title: Dronedarone for the treatment of atrial fibrillation and atrial flutter: approval and efficacy.
abstract: Dronedarone, a new Class III antiarrhythmic agent, has now been approved by the US Food and Drug Administration for use in patients with atrial fibrillation or atrial flutter. Approval came in March 2009 due to the positive results of the ATHENA trial showing significant reductions in all-cause mortality and cardiovascular hospitalization with dronedarone use. A post hoc analysis of the ATHENA data also suggested a decrease in stroke risk with this agent. However, due to safety concerns in the heart failure population in the earlier ANDROMEDA trial, dronedarone is not recommended for patients with an ejection fraction <35% and recent decompensated heart failure. Dronedarone is an amiodarone analog with multichannel blocking electrophysiologic properties similar to those of amiodarone, but several structural differences. Dronedarone's lack of the iodine moiety reduces its potential for thyroid and pulmonary toxicity. Preliminary data from the DIONYSOS trial, and an indirect meta-analysis comparing amiodarone with dronedarone, showed amiodarone to be more effective in maintaining sinus rhythm, while dronedarone was associated with fewer adverse effects resulting in early termination of the drug. Dronedarone is the first antiarrhythmic drug for the treatment of atrial fibrillation and atrial flutter shown to reduce cardiovascular hospitalizations. In patients with structural heart disease who have an ejection fraction >35% and no recent decompensated heart failure, dronedarone should be considered earlier than amiodarone in the treatment algorithm.
authors: Penn State Heart and Vascular Institute, Penn State Milton S Hershey Medical Center, Hershey, Pennsylvania 17033-0850, USA. dwolbrette@hmc.psu.edu
authors: Deborah
authors: D
authors: Wolbrette
authors: Mario
authors: M
authors: Gonzalez
authors: Soraya
authors: S
authors: Samii
authors: Javier
authors: J
authors: Banchs
authors: Erica
authors: E
authors: Penny-Peterson
authors: Gerald
authors: G
authors: Naccarelli
mesh_terms: D000638:Amiodarone / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000889:Anti-Arrhythmia Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000188:drug therapy* / Q000503:physiopathology; D001282:Atrial Flutter / Q000188:drug therapy* / Q000503:physiopathology; D000075202:Contraindications; D000077764:Dronedarone; D017277:Drug Approval; D006801:Humans; D011358:Product Surveillance, Postmarketing; D013318:Stroke Volume / Q000187:drug effects / Q000502:physiology
chemical_list: D000889:Anti-Arrhythmia Agents; D000077764:Dronedarone; D000638:Amiodarone