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/ -

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    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.

    sp (2013-0359E)

    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