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Sanofi-aventis Press Release
Sanofi-aventis Launches Major New Registry Including Over 10,000 patients
Worldwide with Atrial Fibrillation
- The RealiseAF registry will help to better de fine and understand the
cardiovascular risk profile of AF patients and characterize their cardiovascular
outcomes -
Paris, France, November 16, 2009 - Sanofi-aventis (EURONEXT: SAN and NYSE: SNY)
announced today the launch of the RealiseAF registry (Real Life global Survey
Evaluating patients with Atrial Fibrillation), an international,
cross-sectional, observational registry that will be conducted in patients with
atrial fibrillation (AF). This disease can worsen patients' prognosis, increase
the risk of hospitalization, stroke and mortality. RealiseAF will provide a
real-life picture of the global burden of AF in more than 10,000 patients in
27 countries.
"Sanofi-aventis is a major contributor to the efforts to reduce the public
health burden of atrial fibrillation" said Jean-Pierre Lehner, Chief Medical
Officer, sanofi-aventis. "The company strives to respond to the medical needs of
patients and physicians, not only with innovative therapeutic solutions, but
also via investment in registries such as RealiseAF, dedicated to furthering the
understanding of the risk profiles of patients with atrial fibrillation."
RealiseAF is designed to assess the control of atrial fibrillation (AF) and
investigate the CV risk profile of a broad spectrum of AF populations in Europe,
Latin America, Asia, Middle East and North Africa. This new registry is intended
to generate new data on a broad AF population including patients with
paroxysmal, persistent as well as permanent atrial fibrillation, AF due to
transient causes. It will provide a better understanding of this disease and
associated CV consequences, which may help to further improve the burden of AF.
"RealiseAF will provide more data to help physicians to understand the true
impact of AF, its burden and how to improve outcomes," said Professor G. Steg,
Department of Cardiology, Hôpital Bichat, Paris, France, on behalf of the
RealiseAF steering committee. "This study will give us a unique picture both
globally and locally about the AF patient population and how patients are
managed."
RealiseAF was designed to complement the results of the RecordAF registry
(Registry on Cardiac Rhythm Disorders, an international, observational,
prospective survey assessing the control of Atrial Fibrillation), presented
during the late breaking session of the American Heart Association 2009 meeting
in Orlando, USA. The results of the RecordAF registry show that 18% of all
patients had cardiovascular (CV) clinical events at 1 year mainly driven by CV
hospitalization. A rhythm control strategy was preferred by 55% of cardiologists
and achieved better therapeutic success than a rate control strategy (60% vs
47%). Nevertheless, rhythm control strategies with existing therapies at the
time of this study did not translate into better outcomes than rate control.
None of these 2 strategies appeared to be really satisfactory for physicians;
22% of physicians changed their strategy and 52% modified AF treatment within a
strategy during the 12 months period. These results highlight the need for newer
anti-arrhythmic drugs able to successfully achieve rhythm and rate control as
well as decrease clinical events.
The recruitment of the RealiseAF patients recently started at the end of
October 2009 and final results are expected by the end of 2010. RealiseAF is
supported by an unrestricted educational grant from sanofi-aventis.
About RealiseAF
The RealiseAF registry will follow more than 10,000 patients in 926 centers from
27 countries with a history of atrial fibrillation and at least one AF episode
in the last 12 months, or documented current AF.
Adults with paroxysmal, persistent as well as permanent AF, and AF due to
transient causes (thyrotoxicosis, alcohol intoxication, acute phase of
myocardial infarction, pericarditis, myocarditis, electrocution, pulmonary
embolism or other pulmonary disease, hydroelectrolytic disorder, metabolic
disorder, etc.) are included.
Data collected will include the following measures: family and personal
cardiovascular risk factors, history of comorbidities, cardiovascular events
leading to hospitalisation in the last 12 months, cardiovascular interventions,
history and characteristics of AF, AF management, and quality of life
assessment. Cardiologists (office-based and hospital-based) and internists will
be randomly selected to participate in the study.
About RecordAF
The RecordAF registry recruited 5,604 patients with recent onset atrial
fibrillation from 21 countries spanning North and South America, Europe and
Asia. They were studied for a period of one year. The primary outcomes of the
study were therapeutic success and clinical outcomes associated with rhythm-and
rate-control strategies. Therapeutic success at 1 year required that treatment
strategy was unchanged, that no clinical events occurred during follow-up, and
that sinus rhythm was achieved in the rhythm-control group or the heart
rate ?80 bpm in the rate-control group
Physicians involved in the registry were randomly selected from an initial
representative and exhaustive global list of office-and hospital-based
cardiologists.
About atrial fibrillation
Atrial fibrillation is the most common cardiac arrhythmia and affects nearly
7 million people in the European Union and the United States(1). AF currently
represents a major economic burden for society and leads to potential
life-threatening complications. AF increases the risk of stroke up to
five-fold(2), worsens the prognosis of patients with cardiovascular risk
factors(3), and doubles the risk of mortality(4) with significant burden on
patients, health care providers and payers. Hospitalizations for AF have
increased dramatically (two-to-three-fold) in recent years(1). AF
hospitalizations now represent a third of all hospitalizations for arrhythmia
and mortality in the US and Europe(3). Seventy percent of the annual cost of AF
management in Europe is driven by hospital care and interventional
procedures(5).
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and
distributes therapeutic solutions to improve the lives of everyone.
Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
For more information, visit: www.sanofi-aventis.com
Media Contact:
Philippe BARQUET
Tel: +33 (0)6.70.48.61.28
Email: philippe.barquet@sanofi-aventis.com
For more information please visit: www.realiseaf.org and www.recordaf.org
References:
(1) Go AS, Hylek EM, Phillips KA, et al. Prevalence of diagnosed atrial
fibrillation in adults: national implications for rhythm management and stroke
prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA)
Study. JAMA 2001; 285:2370-5.
(2) Lloyd-Jones et al. Lifetime Risk for Development of Atrial Fibrillation: The
Framingham Heart Study. Circulation. 2004; 110:1042-1046.
(3) Fuster V et al. ACC/AHA/ESC 2006 guidelines for the management of patients
with atrial fibrillation. European Heart Journal (2006) 27, 1979-2030.
(4) Benjamin EJ, Wolf PA, D'Agostino RB, Silbershatz H, Kannel WB, Levy D.
Impact of atrial fibrillation on the risk of death: the Framingham Heart Study.
Circulation 1998 Sep 8; 98(10):946-52.
(5) Ringborg A, Nieuwlaat R, Lindgren P, Jönsson B, Fidan D, Maggioni AP,
Lopez-Sendon J, Stepinska J, Cokkinos DV, Crijns HJ. Costs of atrial
fibrillation in five European countries: results from the Euro Heart Survey on
atrial fibrillation. Europace. 2008 Apr;10(4):403-11. Epub 2008 Mar 7.
Sanofi-aventis: www.sanofi-aventis.com
Media Relations: Tél.: (+) 33 1 53 77 44 50 - E-mail: MR@sanofi-aventis.com
Investor Relations : Tél.: (+) 33 1 53 77 45 45 -
E-mail: IR@sanofi-aventis.com
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