Drug safety evaluation of dronedarone in atrial fibrillation.

Article Details

Citation

De Ferrari GM, Dusi V

Drug safety evaluation of dronedarone in atrial fibrillation.

Expert Opin Drug Saf. 2012 Nov;11(6):1023-45. doi: 10.1517/14740338.2012.722994. Epub 2012 Sep 13.

PubMed ID
22971242 [ View in PubMed
]
Abstract

INTRODUCTION: Dronedarone was developed with the intent of replicating the antiarrhythmic effects of amiodarone, while minimizing its side effects. AREAS COVERED: 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). EXPERT OPINION: 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.

DrugBank Data that Cites this Article

Drug Enzymes
DrugEnzymeKindOrganismPharmacological ActionActions
DronedaroneCytochrome P450 2D6ProteinHumans
Unknown
Substrate
Inhibitor
Details
DronedaroneCytochrome P450 3A4ProteinHumans
Unknown
Substrate
Inhibitor
Details
Drug Transporters
DrugTransporterKindOrganismPharmacological ActionActions
DronedaroneP-glycoprotein 1ProteinHumans
No
Inhibitor
Details