University of Mainz-Led Study Shows Benefit of Early Switch from Heparin to Dabigatran for Acute Intermediate-Risk Pulmonary Embolism

University of Mainz-Led Study Shows Benefit of Early Switch from Heparin to Dabigatran for Acute Intermediate-Risk Pulmonary Embolism

Recently, the German Federal Ministry of Education and Research, University Medical Center Mainz, and the world’s largest privately-held pharmaceutical company, Boehringer Ingelheim, led a multinational, multicenter, single-arm Phase 4 clinical trial at 42 trial site hospitals across Europe (Austria, Belgium, France, Germany, Italy, Netherlands, Romania, Slovenia, and Spain) enrolling patients 18 and above with symptomatic intermediate-risk pulmonary embolism, with or without deep-vein thrombosis. Participating patients received low-molecular-weight or unfractionated heparin for 72 hours after the pulmonary embolism diagnosis before switching to oral dabigatran 150 mg twice per day post a standard clinical assessment. With the study terminated early as the data safety and monitoring board advised, the study team found that a strategy of early move from heparin to dabigatran following a standard clinical assessment was effective and safe in patients with intermediate-risk pulmonary embolism. The study team declared in their peer-reviewed report in The Lancet that the study results are helping to “refine guideline recommendations for the initial treatment of acute intermediate-risk ...

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