dronedarone

Last reviewed 01/2018

Dronedarone is an antiarrhythmic drug belonging to the benzofuran class of antiarrhythmic compounds. Dronedarone has a marketing authorisation for the treatment of adult clinically stable patients with a history of, or current, non permanent atrial fibrillation to prevent recurrence of atrial fibrillation or to lower ventricular rate

• according to the SPC, the most frequently observed adverse events in people receiving dronedarone are elevated blood creatinine levels and prolongation of the QT interval. Other common adverse events include bradycardia, gastrointestinal events such as diarrhoea and vomiting, rashes, pruritus, fatigue and asthenia. For full details of side effects and contraindications, see the SPC
• NICE have stated that (1):
  • dronedarone is recommended as an option for the treatment of non-permanent atrial fibrillation only in people:
    • whose atrial fibrillation is not controlled by first-line therapy (usually including beta-blockers), that is, as a second-line treatment option, and
    • who have at least one of the following cardiovascular risk factors:
      • hypertension requiring drugs of at least two different classes
      • diabetes mellitus
      • previous transient ischaemic attack, stroke or systemic embolism
      • left atrial diameter of 50 mm or greater left ventricular ejection fraction less than 40% (noting that the summary of product characteristics [SPC] does not recommend dronedarone for people with left ventricular ejection fraction less than 35% because of limited experience of using it in this group) or
      • age 70 years or older, and
    • who do not have unstable New York Heart Association (NYHA) class III or IV heart failure

Reference:

• 1) NICE (August 2010). Dronedarone for the treatment of non permanent atrial fibrillation