The FDA this week approved dabigatran (Pradaxa) for prevention of DVT and pulmonary embolism following hip arthroplasty surgery. The approval follows FDA analysis of two randomized phase 3 trials (RE-NOVATE and RE-NOVATE II) in which patients who took dabigatran experienced lower rates of venous thromboembolism and all-cause death than those who took enoxaparin. Conversely, those taking the higher dose of dabigatran (220 mg) had higher rates of major bleeding than those taking enoxaparin.
The FDA initially approved dabigatran to reduce the risk of stroke and embolism in patients with nonvalvular atrial fibrillation; the recent hip-replacement indication is the fourth in five years for this novel anticoagulant.
Perhaps most significantly for orthopaedists who now might prescribe dabigatran for hip-replacement patients, last month the FDA approved the first drug (idarucizumab, or Praxbind) to reverse the effects of dabigatran, possibly making the higher risk of bleeding with dabigatran less of a clinical concern.