New study to investigate dabigatran etexilate for prevention of recurrent stroke in high-risk patients

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· Current knowledge around prevention of a recurrent stroke in patients suffering a stroke of undetermined source (ESUS) is limited1,2
· Study addresses significant unmet medical need in patients at high risk of recurrent stroke, aiming to support physician's decisions3
· Study design of new RE-SPECT ESUS™ study announced at European Stroke Conference3

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Ingelheim, Germany, 7 May, 2014 – Details of a new 6,000 patient study of dabigatran etexilate were announced today at the European Stroke Conference, Nice, France. The RE-SPECT ESUS™ study will investigate the blood thinner dabigatran etexilate for the prevention of recurrent stroke in patients who have already suffered an embolic stroke of undetermined source (ESUS).3 Such a stroke occurs when a blood clot (embolus) forms somewhere in the body and travels through the bloodstream to the brain.4 As a company dedicated to preventing and treating stroke, Boehringer Ingelheim will investigate dabigatran etexilate in this area of significant medical need, hoping that even more patients at risk of stroke can benefit from the treatment.

Approximately one quarter of all strokes are due to an embolus from an undetermined source.2 Patients who experience such an embolic stroke of undetermined source, an ESUS, are at increased risk of another stroke.1 This recurrent stroke could lead to potentially devastating consequences, including high rates of morbidity and mortality.5 Currently there are limited treatment options to prevent recurrent stroke following ESUS and studies to increase knowledge are urgently needed.1,2 Dabigatran etexilate has been shown to successfully prevent strokes in patients with an irregular heartbeat, known as atrial fibrillation.6,7 Effective antithrombotic therapy with dabigatran etexilate may also reduce the risk of recurrent stroke in patients who have suffered an ESUS.2

Professor Hans-Christoph Diener, Chairman of the Department of Neurology at the University of Duisburg-Essen in Germany

Professor Hans-Christoph Diener

"The results obtained from the RE-SPECT ESUS™ study will help to address current gaps in knowledge, supporting physician choice of appropriate therapy and improving patient care." said Professor Hans-Christoph Diener, Chairman of the Department of Neurology at the University of Duisburg-Essen in Germany and lead investigator of the RE-SPECT ESUS™ study.

The RE-SPECT ESUS™ study (Randomized Evaluation in Secondary stroke PrEvention Comparing the Thrombin inhibitor dabigatran etexilate versus acetylsalicylic acid (ASA) in Embolic Stroke of Undetermined Source) will involve approximately 6,000 patients worldwide who have experienced an ESUS within the last three to six months and are deemed at risk of recurrent stroke. The study will examine the efficacy and safety of dabigatran etexilate 150 mg or 110 mg twice daily versus acetylsalicylic acid 100mg once daily for secondary stroke prevention, with patients being followed for up to 3 years.3

The RE-SPECT ESUS™ study is just one part of Boehringer Ingelheim's ongoing commitment to stroke prevention and cardiology. Boehringer Ingelheim improved healthcare in the anticoagulant field by bringing Pradaxa®, the first novel oral anticoagulant for stroke prevention, to patients with non-valvular atrial fibrillation.8 The efficacy and safety profile of Pradaxa® is well documented in the extensive RE-VOLUTION® clinical study programme which has led to regulatory approvals in over 100 countries to date.6,7,9-19 Clinical experience with Pradaxa® continues to grow worldwide and currently equates to over 2.9 million patient-years in all licensed indications.19

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 2.9 million patient-years in all licensed indications worldwide. Pradaxa® has already been in the market for more than 6 years and is approved in over 100 countries.19

Currently approved indications for Pradaxa® are:8

  • 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

A number of countries including the USA, have already approved Pradaxa® for patients with a deep vein thrombosis or a pulmonary embolism in the following indication:20

  • Treatment of deep vein thrombosis and pulmonary embolism
  • Prevention of recurrent deep vein thrombosis and pulmonary embolism

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.8,21 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.22 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.21,23

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
1Bang OY, et al. Frequency and Mechanisms of Stroke Recurrence after Cryptogenic Stroke. Ann Neurol. 2003;54:227–34.
2Hart RG, et al. Embolic strokes of undetermined source: the case for a new clinical construct. Lancet Neurol. 2014;13:429–38.
3Diener H-C, et al. Rationale, objectives and design of a secondary stroke prevention study of dabigatran etexilate versus acetylsalicylic acid in patients with embolic stroke of undetermined source (RE-SPECT-ESUS). Presented at the European Stroke Conference, Nice, France on 7 May 2014, 12:45-14:15 PM.
4National Stroke Association “Types of Stroke” Available at http://www.stroke.org/site/PageServer?pagename=TYPE Last accessed April 2014.
5Hankey GJ, et al. Long-Term Disability After First-Ever Stroke and Related Prognostic Factors in the Perth Community Stroke Study, 1989–1990. Stroke. 2002;33:1034–40.
6Connolly SJ, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361:1139-51.
7Connolly SJ, et al. Newly identified events in the RE-LY trial. N Engl J Med. 2010;363:1875-6.
8Pradaxa® European Summary of Product Characteristics 2014.
9Ezekowitz MD, 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 Scientific Sessions, Dallas, Texas, USA.
10Connolly SJ, et al. The Long Term Multi-Center Extension of Dabigatran Treatment in Patients with Atrial Fibrillation (RELY-ABLE) study. Circulation. 2013;128:237-43.
11Eriksson BI, et al. Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial. Lancet. 2007;370:949–56.
12Eriksson BI, et al. Oral dabigatran versus enoxaparin for thromboprophylaxis after primary total hip arthroplasty (RE-NOVATE II*). A randomised, doubleblind, non-inferiority trial. Thromb Haemost. 2011;105:721-9.
13Eriksson BI, et al. Oral dabigatran etexilate vs. subcutaneous enoxaparin for the prevention of venous thromboembolism after total knee replacement: the RE-MODEL randomized trial. Thromb Haemost. 2007;5:2178–85.
14Ginsberg JS, et al. Oral thrombin inhibitor dabigatran etexilate vs North American enoxaparin regimen for prevention of venous thromboembolism after knee arthroplasty surgery. J Arthoplasty. 2009;24:1–9.
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16Schulman S, et al. Treatment of Acute Venous Thromboembolism with Dabigatran or Warfarin and Pooled Analysis. Circulation. Schulman S, et al. Treatment of Acute Venous Thromboembolism with Dabigatran or Warfarin and Pooled Analysis. Circulation published online before print December 16, 2013, doi:10.1161/ CIRCULATIONAHA.113.004450
17Schulman S, et al. Extended use of dabigatran, warfarin or placebo in venous thromboembolism. N Engl J Med. 2013;368:709–18.
18Oldgren J. et al. Dabigatran vs. placebo in patients with acute coronary syndromes on dual antiplatelet therapy: a randomized, double-blind, phase II trial. Eur Heart J. 2011;32:2781-9.
19Boehringer Ingelheim data on file.
20PRADAXA Prescribing Information, 2014. Available at: http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing%20Information/PIs/Pradaxa/Pradaxa.pdf. Last accessed: May 2014.
21Stangier J. Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate. Clin Pharmacokinet. 2008;47(5):285–95.
22Di Nisio M, et al. Direct thrombin inhibitors. N Engl J Med. 2005;353:1028–40.
23Stangier 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

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