Usefulness of vernakalant hydrochloride injection for rapid conversion of atrial fibrillation.

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 1:1 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.

• Authors: Craig M Pratt, Denis Roy, Christian Torp-Pedersen, D George Wyse, Egon Toft, Steen Juul-Moller, Enrique Retyk, David Humphrey Drenning, Atrial Arrhythmia Conversion Trial (ACT-III) Investigators
• Journal: The American journal of cardiology (Am J Cardiol) Vol. 106 Issue 9 Pg. 1277-83 (Nov 01 2010) ISSN: 1879-1913 [Electronic] United States
• PMID: 21029824 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2010 Elsevier Inc. All rights reserved.

Chemical References

• Anisoles
• Anti-Arrhythmia Agents
• Placebos
• Pyrrolidines
• vernakalant

Topics

• Anisoles (administration & dosage, adverse effects, therapeutic use)
• Anti-Arrhythmia Agents (administration & dosage, adverse effects, therapeutic use)
• Atrial Fibrillation (drug therapy, physiopathology)
• Atrial Flutter (drug therapy, physiopathology)
• Chi-Square Distribution
• Double-Blind Method
• Female
• Humans
• Infusions, Intravenous
• Male
• Middle Aged
• Placebos
• Prospective Studies
• Pyrrolidines (administration & dosage, adverse effects, therapeutic use)
• Treatment Outcome