Press releases

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November, 23, 2010
Call for action to improve patients’ health and reduce costs to national health systems...
Call for action to improve patients’ health and reduce costs to national health systems
London, 23 November 2010 – The lives of thousands of patients with atrial fibrillation (AF)i could be at risk due to poor diagnosis, failure to follow treatment guidelines and lack of quality information for patients suffering from this debilitating heart condition, warns a report published today by the AF AWARE partnership. The report argues that poor diagnosis of AF may lead to increased risk of hospitalization, strokei and other cardiovascular complications, as well as to unnecessary costs to individuals and to healthcare systems in Europe.  These findings come at a time when experts are meeting in London to exchange insights about the effective management of AF, at the EuropeAF conference. The findings have prompted a call from the AF AWARE partnership for European-wide improvements.

Six million people across Europe are affected by AF1, making it the most common cardiac arrhythmiai (abnormal heart rhythm). While common symptoms include palpitations, shortness of breath and dizziness, some patients with AF experience no symptoms. AF increases a person’s risk of stroke by four to five fold.2

“AF is a serious, progressive and chronic disease, which can have devastating consequences on patients and healthcare systems” said Professor Gu¨nter Breithardt, spokesperson for the World Heart Federation. “This report highlights missed opportunities to manage AF more effectively, saving costs to European healthcare systems and most importantly, saving patients’ lives.”

The report reveals inconsistencies in adherence to treatment guidelines, inadequate patient resources, and a lack of country-level estimates of AF incidence and prevalence, which raises concerns that AF may be vastly underdiagnosed. This may hinder effective planning within national healthcare systems.

The report highlights that AF may cost the European Union €10 billion per year, based on a French estimate of a total average healthcare costs per year of €3,220 per AF patient. However, costs could be greatly reduced through the use of screening tools in primary care. As a study from the UK indicated, opportunistic screening of primary care patients can cost approximately £200 per patient, but is likely to lead to cost savings, avoiding more expensive secondary care.

The report also highlights substantial costs related to loss of work due to sickness absence, loss of productivity while at work and the need for early retirement. In Italy and Germany, these indirect costs have been estimated at over €3,000 per AF patient per year, while in the Netherlands, Greece and France these costs are in the hundreds of euros for each patient. The result is increased pressure on individuals with AF, their caregivers, employers, as well as the healthcare and welfare systems.

In response to the report, the AF AWARE partnership, led by the World Heart Federation and the Stroke Alliance for Europe, is calling for immediate action in four areas:

1.    Wider availability and use of disease registries, to get a more accurate estimate of AF prevalence and assess the true burden of the disease
2.    More educational tools on interpreting and applying treatment guidelines to country- specific needs
3.    An assessment of clinician training needs, patient information gaps and treatment preferences
4.    Quality patient materials, enabling patients to become true partners in making treatment decisions, with appropriate support from their clinician

“AF is a growing public health concern, with prevalence set to double by 2050” said Dr Markus Wagner, President, Stroke Alliance for Europe. “The AF AWARE partnership is calling for urgent steps to be taken now to improve care for AF patients in Europe and reduce the physical, psychological and economic impact of this disease.”
November, 05, 2010
Consortium awarded European Union grant for 5 years of Atrial Fibrillation research.
Consortium awarded European Union grant for 5 years of Atrial Fibrillation research.

Paris, France – November 5, 2010 – Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that it is a partner in a new multidisciplinary atrial fibrillation research consortium, the “European Network for Translational research in Atrial Fibrillation” (EUTRAF), which has been awarded a €12 million grant to engage in atrial fibrillation (AF)i research. The European consortium is commencing a five-year research project with the objectives of providing highly interactive research with a variety of expertise to improve management of AF including diagnosis, prevention and treatment.

“Sanofi-aventis is committed to further advancing AF patient care and delighted to do so in collaboration with a network of highly respected scientific institutions and recognised clinical experts in the field of AF,” said Marc Cluzel MD, PhD, Executive Vice President, Research and Development, sanofi-aventis. “We are proud to provide sanofi-aventis R&D expertise and to contribute new candidate molecules to the network. Sanofi-aventis’ pioneering research in AF spans several decades and has led to innovations such as amiodarone, and dronedarone.”
September, 01, 2010
Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that results from the RealiseAF (Real-...
Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that results from the RealiseAF (Real-life global survey evaluating patients with Atrial Fibrillation) registry show that control of atrial fibrillation (AF)i (defined by the 2006 ACC/AHA/ESC AF guidelines as either sinus rhythmi or AF with heart ratei at rest = 80 bpm)1 was not achieved in more than 40 percent of the AF patients included in this 10,000 patient cross-sectional registry, as presented today during the European Society of Cardiology Congress in Stockholm, Sweden. In addition, the registry revealed that a majority of patients complain of symptoms, even when AF is controlled 2 (55.7 percent).

Importantly, cardiovascular (CV) events were very frequent in this population, with a high rate of concomitant CV risk factors (72.2% of patients were hypertensive and 46.3% of patients had dyslipidemia) 28.7 percent of AF patients suffered from CV events such as acute coronary syndrome (ACS) acute heart failure or strokei, leading to an unplanned hospitalisation during the last 12 months and 12.4 percent of patients requiring major CV interventions such as Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Graft (CABG) or valvular surgery.

Management of AF in a real-life setting shows that today, AF is not treated according to the 2006 ACC/AHA/ESC AF guidelines:
- 20 percent of AF patients with structural heart disease received Class Ic AADs, despite its contraindication in this patient population.
- 49.9 percent of evaluated paroxysmal and persistent AF patients without congestive heart failurei (CHF) or hypertension with significant left ventricular hypertrophyi received amiodarone as a first-line treatment, despite guidelines recommendations that it be used as a second line agent.
- In addition, patients with a CHADS2 ³ 2 who should receive anti-coagulants agents only received these agents in 52 percent of cases.

“The RealiseAF registry shows that patients suffering from atrial fibrillation not only require symptom relief but management which goes beyond heart rate or rhythm controli, and addresses event-driven hospitalisations,” said Professor Ph. Gabriel Steg, Department of Cardiology, Hôpital Bichat, Paris, France, on behalf of the RealiseAF steering committee. “The data suggest a need for new therapies and an increased focus on cardiovascular outcomes, as well as a more stringent adherence to guidelines.”
August, 29, 2010
Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that the European Society of...
Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that the European Society of Cardiology (ESC) 2010 new Guidelines for the Management of Atrial Fibrillation (AF)i have been released and recommend that Multaq® (dronedarone) should be used for maintenance of sinus rhythmi 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 controli in non-permanent 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.

For access to the guidelines, please visit: http://www.escardio.org/guidelines-surveys/esc-guidelines/Pages/atrial-fibrillation.aspx.