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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
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, 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 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 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 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 discontinuation.
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.
Sanofi Aventis
http://en.sanofi-aventis.com
More info
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