The National Institute for Health and Clinical Excellence (NICE) has reiterated previous draft guidance regarding the antiarrhythmic drug dronedarone (Multaq, Sanofi-Aventis) that recommended the drug be used as a second-line defense for patients with non-permanent atrial fibrillation (AF) who cannot be controlled by first-line therapy.
The final draft guidance published July 16 recommended that the therapy be utilized in limited instances for patients who are diagnosed with heightened cardiovascular risks including hypertension, diabetes mellitus and previous transient ischemic attack or stroke, among others, in addition to AF.
While the appraisal committee found that dronedarone was better than placebo, the drug may not better reduce AF compared to other antiarrhythmic drugs on the market; however, comment from experts concluded that some patients may prefer dronedarone due to the fact that it has shown to produce less side effects.
Additionally, the committee found evidence that showed that dronedarone may be associated with a lower risk of mortality and is more cost effective for patients, but the drug is still only recommended as a therapy for a certain patient population.
“We have recommended that dronedarone is considered as a treatment option only in people who have additional cardiovascular risk factors such as diabetes or high blood pressure,” said NICE Chief Executive Andrew Dillon.
According to NICE, a final appraisal determination has been sent to and will be under appraisal by consultees until July 30. While the institute said it has not yet doled out the guidance to the National Health Service, it expects the final guidance to be published in August.