Translating regulatory advice into practice: Use of dronedarone and older anti-arrhythmics in AF management

There is a lack of clarity around the current use of antiarrhythmic drugs (AADs), highlighted by the recent changes to the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) recommendations for dronedarone use, which were in response to the early termination of the Permanent Atrial Fibrillation Outcome Study Using Dronedarone On Top Of Standard Therapy (PALLAS) trial due to increased mortality in the dronedarone arm. A UK- and Ireland-based multi-disciplinary expert group was convened by Sanofi*, the manufacturers of dronedarone, to address the need for guidance in the practical implementation of guidelines for AADs. This position statement provides the group's evidence-based recommendations for the practical use of AADs and dronedarone in particular. Since AADs are not always used in line with recommendations, the guidelines for the use of AADs, and the evidence base supporting them, are reviewed. The current recommendations for dronedarone use are set within this context. On consideration of the evidence, the recommendation for dronedarone use is for the maintenance of sinus rhythm in non-permanent atrial fibrillation (AF) patients, without severe heart failure, or amiodarone-related liver or lung toxicities, and with appropriate anticoagulation. Given that there have been no new AADs available in 25 years to address the need for an effective anti-arrhythmic with reduced side effects, dronedarone has a place in the treatment of non-permanent AF to provide options for clinicians and patients.