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

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

“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

References

1. Bang OY, et al. Frequency and Mechanisms of Stroke Recurrence after Cryptogenic Stroke. Ann Neurol. 2003;54:227–34.
2. Hart RG, et al. Embolic strokes of undetermined source: the case for a new clinical construct. Lancet Neurol. 2014;13:429–38.
3. Diener 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.
4. National Stroke Association “Types of Stroke” Available at http://www.stroke.org/site/PageServer?pagename=TYPE Last accessed April 2014.
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8. Pradaxa® European Summary of Product Characteristics 2014.
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17. Schulman S, et al. Extended use of dabigatran, warfarin or placebo in venous thromboembolism. N Engl J Med. 2013;368:709–18.
18. Oldgren 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.
19. Boehringer Ingelheim data on file.