Boehringer Ingelheim to unveil new data on the novel oral anticoagulant (NOAC) Pradaxa® (dabigatran etexilate) during the ESC Congress 2013 in Amsterdam

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Ingelheim, Germany, 26-8-2013 — /EuropaWire/ — 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.

Professor Klaus Dugi

“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:
http://spo.escardio.org/default.aspx?eevtid=60

TITLE LEAD AUTHOR DETAILS
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 – CentralVillage
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.

 

NOTES TO THE EDITORS

About Pradaxa® (dabigatran etexilate)
Pradaxa® is approved in over 100 countries worldwide.2 It is licensed for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and for the primary prevention of venous thromboembolism in patients undergoing total hip replacement or total knee replacement surgery.1

Pradaxa®, a direct thrombin inhibitor (DTI),3 was the first of a new generation of direct oral anticoagulants targeting a high unmet medical need in the prevention and treatment of acute and chronic thromboembolic diseases.

Potent antithrombotic effects are achieved with direct thrombin inhibitors by specifically blocking the activity of thrombin (both free and clot-bound), the central enzyme in the process responsible for clot (thrombus) formation. In contrast to vitamin-K antagonists, which variably act via different coagulation factors, dabigatran etexilate provides effective, predictable and consistent anticoagulation with a low potential for drug-drug interactions and no drug-food interactions, without the need for routine coagulation monitoring or dose adjustment.

Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 140 affiliates and more than 46,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim’s endeavors.In 2012, Boehringer Ingelheim achieved net sales of about 14.7 billion euro. R&D expenditure in the business area Prescription Medicines corresponds to 22.5% of its net sales.

References
1Pradaxa European Summary of Product Characteristics, 2013
2Boehringer Ingelheim data on file.
3Di Nisio M, et al. Direct thrombin inhibitors. N Engl J Med. 2005;353:1028-40.

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