Sanofi aventis announced that the European Society of Cardiology (ESC) 2010 new Guidelines for the Management of Atrial Fibrillation (AF) have been released and recommend that Multaq (dronedarone) should be used for maintenance of sinus rhythm as a first-line treatment option in all patients with paroxysmal and persistent AF (class of recommendation I, level of evidence A) other than those with CHF NYHA class III/IV or unstable CHF NYHA class II (class of recommendation III, level of evidence B).

Multaq was granted a Class I recommendation, a designation assigned in the guidelines when "there is evidence and/or general agreement that a given procedure/therapy is beneficial, useful, and effective." The Task Force for the Management of Atrial Fibrillation of the ESC recognised the extensive clinical development of Multaq, giving it their highest ranking A for level of evidence. Moreover, the guidelines recommend that Multaq may also be used to achieve rate control in nonpermanent AF except for patients with NYHA class III - IV or unstable heart failure (class of recommendation IIa, level of evidence B).

Importantly the new guidelines include, for the first time, a statement on the importance of reducing hospitalisation as a key therapeutic goal in the management of AF. They also state that Multaq should be considered in order to reduce cardiovascular hospitalisation in patients with non-permanent AF and cardiovascular risk factors (Class of recommendation IIa, level of evidence B) as well as in patients with AF and stable heart failure (NYHA Class I, II) (Class of recommendation IIa, level of evidence C).

The guidelines do not recommend use of Multaq in patients with NYHA class III and IV or with recently unstable (decompensation within the prior month) NYHA class II heart failure.

"Sanofi-aventis is pleased with this first-line recommendation for Multaq in the AF guidelines which recognises the extensive clinical development for the product as well as the innovative outcome of reducing cardiovascular hospitalisation as demonstrated in the ATHENA trial," said Marc Cluzel, M.D., PhD, executive vice president, research and development, sanofi-aventis. "Multaq provides symptom control and for the first time for an anti-arrhythmic drug, a long term benefit by reducing the risk of distressing and repeat cardiovascular hospitalisations. AF Hospitalisations represent a significant human and economic burden for patients, healthcare practitioners and payers as recently reported."

ESC Clinical Practice Guidelines are scientifically recognised worldwide as providing practicing physicians with the best possible recommendations on diagnosis, treatment and management of specific topics in cardiology medicine. Guidelines are created and edited under the umbrella of the ESC Board and the Committee for Practice Guidelines (CPG), who form a Task Force of appropriate experts from the ESC Associations, Working Groups, Councils, and National Societies, and from other bodies when required. They are the result of consensus amongst the Task Force appointed to prepare them, and they are peer-reviewed in a thorough and rigorous process that ensures accuracy, best-practice and relevance. Guidelines are available in a variety of printed and electronic media and in multiple formats including full documents, pocket guides and summaries.

Multaq, discovered and developed by sanofi-aventis, has been studied in a clinical development programme, including seven international, multicenter, randomized clinical trials involving more than 7000 patients with almost 4000 patients receiving Multaq. The landmark ATHENA trial was the largest anti-arrhythmic drug trial conducted in patients with AF/AFL, involving 4,628 patients with a follow-up of 30 months. In this trial, Multaq, on top of standard cardiovascular therapy, significantly reduced cardiovascular hospitalization or death by 24 percent (p<0.001) when compared to placebo, meeting the study's primary endpoint. This result was entirely attributable to a reduction in cardiovascular hospitalization.

Multaq has a fixed dose regimen of twice daily 400 mg tablets to be taken with morning and evening meals. Treatment with Multaq does not require a loading dose and can be initiated in an outpatient setting. Most common adverse reactions are diarrhoea, nausea, vomiting, abdominal pain, asthenia (weakness) and skin rash.

The European Commission granted marketing authorization for Multaq in November 2009. Multaq is indicated in the EU in adult clinically stable patients with a history of, or current non-permanent atrial fibrillation (AF) to prevent recurrence of AF or to lower ventricular rate. The use of Multaq in unstable patients with NYHA class III and IV heart failure is contraindicated. Because of limited experience in stable patients with recent (1 to 3 months) NYHA class III heart failure or with Left Ventricular Ejection Fraction (LVEF) <35 per cent, the use of Multaq is not recommended in these patients.In the US, Multaq is indicated to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors (i.e , age >70, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter ?50 mm or left ventricular ejection fraction [LVEF] <40%), who are in sinus rhythm or who will be cardioverted.15 Multaq is contraindicated in patients with NYHA Class IV heart failure, or NYHA Class II-III heart failure with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic.

Multaq is currently available in 20 countries including the US, Canada, Switzerland, Mexico, Taiwan, South Korea, Germany, Denmark, Ireland, Norway, Finland, Austria, Cyprus, Malta, Estonia, Sweden, Israel, Peru, Mexico, Hong Kong the UK and is being launched in most European countries in 2010.