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Bayer's Xarelto® (rivaroxaban) Becomes First Fixed Dose Once-Daily Anticoagulant Tablet Approved in the UK for Stroke Prevention in non-valvular Atrial Fibrillation; and the First Single Drug Regimen for Deep Vein Thrombosis
Date:12/19/2011

F patients, especially those with a higher risk profile and with significant co-morbidities, tend to require more frequent INR testing. These additional tests have a significant impact on these patients' quality of life as well as on NHS resources, so the approval of new therapies to prevent stroke in atrial fibrillation are welcome."

Xarelto is the first in a class of drugs known as Factor Xa (ten-A) inhibitors, which act at a critical point in the blood-clotting (coagulation) process to prevent the formation of clots. The features of Factor Xa inhibitors include predictable effects, convenient oral dosing and a lower risk of drug-drug interactions as compared to VKA antagonists, meaning they do not require frequent dose adjustments or routine anticoagulation monitoring. Rivaroxaban will be made available at a fixed price of £2.10 per tablet. This provides the NHS with an effective and simple to use non Vitamin K antagonist (VKA) oral anticoagulant in the UK. For the majority of patients with AF a 20mg dose is appropriate, with a 15mg dose recommended in patients with reduced kidney function.

The most widely-prescribed drug in the UK for the prevention of stroke in patients with AF is warfarin. Warfarin is a highly effective stroke prevention therapy, but is subject to limitations including unpredictable anticoagulant effects which can cause difficulties in maintaining an appropriate therapeutic range, as well as a requirement for frequent routine coagulation monitoring. Additionally, for some patients warfarin can interact with numerous drugs and a wide array of food and drink.

The current standard of care for the treatment of DVT is the dual-drug approach of heparin, which acts quickly to provide an anti-clotting effect, followed by warfarin, which can take several days to begin working. Heparin requires administration by subcutaneous injection, which, although effective, can cause inconvenience, bruising and discomfort. Oral rivaroxaban
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SOURCE Bayer UK
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