PMID- 20569725
OWN - NLM
STAT- MEDLINE
DCOM- 20100715
LR  - 20121115
IS  - 1097-6744 (Electronic)
IS  - 0002-8703 (Linking)
VI  - 159
IP  - 6
DP  - 2010 Jun
TI  - A multicenter, open-label study of vernakalant for the conversion of atrial 
      fibrillation to sinus rhythm.
PG  - 1095-101
LID - 10.1016/j.ahj.2010.02.035 [doi]
AB  - BACKGROUND: The efficacy and safety of vernakalant, a relatively atrial-selective 
      antiarrhythmic agent, in converting atrial fibrillation (AF) to sinus rhythm (SR) 
      were evaluated in this multicenter, open-label study of patients with AF lasting 
      >3 hours and < or =45 days (RCT no. NCT00281554). METHODS: Adult patients with AF 
      and an indication for conversion to SR received a 10-minute intravenous infusion 
      of vernakalant (3 mg/kg). If after a 15-minute observation period AF was present, 
      a second 10-minute infusion of intravenous vernakalant (2 mg/kg) was given. The 
      primary efficacy end point was the proportion of patients with recent-onset AF 
      (AF lasting >3 hours to < or =7 days) who converted to SR within 90 minutes of 
      the start of the first infusion. Safety evaluations included vital signs, 
      telemetry and Holter monitoring, 12-lead electrocardiography, clinical laboratory 
      tests, physical examinations, and adverse events (AEs). RESULTS: A total of 236 
      hemodynamically stable patients with AF received intravenous vernakalant. Among 
      them, 167 (71%) had recent-onset AF and were eligible for the primary efficacy 
      end point. Vernakalant rapidly converted recent-onset AF to SR in 50.9% of 
      patients, with a median time to conversion of 14 minutes among responders. The 
      most common AEs were dysgeusia, sneezing, and paresthesia. These occurred at the 
      time of vernakalant infusion, were transient, and resolved spontaneously. Ten 
      patients (4.2%) discontinued vernakalant treatment because of AEs, most commonly 
      (in 4 of 10) hypotension. There were no episodes of torsades de pointes, 
      ventricular fibrillation, or sustained ventricular tachycardia. CONCLUSIONS: 
      Vernakalant rapidly converted recent-onset AF to SR, was well tolerated, and may 
      be a valuable therapeutic alternative for reestablishing SR in patients with 
      recent-onset AF.
CI  - Copyright 2010 Mosby, Inc. All rights reserved.
FAU - Stiell, Ian G
AU  - Stiell IG
AD  - Department of Emergency Medicine, University of Ottawa, Ottawa, Canada. 
      istiell@ohri.ca
FAU - Roos, Johan S
AU  - Roos JS
FAU - Kavanagh, Katherine M
AU  - Kavanagh KM
FAU - Dickinson, Garth
AU  - Dickinson G
LA  - eng
SI  - ClinicalTrials.gov/NCT00281554
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - Am Heart J
JT  - American heart journal
JID - 0370465
RN  - 0 (Anisoles)
RN  - 0 (Pyrrolidines)
RN  - 9G468C8B13 (vernakalant)
SB  - IM
MH  - Aged
MH  - Anisoles/administration & dosage/*therapeutic use
MH  - Atrial Fibrillation/*drug therapy/physiopathology
MH  - Dose-Response Relationship, Drug
MH  - Electrocardiography/*drug effects
MH  - Female
MH  - Follow-Up Studies
MH  - Heart Rate/drug effects/*physiology
MH  - Humans
MH  - Infusions, Intravenous
MH  - Male
MH  - Middle Aged
MH  - Pyrrolidines/administration & dosage/*therapeutic use
MH  - Sinoatrial Node/drug effects/*physiopathology
MH  - Treatment Outcome
EDAT- 2010/06/24 06:00
MHDA- 2010/07/16 06:00
CRDT- 2010/06/24 06:00
PHST- 2009/10/08 00:00 [received]
PHST- 2010/02/24 00:00 [accepted]
PHST- 2010/06/24 06:00 [entrez]
PHST- 2010/06/24 06:00 [pubmed]
PHST- 2010/07/16 06:00 [medline]
AID - S0002-8703(10)00230-9 [pii]
AID - 10.1016/j.ahj.2010.02.035 [doi]
PST - ppublish
SO  - Am Heart J. 2010 Jun;159(6):1095-101. doi: 10.1016/j.ahj.2010.02.035.