New Pradaxa® data to be presented at the ESC Congress 2014

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• HOTLINE: New results from RE-LY® compare the effect of warfarin and Pradaxa® on kidney function in patients requiring anticoagulation
• HOTLINE: GLORIA™-AF Registry Program benchmarks patient characteristics and antithrombotic use for stroke prevention in AF worldwide

For Non-US/Non-UK/Non-Canadian Media

Ingelheim, Germany, 25 August, 2014 – New Pradaxa® (dabigatran etexilate) data for the treatment of a broad range of thromboembolic diseases will be presented at the ESC Congress 2014, 30th August – 3rd September, 2014, Barcelona, Spain, organised by the European Society of Cardiology. Study results, including data being presented in two Hotline sessions, will provide further clinical insights for Pradaxa® and help inform future anticoagulation treatment decisions.

  • On August 31st, the Registry Hot Line session will reveal data from the first 10,000 patients included in the GLORIA™-AF Registry Program, which will provide insights into patterns of antithrombotic treatment use for stroke prevention in AF. 
  • On September 2nd, a Clinical Trial Update Hot Line session will announce new data from a RE-LY® sub-analysis comparing the effects of warfarin and Pradaxa® on kidney function in AF patients requiring anticoagulation. 
  • Further new data sets from company-sponsored studies involving Pradaxa® in AF, deep vein thrombosis and pulmonary embolism will also feature as poster and oral presentations during the ESC Congress 2014.

Abstracts are available from the ESC website at: http://spo.escardio.org/default.aspx?eevtid=69

In Barcelona, five years ago, the landmark RE-LY® study results were presented at the ESC Congress 2009. Since then, the RE-LY® findings have been reconfirmed in numerous sub-analyses, supported by Regulatory Authorities worldwide and were most recently replicated outside of a clinical study setting by an independent FDA assessment involving 134,000 Medicare patients.1-4

Boehringer Ingelheim will be hosting a media briefing during the ESC congress to present the new data, discuss how Pradaxa® is impacting patients in everyday clinical practice and give an update on the ongoing R&D programme including the progress of the investigational antidote idarucizumab. Medical media who are interested in attending the Boehringer Ingelheim briefing 'Setting the record straight, Pradaxa® protection today and tomorrow' on Monday 1st September, 14.00-15.00 in the Industry Press Conference Room, should contact pradaxa@ogilvy.com

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 3 million patient-years in all licensed indications worldwide. Pradaxa® has been in the market for more than 6 years and is approved in over 100 countries.5

Currently approved indications for Pradaxa® are:6,7

  • Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and a risk factor for stroke
  • Primary prevention of venous thromboembolic events in patients undergoing elective total hip replacement surgery or total knee replacement surgery
  • Treatment of DVT and PE and the prevention of recurrent DVT and PE in adults

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.6,8 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.9 In contrast to vitamin-K antagonists, which variably act via different coagulation factors, Pradaxa® provides effective, predictable and reproducible anticoagulation with a low potential for drug-drug interactions and no drug-food interactions, without the need for routine coagulation monitoring or mandatory dose adjustment.8,10

Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 142 affiliates and a total of more than 47,400 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.

Taking social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects, such as the initiative "Making more Health" and caring for the employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.

In 2013, Boehringer Ingelheim achieved net sales of about 14.1 billion euros. R&D expenditure corresponds to 19.5% of its net sales.

References
1European Medicines Agency Press Release - 25 May 2012: EMA/337406/2012. European Medicines Agency updates patient and prescriber information for Pradaxa. http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/05/news_detail_001518.jsp&mid=WC0b01ac058004d5c1 Last accessed: July 2014.
2FDA Drug Safety Communication: Update on the risk for serious bleeding events with the anticoagulant Pradaxa (dabigatran) – 2 November 2012 http://www.fda.gov/Drugs/drugsafety/ucm326580.htm Last accessed: July 2014.
3FDA Director Communication: Atrial fibrillation and new oral anticoagulant drugs – 17 July 2014. http://www.fda.gov/Drugs/NewsEvents/ucm405148.htm Last accessed: July 2014
4FDA Drug Safety Communication: FDA study of Medicare patients finds risks lower for stroke and death but higher for gastrointestinal bleeding with Pradaxa (dabigatran) compared to warfarin – 13 May 2014. http://www.fda.gov/drugs/drugsafety/ucm396470.htm Last accessed: July 2014
5Boehringer Ingelheim Data on File.
6Pradaxa® European Summary of Product Characteristics, 2014.
7PRADAXA® Prescribing Information, 2014. Available at: http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing%20Information/PIs/Pradaxa/Pradaxa.pdf. Last accessed: July 2014.
8Stangier J. Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate. Clin Pharmacokinet. 2008;47(5):285–95.
9Di Nisio M, et al. Direct thrombin inhibitors. N Engl J Med. 2005;353:1028–40.
10Stangier J, et al. Pharmacokinetic Profile of the Oral Direct Thrombin Inhibitor Dabigatran Etexilate in Healthy Volunteers and Patients Undergoing Total Hip Replacement. J Clin Pharmacol. 2005;45:555–63.

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