Dronedarone For Atrial Fibrillation: Unbridled Enthusiasm Or Just Another Small Step Forward?

The Federal Food and Drug Administration (FDA) approved the marketing of dronedarone (Multaq, sanofi-aventis) for use in patients with atrial fibrillation (AF) or flutter (AFL) [with a requirement for a recent episode] that is paroxysmal or persistent the latter having been converted to sinus rhythm or with conversion planned who have, in addition to AF, certain high-risk markers for adverse outcomes that were derived from the enrollment criteria for the landmark ATHENA trial (1). These markers include one or more of: age >70 yrs, hypertension, diabetes mellitus, prior cerebrovascular accident, left atrial size of 50 mm or larger, or LVEF < 40%. Contraindications include class IV heart failure or symptomatic heart failure with a recent decompensation; second or third degree AV block without a functioning pacemaker; bradycardia < 50 bpm; concomitant use of a strong CYP3A inhibitor or a QT prolonging agent that may induce torsades de pointes; QTc Bazett interval of 500 ms or longer; or severe hepatic impairment.