NICE backs new oral anticoagulant for stroke prevention

The National Institute for Health and Clinical Excellence (NICE) has recommended the oral anticoagulant dabigatran etexilate (Pradaxa) for the prevention of stroke and systemic embolism in patients with atrial fibrillation. The appraisal committee said the drug is a useful alternative to the current standard treatment, warfarin, as it does not require regular blood tests to monitor treatment.

The committee concluded that dabigatran 150 mg twice daily was more clinically effective than warfarin in reducing the risk of stroke or systemic embolism, ischaemic stroke, and vascular mortality and that this represented an important development for people with atrial fibrillation. It also concluded that a lower dose of 110 mg twice daily is as effective as warfarin. The committee said both doses of dabigatran were associated with an increased risk of acute myocardial infarction compared with warfarin, but that this was not statistically significant.

Treatment with dabigatran does result in more gastrointestinal bleeding than warfarin, which may be the result of a local effect of the orally administered drug on the gastrointestinal mucosa. The committee, however, recognised the particular importance of the effects of dabigatran on reducing the risk of haemorrhagic stroke and intracranial haemorrhage for people with atrial fibrillation when compared with warfarin.

Adherence to warfarin treatment can be problematic as it is has numerous food and drug interactions that can have an impact on a patient’s work, social, and family life. It also needs regular monitoring and dose adjustments that can be disruptive.

The NICE recommendations state that the decision about whether to start treatment with dabigatran should be made after an informed discussion between doctor and patient about its risks and benefits compared with warfarin. For people who are already taking warfarin, the potential risks and benefits of switching to dabigatran should be considered in light of their current level of international normalised ratio control.

Carole Longson, director of the NICE Health Technology Evaluation Centre, said: “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 monitoring of international normalised ratio and dose adjustments, which can cause disruption and inconvenience.”

There are as many as 700 000 people with atrial fibrillation in England and Wales. The cost of a pack of 60 tablets of dabigatran is £75.60 (€90; $118) and the cost per day per patient is £2.52 based on the recommended dosage. NICE said its cost is justified by its benefits. It is within the range normally considered to be a cost effective use of NHS resources being less than £20 000 per QALY gained.

Joe Korner, director of communications at the Stroke Association, commented: “We welcome the decision by NICE to make this new medication available to atrial fibrillation patients through the NHS. However, it’s important to note that the medication won’t be suitable for all. Each atrial fibrillation patient needs to be treated as an individual case to ensure that they receive the best possible treatment for them.”

Dabigatran, made by Boehringer Ingelheim, inhibits the formation of the thrombin enzyme. It is authorised for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more of the following risk factors:

• previous stroke, transient ischaemic attack, or systemic embolism

• left ventricular ejection fraction below 40%

• symptomatic heart failure of New York Heart Association class 2 or above

• age 75 years or older

• age 65 years or older with one of the following: diabetes mellitus, coronary artery disease.

The Scottish Medicines Consortium already published guidance in September 2011 supporting the use of dabigatran for the prevention of stroke. In 2008 NICE published guidance recommending the drug as an option for the primary prevention of venous thromboembolic events in adults who have undergone hip replacement or total knee replacement surgery.