In a new Phase III study, BRINAVESS TM (vernakalant) intravenous, an investigational compound being developed in the European Union by Merck (known as MSD outside the USA and Canada) (NYSE: MRK) and Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) to treat atrial fibrillation, showed that BRINAVESS was superior to amiodarone injection, in converting patients' heart rate from atrial fibrillation (AF) to sinus rhythm (SR) within 90 minutes of the start of administration. The results of the study were presented today during a late-breaking clinical trials session at Heart Rhythm 2010, the annual meeting of the Heart Rhythm Society.
In the study, called AVRO (Active-Controlled, Multi-Center Study of Vernakalant Injection versus Amiodarone in Subjects with Recent Onset Atrial Fibrillation), 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). The median time to conversion in patients who responded to BRINAVESS was 11 minutes.
"Atrial fibrillation is the most common abnormal heart rhythm and its prevalence has increased over the past 20 years. It is important to have therapies that convert patients back to a normal heart rhythm as quickly as possible," says John Camm, BSc, M.D., FRCP, professor of Clinical Cardiology at St George's, University of London and lead investigator of the AVRO study. "The efficacy and safety results of vernakalant in this study are encouraging."
About the AVRO studyThis phase III randomized, double blind, active controlled, double dummy, multi-center trial enrolled a total of 254 patients with symptomatic atrial fibrillation of 3 to 48 hours duration of which 232 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).