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Boehringer Ingelheim. (11/10/17). "Press Release: Boehringer Ingelheim Presents New Data for Pradaxa and Its Specific Reversal Agent Praxbind at AHA Scientific Sessions 2017". Ingelheim.

Organisations Organisation Boehringer Ingelheim (Group)
  Organisation 2 American Heart Association (AHA)
Products Product Pradaxa®
  Product 2 Praxbind®
Person Person Kreuzer, Jörg (Boehringer Ingelheim 201604 VP Medicine, Therapeutic Area Cardiovascular)
     


> Presentations of data sub-analyses in different therapeutic settings in atrial fibrillation, including for three major studies which have all been published in the New England Journal of Medicine this year

> Additional analyses from RE-DUAL PCI™, RE-CIRCUIT® and RE-VERSE AD™ will further broaden knowledge in anticoagulation care


Boehringer Ingelheim today announced that important sub-analyses from three major trials in anticoagulation care will be presented at the American Heart Association (AHA) Scientific Sessions 2017 in Anaheim, California, 11-15 November. In total, six abstracts investigating Pradaxa® (dabigatran etexilate) and reversal agent Praxbind® (idarucizumab) have been accepted.

“We will be providing highly relevant insights from three important trials for Pradaxa® and Praxbind®, which were all published in the New England Journal of Medicine this year – RE-DUAL PCI™, RE-CIRCUIT® and RE-VERSE AD™,” commented Professor Jörg Kreuzer, Vice President Medicine, Therapeutic Area Cardiovascular, Boehringer Ingelheim. “The sub-analyses due to be presented at AHA Scientific Sessions 2017 really build on the evidence for how patients with atrial fibrillation can be effectively managed as they face challenges such as the need for stent placement, catheter ablation or an emergency procedure.”

Details of the data presented at the AHA Scientific Sessions 2017 are as follows:

Abstract Title Details:
(Venue: Anaheim Convenion Centre, Anaheim, California, USA)

Monitoring of safety and effectiveness of dabigatran relative to warfarin in routine care Oral presentation, session entitled: EP.RFO.21 - Pharmacoepidemiology
Date/time: Monday Nov 13, 1:30pm - 2:40pm; Presentation time: 2:30pm - 2:45pm
Location: Science and Technology Hall- Population Science Forum
Speaker: Chandrasekar Gopalakrishnan

Similar heparin dosing in uninterrupted anticoagulation treatment with dabigatran etexilate versus warfarin in catheter ablation of atrial fibrillation: The RE-CIRCUIT study Poster, session entitled: Imaging and Clinical Risk Prediction in Patients Before and After Catheter Ablation
Date/time: Monday Nov 13, 3:00pm - 4:15pm.
Location: Science and Technology Hall-Clinical Science Section
Speaker: Hugh Calkins

Idarucizumab is effective and safe in the inhibition of dabigatran anticoagulation in patients presenting with a gastrointestinal bleeding: Insights from the RE-VERSE AD study. Poster, session entitled: Clinical Studies and Trials for Prevention
Date/time: Monday Nov 13, 3:00pm - 4:15pm.
Location: Clinical Science III Section, Science and Technology Hall
Speaker: Menno V. Huisman

Idarucizumab in dabigatran-treated patients requiring emergency surgery or intervention:
Updated/final results from the RE-VERSE AD study Oral presentation, session titled: Cardiovascular Surgery Research: The Cutting Edge
Date/time: Monday Nov 13, 5:30pm - 6:45 pm; Presentation time: 5:30pm - 5:40pm.
Location: 202AB (Main Building)
Speaker: Jerrold Levy

Regional differences in patient characteristics and outcomes during uninterrupted anticoagulation with dabigatran versus warfarin in catheter ablation of atrial fibrillation: The RE-CIRCUIT study Poster, session entitled: Stroke Risk Stratification and Prevention in Atrial Fibrillation
Date/time: Tuesday Nov 14, 10:30am - 11:45am
Location: Science and Technology Hall-Clinical Science Section
Speaker: Stefan Hohnloser

Subgroup analysis from the RE-DUAL PCI trial: Dual antithrombotic therapy with dabigatran in patients with atrial fibrillation undergoing percutaneous coronary intervention Oral presentation, session titled: New Insights into the Risks, Benefits, and Costs of Antithrombotic Therapy
Date/time: Tuesday Nov 14, 10:45am - 12:00pm; Presentation time: 11:00am - 11:10am
Location: Main Event I (Hall D, Main Building)
Speaker: Jonas Oldgren

More information on the Boehringer Ingelheim data due be presented at the AHA Scientific Sessions 2017 can be found here (link is external).


NOTES TO EDITORS


About Pradaxa® (dabigatran etexilate)

Clinical experience of Pradaxa® equates to over 7.9 million patient-years in all licensed indications worldwide. Pradaxa® has been in the market for more than eight years and is approved in over 100 countries.1

Currently approved indications for Pradaxa® are: 2,3
> 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 recurrent PE in adults

Dabigatran, 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.4-6 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.6 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.4,6

Pradaxa® is the only non-vitamin K antagonist oral anticoagulant with an approved reversal agent. Praxbind® is approved in the European Union and United States 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.7,8


About 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 percent 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.


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. Boehringer Ingelheim Data on File.
2. Pradaxa® US Prescribing Information, 2015.
3. Pradaxa® European Summary of Product Characteristics, 2016.
4. Stangier J. Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate. Clin Pharmacokinet. 2008;47(5):285–95.
5. Di Nisio M. et al. Direct thrombin inhibitors. N Engl J Med.2005;353:1028–40.
6. 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.
7. Praxbind® European Summary of Product Characteristics, 2016.
8. Praxbind® US Prescribing Information 2015.

   
Record changed: 2017-11-17

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