dabigatran (Pradaxa)

following a full submission

dabigatran etexilate (Pradaxa®) is accepted for use within NHS Scotland.

Indication under review: 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 <40%
• symptomatic heart failure, ≥ New York Heart Association (NYHA) Class 2
• age ≥75 years
• age ≥65 years associated with one of the following: diabetes mellitus, coronary artery disease or hypertension 

Dabigatran etexilate was at least as effective as standard oral anticoagulation at preventing stroke or systemic embolism in one large, open-label study in patients with atrial fibrillation and at least one risk factor for stroke. This was not associated with an increased risk of major bleeding.

The economics case made supports the use of the proposed sequenced dosing regimen (whereby the dose is reduced from 150mg twice daily to 110mg twice daily in patients aged ≥ 80 years).  This applies whether the alternative treatment is warfarin, aspirin or ‘no treatment’ (i.e. neither warfarin nor aspirin).