Merck and Cardiome Announce Phase III Study Results Comparing Investigational Compound BRINAVESSTM (Vernakalant) Intravenous to Amiodarone Injection in Conversion of Atrial Fibrillation to Normal Sinus Rhythm
Data Presented During Late-Breaking Clinical Trials Session at the Heart Rhythm Society (HRS) Annual Meeting
Friday May 14, 2010, 10:00 am EDT
DENVER--(BUSINESS WIRE)--In a new Phase III study, BRINAVESSTM (vernakalant) intravenous, an investigational compound being developed in the European Union by Merck (known as MSD outside the USA and Canada) (NYSE: MRK - News) 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 study
This 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).
The primary endpoint of the AVRO study was the proportion of patients with conversion to SR within 90 minutes. The secondary endpoints were (1) time to conversion of SR within 90 minutes; (2) proportion of patients without AF symptoms at 90 minutes; and (3) change in quality of life, assessed at hour two using a 100-point visual analogue scale (VAS). Safety was assessed through the monitoring of adverse events, vital signs, continuous telemetry monitoring, 12-lead Holter monitoring, 12-lead ECGs, and laboratory tests.
Data on the secondary endpoint showed that 53.4 percent of patients (n=116) in the BRINAVESS group had no AF symptoms at 90 minutes versus 32.8 percent in the amiodarone (n=116) group (p=0.0012). There was also a significant improvement in quality of life (p=.0006) in the BRINAVESS group, n=116, (10.9 point increase) compared to the amiodarone group, n=116, (5.6 point increase). Quality of life was assessed at screening and two hours after the start of infusion using the EQ-5D Health Questionnaire. The EQ-5D is a standardized instrument, self-completed by respondents, used to measure health outcomes.
The most common adverse events within 24 hours of infusion (> 2 events in either group) were dysgeusia (bad taste in mouth) which occurred in 6.9 percent of patients on BRINAVESS (n=116) versus zero on amiodarone (n=116); cough (3.4 percent on BRINAVESS vs. 1.7 percent on amiodarone); sneezing (3.4 percent on BRINAVESS vs. zero on amiodarone); atrial fibrillation (3.4 percent on BRINAVESS vs. zero on amiodarone); nausea (2.6 percent on BRINAVESS vs. 1.7 percent on amiodarone); dizziness (2.6 percent in both the BRINAVESS and amiodarone groups); and hypertension (2.6 percent on BRINAVESS vs. zero on amiodarone).
About BRINAVESS
BRINAVESS is an investigational compound being developed in two formulations, oral and IV, for the treatment of atrial fibrillation. BRINAVESS in the intravenous (IV) formulation is currently under review in the European Union (EU). BRINAVESS in the oral formulation is being developed for daily maintenance of normal heart rhythm in patients with atrial fibrillation to prevent reoccurrence of atrial fibrillation and is currently in Phase II development.
In April 2009, Cardiome and Merck announced a collaboration and license agreement for the development and commercialization of vernakalant. The agreement provides a Merck affiliate, Merck Sharp & Dohme Corp., with exclusive global rights to vernakalant oral, and provides another Merck affiliate, Merck Sharp & Dohme (Switzerland) GmbH, with exclusive rights outside of the United States, Canada and Mexico to vernakalant IV
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