Sanofi-aventis launches major new registry including over 10,000 patients worldwide with atrial fibrillation

Published November 29th, 2009 - 02:34 GMT

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


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