New Pradaxa® data to be presented during the American College of Cardiology’s 63rd Annual Scientific Session

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

Ingelheim, Germany, 24 March 2014 – Boehringer Ingelheim has today announced that new findings from ongoing Pradaxa® (dabigatran etexilate) research will be presented during the American College of Cardiology's 63rd Annual Scientific Session (ACC.14) in Washington, USA, 29 – 31 March 2014. The data form part of Boehringer Ingelheim's ongoing commitment to scientific innovation and advancing patient care.

Data from three separate company-sponsored Pradaxa®-related studies will be announced during the congress. The presentations will cover subgroup results from the pivotal RE-LY® trial, evaluating the use of Pradaxa® compared to warfarin in patients with atrial fibrillation and valvular heart disease*.1 An oral presentation will highlight new data from pre-clinical research into an investigational antidote for Pradaxa®.2 Furthermore, first data from GLORIA™-AF, one of the largest worldwide atrial fibrillation registries will be announced.3 The GLORIA™-AF registry programme is expected to provide meaningful knowledge on the global role and use of antithrombotic treatments in protecting patients with atrial fibrillation against the devastating effects of stroke.4

Professor Klaus Dugi
Professor Klaus
Dugi

"The American College of Cardiology's 63rd Annual Scientific Session provides a key opportunity to share new data with physicians to increase understanding of the latest developments in the field of anticoagulation," said Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim. "At Boehringer Ingelheim we are proud of our commitment to driving research and innovation in the cardiovascular area. We hope this new data will support ongoing efforts to improve patient outcomes, especially in the area of stroke prevention in atrial fibrillation."

Details of the Pradaxa® abstracts to be presented during the American College of Cardiology's 63rd Annual Scientific Session can be found within the Scientific Programme, available at:

http://accscientificsession.acc.org/ACC.aspx

Additional information about Pradaxa® will be available at the Boehringer Ingelheim booth #3227 at the American College of Cardiology’s 63rd Annual Scientific Session.

NOTES TO THE EDITORS

About Pradaxa® (dabigatran etexilate)
Clinical experience of Pradaxa® (dabigatran etexilate) exceeds that of all other novel oral anticoagulants, equating to over 2.7 million patient-years in all licensed indications worldwide.5 Currently approved indications for Pradaxa® are:6

  • Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF) and a risk factor for strok
  • Primary prevention of venous thromboembolic events in patients undergoing elective total hip replacement surgery
  • Primary prevention of venous thromboembolic events in patients undergoing elective total knee replacement surgery

In June 2013 Boehringer Ingelheim started submitting new applications to regulatory authorities for Pradaxa® for the following indications:5

  • Treatment of acute deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of related death
  • Prevention of recurrent deep vein thrombosis and pulmonary embolism and related death

Pradaxa®, a direct thrombin inhibitor (DTI), was the first widely approved drug in a new generation of direct oral anticoagulants, available to target a high unmet medical need in the prevention and treatment of acute and chronic thromboembolic diseases.6,7 Potent antithrombotic effects are achieved with direct thrombin inhibitors by specifically blocking the activity of thrombin, the central enzyme in the process responsible for clot (thrombus) formation.8 In contrast to vitamin-K antagonists, which are highly unpredictable in their anticoagulant effect for numerous drug-drug and drug-food interactions, Pradaxa® provides effective, predictable and reproducible anticoagulation with a favourable safety profile and a low potential for drug-drug interactions and no drug-food interactions, without the need for routine coagulation monitoring or dose adjustment.7,9

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.

Social responsibility is a central element of Boehringer Ingelheim's culture. 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.

Please be advised
This release is from Boehringer Ingelheim Corporate Headquarters in Germany. Please be aware that there may be national differences between countries regarding specific medical information, including licensed uses. Please take account of this when referring to the information provided in this document. This press release is not intended for distribution within the U.S., the UK or Canada

Referências

  1. Ezekowitz M, et al. Comparison of Dabigatran versus Warfarin in Patients with Atrial Fibrillation and Valvular Heart Disease: The RE-LY®Trial. Poster Presentation #115 at 9:30am-12:30pm EDT, Saturday 29 March 2014 in Hall C at the American College of Cardiology’s 63rd Annual Scientific Session, Washington, USA.
  2. Grottke O, et al. A Specific Antidote to Dabigatran Reduces Blood Loss in Dabigatran- and Trauma-induced Bleeding in Pigs. Oral Presentation Session #921 at 10:45am EDT, Sunday 30 March 2014 in Room 145B at the American College of Cardiology’s 63rd Annual Scientific Session, Washington, USA.
  3. Rothman K, et al. The Global Registry Program on Long-Term Oral Anti-Thrombotic Treatment in Patients with Atrial Fibrillation (GLORIA-AF): First Assessment of Baseline Characteristics of Dabigatran and VKA Cohorts in North America. Poster Presentation #104 at 1:30pm-4:30pm, Sunday 30 March 2014 in Hall C at the American College of Cardiology’s 63rd Annual Scientific Session, Washington, USA.
  4. GLORIA-AF Registry website. https://www.gloria-af.com/public/about-objectives.html Last accessed 19 March 2014.
  5. Boehringer Ingelheim data on file.
  6. Pradaxa® European Summary of Product Characteristics 2013.
  7. Stangier J. Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate. Clin Pharmacokinet. 2008;47(5):285–95.
  8. Di Nisio M, et al. Direct thrombin inhibitors. N Engl J Med. 2005;353:1028–40.
  9. Stangier J, et al. Pharmacokinetic Profile of the Oral Direct Thrombin Inhibitor Dabagitran Etexilate in Healthy Volunteers and Patients Undergoing Total Hip Replacement. J Clin Pharmacol. 2005;45:555–63.