10 April 2012
New Drug for Stroke Prevention Approved by NICE
Patients with atrial fibrillation can now be offered the drug dabigatran (Pradaxa) as an alternative to warfarin in order to reduce the risk of stroke and blood clots, says NICE.
Atrial fibrillation (AF) is a condition affecting the heart causing it to beat irregularly, and occasionally, too fast. When this happens the heart cannot efficiently pump blood around the body.
People with AF are at higher risk of developing blood clots and subsequent stroke. The risk of stroke can be reduced substantially through anticoagulants such as warfarin.
Warfarin has been a routine medication for preventing strokes. But it is inconvenient for some patients because careful monitoring and regular blood tests are needed to prevent excessive bleeding from cuts or stomach ulcers, requiring frequent clinic visits.
Dabigatran is the first new treatment in 50 years to be approved for the prevention of stroke in patients with AF.
The drug is a type of anticoagulant, taken orally, that inhibits the thrombin enzyme and so helps prevents blood from clotting.
In final guidance, NICE recommends that the drug be offered as an option for preventing stroke and blood clots for people with nonvalvular atrial fibrillation who have one or more of certain risk factors.
These include if the patient has had a stroke, a transient ischaemic attack (mini stroke) or embolism in the past, their left ventricular ejection fraction is below 40 per cent, they have had heart failure of New York Heart Association class 2 or above, are 75 or older, or 65 or older with either diabetes mellitus, coronary artery disease or hypertension.
NICE also says that the decision as to whether to start the treatment with dabigatran should be taken after a discussion over its risks and benefits in comparison with warfarin.
These risks and benefits should be considered in light of the person's international normalised ration (INR), in other words, how fast their blood clots.
Professor Carole Longson, Health Technology Evaluation Centre Director, said: "AF 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 useful alternative option for people with atrial fibrillation.”
Professor Longson said that The Independent Appraisal Committee had looked at evidence from clinical trials that showed the dabigatran is more clinically effective than warfarin in reducing the risk of stroke or systemic embolism, and that dabigatran 110 mg twice daily is as effective as warfarin.