ESC issues position paper on new anticoagulants

Br J Cardiol 2012;19:57 Leave a comment
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In a new position paper, the European Society of Cardiology welcomes the new oral anticoagulants for use in atrial fibrillation (J Am Coll Cardiol 2012;59:1413–25).

Of the three new drugs, the paper appears to particularly highlight apixaban saying it “is currently the best-documented alternative to both warfarin and aspirin for stroke prevention in a broad population with AF”.

It adds that “apixaban has been shown to be superior compared with warfarin concerning the reduction of stroke and mortality in combination with a reduction in major bleeding, with a bleeding risk similar to that of low-dose aspirin, and with better tolerability than both these alternatives, albeit with no reduction in ischaemic stroke compared with warfarin”.

The paper says dabigatran 150 mg is also a well-documented alternative to warfarin “based on its reduction of haemorrhagic stroke as well as of ischaemic stroke and systemic embolism, with a similar risk of major bleeding and a reduced risk of intracranial bleeding”. But it points out that dabigatran is associated with some specific side effects, such as dyspepsia and gastrointestinal bleeding, a trend toward an increased risk of myocardial infarction and needs caution in patients with impaired renal function.

The position paper notes that rivaroxaban has a once daily dose regimen, which may improve compliance, and was “noninferior to warfarin concerning stroke prevention and major bleeding, with a lower risk of intracranial but a higher rate of gastrointestinal bleeding”.

Who to treat

On who should receive these new drugs first, the position paper notes that new patients and those not well managed on wafarin are the obvious candidates. It adds that patients already on long-term warfarin with well-controlled INRs and handling the monitoring without problems derive “uncertain overall advantages” from switching to the new oral anticoagulants.

NICE issues guidance on dabigatran

The National Institute for Health and Clinical Excellence (NICE) has issued its final technology appraisal on dabigatran etexilate (Pradaxa®, Boehringer Ingelheim) recommending it as a possible treatment to prevent stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) and one or more risk factors. NICE said its cost was justified by the benefits it provides compared with other treatments on the NHS.

NICE said the decision about whether to start treatment with dabigatran etexilate should be made after an informed discussion between the clinician and the person about the risks and benefits of dabigatran etexilate compared with warfarin. Full guidance is available at

Since the NICE announcement, Boehringer Ingelheim have reduced the NHS cost of dabigatran from £2.52 to £2.20 per day.