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Circulation Publishes Data Showing KYNAPID(TM) (Vernakalant Hydrochloride) Injection Rapidly Converted Short-Duration Atrial Fibrillation to Sinus Rhythm
Date:3/25/2008

conversion of AF. Results of the study showed KYNAPID demonstrated rapid conversion of short-duration AF and was well tolerated.

The efficacy and safety evaluable populations included 220 patients in the short-duration AF group and 116 patients in the long-duration AF group. Patients with AF were randomly assigned in a 2:1 ratio to KYNAPID 3 mg/kg or placebo infused over 10 minutes. After 15 minutes, a second 10 minute infusion of KYNAPID 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 in the short-duration AF group.

The most common adverse events (AEs) reported within the first 24 hours in patients given KYNAPID were taste disturbance (29.9%), sneezing (16.3%), skin sensation (10.9%), nausea (9%), and hypotension (6.3%). These events were generally transient. Four serious AEs possibly or probably related to KYNAPID occurred in three patients and included hypotension (2 events), complete atrioventricular block and cardiogenic shock.

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. 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). AF is the most common cardiac arrhythmia. AF patients are three to five times more likely to develop stroke, and 15% of stroke cases are attributed to AF. The number of AF patients is expected to triple over the next 50 years due to the increased prevalence of risk fac
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SOURCE Astellas Pharma US, Inc.
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