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23-05-2012 | Cardiology | Article

NICE publishes final guidance for rivaroxaban

Abstract

NICE guidance

MedWire News: The UK National Institute for Health and Clinical Excellence (NICE) has published its final guidance recommending rivaroxaban for the prevention of stroke and systolic embolism in atrial fibrillation (AF) patients.

The guidance states that patients are suitable for rivaroxaban treatment if they have AF without underlying valvular disease and at least one of the following risk factors: congestive heart failure, hypertension, diabetes, previous stroke or transient ischemic attack, or age 75 years or older.

It also states that the decision about whether to start treatment with the oral anticoagulant, which is marketed in the UK as Xarelto (Bayer Healthcare, Berkshire, UK), should be made after an informed discussion between the clinician and patient about the risks and benefits of rivaroxaban compared with warfarin.

In addition, the potential risks and benefits of switching to rivaroxaban should be considered in light of the international normalized ratio (INR) of the patient, NICE says.

The decision to recommend the drug for the indications of stroke and systolic embolism prevention in AF patients was made "because its cost is justified by the benefits it provides compared with other treatments available on the National Health Service," it adds.

The primary clinical evidence for the guidance came from the multicenter double-blind randomized controlled trial, ROCKET-AF (Rivaroxaban once daily oral direct factor Xa inhibitor compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation).

As reported previously by MedWire News, in the primary per-protocol analysis of this trial, which included 14,264 as-treated AF patients, stroke or systolic embolism occurred at rates of 1.7% per year in the rixaroxaban group and 2.2% per year in the warfarin group. This yielded a hazard ratio of 0.79 for the primary endpoint with rixaroxaban versus warfarin, which was statistically significant for noninferiority.

Commenting on the guidance, Carole Longson, Director of the NICE Health Technology Evaluation Centre, said: "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 AF."

"We are therefore pleased to recommend rivaroxaban as another cost-effective option for the prevention of stroke and systolic embolism in people with AF."

MedWire (www.medwire-news.md) is an independent clinical news service provided by Springer Healthcare Limited. © Springer Healthcare Ltd; 2012

By Piriya Mahendra

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