- Sanofi-aventis announced today that one
year findings from the landmark ExTRACT-TIMI 25 and STEEPLE studies
confirm clear net clinical benefit for patients with acute ST-segment
elevation myocardial infarction (STEMI) for Lovenox(R) vs
Unfractionnated Heparin (UFH).
The ExTRACT-TIMI 25 and STEEPLE one year results were presented
during hotline sessions at the European Society of Cardiology (ESC)
Congress in Vienna, Austria.
ExTRACT-TIMI 25 (Enoxaparin and Thrombolysis Reperfusion for Acute
Myocardial Infarction Treatment, Thrombolysis in Myocardial
Infarction -- Study 25) trial showed that in patients with STEMI
treated with fibrinolysis, at one year, the primary endpoint of death
or nonfatal myocardial infarction remained significantly in favor or
enoxaparin vs UFH (15.8% vs 17.0% p-0.01). Net clinical benefit (all
cause of death / nonfatal MI / nonfatal disabling stroke) was also
significantly in favour of enoxaparin vs UFH through one year of
follow up (16.0% vs 17.3% p=0.007).
"This was a very large trial with conclusive results at 30 days.
The persistence of significant net clinical benefit a full year after
treatment is further evidence of the viability of the strategy of
using enoxaparin as adjunctive anticoagulant therapy to fibrinolysis
in the STEMI patient population," noted ExTRACT TIMI 25 principal
investigator Dr. Elliott Antman, M.D., Senior Investigator TIMI Study
Group, Director, Samuel A. Levine Cardiac Unit at Brigham and Women's
Hospital, Professor of Medicine, Harvard Medical School, and lead
investigator of the ExTRACT-TIMI 25 study.
ExTRACT TIMI 25 was a major randomized clinical trial that
supported the worldwide submission and subsequent approval by the FDA
and some European countries of the new Lovenox(R) indication for the
treatment of patients with acute ST-segment elevation myocardial
STEEPLE (SafeTy and Efficacy of Enoxaparin in Percutaneous
Coronary Intervention Patients) trial one year follow up shows that
the composite of all cause death at 1 year and major bleeding was
3.1% for Lovenox(R) 0.5 mg/kg (p=0.06 vs. UFH), 3.4% for Lovenox(R)
0.75 mg/kg (p=0.07 vs. UFH), 3.3% for the two Lovenox(R) arms
combined (p=0.03 vs. UFH) and 4.7% for UFH.
There were low and statistically similar 1-year death rates in the
enoxaparin groups (0.5mg/kg or 0.75 mg/kg) and UFH during and after
elective percutaneous intervention (PCI). In addition to patient risk
factors, ischemic events and major bleeding were found to be
independent predictors of death at 1 year.
Commenting on the results, Dr. Gilles Montalescot who is Professor
of Cardiology at the Institute of Cardiology, Hopital de la Pitie
Salpetriere, Institut du Coeur, Paris, France and a member of the
STEEPLE steering committee noted, "The significant reduction in major
bleeding and similar efficacy compared with UFH confirms Lovenox(R)
is an appropriate anticoagulant for elective PCI."
About Coronary Artery Disease (CAD) and Acute Coronary
Coronary artery disease (CAD) is the most common type of heart
disease globally and is a serious health problem worldwide. CAD
causes approximately 17 million deaths per year: the equivalent of
one out of every three deaths worldwide. According to the American
Heart Association, more than 13 million Americans have a history of
CAD and 7.5 million have experienced an acute heart attack.
Acute coronary syndrome (ACS) is an umbrella term used to describe
a group of clinical diagnoses caused by narrowing of the coronary
arteries and cover any group of clinical symptoms compatible with
acute myocardial ischemia, caused by an imbalance between myocardial
oxygen supply and demand that results from CAD.
Immediate treatment is required for all ACS. The treatment
approach is multifaceted and aims to try and protect the affected
heart muscle from further damage, reinstate blood flow through the
artery and reduce the heart's demand for oxygen. In the emergency
room, the primary goals are to rapidly identify patients with MI
(STEMI), exclude alternative causes of chest pain, and stratify
patients into low- and high-risk groups and provide appropriate
therapy to minimize further damage or ischemia to cardiac muscle.
Restoration of blood to the heart (reperfusion) can be achieved
either via the use of certain drugs (fibrinolytics), used to break
down blood clots, or mechanically by surgery, i.e. Percutaneous
Coronary Intervention (PCI). Pharmacological options for the
treatment ACS include the use of antiplatelet agents, to help prevent
platelets from sticking together and forming clots, and
anticoagulants to prevent blood clotting. Anticoagulants prevent
clots from growing and new ones from forming, but they do not
About Percutaneous Coronary Intervention (PCI)
PCI is a treatment procedure that unblocks coronary arteries that
have narrowed due to atherosclerosis or atherothrombosis. The
procedure restores coronary arterial flow (or coronary perfusion) in
an acutely or sub-acutely occluded artery during acute myocardial
infarction or unstable angina. PCI includes balloon angioplasty and
implantation of intracoronary stent. The main long-term concern of
PCI is re-stenosis. However, the use of coated and drug-eluting
stents has been shown to reduce this risk. Primary PCI is defined as
intervention in the culprit vessel within 12 hours after the onset of
chest pain or other symptoms of acute myocardial infarction, without
prior (full or concomitant) thrombolytic or other clot-dissolving
therapy. Elective PCI is performed in all other less-urgent cases in
patients with coronary artery disease (CAD).
About Clexane(R) / Lovenox(R) (enoxaparin)
Lovenox(R) is a unique chemical entity in a class of
antithrombotic agents known as low-molecular weight heparin (LMWH).
The no. 1 selling low-molecular weight heparin in the world,
Lovenox(R) is obtained by alkaline degradation of heparin benzyl
ester and is about one-third the molecular size of unfractionated
heparin. Lovenox(R) is the most widely studied LMWH, with 20 years of
use in the treatment of 185 million patients in 96 countries.
Its clinical applications are linked to its antithrombotic
properties. It is used to inhibit clot formation in venous and
arterial vessels to prevent potential acute or chronic complications
of venous or arterial thrombosis. As with all anticoagulants, the
most frequently reported side effect with Lovenox(R) is bleeding.
Clinical indications for Lovenox(R) may vary from one country to
Sanofi-aventis is one of the world's leading pharmaceutical
companies, ranking number one in Europe. Backed by a world-class R&D
organisation, sanofi-aventis is developing leading positions in seven
major therapeutic areas: cardiovascular, thrombosis, oncology,
metabolic diseases, central nervous system, internal medicine and
vaccines. 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 financial 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
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, 2006. Other than as required by applicable
law, sanofi-aventis does not undertake any obligation to update or
revise any forward-looking information or statements.
1. Antman EM, Morrow DA, McCabe CH, et al; ExTRACT-TIMI 25
Investigators. Enoxaparin versus unfractionated heparin with
fibrinolysis for ST-elevation myocardial infarction. N Engl J Med.
2. Montalescot G, White HD, Gallo R, et al; STEEPLE
Investigators. Enoxaparin versus unfractionated heparin in elective
percutaneous coronary intervention. N Engl J Med. 2006;355:1006-1017.
3. Murphy SA, Gibson CM, Morrow DA, et al. Efficacy and safety of
the low-molecular weight heparin enoxaparin compared with
unfractionated heparin across the acute coronary syndrome spectrum: a
meta-analysis. Eur Heart J. 2007 [e-pub ahead of print].
ots Originaltext: sanofi-aventis Group
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