Boehringer Ingelheim pharmaceutical company recently announced the launch and enrollment of the first patient in its RE-COVERY DVT/PE global observational study, which will eventually include 14,000 patients globally and collect data on the risk reduction and management of deep vein thrombosis (DVT) and pulmonary embolism (PE) with Pradaxa.
Pradaxa (dabigatran etexilate), on the market for more than seven years, is a direct thrombin inhibitor with powerful antithrombotic and anticoagulant effects due to its ability to specifically block thrombin, the central enzyme in the process of clot formation. It is approved for prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation, for primary prevention of venous thromboembolic events in patients undergoing elective total hip replacement surgery or total knee replacement surgery, and for the treatment of DVT and PE, and prevention of recurrent DVT and recurrent PE in adults.
The RE-COVERY DVT/PE study aims to assess how patients with DVT and PE are being treated in real-world clinical practice, and also to add more real-world data on the safety and effectiveness of Pradaxa compared to warfarin, another anticoagulant drug.
Patients will be divided according to the anticoagulant treatment they are receiving — either Pradaxa 110 mg or 150 mg twice daily, or warfarin. All patients will be followed up for one year, with special attention to their personal characteristics and treatment patterns, as well as incidence of bleeding rates and recurrent symptomatic DVT/PE.
The study is part of a larger Boehringer Ingelheim research program for Pradaxa which will involve more than 120,000 patients worldwide with cardiovascular-related diseases, and aims to deepen the scientific knowledge behind prevention of blood clots, and make more effective management and support of patients with these complications.
“Large pivotal randomized trials have revolutionized our strategies to manage and reduce the risk of deep vein thrombosis and pulmonary embolism. 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 Samuel Z. Goldhaber, M.D., professor of medicine at Harvard Medical School and chair of the RE-COVERY DVT/PE Steering Committee, in a Boehringer press release.