Efficacy and Safety of Vernakalant for Cardioversion of Recent-onset Atrial Fibrillation in the Asia-Pacific Region: A Phase 3 Randomized Controlled Trial.
Atrial fibrillation (AF) is a common clinically significant cardiac arrhythmia. This phase 3 randomized, double-blind, placebo-controlled trial assessed the efficacy and safety of vernakalant hydrochloride for the pharmacological conversion of AF to sinus rhythm in patients with recent-onset (>3 hours to ≤7 days) symptomatic AF from the Asia-Pacific region. Patients received an infusion of vernakalant (3 mg/kg) or placebo for 10 minutes. If AF had not been terminated 15 minutes later, a second infusion of vernakalant (2 mg/kg) or placebo for 15 minutes was administered. The primary efficacy end point was conversion of AF to sinus rhythm for >1 minute within 90 minutes. The study was terminated early for administrative reasons; 123 patients from Korea, Taiwan, and India were randomized to receive vernakalant (n = 55) or placebo (n = 56). A greater proportion of patients who received vernakalant (52.7%) than placebo (12.5%) met the primary end point (P < 0.001), and cardioversion was faster in the vernakalant group than in the placebo group (P < 0.001). Vernakalant was generally well tolerated; the incidence of treatment-emergent adverse events was similar between the groups. We conclude that vernakalant is efficacious in the rapid cardioversion of recent-onset AF in patients from the Asia-Pacific region.
Clinical Department Cardiome Pharma Corp, Vancouver, British Columbia, Canada.
Gregory N
GN
Beatch
Kiran
K
Bhirangi
Steen
S
Juul-Moller
Jörg
J
Rustige
D000368:Aged; D000369:Aged, 80 and over; D000840:Anisoles / Q000627:therapeutic use*; D000889:Anti-Arrhythmia Agents / Q000627:therapeutic use*; D001208:Asia / Q000453:epidemiology; D001281:Atrial Fibrillation / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology; D004311:Double-Blind Method; D004554:Electric Countershock / Q000379:methods*; D005260:Female; D006801:Humans; D007194:India / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D011759:Pyrrolidines / Q000627:therapeutic use*; D056910:Republic of Korea / Q000453:epidemiology; D013624:Taiwan / Q000453:epidemiology; D016896:Treatment Outcome
D000840:Anisoles; D000889:Anti-Arrhythmia Agents; D011759:Pyrrolidines; C524581:vernakalant