Further Analysis From ATHENA Study Showed That Multaq(R) (Dronedarone) Reduced the Risk of Stroke in Patients With Atrial Fibrillation

    - This Analysis Showed That Multaq(R) (Dronedarone) Decreased the Risk of
    Stroke by 34% in Patients With Atrial Fibrillation or Atrial Flutter
    Already Adequately Treated by Antithrombotic Therapy

    PARIS, Sept. 3 /CNW/ - The results of a post-hoc analysis of the data
from the ATHENA study were presented today at the clinical trial update
session of the European Society of Cardiology congress 2008, in Munich,
Germany. Previous results from the landmark ATHENA study have shown that the
investigational medicine Multaq(R) (dronedarone) on top of standard therapy
decreased the combined primary endpoint of the risk of cardiovascular
hospitalisations or death from any cause by a statistically significant 24%
(p=0.00000002) as compared to placebo.
    The ATHENA stroke post-hoc analysis on non-pre-specified secondary
endpoints showed that Multaq(R) decreased the risk of stroke (ischemic or
haemorrhagic) compared to placebo by 34% (46 vs 70 stroke events respectively;
p=0.027) in atrial fibrillation/atrial flutter patients adequately treated by
standard therapy including antithrombotics.
    The significant reduction in stroke risk with Multaq(R) was incremental
to background anti-thrombotic therapy like oral anticoagulants and/or
anti-platelet agents. Similar to the ATHENA primary endpoint of CV
hospitalizations or death, this effect appeared early and was maintained
during the study follow-up (12 to 30 months).
    "ATHENA is a landmark trial that will lead to a paradigm shift in the
management of atrial fibrillation as it is the first time that an
anti-arrhythmic drug has shown a significant impact on cardiovascular
outcomes. As stroke is one of the leading complications of atrial
fibrillation, and a major cause of death and long-term disability, these new
results demonstrate the unique profile of Multaq(R) beyond its pure rhythm and
rate-controlling effects," said Professor Stuart Connolly, McMaster
University, Department of Cardiology, Hamilton Canada, co-principal
investigator of the ATHENA study.
    The most frequently reported adverse events of Multaq(R) vs. placebo in
the ATHENA trial as seen in the pre-specified safety analysis, were
gastrointestinal effects (26% vs. 22%), skin disorders (10% vs. 8%, mainly
rash) and a mild increase in blood creatinine (4.7% vs. 1%) due to inhibition
of tubular secretion of creatinine in the kidneys. The mechanism of blood
creatinine increase was well defined in a separate study of healthy
volunteers. In the ATHENA trial, compared to placebo, Multaq(R) showed a low
risk of pro-arrhythmia and no excess of hospitalisations for congestive heart
failure. There was a similar rate of study drug discontinuation between the
study groups.

    About Atrial Fibrillation/Flutter and Stroke

    Atrial Fibrillation (AF) is the most common cardiac arrhythmia in
clinical practice and is one of the most important independent risk factors
for stroke. Stroke is a major public health problem because this acute event
often causes permanent neurological disabilities and death.
    Atrial fibrillation increases the risk of stroke by up to 5 times. It
also is responsible for 15-20% of all strokes, which if caused by AF, are
2.2 times more likely to leave patients bedridden.
    Atrial fibrillation is a major cause of hospitalisation and mortality and
affects about 2.5 million people in the USA and 4.5 million people in the
European Union. The Atrial Fibrillation Foundation expects the number of
patients with AF to double in the next 20 years. Without appropriate
management, atrial fibrillation can lead to serious complications, such as
stroke and congestive heart failure.

    About the ATHENA Study

    The landmark ATHENA study is the only double-blind, anti-arrhythmic,
morbidity-mortality study in patients with atrial fibrillation. It was
conducted in more than 550 sites in 37 countries and enrolled a total of
4,628 patients.
    The patients studied in ATHENA were either 75 years of age or older (with
or without cardiovascular risk factor) or above 70 years of age with at least
one additional cardiovascular risk factor (hypertension, diabetes, previous
cerebrovascular event, left atrium size greater than 50 mm or left ventricular
ejection fraction lower than 40%). Patients were randomized to receive
Multaq(R) 400 mg BID or placebo, with a maximum follow-up of 30 months.
    The ATHENA study objectives were to show a potential benefit of Multaq(R)
on the primary composite endpoint of all-cause mortality combined with
cardiovascular hospitalization as compared to placebo. The pre-specified
secondary endpoints were death from any cause, cardiovascular death and
hospitalisation for cardiovascular reasons. The pre-specified safety endpoint
was the incidence of treatment emergent adverse events (between first study
drug intake and last study drug intake plus 10 days) including: all adverse
events, serious adverse events, adverse events leading to study drug
    The ATHENA stroke post-hoc analysis on a non-pre-specified secondary
endpoint was conducted in order to confirm the consistent benefit of Multaq(R)
in atrial fibrillation or atrial flutter patients in reducing major
cardiovascular complications like stroke, which is a leading cause of
cardiovascular hospitalizations or death in this patient population.

    About Multaq(R) (dronedarone)

    Multaq(R) is an investigational treatment and the only anti-arrhythmic
drug (AAD) to have shown a significant reduction in morbidity and mortality in
atrial fibrillation/atrial flutter patients with a favourable safety profile
as evidenced by a low incidence of pro-arrhythmia (including torsades de
pointes) and extra-cardiac organ toxicity.
    Multaq(R), discovered and developed by sanofi-aventis, has been studied
in a clinical development program including more than 7,000 patients.
Multaq(R) is one of the major therapeutic innovations in the field of atrial
fibrillation in the last twenty years.
    Multaq(R) has been granted a priority review by the U.S. Food and Drug
Administration (FDA) and a registration dossier is also under regulatory
review by the European Medicines Agency (EMEA).

    About sanofi-aventis

    Sanofi-aventis, a leading global pharmaceutical company, contributes to
improving life by providing a broad offering of medicines, vaccines, and
integrated healthcare solutions adapted to local needs and means.

    Forward-Looking Statements

    This press release contains forward-looking statements as defined in the
Private Securities Litigation Reform Act of 1995, as amended.
    Forward-looking statements are statements that are not historical facts.
    These statements include product development, product potential
projections and estimates and their underlying assumptions, statements
regarding plans, objectives, intentions and expectations with respect to
future events, operations, products and services, and statements regarding
future performance. Forward-looking statements are generally identified by the
words "expects," "anticipates," "believes," "intends," "estimates," "plans"
and similar expressions. Although sanofi-aventis' management believes that the
expectations reflected in such forward-looking statements are reasonable,
investors are cautioned that forward-looking information and statements are
subject to various risks and uncertainties, many of which are difficult to
predict and generally beyond the control of sanofi-aventis, that could cause
actual results and developments to differ materially from those expressed in,
or implied or projected by, the forward-looking information and statements.
    These risks and uncertainties include among other things, the
uncertainties inherent in research and development, future clinical data and
analysis, including post marketing, decisions by regulatory authorities, such
as the FDA or the EMEA, regarding whether and when to approve any drug, device
or biological application that may be filed for any such product candidates as
well as their decisions regarding labelling and other matters that could
affect the availability or commercial potential of such products candidates,
the absence of guarantee that the products candidates if approved will be
commercially successful, the future approval and commercial success of
therapeutic alternatives as well as those discussed or identified in the
public filings with the SEC and the AMF made by sanofi-aventis, including
those listed under "Risk Factors" and "Cautionary Statement Regarding
Forward-Looking Statements" in sanofi-aventis' annual report on Form 20-F for
the year ended December 31, 2007. Other than as required by applicable law,
sanofi-aventis does not undertake any obligation to update or revise any
forward-looking information or statements.

For further information:

For further information: Philippe Barquet, Tel: +33(0)6-70-48-61-28,
E-mail: philippe.barquet@sanofi-aventis.com

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