New efficacy and safety data for Pradaxa® (dabigatran etexilate) to be announced at American Heart Association's Scientific Sessions 2013

  • Pradaxa® is the only novel oral anticoagulant with long term clinical evidence over six years of patient follow up data to be presented1
  • Key published Pradaxa® data to receive 'Best Paper in Clinical Science Awar' and feature in 'Best of AHA Specialty Conference'2,3
  • First results from healthy volunteer study of antidote for reversal of dabigatran-induced anticoagulation4

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

Ingelheim, Germany, 12 November 2013 – Boehringer Ingelheim today announces the upcoming presentation of the latest efficacy and safety data for the novel oral anticoagulant Pradaxa® (dabigatran etexilate) at the 2013 American Heart Association's (AHA) Scientific Sessions, 16-20 November 2013 in Dallas, USA. Data from eight presentations sponsored by Boehringer Ingelheim are included in the Scientific Programme, adding to the growing body of evidence on the clinical benefits of Pradaxa®.

Presentations will include the first results from a healthy volunteer study of a dabigatran-specific antidote as an additional option for physicians in emergency situations where the reversal of the anticoagulation effect of Pradaxa® is required.4 In addition, unique outcome data from over six years of follow-up data from the pivotal Phase III RE-LY® trial and its extension study RELY-ABLE® will be announced,1 as well as real-world data from routine care on Pradaxa® compared to warfarin in patients with non-valvular atrial fibrillation.5 This data will provide further insights into the safety and efficacy of Pradaxa®.

"The American Heart Association’s Scientific Sessions provide a vital forum for physicians to share the most recent clinical developments in the field of cardiology", said Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. "At Boehringer Ingelheim, we are committed to driving research and innovation forward in anticoagulation. We are thus very proud to be able to present unique long-term data on Pradaxa® at this congress, as well as the first clinical results from our own development programme of a specific antidote for dabigatran."

In addition, previously presented clinical research on Pradaxa® from the RE-LY® trial, one of the largest clinical studies ever conducted in stroke prevention in patients with non-valvular atrial fibrillation, will be recognised and awarded during the congress, highlighting the scientific value the work around this trial continues to provide to the medical community. An article by Prof. Stefan Hohnloser, University Hospital, Frankfurt, Germany, which was originally published in 2012, has been chosen by the Circulation editors to receive the 'Best Paper Award: Clinical Science'. The article analysed data on myocardial ischaemic events reported in the RE-LY® trial and concluded that for the broader composite endpoint of relevant cardiovascular ischaemic events*, the incidence was numerically lower with dabigatran than with warfarin.2 A scientific presentation by Prof. Jean-Yves Le Heuzey, European Georges Pompidou Hospital, Paris, France, first shown at the International Stroke Conference 2013, will be featured in the 'Best of AHA Specialty Conferences'.3

An overview of the Pradaxa® abstracts being presented during the American Heart Association's Scientific Sessions are listed below. Further information on the scientific programme is available at:http://www.abstractsonline.com/plan/start.aspx?mkey=%7b951E351E-429C-4B2E-84D0-8DA73B00DE45%7d

TITLE

LEAD AUTHOR

DETAILS

Special Conferences and Awards

Groundbreaking Studies in the Practice of Cardiovascular Medicine: Circulation Editors’ Choices
Best Paper Award Clinical Science:
Myocardial Ischemic Events in Patients With Atrial Fibrillation Treated With Dabigatran or Warfarin in the RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) Trial

S. Hohnloser

Award Presentation
Date: Sunday, 17 Nov
Time: 10:55 - 11:00
Room D227

Best of AHA Specialty Conferences:
Stroke-Related Specific Mortality and Influencing Factors in Patients with Atrial Fibrillation in the RE-LY Trial

J-Y. Le Heuzey

Poster Presentation
Poster number: 9191
Date: Monday, 18 Nov
Time: 09:30 - 11:00
Hall F, Best of AHA Specialty Conferences, Poster Board: ISC39

Oral Presentations

A Specific Antidote for Dabigatran: Immediate, Complete and Sustained Reversal of Dabigatran Induced Anticoagulation in Healthy Male Volunteers

S. Glund

Oral Presentation
Abstract number: 17765
Date: Monday, 18 Nov
Time: 09:30 - 09:45
Room C140

RE-LY and RELY-ABLE: Long-term Follow-up of Patients With Non-valvular Atrial Fibrillation Receiving Dabigatran Etexilate for Up to 6.7 Years

M. Ezekowitz

Oral Presentation
Abstract number: 10684
Date: Monday, 18 Nov
Time: 11:45 - 12:00
Room C140

Monitoring the Safety and Effectiveness of Dabigatran and Warfarin in Routine Care: An Interim Analysis Using U.S. Healthcare Utilization Data

J. Seeger

Oral Presentation
Abstract number: 15187
Date: Wednesday, 20 Nov
Time: 11:00 - 11:15
Room D170

Poster Presentations

Resuscitation With Different Infusion Solutions does not Influence Binding of Dabigatran to its Specific Antidote in a Pig Model of Hemorrhagic Shock

O. Grottke

Poster Presentation
Poster number: 356
Date: Sunday, 17 Nov
Time: 07:00 - 08:30
Omni Dallas Hotel, Dallas Ballroom D-H

Efficacy and Safety of Dabigatran Compared With Warfarin in Relation to Baseline Renal Function in Patients With Atrial Fibrillation - a RE-LY Trial Analysis

Z. Hijazi

Poster Presentation
Poster number: 13190
Date: Sunday, 17 Nov
Time: 15:00 - 16:30
Hall F, Core 4, Poster Board 4026

Benefits of Dabigatran versus Warfarin in Hypertensive Patients With Atrial Fibrillation: Results From The RE-LY Trial

R. Nagarakanti

Poster Presentation
Poster number: 11087
Date: Tuesday, 19 Nov
Time: 15:00 - 16:30
Hall F, Core 4, Poster Board 4072

Pradaxa® is currently approved in over 100 countries worldwide for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and for the primary prevention of VTE following total hip replacement or total knee replacement surgery.6 The extensive in-market experience of over 2 million patient-years puts Pradaxa® first among the novel oral anticoagulants.6

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 million patient-years in all licensed indications worldwide.6 Pradaxa® has already been in the market for more than 5 years and is approved in over 100 countries.6 Currently approved indications for Pradaxa® are:7

  • Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF) and a risk factor for stroke
  • 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:6

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

Important Notice: Pradaxa® is currently not approved for the acute treatment or prevention of recurrent DVT and/or PE7

Pradaxa®, a direct reversible 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.7,8 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 dose adjustment.8,10

About Pradaxa® and Stroke Prevention in Atrial Fibrillation (AF)
Pradaxa® 150mg bid is the only novel oral anticoagulant, for which its pivotal trial vs. warfarin has shown a statistically significant reduction in both haemorrhagic and ischaemic strokes when compared to warfarin.11,12 Pradaxa® 110mg bid was as effective as warfarin in overall stroke risk reduction.11,12These results were shown in RE-LY®, a phase III PROBE (prospective, randomized, open-label with blinded endpoint evaluation) trial.11-13 Additionally, treatment with Pradaxa® was associated with great reductions in intracranial haemorrhage, one of the most devastating complications of anticoagulation therapy.14

Stroke Prevention in Atrial Fibrillation (AF)
AF is the most common sustained heart rhythm condition, with one in four adults over the age of 40 developing the condition in their lifetime.15 People with AF are more likely to experience blood clots, which increases the risk of stroke by five-fold.16 Ischaemic strokes are the most common type of AF-related stroke, accounting for 92% of strokes and frequently leading to severe debilitation.17,18

Appropriate anticoagulation therapy has been proven to be highly effective in preventing AF-related strokes and saving patients from its consequences.16,19

For further information on the prevalence, medical background and societal burden of AF please visit:
http://www.newshome.com/af-stroke.aspx

About 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 endeavours.

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.

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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.

Footnotes

*Composite endpoint including myocardial infarction, unstable angina, cardiac arrest and cardiac death

Referências

  1. Ezekowitz M, et al. RE-LY and RELY-ABLE: Long-term Follow-up of Patients With Non-valvular Atrial Fibrillation Receiving Dabigatran Etexilate for Up to 6.7 Years. Oral presentation #10684 on Monday 18 November 2013 at the American Heart Association’s Scientific Sessions, Dallas, Texas, USA.
  2. Hohnloser S, Myocardial Ischemic Events in Patients With Atrial Fibrillation Treated With Dabigatran or Warfarin in the RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) Trial. Groundbreaking Studies in the Practice of Cardiovascular Medicine: Circulation Editors’ Choices - Best Paper Award Clinical Science. Awarded on Sunday 17 November 2013 at the American Heart Association’s Scientific Sessions, Dallas, Texas, USA.
  3. Le Heuzey J-Y, et al. Stroke-Related Specific Mortality and Influencing Factors in Patients with Atrial Fibrillation in the RE-LY Trial. Best of AHA Speciality Conferences. Awarded on Monday 18 November 2013 at the American Heart Association’s Scientific Sessions, Dallas, Texas, USA.
  4. Glund S, et al. A Specific Antidote for Dabigatran: Immediate, Complete and Sustained Reversal of Dabigatran Induced Anticoagulation in Healthy Male Volunteers. Oral presentation #17765 on Monday 18 November 2013 at the American Heart Association’s Scientific Sessions, Dallas, Texas, USA.
  5. Seeger J, et al. Monitoring the Safety and Effectiveness of Dabigatran and Warfarin in Routine Care: An Interim Analysis Using U.S. Healthcare Utilization Data. Oral presentation #15187 on Wednesday 20 November 2013 at the American Heart Association’s Scientific Sessions, Dallas, Texas, USA.
  6. Boehringer Ingelheim data on file
  7. Pradaxa® European Summary of Product Characteristics 2013.
  8. Stangier J. Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate. Clin Pharmacokinet. 2008;47(5):285–95.
  9. Di Nisio M, et al. Direct thrombin inhibitors. N Engl J Med. 2005;353:1028–40.
  10. 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.
  11. Connolly SJ, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361:1139-51.
  12. Connolly SJ, et al. Newly identified events in the RE-LY trial. N Engl J Med. 2010;363:1875-6.
  13. Ezekowitz MD, et al. Rationale and design of RE-LY®: Randomized evaluation of long-term anticoagulant therapy, warfarin, compared with dabigatran. Am Heart J. 2009;157(5):805-10.
  14. Hart RG, et al. Intracranial hemorrhage in atrial fibrillation patients during anticoagulation with Warfarin or Dabigatran: The RE-LY® Trial. Stroke. 2012;43(6):1511-7.
  15. Lloyd-Jones DM, et al. Lifetime risk for development of atrial fibrillation: the Framingham Heart Study. Circulation. 2004;110(9):1042-46.
  16. 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.
  17. Andersen KK, et al. Hemorrhagic and ischemic strokes compared: stroke severity, mortality, and risk factors. Stroke. 2009;40(6):2068-72.
  18. Gladstone DJ, et al. Potentially Preventable Strokes in High-Risk Patients With Atrial Fibrillation Who Are Not Adequately Anticoagulated. Stroke. 2009;40:235-240.
  19. Aguilar MI, Hart R. Oral anticoagulants for preventing stroke in patients with non-valvular atrial fibrillation and no previous history of stroke or transient ischemic attacks. Cochrane Database of Syst Rev. 2005;(3):CD001927.