From today, dabigatran is available in the UK for deep vein thrombosis (DVT) and pulmonary embolism.
Dabigatran was previously only approved for use in stroke prevention in non-valvular atrial fibrillation and primary prevention of venous thromboembolic events. In June this year, it was granted approval for the treatment of DVT and pulmonary embolism, and the prevention of recurrent DVT and pulmonary embolism in adults, by the European Medicines Agency at 110mg and 150mg doses.
European approval of dabigatran for DVT and pulmonary embolism is based on results from three phase 3 clinical trials that have demonstrated its efficacy in treatment and prevention of these conditions in adults, compared with warfarin. These trials also demonstrated that patients on dabigatran experienced lower rates of bleeding, compared with those on warfarin. A fourth trial showed a reduction in the risk of recurrent DVT and pulmonary embolism in patients treated with dabigatran, compared with placebo.
Dabigatran, unlike warfarin, does not require anticoagulation monitoring. Patients with DVT or pulmonary embolism can start taking dabigatran in a fixed dose regimen after initial treatment with an injectable anticoagulant for at least five days.