MEDIA RELEASE PR37116
Sanofi-aventis Launches Major New Registry Including Over 10,000 Patients Worldwide
With Atrial Fibrillation
PARIS, Nov. 17 /PRNewswire-AsiaNet/ --
- The RealiseAF Registry Will Help to Better Define and Understand the
Cardiovascular Risk Profile of AF Patients and Characterize Their
Cardiovascular Outcomes
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, Hopital 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 less than or equal to 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:
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, Jonsson 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.
SOURCE: Sanofi-aventis
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