Paris, March 30, 2010 (ots/PRNewswire) – Sanofi-aventis announced today that the National Institute for Health and Clinical Excellence (NICE) in England and Wales, has just published a new appraisal consultation document (ACD)[1] for Multaq(R) (dronedarone) indicating its intention to recommend Multaq(R) use for the management of patients with atrial fibrillation (AF).
The NICE appraisal committee’s preliminary recommendation is to endorse Multaq(R) as a first choice therapeutic option after beta-blockers, which are the initial therapeutic option in the NICE clinical guidelines. Based on this recommendation, Multaq(R) 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 50mm of greater, LVEF less than 40% or age 70 years or older and who do not have unstable New York Heart Association (NYHA) class III or IV heart failure.
This patient population corresponds to the patients included in the landmark ATHENA study, the largest study ever performed with an anti-arrhythmic drug in atrial fibrillation and the only study to have ever demonstrated a positive impact on cardiovascular (CV) morbidity and mortality.
In ATHENA, Multaq(R) reduced the risk of cardiovascular hospitalization or death by a significant 24% vs. placebo on top of standard of care including beta-blockers (p
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