1 Guidance

1 Guidance

This guidance has been amended and re-issued in December 2012 to reflect changes to dronedarone's UK marketing authorisation. Please see the European Medicines Agency (EMA) website for details of the decision and the revised marketing authorisation. The therapeutic indication for dronedarone is now more restricted than that originally appraised in NICE technology appraisal guidance 197. For more information, see the summary of product characteristics for dronedarone.

1.1 Dronedarone is recommended as an option for the maintenance of sinus rhythm after successful cardioversion in people with paroxysmal or persistent atrial fibrillation:

  • whose atrial fibrillation is not controlled by first-line therapy (usually including beta-blockers), that is, as a second-line treatment option and after alternative options have been considered and

  • who have at least 1 of the following cardiovascular risk factors:

    • hypertension requiring drugs of at least 2 different classes

    • diabetes mellitus

    • previous transient ischaemic attack, stroke or systemic embolism

    • left atrial diameter of 50¬†mm or greater or

    • age 70 years or older and

  • who do not have left ventricular systolic dysfunction and

  • who do not have a history of, or current, heart failure.

1.2 People who do not meet the criteria in section 1.1 who are currently receiving dronedarone should have the option to continue treatment until they and their clinicians consider it appropriate to stop.

  • National Institute for Health and Care Excellence (NICE)