Results from Phase III Pooled EINSTEIN Studies Reaffirm Bayer's Xarelto(R) as an Effective Single-Drug Solution for Venous Thromboembolism

BERLIN, Sept. 21, 2013 /PRNewswire/ --

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^® (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.

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"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 54^th 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