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Study Shows Vernakalant Hydrochloride is Effective in Conversion to Normal Heart Rhythm in Atrial Fibrillation Patients Following Cardiac Surgery
Date:11/7/2007

ORLANDO, Fla., Nov. 7 /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) following coronary artery bypass graft (CABG) or valvular surgeries. AF is a potentially serious condition characterized by an irregular heart rhythm and a high heart rate. The study results were presented at the annual meeting of the American Heart Association.

"Postoperative AF is common after cardiac surgery, occurring in up to 40% of patients and has a significant effect on both the intensive care unit and overall hospital length of stay," said Peter Kowey, MD, William Wikoff Smith Chair in Cardiovascular Research at the Main Line Health System. "This study shows that vernakalant may be an effective treatment option for converting AF to SR following CABG or valvular surgeries."

Study Results

The Atrial arrhythmia Conversion Trial or ACT II was a randomized, double-bind, placebo-controlled, parallel-group, multinational, multicenter study evaluating the efficacy and safety of vernakalant among patients who experienced AF or atrial flutter within 24 hours to 7 days after cardiac surgery.

Patients received vernakalant 3 mg/kg (n=107) or placebo (n=54) infused over 10 minutes. After 15 minutes, a second 10 minute infusion of vernakalant 2 mg/kg or placebo was given if AF or atrial flutter was present. The primary efficacy measure was the percentage of patients with treatment-induced conversion of AF/atrial flutter to SR for at least one minute within 90 minutes.

Patients demonstrating conversion within 90 minutes were categorized as responders. Other efficacy measures included time to conversion of all responders and percentage of AF patients demonstrating conversion to SR within 90 minutes for . one minute.

Following CABG or valvular surgery, a significantly higher percentage of pati
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SOURCE Astellas Pharma US, Inc.
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