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12:00 AM
 | 
Jan 28, 2008
 |  BioCentury  |  Regulation

The Kynapid dilemma

The Jan. 19 PDUFA date for Kynapid vernakalant IV from Cardiome Pharma Corp. and Astellas Pharma Inc. came and went without a decision or an extension from FDA. While the agency would not provide any clues, cardiologists are not surprised if the reviewers are having trouble sorting out the complicated issues surrounding the management of atrial fibrillation. The drug does not approach the success rates produced by electrical shock. But it is clear that many practicing physicians would welcome a new drug that converts AF patients to a normal rhythm if it is safer and more efficacious than those currently available.

A healthy heart beats about 60-80 times per minute at rest. During AF, the atria contract irregularly and at rates of more than 300 beats per minute. The irregular rhythm is not passed on to the ventricle, but the heart rate does increase to an unhealthy 110-180 beats per minute.

According to the latest guidelines for managing patients with AF published in Circulationby the American College of Cardiology Foundation(ACC), the American Heart Association Inc.(AHA) and the European Society of Cardiology (ESC) in 2006, the initial management decision is whether to treat the irregular rhythm or the too-fast rate (see Online Links, A21).

Both strategies typically include antithrombotics to prevent stroke, which is a common result of AF because clots can form in the atria and then break loose and lodge in the brain.

The preference of many physicians is to convert the rhythm to normal (sinus) rhythm, because that also fixes the correlated high rate.

But in the past few years, emerging clinical evidence suggests treating rate and leaving a patient in AF is as efficacious as treating rhythm. Indeed, the NIH-funded Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) study found no difference in mortality or stroke rate between patients assigned to one strategy or the other.

Furthermore, rate-treating drugs are much safer than current antiarrhythmics, which may fix the atrial arrhythmia but can cause ventricle arrhythmias. Indeed the AFFIRM study also showed that long-term treatment of AF with antiarrhythmic drugs is linked with increased overall mortality compared with...

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