Xarelto promising venous blood clot treatment

BERLIN – Data from the Phase III EINSTEIN clinical trial programme published 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.

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.

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.

Pooled analysis from EINSTEIN

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-infeADIDAS