Advanced

Usefulness of Vernakalant Hydrochloride Injection for Rapid Conversion of Atrial Fibrillation

Pratt, Craig M.; Roy, Denis; Torp-Pedersen, Christian; Wyse, D. George; Toft, Egon; Juul-Möller, Steen LU ; Retyk, Enrique and Drenning, David Humphrey (2010) In American Journal of Cardiology 106(9). p.1277-1283
Abstract
The objective of the present study was to assess the safety and effectiveness of vernakalant hydrochloride injection (RSD1235), a novel antiarrhythmic drug, for the conversion of atrial fibrillation (AF) or atrial flutter to sinus rhythm (SR) Patients with either AF or atrial flutter were randomized in a 11 ratio to receive vernakalant (n = 138) or placebo (n = 138) and were stratified by an arrhythmia duration of >3 hours to <= 7 days (short duration) and 8 to <= 45 days (long duration) The first infusion of placebo or vernakalant (3 mg/kg) was given for 10 minutes followed by a second infusion of placebo or vernakalant (2 mg/kg) 15 minutes later if the arrhythmia had not terminated A total of 265 patients were randomized and... (More)
The objective of the present study was to assess the safety and effectiveness of vernakalant hydrochloride injection (RSD1235), a novel antiarrhythmic drug, for the conversion of atrial fibrillation (AF) or atrial flutter to sinus rhythm (SR) Patients with either AF or atrial flutter were randomized in a 11 ratio to receive vernakalant (n = 138) or placebo (n = 138) and were stratified by an arrhythmia duration of >3 hours to <= 7 days (short duration) and 8 to <= 45 days (long duration) The first infusion of placebo or vernakalant (3 mg/kg) was given for 10 minutes followed by a second infusion of placebo or vernakalant (2 mg/kg) 15 minutes later if the arrhythmia had not terminated A total of 265 patients were randomized and received treatment The primary end point was conversion of AF to SR for >= 1 minute within 90 minutes of the start of the drug infusion in the short-duration AF group Of the 86 patients receiving vernakalant in the short-duration AF group, 44 (51 2%) demonstrated conversion to SR compared to 3 (3 6%) of the 84 in the placebo group (p <0 0001) The median interval to conversion of short-duration AF to SR in the responders given vernakalant was 8 minutes Of the entire AF population (short- and long-duration AF), 47 (39 8%) of the 118 vernakalant patients experienced conversion of AF to SR compared to 4 (3 3%) of the 121 placebo patients (p <0 0001) Transient dysgeusia and sneezing were the most common adverse events in the vernakalant patients One vernakalant patient who had severe aortic stenosis experienced hypotension and ventricular fibrillation and died In conclusion, vernakalant demonstrated a rapid and high rate of conversion for short-duration AF and was well tolerated (C) 2010 Elsevier Inc All rights reserved (Am J Cardiol 2010,106 1277-1283) (Less)
Please use this url to cite or link to this publication:
author
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
American Journal of Cardiology
volume
106
issue
9
pages
1277 - 1283
publisher
Excerpta Medica
external identifiers
  • wos:000284177200013
  • scopus:77958570420
ISSN
1879-1913
DOI
10.1016/j.amjcard.2010.06.054
language
English
LU publication?
yes
id
5ca33b1e-777b-4f65-915b-ad3d440673cc (old id 1753554)
date added to LUP
2011-01-04 08:15:25
date last changed
2018-06-10 03:08:06
@article{5ca33b1e-777b-4f65-915b-ad3d440673cc,
  abstract     = {The objective of the present study was to assess the safety and effectiveness of vernakalant hydrochloride injection (RSD1235), a novel antiarrhythmic drug, for the conversion of atrial fibrillation (AF) or atrial flutter to sinus rhythm (SR) Patients with either AF or atrial flutter were randomized in a 11 ratio to receive vernakalant (n = 138) or placebo (n = 138) and were stratified by an arrhythmia duration of &gt;3 hours to &lt;= 7 days (short duration) and 8 to &lt;= 45 days (long duration) The first infusion of placebo or vernakalant (3 mg/kg) was given for 10 minutes followed by a second infusion of placebo or vernakalant (2 mg/kg) 15 minutes later if the arrhythmia had not terminated A total of 265 patients were randomized and received treatment The primary end point was conversion of AF to SR for &gt;= 1 minute within 90 minutes of the start of the drug infusion in the short-duration AF group Of the 86 patients receiving vernakalant in the short-duration AF group, 44 (51 2%) demonstrated conversion to SR compared to 3 (3 6%) of the 84 in the placebo group (p &lt;0 0001) The median interval to conversion of short-duration AF to SR in the responders given vernakalant was 8 minutes Of the entire AF population (short- and long-duration AF), 47 (39 8%) of the 118 vernakalant patients experienced conversion of AF to SR compared to 4 (3 3%) of the 121 placebo patients (p &lt;0 0001) Transient dysgeusia and sneezing were the most common adverse events in the vernakalant patients One vernakalant patient who had severe aortic stenosis experienced hypotension and ventricular fibrillation and died In conclusion, vernakalant demonstrated a rapid and high rate of conversion for short-duration AF and was well tolerated (C) 2010 Elsevier Inc All rights reserved (Am J Cardiol 2010,106 1277-1283)},
  author       = {Pratt, Craig M. and Roy, Denis and Torp-Pedersen, Christian and Wyse, D. George and Toft, Egon and Juul-Möller, Steen and Retyk, Enrique and Drenning, David Humphrey},
  issn         = {1879-1913},
  language     = {eng},
  number       = {9},
  pages        = {1277--1283},
  publisher    = {Excerpta Medica},
  series       = {American Journal of Cardiology},
  title        = {Usefulness of Vernakalant Hydrochloride Injection for Rapid Conversion of Atrial Fibrillation},
  url          = {http://dx.doi.org/10.1016/j.amjcard.2010.06.054},
  volume       = {106},
  year         = {2010},
}