Monday, November 25, 2013

Pradaxa® (dabigatran etexilate) 150mg bid continues to be the only oral anticoagulant which showed superior ischaemic stroke reduction vs. warfarin in its pivotal study RE-LY®

Results of the ENGAGE AF-TIMI 48 trial published for edoxaban vs. warfarin do not change the position of Pradaxa®

INGELHEIM, Germany - Monday, November 25th 2013 [ME NewsWire]

    Presented at the American Heart Association’s Scientific Sessions 2013, results from the large-scale phase III trial ENGAGE AF-TIMI 48 demonstrate non-inferiority of edoxaban compared with warfarin for prevention of stroke in patients with non-valvular atrial fibrillation (AF)1,2
    With data now available from all four trials of novel oral anticoagulants (NOACs) for stroke prevention in atrial fibrillation,1-6 Pradaxa® (dabigatran etexilate) 150mg bid continues to be the only NOAC, study of which showed a significant reduction of both ischaemic and haemorrhagic strokes compared to warfarin in its pivotal trial RE-LY®3,4
    RE-LY® was a global, phase III, PROBE (prospective, randomized, open-label with blinded endpoint evaluation) design trial comparing two fixed doses of the oral direct thrombin inhibitor Pradaxa® (110mg and 150mg bid) each administered in a blinded manner, with open label warfarin.3,4,7 Pradaxa® 110mg bid, which is indicated for certain patients,8 showed non-inferior efficacy versus warfarin for reducing risk of stroke3,4

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Prevention of ischaemic stroke (a stroke caused by a blood clot)9 is the reason to treat patients with atrial fibrillation (AF) with an anticoagulant treatment.10 Examining all phase III trial analyses now available (RE-LY®3,4 [Pradaxa® (dabigatran etexilate)], ROCKET-AF5 [rivaroxaban], ARISTOTLE6 [apixaban]) as well as ENGAGE-AF-TIMI 481,2 [edoxaban], for which new data were presented on 19 November at the American Heart Association’s Scientific Sessions), Pradaxa® 150mg bid continues to be the only NOAC to offer a statistically significant superior reduction in the risk of ischaemic stroke versus well controlled warfarin.3,4 In all of the trials, ischaemic stroke was included as part of the composite of stroke (ischaemic and haemorrhagic or systemic embolism), the primary study outcome.1-6

In the RE-LY® (Randomized Evaluation of Long term anticoagulant therapY) trial, Pradaxa® 150mg bid demonstrated a 25% reduction in the risk of ischaemic strokes and a 74% reduction in the risk of haemorrhagic strokes versus warfarin. Furthermore, rates of total bleeds and life threatening bleeds were significantly reduced versus warfarin.3,4 Pradaxa® 110mg bid, which is indicated for certain AF patients,8 showed non-inferior efficacy versus warfarin for reducing risk of stroke with significantly reduced rates of total and major bleeds.3,4

“With its positive efficacy and safety profile which is well established worldwide, Pradaxa® offers substantial advantages over warfarin for AF patients requiring anticoagulant treatment,” stated Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. “The breakthrough results of the RE-LY® trial as well as numerous additional data support the breadth of benefit that Pradaxa® offers to AF patients, including superior protection against ischaemic stroke compared to warfarin.”

With over 9 out of 10 strokes suffered by patients with AF being of ischaemic type,11 protection against ischaemic stroke is the key clinical benefit that should be achieved by anticoagulant treatment.12 Ischaemic strokes associated with AF are often fatal, and those patients who survive are on average left more disabled by their stroke and have a higher likelihood of stroke recurrence than patients with other causes of stroke.12

“Trying to prevent ischaemic stroke, so the stroke caused by the blood clot that can form in the hearts of patients with atrial fibrillation, is the reason why we treat these patients with oral anticoagulants,” commented Professor Hans-Christoph Diener, Professor of Neurology and Chairman of the Department of Neurology, University of Essen, Germany.

A draft guideline from the European Medicines Agency, which is currently undergoing public consultation, further highlights the importance of ischaemic stroke prevention. The draft guideline recommends that Phase III trials of anticoagulant treatments for patients with AF should be designed to include a primary composite efficacy endpoint that shows a treatment’s ability to reduce the number of thromboembolic events, including ischaemic strokes, undefined strokes and systemic embolic events (SEE).12

The efficacy and safety profile of Pradaxa® in its licensed indications is well documented in the extensive RE-VOLUTION® clinical trial programme which will include over 55,000 patients worldwide3,4,13-23 and has led to regulatory approvals in over 100 countries to date.22 The favourable benefit-risk profile of Pradaxa® is supported by assessments from regulatory authorities including the European Medicines Agency and the U.S. Food and Drug Administration (FDA).24,25 Clinical experience with Pradaxa® continues to grow and equates to over 2 million patient-years in all licensed indications to date supporting Pradaxa® as the leading novel oral anticoagulant.22

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


Boehringer Ingelheim Corporate Communications Media + PR

Sara McClelland

Phone: +49 6132 – 77 8271

Fax: +49 6132 – 77 6601



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