The Scottish Medicines Consortium (SMC) has accepted dabigatran etexilate (Pradaxa®) for use within NHS Scotland for the prevention of stroke and systemic embolism in adults with non-valvular atrial fibrillation (AF) 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

The drug advice (available via the link below) notes that a large, open-label study found dabigatran etexilate to be at least as effective as standard oral anticoagulation in the prevention of stroke or systemic embolism in patients with AF and at least one risk factor for stroke, with no increased risk of major bleeding.

The economic case supplied by the company supported the use of the proposed sequenced dosing regimen (reduced from 150mg to 110mg twice daily in patients aged ≥ 80 years), and that this applies regardless of the alternative treatment considered (warfarin, aspirin or ‘no treatment’).