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Boehringer Ingelheim. (6/21/17). "Press Release: New Data Reveal High Rates of Stroke History in Asymptomatic Atrial Fibrillation Patients". Ingelheim.

Organisation Organisation Boehringer Ingelheim (Group)
Products Product Pradaxa®
  Product 2 clinical research
Person Person Kreuzer, Jörg (Boehringer Ingelheim 201604 VP Medicine, Therapeutic Area Cardiovascular)
     


• Findings from global observational study, GLORIA™-AF, reinforce the high need for screening programmes1

• Data presented at EHRA-EUROPACE CARDIOSTIM 2017 and selected for Highlights Session1


Boehringer Ingelheim today announced findings from GLORIA™-AF which show that people with non-valvular atrial fibrillation (AF) with few or no symptoms are more likely to have had a stroke prior to AF diagnosis than symptomatic AF patients.1 This may be a consequence of asymptomatic AF patients taking longer to receive a diagnosis.

Dr. Steffen Christow, Cardiologist and Head of the Electrophysiology Lab at the Hospital Ingolstadt GmbH, Germany commented, “Without detection, AF patients remain at risk of stroke, which can be a debilitating, life-changing and potentially fatal condition. GLORIA™-AF underscores a public health need for AF screening programmes in high risk populations, so that people can be diagnosed early and receive appropriate anticoagulant therapy as well as risk factor management to reduce the risk of AF-related stroke and mortality.”

The sub-analysis of global registry programme GLORIA™-AF, one of the largest, observational studies collecting real-world safety, effectiveness and patient outcomes data on the long-term use of anticoagulants in patients with AF, compared patient characteristics of 6,011 patients with AF in Western Europe. 4,119 patients (69%) showed few or no symptoms and 1,892 patients (31%) reported symptoms at the point of diagnosis. Those patients without symptoms were more than twice as likely to have had a previous stroke (14.7% versus 6.0%).1

Professor Jörg Kreuzer, Vice President Medicine, Therapeutic Area Cardiovascular, Boehringer Ingelheim commented, “The GLORIA™-AF study is an important initiative and we are really pleased that these findings have been included in the EHRA Highlights Session today. We look forward to further results from GLORIA™-AF that will support physician prescribing decisions for stroke prevention. Future data analyses will include two year follow-up data from about 5,000 dabigatran patients from routine clinical practice worldwide.”

AF is the most common sustained heart rhythm condition worldwide,2 with numbers expected to rise in the coming years. Overall, people diagnosed with AF have a five-fold increased risk of stroke,3 which occurs when a blood clot blocks a vessel in the brain. Each year three million patients suffer AF-related strokes.4,5

Anticoagulation treatment options include vitamin K antagonists (VKAs) such as warfarin and the newer class of treatments, non-vitamin K oral anticoagulants (NOACs), such as dabigatran etexilate. Marketed as Pradaxa® by Boehringer Ingelheim, dabigatran etexilate was the first NOAC to be approved for stroke prevention in AF, which represented a major advancement in anticoagulation care. Pradaxa® is the only NOAC with an approved and widely available reversal agent, Praxbind® (idarucizumab).


NOTES TO THE EDITORS

About GLORIA™-AF (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation)

GLORIA™-AF is one of the largest worldwide registry programmes to investigate the long-term use of oral antithrombotic therapies in the prevention of non-valvular AF-related strokes in a routine clinical setting. The Registry examines physicians’ prescribing behaviours in treating AF, as well as the factors behind their prescribing decisions. The study is collecting long-term safety and effectiveness data on a range of antithrombotics, including warfarin, ASA (aspirin), and NOACs for stroke prevention in AF, as well as patient outcomes data.6,7

The Registry will enrol up to 56,000 patients newly diagnosed with AF at risk of stroke from up to 2,200 sites in nearly 50 countries.6 So far more than 38,000 patients have been included. Phase II of GLORIA™-AF began after the first NOAC, dabigatran etexilate, was approved in November 2011 in the U.S.8

For more information please visit:
https://www.gloria-af.com/public/about.html (link is external)


About dabigatran etexilate (Pradaxa®)

Clinical experience of dabigatran equates to over 6.9 million patient-years in all licensed indications worldwide.8 Dabigatran has been in the market for more than 8 years and is approved in over 100 countries.8

Currently approved indications for dabigatran are:9,10

> Prevention of stroke and systemic embolism in patients with non-valvular AF 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 recurrent PE in adults

Dabigatran, a direct thrombin inhibitor (DTI)11, 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. 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.12 In contrast to vitamin K antagonists, which variably act via different coagulation factors, dabigatran 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.12,13

Dabigatran is the only NOAC with an approved reversal agent.9,10,14,15 Praxbind® (idarucizumab) is approved for adult patients treated with Pradaxa® who require rapid reversal of its anticoagulant effects prior to urgent procedures/emergency surgery or in life threatening or uncontrolled bleeding.14,15


Boehringer Ingelheim

Innovative medicines for people and animals have for more than 130 years been what the research-driven pharmaceutical company Boehringer Ingelheim stands for. Boehringer Ingelheim is one of the pharmaceutical industry’s top 20 companies and to this day remains family-owned. Day-by-day, some 50,000 employees create value through innovation for the three business areas human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. In 2016, Boehringer Ingelheim achieved net sales of around 15.9 billion euros. With more than three billion euros, R&D expenditure corresponds to 19.6 per cent of net sales.

Social responsibility comes naturally to Boehringer Ingelheim. That is why the company is involved in social projects such as the “Making More Health” initiative. Boehringer Ingelheim also actively promotes workforce diversity and benefits from its employees’ different experiences and skills. Furthermore, the focus is on environmental protection and sustainability in everything the company does.

More information about Boehringer Ingelheim can be found on www.boehringer-ingelheim.com or in our annual report: http://annualreport.boehringer-ingelheim.com.


Intended audiences:

This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.


References

1. Christow. SP. et al. Increased Rate of Previous Stroke in Asymptomatic/Minimally Symptomatic versus Symptomatic Patients with Newly Detected Atrial Fibrillation in Western Europe – Results From the GLORIA-AF Registry. (Abstract 1669) Presented at EHRA-EUROPACE CARDIOSTIM, June 21 2017.
2. Lloyd-Jones. DM. et al. Lifetime risk for development of atrial fibrillation: the Framingham Heart Study. Circulation. 2004;110(9):1042-46.
3. Camm. AJ. et al. 2012 focused update of the ESC Guidelines for the management of atrial fibrillation. Eur Heart J. 2012;33(21):2719-47.
4. Kirchhof. P. et al. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J. 2016;37(38):2893-2962.
5. Atlas of Heart Disease and Stroke, World Health Organization, September 2004.
6. Huisman MV. et al. Design and rationale of Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation: A global registry program on long-term oral antithrombotic treatment in patients with atrial fibrillation. Am Heart J. 2014;167:329–34.
7. GLORIA-AF Registry website: Registry Design. https://www.gloria-af.com/public/about-regDesign.html Last accessed June 2017.
8. Boehringer Ingelheim, data on file.
9. Pradaxa® European Summary of Product Characteristics, 2017.
10. PRADAXA US Prescribing Information, 2014.
11. Stangier J. Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate. Clin Pharmacokinet. 2008;47(5):285–95.
12. Di Nisio M. et al. Direct thrombin inhibitors. N Engl J Med. 2005;353:1028–40.
13. Stangier 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.
14. Praxbind® European Summary of Product Characteristics, 2016.
15. PRAXBIND US Prescribing Information, 2015.


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Record changed: 2017-06-25

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