Dronedarone is a new Class III antiarrhythmic drug, both structurally and electrophysiologically related to amiodarone. It is approved for treatment of clinically stable patients with non-permanent atrial fibrillation (AF), with an intention to prevent relapse of AF or slowing ventricular rate (frequency regulating effect).
A reduced risk of recurrence of atrial fibrillation after both spontaneous and DC-conversion has been documented, when comparing dronedarone with placebo. Furthermore, also in comparison with placebo, a reduced risk of hospitalisation caused by a cardiovascular event after conversion was seen over a period of about 20 months. Additionally, a slightly reduced risk of cardiovascular death was seen. A better regulation of frequency has been shown, both at rest and during exertion, when using dronedarone compared with placebo.
Two studies, one comparing amiodarone and dronedarone directly, and one indirectly, have shown a better effect of amiodarone regarding the risk of recurrence of atrial fibrillation. On the other hand, the studies showed a lower occurrence of side effects when using dronedarone. Dronedarone does not seem to carry the same risk for lung-, thyreoid- and neurological diseases as amiodarone.
Because of a slight increased risk of proarythmic effect, certain cardiological contraindications, and a risk of interactions, restrictions and guidance for safe and effective use have been implemented as part of a risk management programme. Learn more here.
Treatment is recommended to be initiated by a cardiologist, and should preferably be restricted to patients in whom other prophylactic antiarrhythmic or frequency regulating treatments have not been effective or tolerated.
The price is significantly higher than for amiodarone.