Dronedarone hydrochloride

Table of contents

• What is dronedarone hydrochloride?
• How does dronedarone hydrochloride work?
• Which conditions is dronedarone hydrochloride used or studied for?
• How is dronedarone hydrochloride given?
• What do the clinical trials show?
• What side effects are known?

What is dronedarone hydrochloride?

Dronedarone hydrochloride is a medicine that belongs to a group called antiarrhythmics. These medicines act on the electrical signals of the heart to help keep its rhythm steady. The substance is also known by the brand name Multaq and the development code SR33598B.^[2] It is an authorised medicine, and in the United Kingdom it is listed on NHS formularies as a restricted option for the treatment of non-permanent atrial fibrillation, where the aim is to maintain a normal sinus rhythm.^[3][4]

How does dronedarone hydrochloride work?

Dronedarone has antiarrhythmic properties that belong to all four Vaughan-Williams classes, which are categories used to describe how heart rhythm medicines work. The contribution of each of these activities to the overall clinical effect is not fully separated.^[2] In simple terms, it works on several channels and receptors in heart muscle cells to slow down abnormal electrical signals and help the heart return to or stay in a steady rhythm.

Which conditions is dronedarone hydrochloride used or studied for?

• Non-permanent atrial fibrillation: Dronedarone is used to maintain sinus rhythm after successful cardioversion in patients with paroxysmal or persistent atrial fibrillation.^[4]
• Acute ischemic stroke with atrial fibrillation: The medicine is being studied in a Phase 3 trial to see whether early rhythm-control therapy can reduce the rate of adverse cardiovascular outcomes, including recurrent stroke, in people who have had an acute ischemic stroke and also have atrial fibrillation.^[1]

How is dronedarone hydrochloride given?

Dronedarone hydrochloride is given by mouth as a tablet. In the clinical trial, the oral dose used is 800 mg. The medicine is available as a tablet formulation for oral use.^[1]

What do the clinical trials show?

The registry data includes one clinical trial of dronedarone hydrochloride. This is a Phase 3 interventional study that has been authorised to proceed.^[1] The trial compares early rhythm-control therapy using dronedarone or other antiarrhythmic medicines (amiodarone, propafenone, or flecainide) in addition to usual care against usual care alone.^[1]

The trial enrols 1,746 participants with acute ischemic stroke and atrial fibrillation. The main outcome it measures is a composite of first recurrent ischaemic stroke, haemorrhagic stroke, unclassified stroke, cardiovascular death, or hospitalisation due to worsening of heart failure or acute coronary syndrome. This is analysed as the time to the first occurrence of any of these events.^[1]

What side effects are known?

Formulary sources note that dronedarone has been the subject of a Medicines and Healthcare products Regulatory Agency (MHRA) Drug Safety Update from October 2011 concerning cardiovascular, pulmonary and hepatic adverse effects.^[3] The same source recommends that prescribing follow NICE technology appraisal guidance and notes that the medicine is not for initiation in primary care.^[3] Detailed side effect information is available in the Summary of Product Characteristics linked from the formulary, but the provided sources do not list individual common or serious side effects.