First patient enrolled in RE-SPECT ESUS™, which evaluates dabigatran in prevention of recurrent Embolic Stroke of Undetermined Source (ESUS)
• Patients who suffer an ESUS are at high risk of another fatal or disabling stroke due to lack of effective treatment options 1–4
• RE-SPECT ESUS™ aims to close gaps in clinical data and knowledge on prevention of recurrent ESUS
• RE-VOLUTIONTM clinical study programme for dabigatran encompasses 60,000 patients5
INGELHEIM, Germany I December 15, 2014 I Boehringer Ingelheim announces that the first patient has been enrolled in the RE-SPECT ESUS™ phase III study to investigate the efficacy and safety of dabigatran etexilate for the prevention of recurrent Embolic Stroke of Undetermined Source, also called ESUS. An ESUS occurs when a blood clot from somewhere in the body blocks a blood vessel in the brain and the source of this blood clot is unknown.4,6 RE-SPECT ESUS™ aims to include 6,000 patients in 35 countries.5
Patients who experience an embolic stroke of undetermined source, an ESUS, are at increased risk of another stroke.1–3 These recurrent strokes can lead to potentially devastating consequences and are associated with high rates of morbidity and mortality.1 The currently available treatment options to prevent recurrent stroke following ESUS offer only limited efficacy.4 There is also limited knowledge and data available to guide treatment decisions in these patients, resulting in a considerable unmet need.3
Professor Hans-Christoph Diener, Professor of Neurology and Chairman of the Department of Neurology, University of Essen, Germany, said “We are delighted to report that the first patient was randomized. This trial investigates the safety and efficacy profile of dabigatran etexilate versus acetylsalicylic acid in patients with embolic strokes of undetermined source. These patients are at high risk of a recurrent embolic stroke. Embolic strokes of undetermined sources make up a quarter of all strokes and are caused by blood clots, which travel into the brain via large blood vessels. We look forward to investigating whether dabigatran etexilate can be a treatment alternative for these patients compared to the present standard of care, which is acetylsalicylic acid.”
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) aims to include 6,000 patients from study sites in Asia, Europe, North and South America. It is part of Boehringer Ingelheim’s extensive clinical trial programme, RE-VOLUTION™. Also including the recently announced RE-CIRCUIT™ and RE-DUAL PCI™ studies, the entire programme will involve over 60,000 patients globally.5
About RE-SPECT ESUS™
The RE-SPECT ESUS™ study will evaluate dabigatran etexilate compared to acetylsalicylic acid 100 mg once daily (the current standard of care) for reduction of recurrent stroke. The majority of patients will receive dabigatran etexilate 150 mg twice daily. Patients aged 75 or older or who have moderate renal impairment (CrCl 30-50 mL/min) will receive dabigatran etexilate 110 mg twice daily. Treatments will be given for six months up to three years, and major outcomes will be assessed up to 30 days after the end of treatment.7
About Pradaxa® (dabigatran etexilate)
Clinical experience of Pradaxa® (dabigatran etexilate) equates to over 3 million patient-years in all licensed indications worldwide. Pradaxa® has been in the market for more than 6 years and is approved in over 100 countries.5
Currently approved indications for Pradaxa® are:8,9
- 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
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.10 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.11 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 mandatory dose adjustment.10,12
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.For more information please visit www.boehringer-ingelheim.com
References
1.Hankey 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.
2.Mohr JP, et al. A comparison of warfarin and aspirin for the prevention of recurrent ischemic stroke. N Engl J Med. 2001;345:1444–51.
3.Bang OY, et al. Frequency and mechanisms of stroke recurrence after cryptogenic stroke. Ann Neurol. 2003;54:227–34.
4.Hart RG, et al. Embolic strokes of undetermined source: the case for a new clinical construct. Lancet Neurol. 2014;13:429–38.
5.Boehringer Ingelheim. Data on File.
6.National Stroke Association “Ischemic Stroke” Available at: http://www.stroke.org/understand-stroke/what-stroke/ischemic-stroke Last accessed December 2014.
7.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.
8.Pradaxa® European Summary of Product Characteristics, 2014.
9.PRADAXA US Prescribing Information, 2014.
10.Stangier J. Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate. Clin Pharmacokinet. 2008;47(5):285–95.
11.Di Nisio M. et al. Direct thrombin inhibitors. N Engl J Med. 2005;353:1028–40.
12.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.
SOURCE: Boehringer Ingelheim
