46257
document
A multicenter , open-label study of vernakalant for the conversion of atrial fibrillation to sinus rhythm . 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 .
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Intervention_Pharmacological
10-minute intravenous infusion of vernakalant
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Intervention_Pharmacological
intravenous vernakalant
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Outcome_Other
efficacy and safety
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Outcome_Physical
atrial fibrillation ( AF )
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Outcome_Physical
sinus rhythm ( SR )
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Outcome_Physical
SR
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Outcome_Physical
AF
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Outcome_Physical
vital signs
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Outcome_Physical
telemetry and Holter monitoring
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Outcome_Physical
12-lead electrocardiography
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Outcome_Physical
clinical laboratory tests
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Outcome_Physical
physical examinations
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Outcome_Physical
adverse events ( AEs )
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Outcome_Physical
recent-onset AF
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Outcome_Physical
recent-onset AF to SR
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Outcome_Adverse-effects
dysgeusia
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Outcome_Physical
,
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Outcome_Adverse-effects
sneezing
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Outcome_Physical
, and
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Outcome_Adverse-effects
paresthesia
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Outcome_Physical
.
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Outcome_Adverse-effects
hypotension
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Outcome_Physical
.
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Outcome_Adverse-effects
torsades de pointes
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Outcome_Physical
,
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Outcome_Adverse-effects
ventricular fibrillation
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Outcome_Physical
, or
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Outcome_Adverse-effects
sustained ventricular tachycardia
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Outcome_Physical
.
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Participant_Condition
atrial fibrillation
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Participant_Age
Adult patients
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Participant_Sample-size
236
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Participant_Sample-size
167