The guidelines evaluated in this study were those issued by the American Heart Association, the European Society of Cardiology and the Canadian Cardiovascular Society.
In technology appraisal guidance (TAG) 197, NICE recommends dronedarone as an option for the maintenance of sinus rhythm after successful cardioversion in people with paroxysmal or persistent atrial fibrillation, who meet a number of criteria as set out in section 1.1 of the guidance.
Following safety concerns, the European Medicines Agency amended the marketing authorisation for dronedarone to include a more restricted therapeutic indication than that originally appraised in NICE TAG 197. The guidance was therefore amended and reissued in December 2012 to reflect the changes in the UK marketing authorisation.