Dabigatran for the treatment of venous thromboembolism

Venous thromboembolism (VTE) is a major cause of morbidity and mortality, and individuals with a first VTE are at risk of recurrent VTE. VTE treatment is divided into three phases: a first short phase of acute (traditionally parenteral) anticoagulation, followed by a second maintenance phase with an oral anticoagulant, which may be continued into a third extended maintenance phase in patients considered to be at increased risk of recurrent VTE. Vitamin K antagonists are effective oral anticoagulants but have well-known limitations; non-vitamin K oral anticoagulants including dabigatran etexilate (DE) were therefore developed. DE was approved for VTE treatment on the basis of an extensive clinical trial program that evaluated DE during both the maintenance phase and the extended maintenance phase of VTE treatment. This article provides a comprehensive overview of DE in VTE treatment, from its preclinical characteristics and pharmacokinetic properties to its efficacy and safety in major clinical trials.