The National Institute for Health and Clinical Excellence (NICE) has published a draft guidance, recommending that dronedarone (Multaq, Sanofi-Aventis) be used in limited doses as a second-line treatment for patients with increased cardiovascular risk factors and whose atrial fibrillation (AF) is not initially controlled by first-line therapy.
The new recommendation comes after NICE considered public comment on the previous draft guidance which the independent Appraisal Committee revised to say that the drug should not be indicated for use to treat AF.
While NICE has not changed its recommendation that the drug is not as effective as other anti-arrhythmic drugs in preventing recurrent AF, it accepted evidence that the drug does not lead to an increased risk of mortality, like other anti-arrhythmic drugs with which it was compared. Public comments received by NICE indicated that all current anti-arrhythmic drugs, but particularly amiodarone (Cordarone, Wyeth/Pfizer), had side effects which had a significant impact on quality of life with long-term use.
"While dronedarone has not been shown to be as effective as existing treatment options in controlling AF, and is more expensive, short-term evidence suggests that it is associated with fewer side-effects,” said Andrew Dillon, chief executive of NICE.
“Following public consultation on the first draft of this guidance, we have been able to identify circumstances in which dronedarone could be offered as a cost-effective treatment option," he said.
Based on this recommendation, dronedarone should be prescribed in non-permanent AF patients with at least one of the following cardiovascular risk factors: hypertension requiring drugs of at least two different classes; diabetes mellitus; previous transient ischemic attack, stroke or systemic embolism; left atrial diameter of 50 mm or greater; left ventricular ejection fraction less than 40 percent; or patients aged 70 years or older and who do not have unstable New York Heart Association (NYHA) class III or IV heart failure.
According to NICE, the final guidance has not been issued to the NHS, but has been issued for consultation. Preliminary recommendations will be open to a public comment period between March 30 and April 22.