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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

nfused over 10 minutes. After 15 minutes, a second 10 minute infusion of vernakalant 2 mg/kg or placebo was given if AF persisted or atrial flutter was present. The primary efficacy measure was the percentage of patients demonstrating conversion to SR for at least one minute within 90 minutes of dosing. Patients demonstrating conversion within 90 minutes were categorized as responders. Other efficacy measures included median time to conversion and the percentage of patients still in sinus rhythm at hour 24 and day 7.

In this subanalysis, a significantly higher percentage of patients with acute AF given vernakalant (61.8 percent) demonstrated conversion to SR within 90 minutes compared to patients given placebo (5.1 percent), P<.0001. Conversion from AF to SR with vernakalant was rapid and sustained. Among vernakalant responders, median conversion time was 11 minutes, and SR was maintained for 24 h in 97 percent and for 7 days in 93 percent. Seventy-eight percent of vernakalant responders required only one dose of the drug.

The most common adverse events (AEs) in patients given vernakalant were taste disturbance (32.4 percent), sneezing (16.7 percent), nausea (15.7 percent) and dizziness (11.8 percent). The incidence of serious AEs was similar in the vernakalant and placebo treatment groups for both the entire period and the first 24 hours (11.8 percent vs. 15.3 percent and 3.9 percent vs. 1.7 percent, respectively).

About Atrial Fibrillation

Atrial fibrillation (AF) is an interruption of the normal sinus rhythm (arrhythmia) of the heart in which the atria, the two uppermost chambers of the heart, beat irregularly and at an extremely rapid rate.(1) During AF, rapid and uncoordinated electrical discharges are generated by the heart's natural pacemaker (sinoatrial node) and other parts of the atria. This causes ineffective contractions of the atria and reduces the ability of the heart to pump blood through the body. Symptoms include dizziness, h
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SOURCE Astellas Pharma US, Inc.
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