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Dabigatran approved for DVT, PE prophylaxis after hip replacement surgery
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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.
The rates of major bleeding were higher in the dabigatran group in both trials (RE-NOVATE, 2% vs. 1.6%; RE-NOVATE II, 1.4% vs. 0.9%), the company stated in the release.
Samuel Z. Goldhaber
“Many Americans will undergo hip replacement surgery each year. Proactive anticoagulation is vital for reducing the risk of VTE in these patients and helping to improve patient outcomes,” Samuel Z. Goldhaber, MD, director of the Thrombosis Research Group at Brigham & Women’s Hospital and professor of medicine at Harvard Medical School, said in the release. “The FDA approval of this new indication for Pradaxa will help address an important public health need and provide a new therapeutic option for this large patient population.”
Disclosure: Goldhaber reports receiving research support from Bristol-Myers Squibb, BTG, Daiichi Sankyo, the NHLBI and the Thrombosis Research Institute, and consulting for Ariad, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Janssen Pharmaceuticals, Merck, Pfizer and Portola.