Monday, August 26, 2013

ESC Congress 2013: New data provide evidence for the positive safety and efficacy profile of Pradaxa in various atrial fibrillation patient populations

ME Newswire/ Business Wire

INGELHEIM, Germany - Monday, August 26th 2013

For media outside of the US, the UK & Canada only

Boehringer Ingelheim today announced the upcoming presentation of new data on the novel oral anticoagulant (NOAC) Pradaxa® (dabigatran etexilate) during the ESC Congress 2013 organised by the European Society of Cardiology (August 31 – September 4, Amsterdam, The Netherlands). The new data will add to the already available extensive body of knowledge on Pradaxa®’s positive safety and efficacy profile.

Boehringer Ingelheim remains committed to advancing the cardiology field and supporting physicians in their search for optimal stroke protection. Data being presented at the ESC Congress 2013 will complement the ongoing clinical trial programme of Pradaxa®, including results from the pivotal RE-LY® trial and the only long-term NOAC study, RELY-ABLE®, as well as new preclinical research on the company’s investigational antibody fragment antidote for dabigatran.

“The breadth of data being presented for Pradaxa® at this year’s ESC Congress 2013 demonstrates Boehringer Ingelheim’s continued dedication to improving the lives of patients with cardiovascular disorders. Our extensive and ongoing investment into clinical research will provide additional evidence on the positive efficacy and safety profile of Pradaxa® as well as important insights on its use in a wide range of patients and clinical settings”, said Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim.

Details of the key Pradaxa® abstracts being presented at the ESC Congress 2013 are listed below. Further information and the full list of abstracts can be found within the Scientific Programme, available at:




Management of dyspepsia symptoms on dabigatran during RELY-ABLE: long-term follow up study after RE-LY

Robby Nieuwlaat (Hamilton, CA)

Poster Presentation ESC Number: P549 Poster Session 1: Arrhythmias – Pacing – Resynchronisation Date: 31 August Display Time: 14:00-18:00 Presentation Time: 15:30-16:30 Location: Posters – Village 9

Effects of the direct thrombin inhibitor dabigatran etexilate vs warfarin on platelet function in patients with atrial fibrillation

Giulia Renda (Chieti, IT)

Poster Presentation ESC Number: P1430 Poster Session 2: Treatment of Hypertension Date: 1 September Display Time: 08:30-12:30 Presentation Time: 10:00-11:00 Location: Posters – Village 9

RE-ALIGN: Dabigatran in patients with a mechanical heart valve

Frans Van de Werf (Leuven, BE)

Hot Line Presentation ESC Number: 937 Hot Line 1: Late Breaking Trials on Thrombosis Date: 1 September Time: 11:54-12:06 Location: Amsterdam – Central Village

Guidance adherent dabigatran etexilate treatment versus warfarin in the RE-LY population: an analysis on the basis of the European label recommendations for dabigatran etexilate

Gregory Y H Lip (Birmingham, GB)

Poster Presentation ESC Number: P4278 Poster Session 5: Atrial Fibrillation: New Insights Date: 2 September Display Time: 14:00-18:00 Presentation Time: 15:30-16:30 Location: Posters – Village 9

Reversal of dabigatran clotting activity in the rat ex vivo by a specific and selective antibody fragment antidote: are there non-specific effects on warfarin, rivaroxaban and apixaban?

Joanne Van Ryn (Biberach, DE)

Poster Presentation ESC Number: P4848 Poster Session 6: Thrombosis and Antithrombotic Therapy Date: 3 September Display Time: 08:30-12:30 Presentation Time: 10:00-11:00 Location: Posters – Village 9

Pradaxa® is widely approved for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and for primary prevention of VTE following total hip replacement or total knee replacement surgery.1 The extensive in-market experience of over 2 million patient-years in all licensed indications puts Pradaxa® first among the novel oral anticoagulants.2 In addition, Boehringer Ingelheim recently started submitting applications to regulatory authorities for the use of Pradaxa® in the acute treatment and prevention of recurrent deep vein thrombosis and pulmonary embolism.

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


Boehringer Ingelheim GmbH

Sara McClelland

Corporate Communications

Media + PR

Phone: +49 6132 – 77 8271



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