2 The technology

2 The technology

Please note that the recommendations in section 1 for dronedarone have been amended to reflect changes made to the UK marketing authorisation. The information in this section is based on dronedarone's marketing authorisation at the time the appraisal was initially considered in 2010. Please refer to the revised summary of product characteristics for dronedarone for further information.

2.1 Dronedarone (Multaq, Sanofi-Aventis) 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.

2.2 The SPC states that because of the unexplained results of the ANDROMEDA study, the use of dronedarone in unstable patients with NYHA class III and IV heart failure is contraindicated. There is also a recommendation in the SPC (under 'special warnings and precautions for use') which states that because of limited experience in stable patients with recent (1 to 3 months) NYHA class III heart failure or with left ventricular ejection fraction less than 35%, the use of dronedarone is not recommended in these patients.

2.3 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.

2.4 The recommended dosage of dronedarone is 400 mg twice daily. Dronedarone is available in 400 mg tablets and comes in packs of 20 tablets or 60 tablets. The cost of a pack of 20 tablets is £22.50 and the cost of a pack of 60 tablets is £67.50 (excluding VAT; 'Monthly index of medical specialities' [MIMS]). The cost per patient per day based on the recommended dosage is £2.25 (excluding VAT). Costs may vary in different settings because of negotiated procurement discounts.

  • National Institute for Health and Care Excellence (NICE)