Briefing Note: rivaroxaban (Xarelto) AF

SMC accepted rivaroxaban for restricted use in the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age = 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. Use is restricted to patients who have poor INR control (a measure of how blood is clotting) despite evidence that they are complying with a coumarin anticoagulant and in patients who are allergic to or unable to tolerate coumarin anticoagulants.

• Blood clotting is the normal mechanism the body uses to give protection against blood loss following injury to a vein or artery (blood vessels). A blood clot causing a blockage in any artery (other than those in the lungs) is called a systemic embolism. If the embolism occurs in the arteries of the brain it prevents its supply of oxygen and can cause a stroke. Blood thinning drugs (known as anticoagulants) are used to reduce the risk of these events happening. Warfarin is a type of anticoagulant known as a coumarin anticoagulant and it is currently the most commonly used anticoagulant.
• Rivaroxaban is a blood-thinning medicine used to prevent harmful blood clots forming. It works by blocking Factor Xa, which is an important component in blood clotting. It is given as a tablet.
• Rivaroxaban has previously been accepted by SMC for the prevention of venous thromboembolism (VTE) in adults undergoing hip and knee surgery. It has now also been licensed for use in the prevention of stroke and systemic embolism in adults with non-valvular atrial fibrillation.
• A study showed that rivaroxaban worked as well as standard therapy for the prevention of systemic embolism.
• A side effect of all blood-thinning drugs can be unwanted bleeding. The risk of unwanted bleeding in patients taking rivaroxaban appears to be similar to that in patients taking warfarin.
• SMC accepted rivaroxaban for restricted use in the prevention of stroke and systemic embolism because it offers value for money in patients who have poor INR control despite evidence that they are complying with a coumarin anticoagulant and in patients who are allergic to or unable to tolerate coumarin anticoagulants.

21 February 2012