(Graphic: Business Wire)
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).
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.
- Real Money + Doug Kass + 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV