Dronedarone: An amiodarone analog for the treatment of atrial fibrillation and atrial flutter

OBJECTIVE: To review the pharmacology, pharmacokinetics, clinical efficacy, and safety profile of dronedarone for the treatment of atrial fibrillation. DATA SOURCES: A literature search was conducted using the search terms dronedarone, SR 33589, atrial fibrillation, and antiarrhythmic medication in MEDLINE (1966-February 2007), International Pharmaceutical Abstracts (1970-February 2007), and EMBASE (1990-February 2007). References from the identified trials and selected review articles were evaluated. Additional information, including abstracts and posters, was obtained from Sanofi-Aventis. STUDY SELECTION AND DATA EXTRACTION: Published studies and meeting abstracts evaluating the effects of dronedarone in humans and animals were reviewed. DATA SYNTHESIS: Dronedarone is a novel antiarrhythmic medication to treat atrial fibrillation. Dronedarone has a multifaceted mechanism of action similar to that of amiodarone. Dronedarone works by blocking potassium, sodium, and calcium channels and exhibits antiadrenergic properties. The drug has been evaluated at doses of 400, 600, and 800 mg twice daily. It prolonged the time to atrial fibrillation recurrence to 60-158 days compared with 5-59 days with placebo and decreased heart rate during atrial fibrillation by 12-25 beats/min in clinical trials. Major adverse events include gastrointestinal side effects and risk of proarrhythmia. Dronedarone may increase the risk of mortality in patients with congestive heart failure. CONCLUSIONS: Dronedarone is a new antiarrhythmic agent for the treatment of atrial fibrillation. Further studies are needed to better define dronedarone's safety profile and place in therapy.