INGELHEIM, Germany - Wednesday, March 23rd 2016 [ME NewsWire]
First patient enrolled in RE-COVERY DVT/PE™
Involving 14,000 patients worldwide, the study will collect real-world data on reducing the risk of DVT and PE with Pradaxa®1
(BUSINESS WIRE)-- 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
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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