title: Drug safety evaluation of dronedarone in atrial fibrillation.
abstract: BACKGROUND
  Dronedarone was developed with the intent of replicating the antiarrhythmic effects of amiodarone, while minimizing its side effects.
  
  
  METHODS
  Side effects reported in eight randomized clinical trials are discussed, comparing dronedarone and placebo (DAFNE, EURIDIS, ADONIS, ERATO, ANDROMEDA, ATHENA, PALLAS, total number of patients treated with dronedarone 5347), or dronedarone and amiodarone (DIONYSOS, total number of patients treated with dronedarone 249).
  
  
  CONCLUSIONS
  The results of the first trials, including ATHENA, set high expectations by suggesting that dronedarone may decrease the risk of hospitalization (and even cardiovascular mortality) among patients with paroxysmal and persistent atrial fibrillation (AF), and that it could be regarded as an easy-to-use drug that could be prescribed by general practitioners; unfortunately, dronedarone has not met these expectations. Dronedarone may increase mortality and heart failure hospitalization in patients with advanced NYHA class and in patients with permanent AF, preventing its use in these settings. In addition to gastrointestinal side effects that may lead to discontinuation in 5 - 10% of patients, dronedarone may induce very rare but severe liver and lung toxicity. Despite these limitations and its relatively limited antiarrhythmic potency, dronedarone may still be a useful drug for well-selected patients.
authors.affiliation: Department of Cardiology, Fondazione IRCCS Policlinico San Matteo, Viale Golgi 19, 27100, Pavia (PV), Italy. g.deferrari@smatteo.pv.it
authors.forename: Gaetano M
authors.initials: GM
authors.lastname: De Ferrari
authors.forename: Veronica
authors.initials: V
authors.lastname: Dusi
mesh_terms: D000638:Amiodarone / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D000818:Animals; D000889:Anti-Arrhythmia Agents / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use; D001281:Atrial Fibrillation / Q000188:drug therapy* / Q000503:physiopathology; D000077764:Dronedarone; D004348:Drug Labeling; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000889:Anti-Arrhythmia Agents; D000077764:Dronedarone; D000638:Amiodarone