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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

ents with AF/atrial flutter given vernakalant (45 percent) demonstrated conversion to SR within 90 minutes compared to patients given placebo (15 percent), p=.0002. In the subset of patients with AF at baseline, conversion was observed in 47 percent treated with vernakalant compared with 14 percent given placebo, p=.0001. Median time to conversion among vernakalant responders was 12 minutes and SR was maintained for patients with AF/atrial flutter for 24 hours in 60 percent and for seven days in 57 percent. Seventy-five percent of vernakalant responders required only one dose of drug. Vernakalant is not effective in atrial flutter.

The most common adverse events (AEs) in patients given vernakalant were AF (20 percent), nausea (6 percent), constipation (5 percent), weight increase (5 percent) and dyspnea (5 percent). Rates of serious AEs over the entire study were similar with placebo (11 percent) and vernakalant (9 percent). In the first 24 hours, only 2 patients (2 percent) given vernakalant experienced a serious AE (complete AV block and hypotension). There were no deaths or cases of torsade de pointes.

About 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, heart palpitations, weakness, shortness of breath and angina (chest pain)(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).

About Astellas

Astellas Pharma US, Inc
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SOURCE Astellas Pharma US, Inc.
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