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Analysis Shows Vernakalant Hydrochloride Injection Increases Conversion to Normal Heart Rhythm in Acute Atrial Fibrillation Patients Treated Within 48 Hours of Onset
Date:10/10/2007

DEERFIELD, Ill., Oct. 10 /PRNewswire/ -- Astellas Pharma US, Inc. today announced that the investigational agent vernakalant hydrochloride increased conversion to normal heart rhythm (sinus rhythm, or SR) in patients with atrial fibrillation (AF) treated within 48 hours of the onset of symptoms. AF is a serious condition characterized by an irregular heart rhythm and a high heart rate, and frequently leads to emergency department visits. The study results were presented during the annual meeting of the American College of Emergency Physicians in Seattle.

"Most patients who develop symptoms of AF come to the emergency department within the first 48 hours," said Ian Stiell, MD of the University of Ottawa, Canada. "This analysis shows that vernakalant may provide emergency medicine physicians with an effective treatment option for managing acute AF."

AF is the most common cardiac arrhythmia, which leads to approximately 15 percent of all strokes.(1) The number of AF patients is expected to triple over the next 50 years due to the increased prevalence of risk factors including hypertension, obesity, diastolic dysfunction, inflammation, diabetes and sleep apnea.(2)

Study Results

The study, referred to as the atrial arrhythmia conversion trial or ACT I, was a prospective, randomized, double-blind, placebo-controlled trial of patients with symptomatic AF or nontypical atrial flutter, conducted at 44 sites in Canada, the United States, Denmark, and Sweden. This study assessed the efficacy and safety of vernakalant in converting AF lasting 3 h to <45 d to SR. The current findings are based on a sub-analysis in patients with acute AF lasting 3 to 48 h.

A total of 161 of 356 patients (45 percent) in ACT I presented within 48 hours of AF onset. Of these, 102 patients (63 percent) received vernakalant and 59 patients (37 percent) received placebo.

Patients with AF were randomly assigned in a 2:1 ratio to vernakalant 3 mg/kg or placebo i
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SOURCE Astellas Pharma US, Inc.
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