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.
Credits: James A. Reiffel M.D.