Further Analysis From ATHENA Study Showed That Multaq(R) (dronedarone) Reduced the Risk of Stroke in Patients With Atrial Fibrillation
Published In: Health, New Jersey 
Wednesday, September 3, 2008 8:00 AM
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BRIDGEWATER, N.J., Sept. 3 /PRNewswire-FirstCall/ -- 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 hospitalizations 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, Mc Master
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 mild increase in blood creatinine (4.7% vs. 1%). 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 2
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 hospitalization 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
hospitalization 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
discontinuation.

The ATHENA stroke post-hoc analysis on non-pre-specified secondary
endpoint was conducted in order to confirm the consistent benefit of Multaq in
atrial fibrillation or atrial flutter patients in reducing major
cardiovascular complications like stroke, which is a leading cause of
cardiovascular hospitalization 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 for 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, 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).


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.


CONTACT Marisol Peron: 908-981-6565

email marisol.peron@sanofi-aventis.com


SOURCE sanofi-aventis


 
Wednesday, September 3, 2008 8:00 AM

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