UK’s NICE releases final guidance on rivaroxaban for prevention of stroke and systemic embolism in people with atrial fibrillation

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On 23 May, the UK’s National Institute for Health and Clinical Excellence (NICE) published final guidance recommending rivaroxaban (Xarelto, Bayer HealthCare) as an option for the prevention of stroke and systemic embolism in people with atrial fibrillation.

The guidance recommends rivaroxaban for people with non-valvular atrial fibrillation who have one or more risk factors such as congestive heart failure, hypertension, age 75 years or older, diabetes mellitus, prior stroke or transient ischaemic attack.

The guidance states that the decision about whether to start treatment with rivaroxaban should be made after an informed discussion between the clinician and the person about the risks and benefits of rivaroxaban compared with warfarin. It also recommends that for people who are taking warfarin, the potential risks and benefits of switching to rivaroxaban should be considered in light of their level of international normalised ratio (INR) control.


“We know that some people taking warfarin can find it difficult to maintain their blood clotting at a proper level. Rivaroxaban, like dabigatran etexilate*, which NICE recently approved as an option for this indication, can benefit people with atrial fibrillation. We are therefore pleased to recommend rivaroxaban as another cost-effective option for the prevention of stroke and systemic embolism in people with atrial fibrillation,” said Carole Longson, director, NICE Health Technology Evaluation


The Scottish Medicines Consortium published guidance in February 2012 accepting rivaroxaban for use in patients who have poor INR control despite evidence that they are complying with a coumarin anticoagulant [such as warfarin] and in patients who are allergic to or unable to tolerate coumarin anticoagulants.


On 22 April 2009, NICE recommended rivaroxaban for the prevention of venous thromboembolism in adults having elective total hip replacement surgery or elective total knee replacement surgery. The full guidance on this indication is available here.

The full guidance on NICE’s recommendation of rivaroxaban for prevention of stroke and systemic embolism in people with atrial fibrillation is available here.


*On 15 March 2012, NICE published its final guidance recommending dabigatran (Pradaxa, Boehringer Ingelheim) for the latest indication of rivaroxaban.

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