title: A randomized active-controlled study comparing the efficacy and safety of vernakalant to amiodarone in recent-onset atrial fibrillation.
abstract: OBJECTIVE
  This randomized double-blind study compared the efficacy and safety of intravenous vernakalant and amiodarone for the acute conversion of recent-onset atrial fibrillation (AF).
  
  
  BACKGROUND
  Intravenous vernakalant has effectively converted recent-onset AF and was well tolerated in placebo-controlled studies.
  
  
  METHODS
  A total of 254 adult patients with AF (3 to 48 h duration) eligible for cardioversion were enrolled in the study. Patients received either a 10-min infusion of vernakalant (3 mg/kg) followed by a 15-min observation period and a second 10-min infusion (2 mg/kg) if still in AF, plus a sham amiodarone infusion, or a 60-min infusion of amiodarone (5 mg/kg) followed by a maintenance infusion (50 mg) over an additional 60 min, plus a sham vernakalant infusion.
  
  
  RESULTS
  Conversion from AF to sinus rhythm within the first 90 min (primary end point) was achieved in 60 of 116 (51.7%) vernakalant patients compared with 6 of 116 (5.2%) amiodarone patients (p < 0.0001). Vernakalant resulted in rapid conversion (median time of 11 min in responders) and was associated with a higher rate of symptom relief compared with amiodarone (53.4% of vernakalant patients reported no AF symptoms at 90 min compared with 32.8% of amiodarone patients; p = 0.0012). Serious adverse events or events leading to discontinuation of study drug were uncommon. There were no cases of torsades de pointes, ventricular fibrillation, or polymorphic or sustained ventricular tachycardia.
  
  
  CONCLUSIONS
  Vernakalant demonstrated efficacy superior to amiodarone for acute conversion of recent-onset AF. Both vernakalant and amiodarone were safe and well tolerated in this study. (A Phase III Superiority Study of Vernakalant vs Amiodarone in Subjects With Recent Onset Atrial Fibrillation [AVRO]; NCT00668759).
authors.affiliation: St. George's University of London, United Kingdom. jcamm@sgul.ac.uk
authors.forename: A John
authors.initials: AJ
authors.lastname: Camm
authors.forename: Alessandro
authors.initials: A
authors.lastname: Capucci
authors.forename: Stefan H
authors.initials: SH
authors.lastname: Hohnloser
authors.forename: Christian
authors.initials: C
authors.lastname: Torp-Pedersen
authors.forename: Isabelle C
authors.initials: IC
authors.lastname: Van Gelder
authors.forename: Brian
authors.initials: B
authors.lastname: Mangal
authors.forename: Gregory
authors.initials: G
authors.lastname: Beatch
mesh_terms: D000208:Acute Disease; D000368:Aged; D000638:Amiodarone / Q000009:adverse effects / Q000627:therapeutic use*; D000840:Anisoles / Q000009:adverse effects / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000188:drug therapy* / Q000503:physiopathology; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011759:Pyrrolidines / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000840:Anisoles; D011759:Pyrrolidines; C524581:vernakalant; D000638:Amiodarone