Results from Phase III Pooled EINSTEIN Studies Reaffirm Bayer's Xarelto(R) as an Effective Single-Drug Solution for Venous Thromboembolism
Results from Phase III Pooled EINSTEIN Studies Reaffirm Bayer's Xarelto(R) as an Effective Single-Drug Solution for Venous Thromboembolism
AsiaNet 54352
BERLIN, Sep. 20 /PRN=KYODO JBN/ -
Not intended for U.S. and UK Media
Treatment and prevention of venous blood clots:
- 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'
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(R) (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.
To view the Multimedia News Release, please click:
http://www.multivu.com/mnr/62405-pooled-einstein-study-bayer-xarelto
"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(R) (Rivaroxaban)
Rivaroxaban is the most broadly indicated novel oral anticoagulant and is
marketed under the brand name Xarelto(R). 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.
Our online press service is just a click away: press.healthcare.bayer.com
Find more information at http://www.bayerpharma.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.
http://www.multivu.com/mnr/62405-pooled-einstein-study-bayer-xarelto
SOURCE: Bayer Healthcare
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