NICE publishes final draft guidance on the use of dronedarone for treating atrial fibrillation – 16 July 2010

Posted on July 27, 2010. Filed under: Cardiol / Cardiothor Surg | Tags: , |

NICE publishes final draft guidance on the use of dronedarone for treating atrial fibrillation – 16 July 2010

“The National Institute for Health and Clinical Excellence (NICE) is currently appraising the use of dronedarone (Multaq) for the treatment of atrial fibrillation (AF) – a disturbance of the heart’s rhythm. In its final draft guidance published today, (16 July), NICE has reaffirmed the decision in its previous draft to recommend the limited use of the drug as a second-line treatment in people with additional cardiovascular risk factors whose AF has not been controlled by first-line therapy.

Sir Andrew Dillon, NICE Chief Executive, said: “The independent Appraisal Committee concluded that although dronedarone reduced atrial fibrillation recurrence compared with placebo, it appeared to be less effective for atrial fibrillation recurrence than other antiarrhythmic drugs. However, it noted comments from patients and clinical experts received during consultation on a previous draft that all current antiarrhythmic drugs have side effects that have a significant impact on quality of life with long-term use. It heard from patient experts that some people with atrial fibrillation might prefer to take dronedarone because it has fewer side effects, despite it being less effective in preventing recurrence of atrial fibrillation.

He continued: “The Committee also accepted evidence that the risk of mortality with dronedarone was likely to be lower than with current anti-arrhythmic drugs. Finally, because the cost-effectiveness estimates for the drug were largely based on a single clinical trial, which included people who had a higher risk of a major cardiovascular event, 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.”

In line with the NICE technology appraisals process this draft guidance is now with consultees, who have the opportunity to appeal against the proposed guidance. NICE has not yet issued final guidance to the NHS. Final guidance is expected to be published in August 2010.  …continues

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