years) with atrial flutter or fibrillation of 3 h to 90 days' (mean 21 days) duration were randomized to receive either two 10-min IV infusions of 1 mg of ibutilide fumarate, separated by a 10-min infusion of 5% dextrose in sterile water, or three successive 10-min IV infusions of 400 mg of procainamide hydrochloride. Results. Of the 127 patients, 120 were evaluated for efficacy: 35 (58.3%) of 60 in the ibutilide group compared with 11 (18.3%) of 60 in the procainamide group had successful termination within 1.5 h of treatment (p < 0.0001). Seven patients were found to have violated the protocol and were not included in the final evaluation. In the patients with atrial flutter, ibutilide had a significantly higher success rate than procainamide (76% [13 of 17] vs. 14% [3 of 22], p = 0.001). Similarly, in the atrial fibrillation group, ibutilide had a significantly higher success rate than procainamide (51% [22 of 43] vs. 21% [8 of 38], p = 0.005). One patient who received ibutilide, which was found to be a protocol violation, had sustained polymorphic ventricular tachycardia requiring direct current cardioversion. Seven patients who received procainamide became hypotensive. Conclusions. This study establishes the superior efficacy of ibutilide over procainamide when administered to patients to convert either atrial fibrillation or atrial flutter to sinus rhythm. Hypotension was the major adverse effect seen with procainamide. A low incidence of serious proarrhythmia was seen with the administration of ibutilide occurring at the end of infusion.

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