Boehringer Ingelheim announced that the FDA has approved a new indication for dabigatran to prevent deep vein thrombosis or pulmonary embolism after hip replacement surgery.
According to a press release issued by the company, DVT occurs in 40% to 60% of patients undergoing primary elective hip surgery without preventive anticoagulation.
The approval was granted based on the results of the RE-NOVATE and RE-NOVATE II trials of patients undergoing total hip replacement, according to the release. In RE-NOVATE, patients assigned dabigatran (Pradaxa, Boehringer Ingelheim) 220 mg/day had a lower rate of a composite endpoint of venous thromboembolism and all-cause mortality than those assigned enoxaparin 40 mg/day (6% vs. 6.7%), and in RE-NOVATE II, those figures were 7.7% in the dabigatran group and 8.8% in the enoxaparin group. 