May 17, 2010
Phase 3 study of Brinavess for the treatment of atrial fibrillation (AF)Merck and Cardiome Pharma announced results from their Phase 3 trial of Brinavess (vernakalant intravenous injection) for the treatment of atrial fibrillation (AF). This randomized, double blind, active controlled, double dummy, multi-center trial (also known as the AVRO trial) enrolled a total of 254 patients with symptomatic atrial fibrillation of 3 to 48 hours duration. Two hundred thirty two of these patients were randomized to receive either Brinavess, n=116 (3 mg/kg over 10 minutes; followed by 2 mg/kg over 10 minutes if needed after a 15-minute break) or amiodarone, n=116 (5 mg/kg over 60 minutes, followed by 50 mg over 60 minutes until patient converts). The primary endpoint of the AVRO study was the proportion of patients with conversion to SR within 90 minutes. In the study, 51.7 percent (n=116) of patients on Brinavess converted from atrial fibrillation to normal sinus rhythm within 90 minutes, versus 5.2 percent (n=116) in the amiodarone group (p<0.0001).
Vernakalant selectively blocks ion channels in the heart that are known to be active during episodes of atrial fibrillation.
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