Boehringer Ingelheim launches RE-COVERY DVT/PE: global observational study on management of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE) with Pradaxa® (dabigatran etexilate)
OREANDA-NEWS. March 25, 2016.
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
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.
For more information please visit www.boehringer-ingelheim.com
This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.
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