New atrial fibrillation treatment approved

1st November 2011 - A Stroke charity is welcoming the decision to offer a new treatment for atrial fibrillation by the NHS.

The National Institute for Health and Clinical Excellence (NICE) is recommending dabigatran (Pradaxa) for the prevention of stroke and systemic embolism in people with atrial fibrillation.

Atrial fibrillation (AF)

Atrial fibrillation happens when the electrical impulses controlling the heart rhythm become disorganised, so that the heart beats irregularly and, sometimes, too fast. If this happens it cannot pump blood around the body efficiently.

People with atrial fibrillation are at higher risk of developing blood clots and suffering a stroke. Anticoagulant treatment like warfarin can cut stroke risk.

Dabigatran

Dabigatran is given as capsules and works as an anticoagulant preventing the formation of the thrombin enzyme.

It is licenced in the UK for the prevention of stroke and systemic embolism in patients aged 75 years and over with nonvalvular atrial fibrillation who have had a previous stroke, transient ischaemic attack or systemic embolism, and some other heart conditions.

It is also licenced for people with AF aged 65 years or over who have diabetes, coronary heart disease or hypertension (high blood pressure).

The final draft guidance also recommends that the decision about whether to start treatment with dabigatran should be made discussions about the risks and benefits of dabigatran compared with warfarin. A patient's current INR control readings should also be taken into account if they are already taking warfarin.

Cost effective

In a statement, Professor Carole Longson, NICE Health Technology Evaluation Centre Director, says: "Atrial fibrillation can be a distressing condition and people with it have an increased risk of suffering a stroke. Many people with the condition find it difficult to comply with the most commonly used antithrombotic, warfarin, because, among other things, it requires regular INR monitoring and dose adjustments which can cause disruption and inconvenience.

"Because dabigatran does not require frequent blood tests to monitor treatment it represents a significant potential benefit for many people with AF."

NICE says the treatment will be cost effective to the NHS, with dabigatran (150 mg) twice daily being more clinically effective than warfarin in reducing the risk of stroke or systemic embolism, and dabigatran (110 mg) twice daily being as effective as warfarin.

The treatment will cost around £920 per patient a year. NICE will issue final guidance in December, until then local NHS organisations will continue to make their own decisions about funding the treatment.

Reaction

In a statement, Joe Korner, Director of Communications from The Stroke Association says: "For a long time there has been a need for useful alternative treatments to warfarin that can be used when warfarin is not appropriate.  We welcome this decision from NICE and are pleased that patients and doctors now have a new alternative treatment.  However, it’s important to note that this new medication won’t be suitable for all and every AF patient needs to be treated on a case by case basis to ensure that they receive the best possible treatment for them."

The Stroke Association believes warfarin is often underused by health professionals. In recent research conducted for the charity only 40% of GPs said they would treat AF patients with warfarin.