Pradaxa® (dabigatran etexilate) – first new oral anticoagulant in nearly 60 years receives final NICE recommendation for stroke prevention in atrial fibrillation in the UK1

INGELHEIM, Germany - Monday, March 19th 2012 [ME NewsWire]

(BUSINESS WIRE)-- For NON-US, NON-UK & NON- Canadian Healthcare Media Only

On 15 March, the National Institute for Health and Clinical Excellence (NICE) has issued final guidance recommending the novel oral anticoagulant, Pradaxa® (dabigatran etexilate)2 as a cost-effective option for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) and one or more risk factors.1

This landmark decision means Pradaxa® must now be made available for use by the UK National Health Service (NHS) and that patients have the right to receive it if clinicians deem it clinically appropriate.

Professor Gregory Lip, Consultant Cardiologist & Professor of Cardiovascular Medicine, University of Birmingham Centre for Cardiovascular Sciences, Birmingham, United Kingdom commented, “The final NICE recommendation of dabigatran etexilate in the UK represents a major advance in the treatment of this condition. NICE estimates that only half of eligible patients receive warfarin due to the treatment having many limitations such as the need for regular monitoring and various food-drug and drug-drug interactions. This means that many AF patients are not currently taking an anticoagulant and may therefore be at an increased risk of stroke. The approval of dabigatran etexilate has the potential to significantly reduce the risk of stroke in patients with AF who are eligible for anticoagulation therapy.”

AF affects around 1% of the total population worldwide with approximately 1.2 million people diagnosed with AF in the UK alone,4 of which 77% are eligible for treatment with an anticoagulant.5 AF increases the risk of stroke by five-fold,3,6 with AF-related stroke tending to be severe and associated with a likelihood of death (20%) and disability (60%).7

Pradaxa® is now the only novel oral anticoagulant recommended for use in the UK for the prevention of stroke in AF, offering the first treatment alternative to current standard of care warfarin. This is an important landmark given that the use of Pradaxa® 150mg twice daily has the potential to prevent 470 more strokes per 100,000 patients every year compared to warfarin.8-11

The final NICE guidance of Pradaxa® for stroke prevention in AF is based on the groundbreaking results from RE-LY®, one of the largest studies ever conducted in AF including over 18,000 patients. RE-LY® was a PROBE (prospective, randomized, open-label with blinded endpoint evaluation) trial, comparing two fixed doses of the oral direct thrombin inhibitor dabigatran etexilate (110mg and 150mg bid) each administered in a blinded manner, with open label warfarin.9,10,12

Pradaxa® 150mg bid is the only novel oral anticoagulant proven superior to well-controlled warfarin (median TTR 67%12) in significantly reducing both ischaemic and haemorrhagic stroke in patients with non-valvular AF.9,10 Pradaxa® 150mg bid reduced the risk of stroke and systemic embolism by 35% while also significantly lowering the risk of life-threatening and intracranial bleeding, compared to well-controlled warfarin.9,10 The novel treatment also does not require frequent coagulation monitoring or routine dose adjustment and has no known dietary restrictions, which can be associated with warfarin.

Pradaxa® is also approved in the UK (by NICE) for the primary prevention of venous thromboembolic events (blood clots) in adults who have undergone elective total hip or elective total knee replacement surgery.13

~ENDS~

Please click on the link below for ‘Notes to Editors’ and ‘References’:

http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2012/16_march_2012_dabigatranetexilate.html

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