BAYER SAYS STUDIES REAFFIRM EFFECTIVENESS OF XARELTO (ENGLISH)

     (The following press release from Bayer was received by e-mail. It was not 
confirmed by the sender.) 
News-Release 
Not intended for U.S. and UK Media - Treatment and prevention of venous
blood clots:
Results from Phase III Pooled EINSTEIN Studies Reaffirm Bayer’s Xarelto® as
an Effective Single-Drug Solution for Venous Thromboembolism
Blood clots obstructing blood flow in deep veins or in the lungs kill one
person every 37 seconds in the Western World / Pooled data of over 8,000
patients reaffirm the improved benefit-risk profile of Xarelto as an
effective single-drug solution compared with the traditional dual-drug
therapy / Xarelto associated with 46% less major bleeding events, including
fatal bleeding compared to standard dual-drug therapy, whilst having
similar overall incidence rates for the principal safety outcome of major
or non-major clinically relevant bleeding / Additionally, a sub-analysis of
the EINSTEIN DVT study published in the journal Thrombosis and Haemostasis
confirms that Xarelto improves treatment satisfaction compared with
traditional dual-drug therapy and indicates better adherence and
persistence in long-term prevention of recurrent venous blood clots
compared with vitamin K antagonists (VKAs) / Bayer’s 'Responsible Use
Programme' for physicians and patients supports best practice, helping to
achieve improved clinical outcomes with 'Xarelto' 
Berlin, Germany, September 20, 2013 - Data from the Phase III EINSTEIN
clinical trial programme published today in the Thrombosis Journal
underline that single-drug therapy with Bayer HealthCare’s novel oral
anticoagulant Xarelto® (rivaroxaban) is effective in both the treatment and
subsequent prevention of recurrent deep vein thrombosis (DVT) and pulmonary
embolism (PE), with an overall comparable safety to the traditional
dual-drug therapy. 
In addition, compared to the traditional dual-drug approach of injectable
low molecular weight heparin (LMWH) followed by a vitamin K antagonist
(VKA), Xarelto significantly reduced the rate of major bleeding events by
46 per cent, including the risk of fatal bleeding, whilst offering an
improved benefit-risk profile regardless of patient age, frailty, gender,
weight or renal function. 
"Today’s publication of these impressive data further highlights the
potential of this drug to change current clinical practice in both the
treatment of initial acute DVT and PE, as well as the prevention of
recurrent DVT and PE," said Dr Alexander T. Cohen, King’s College Hospital,
London, and member of the Steering Committee of the EINSTEIN studies. "The
unique single-drug therapy of rivaroxaban has the potential to not only
improve clinical outcomes, but also reduce the overall burden of
anticoagulation therapy by providing continuous patient management from
hospital to home while avoiding the need for injections or routine
coagulation monitoring." 
Additionally, a sub-analysis of the EINSTEIN DVT study recently
pre-published online in the journal Thrombosis and Haemostasis confirms
that Xarelto improves treatment satisfaction compared with traditional
dual-drug therapy. The data also indicate improved adherence and
persistence with Xarelto in long-term prevention of recurrent venous blood
clots compared with VKAs such as warfarin. These findings complement an
analysis of patient-reported satisfaction in the EINSTEIN PE study, and
indicate an important adherence and persistence benefit with Xarelto in
both acute treatment and long-term prevention regardless of the type of
venous blood clot experienced. 
"These analyses add to the large amount of clinical data and real-life
experience supporting Xarelto in the management of both venous and arterial
blood clots, providing further reassurance regarding the clinical use of
Xarelto across a broad range of clinical settings," said Dr. Kemal Malik,
Member of the Bayer HealthCare Executive Committee and Head of Global
Development. 
Xarelto is approved for five indications across seven distinct areas of
use, consistently protecting patients across more venous and arterial
thromboembolic (VAT) conditions than any other novel oral anticoagulant. 
About The EINSTEIN Clinical Trial Programme and Pooled Analysis
The pivotal EINSTEIN Clinical Trial Programme comprises three Phase III
studies evaluating rivaroxaban alone versus the dual-drug regimen of low
molecular weight heparin (LMWH) and a vitamin K antagonist (VKA) in the
treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and
the prevention of recurrent DVT and PE. 
In the pooled analysis of over 8,000 patients, rivaroxaban showed
non-inferiority versus the LMWH enoxaparin and VKA in terms of efficacy (HR
0.89 (95% CI 0.66-1.19), p=<0.0001) and similar overall incidence rates to
enoxaparin and VKA for the principal safety outcome of major or non-major
clinically relevant bleeding (HR 0.93 (95% CI 0.81-1.06), p=0.272).
Importantly, rivaroxaban showed a significant reduction in major bleeding
(HR 0.54 (95% CI 0.37-0.79), p=0.002) over traditional dual-drug therapy.
Overall, the principal safety results were consistent regardless of the
patient’s age, frailty, weight, gender and renal function. Results from the
pooled analysis were previously presented at the 54th American Society of
Hematology (ASH) Annual Meeting in Atlanta in December 2012. 
Xarelto is approved as the single-drug solution for the treatment of DVT
and PE as well as for the prevention of recurrent DVT and PE in adults in a
number of countries worldwide including Europe and the U.S. 
About Venous Arterial Thromboembolism (VAT)
Thrombosis is the formation of a blood clot inside a blood vessel, blocking
a vein (venous thrombosis) or artery (arterial thrombosis). Venous Arterial
Thromboembolism (VAT) is caused when some or all of a clot detaches and is
moved within the blood stream until it obstructs a smaller vessel. This can
result in damage to vital organs, because the tissue beyond the blockage no
longer receives nutrients and oxygen. 
VAT is responsible for a number of serious and life threatening conditions: 
• Venous Thromboembolism (VTE) occurs when part of a clot formed in a deep
vein, for example in the leg (known as deep vein thrombosis, or DVT), is
carried to the lung, via the heart, preventing the uptake of oxygen. This
is known as a pulmonary embolism (PE), an event which can be rapidly fatal.
Blood clots that obstruct blood flow in deep veins or in the lungs kill one
person every 37 seconds in the Western World 
• Arterial Thromboembolism occurs when oxygenated blood flow from the heart
to another part of the body (via an artery) is interrupted by a blood clot.
If this occurs in a vessel supplying blood to the brain, it can lead to a
stroke, an event that can be severely debilitating or fatal. If it occurs
in a coronary artery, it can lead to acute coronary syndrome (ACS), a
complication of coronary heart disease which includes conditions such as
myocardial infarction and unstable angina 
VAT is responsible for significant morbidity and mortality, and requires
active or preventative treatment to avoid potentially serious or fatal
patient outcomes. 
To learn more about VAT, please visit http://www.VATspace.com 
About Xarelto® (Rivaroxaban)
Rivaroxaban is the most broadly indicated novel oral anticoagulant and is
marketed under the brand name Xarelto®. Xarelto is approved for five
indications across seven distinct areas of use, consistently protecting
patients across more venous and arterial thromboembolic (VAT) conditions
than any other novel OAC: 
• The prevention of stroke and systemic embolism in adult patients with
non-valvular atrial fibrillation (AF) with one or more risk factors 
• The treatment of deep vein thrombosis (DVT) in adults 
• The treatment of pulmonary embolism (PE) in adults 
• The prevention of recurrent DVT and PE in adults 
• The prevention of venous thromboembolism (VTE) in adult patients
undergoing elective hip replacement surgery 
• The prevention of venous thromboembolism (VTE) in adult patients
undergoing elective knee replacement surgery 
• The prevention of atherothrombotic events (cardiovascular death,
myocardial infarction or stroke) after an Acute Coronary Syndrome in adult
patients with elevated cardiac biomarkers when co-administered with
acetylsalicylic acid (ASA) alone or with ASA plus a thienopyridine
(clopidogrel or ticlopidine) 
Whilst licences may differ from country to country, across all indications
Xarelto is approved in more than 120 countries. 
Rivaroxaban was discovered by Bayer HealthCare, and is being jointly
developed with Janssen Research & Development, LLC. Xarelto is marketed
outside the U.S. by Bayer HealthCare and in the U.S. by Janssen
Pharmaceuticals, Inc. (a Johnson & Johnson Company). 
Anticoagulant medicines are potent therapies used to prevent or treat
serious illnesses and potentially life-threatening conditions. Before
initiating therapy with anticoagulant medicines, physicians should
carefully assess the benefit and risk for the individual patient. 
Responsible use of Xarelto is a very high priority for Bayer, and the
company has developed a Prescribers Guide for physicians and a Xarelto
Patient Card for patients to support best practice. 
To learn more, please visit https://prescribe.xarelto.com
To learn more about thrombosis, please visit
http://www.thrombosisadviser.com
To learn more about Xarelto, please visit http://www.xarelto.com 
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields
of health care, agriculture and high-tech materials. Bayer HealthCare, a
subgroup of Bayer AG with annual sales of EUR 18.6 billion (2012), is one
of the world’s leading, innovative companies in the healthcare and medical
products industry and is based in Leverkusen, Germany. The company combines
the global activities of the Animal Health, Consumer Care, Medical Care and
Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover, develop,
manufacture and market products that will improve human and animal health
worldwide. Bayer HealthCare has a global workforce of 55,300 employees (Dec
31, 2012) and is represented in more than 100 countries. More information
at http://www.healthcare.bayer.com. 
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Forward-Looking Statements
This release may contain forward-looking statements based on current
assumptions and forecasts made by Bayer Group or subgroup management.
Various known and unknown risks, uncertainties and other factors could lead
to material differences between the actual future results, financial
situation, development or performance of the company and the estimates
given here. These factors include those discussed in Bayer’s public reports
which are available on the Bayer website at http://www.bayer.com. The
company assumes no liability whatsoever to update these forward-looking
statements or to conform them to future events or developments. 
Contact:
Pharmaceuticals
Astrid Kranz, Tel. +49 30 468-12057
E-Mail: mailto:astrid.kranz@bayer.com 
Pharmaceuticals
Stephanie Prate, Tel. +49 30 468 196053
E-Mail: mailto:stephanie.prate@bayer.com 
This press release is available here:
http://www.baynews.bayer.de/baynews/baynews.nsf/id/2013-0359-e 
Yours BayNews Editorial Team 
Bayer AG
Communications
Building W11
51368 Leverkusen, Germany 
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