Credit: Andre E.X. Brown
The US Food and Drug Administration (FDA) has approved dabigatran etexilate (Pradaxa) for the treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients who have already received anticoagulation therapy.
The drug is now approved to treat DVT and PE in patients who have received parenteral anticoagulant therapy for 5 to 10 days.
And it is approved as prophylaxis to reduce the risk of recurrent DVT and PE in previously treated patients.
The FDA’s approval of dabigatran is based on the results of four phase 3 trials.
The first of these, the RE-COVER trial, was published in NEJM in 2009. The results suggested that a fixed dose of dabigatran was as effective as warfarin for treating acute venous thromboembolism (VTE). And the safety profiles of the 2 drugs were deemed similar.
Data from a second trial, RE-SONATE, indicated that dabigatran was significantly more effective than placebo as long-term VTE prophylaxis. But the anticoagulant posed a higher risk of clinically relevant bleeding.
Results from the third trial, RE-MEDY, suggested dabigatran was non-inferior to warfarin as VTE prophylaxis. And warfarin conferred a higher risk of clinically relevant bleeding.
Both RE-MEDY and RE-SONATE were published in NEJM last year.
Data from the fourth trial, RE-COVER II, indicated that dabigatran had a similar effect on VTE recurrence and a lower risk of bleeding than warfarin when used to treat acute VTE. These results were published in Circulation last year.
Dabigatran is already approved by the FDA as prophylaxis for stroke and systemic embolism in patients with non-valvular atrial fibrillation. The drug is marketed as Pradaxa by Boehringer Ingelheim.
