Boehringer Ingelheim today announces the enrollment of the first patient in RE-COVERY DVT/PE™, a global observational study on the management of blood clots in the legs (deep vein thrombosis, DVT) and in the lungs (pulmonary embolism, PE). The new study will provide insights into how patients with DVT and PE are being treated in real-world clinical practice, and will add to the growing body of data on the safety and effectiveness of Pradaxa® (dabigatran etexilate) compared to warfarin.(1)
"Large pivotal randomised trials have revolutionised our strategies to manage and reduce the risk of deep vein thrombosis (DVT) and pulmonary embolism (PE). However, it remains uncertain how the results of these trials impact everyday clinical practice in the ‘real world’. We are launching RE-COVERY DVT/PE™, an exciting new global prospective observational cohort study, to learn more about DVT and PE patient treatments and outcomes," said Professor Samuel Z. Goldhaber, MD, Professor of Medicine at Harvard Medical School, Section Head of Vascular Medicine at Brigham and Women's Hospital, and Chair of the RE-COVERY DVT/PE™ Steering Committee.
A DVT occurs when a blood clot blocks the normal flow of blood through a vein, usually in the leg or pelvis, which may lead to swelling or pain in the affected leg.(2) A PE occurs when a DVT, or part of it, breaks off and travels through the bloodstream to the lungs, blocking a vessel.(2) The symptoms of a PE include shortness of breath and chest pain.(2) It may also cause other symptoms like cough, rapid heart rate and dizziness.(3) Treatment for patients with a DVT and/or PE includes anticoagulation therapy, like novel oral anticoagulants, low-molecular-weight heparin or vitamin K antagonists such as warfarin, which are used to reduce the risk of blood clots recurring and existing ones from growing.(4) DVT and PE can be very dangerous; almost one in three PE patients dies within three months and four out of 10 patients suffer a repeat blood clot within 10 years of the first.(5) PE as a consequence of a DVT is the leading cause of preventable death in hospital.(6)
Pradaxa® was approved for the treatment of DVT and PE in patients who have been treated with a parenteral anticoagulant for five to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated.(7, 8)
The overall Boehringer Ingelheim research programme for Pradaxa®, which includes the RE-COVERY DVT/PE™ study, will involve more than 120,000 patients worldwide across cardiovascular-related therapy areas, including stroke risk reduction in atrial fibrillation. The aim of the research programme is to deepen the science behind effective clot prevention and provide everyday support for patient management.(1)
About RE-COVERY DVT/PE™
RE-COVERY DVT/PE™ will enroll up to 14,000 DVT/PE patients. Following a DVT or PE diagnosis, patients will be categorised according to the anticoagulant treatment they receive. Those receiving either Pradaxa® 110mg or 150mg twice daily or warfarin will be followed for up to one year. In addition to collecting data on patient characteristics including patient history and treatment patterns, RE-COVERY DVT/PE™ will evaluate the incidence of bleeding rates and recurrent symptomatic DVT/PE.(1)
About Pradaxa® (dabigatran etexilate)
Clinical experience of dabigatran equates to more than 5 million patient-years in all licensed indications worldwide.(1) Dabigatran has been in the market for more than 7 years and is approved in over 100 countries.(1)
Currently approved indications for dabigatran are:(7,8)
- 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.(9) 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.(10) 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.(9,11)
Dabigatran is the only novel oral anticoagulant with an approved reversal agent. Praxbind® (idarucizumab) 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.(1,12,13)
About 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 146 affiliates and a total of more than 47,700 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.
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 2014, Boehringer Ingelheim achieved net sales of about 13.3 billion euros. R&D expenditure corresponds to 19.9 per cent of its net sales.
1. Boehringer Ingelheim. Data on file.
2. Clot Care Online Resource. Available at: http://www.clotcare.com/dvt.aspx Last accessed: March 2016.
3. Medline Plus. Pulmonary embolus. Available at: http://www.nlm.nih.gov/medlineplus/ency/article/000132.htm Last accessed: March 2016.
4. Centers for Disease Control and Prevention. DVT Diagnosis and Treatment. Available at: http://www.cdc.gov/ncbddd/dvt/diagnosis-treatment.html Last accessed: March 2016.
5. Heit JA. et al. Predictors of Survival after Deep Vein Thrombosis and Pulmonary Embolism. Arch Intern Med. 1999;159:445-453.
6. BMJ Best Practice. VTE Prophylaxis. Available at: http://bestpractice.bmj.com/best-practice/monograph/1087.html Last accessed: March 2016.
7. Pradaxa® European Summary of Product Characteristics. 2016.
8. PRADAXA® U.S. Prescribing Information. 2016.
9. Stangier J. Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate. Clin Pharmacokinet. 2008;47(5):285–95.
10. Di Nisio M. et al. Direct thrombin inhibitors. N Engl J Med. 2005;353:1028–40.
11. 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.
12. Praxbind®. European Summary of Product Characteristics. 2015.
13. PRAXBIND® U.S. Prescribing Information. 2015.