Dronedarone--a new alternative for management of atrial fibrillation

The maintenance of sinus rhythm in patients with Atrial Fibrillation (AF) is difficult and is complicated by adverse drug reactions of antiarrhythmic drugs or the adverse events related with ablation procedures. Amiodarone can be used for preventing AF recurrence; but it has the risk of serious toxicities secondary to its iodinated nature. Dronedarone, an amiodarone analogue without iodine, has been shown to decrease the frequency of AF recurrence and to provide heart rate control during AF recurrence. Dronedarone is a benzofuran derivative; specifically N-[2-Butyl-3-[4-[3-(dibutylamino)propoxy]benzoyl]-5-benzofuranyl]methane-sulfonamide and its production process has been patented. In the ATHENA trial, dronedarone therapy was associated with a significant reduction in the combined primary endpoint of death from any cause or hospitalization due to cardiovascular causes. However, dronedarone has been noted to increase cardiovascular mortality among patients with advanced congestive heart failure (NYHA class III and IV). On March 18, 2009, the Cardiovascular and Renal Drugs Advisory Committee of the Food and Drug Administration (FDA) approved dronedarone for an indication of atrial fibrillation suppression, with a warning against its use in patients with NYHA class III and IV heart failure or recently decompensated heart failure.