The US Food and Drug Administration (FDA) has approved dabigatran etexilate mesylate (Pradaxa, Boehringer Ingelheim Pharmaceuticals Inc) for prophylaxis of deep-vein thrombosis (DVT) and pulmonary embolism (PE) after hip replacement surgery, according to a company release.
Approximately 300,000 total hip replacement surgeries are performed in the United States each year. Patients who undergo primary elective hip surgery and do not receive preventive anticoagulant treatment have a 40% to 60% risk for DVT.
This is the fourth FDA-approved indication for Pradaxa in 5 years, according to the release.
Two Phase 3 Trials
The approval follows an analysis of data from two randomized, double-blind, phase 3 trials in patients undergoing total hip replacement. The RE-NOVATE study randomly assigned 3494 patients to receive dabigatran 220 mg, dabigatran 150 mg, or enoxaparin 40 mg once daily for 28 to 35 days. Those who took dabigatran 220 mg experienced a lower composite total of venous thromboembolism and deaths from all causes (6.0%) than patients who took enoxaparin 40 mg (6.7%).
In RE-NOVATE II, researchers randomly assigned 2055 patients to receive dabigatran 220 mg or enoxaparin 40 mg once daily for 28 to 35 days. Patients who took dabigatran experienced a lower composite total of venous thromboembolism and all-cause deaths (7.7%) compared with those who took enoxaparin (8.8%).
Patients who took dabigatran 220 mg experienced higher rates of major bleeding than those who took enoxaparin in RE-NOVATE (2.0% vs 1.6%) and RE-NOVATE II (1.4% vs 0.9%).
The rate of major gastrointestinal bleeding in patients who took dabigatran and enoxaparin was the same (0.1%) in the two studies. The rate of any gastrointestinal bleeding was 1.4% for those who took dabigatran and 0.9% for those who took enoxaparin.
In both studies, the most frequent adverse events were gastrointestinal disorders, which occurred in 39.5% of patients in both the dabigatran and enoxaparin groups. Dyspepsia was reported more frequently among patients who took dabigatran (4.1%) compared with those who took enoxaparin (3.8%). Gastritis-like symptoms (including gastritis, gastroesophageal reflux disease, esophagitis, erosive gastritis, and gastric hemorrhage) were reported less often in those who took dabigatran (0.6%) than enoxaparin recipients (1.0%).
Clinical myocardial infarction occurred in 2 (0.1%) patients who took dabigatran and 6 (0.3%) patients who took enoxaparin.
"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 and Women's Hospital and professor of medicine, Harvard Medical School, Boston, Massachusetts, said in the company news 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."
The FDA originally approved dabigatran in 2010 to reduce the risk for stroke and systemic embolism in those with nonvalvular atrial fibrillation. The FDA approved two additional indications for the drug for the treatment of DVT and pulmonary embolism in patients who have received treatment with a parenteral anticoagulant for 5 to 10 days, and to lower the risk for recurrent DVT and pulmonary embolism in those who have been treated previously.
In October this year, the FDA approved idarucizumab (Praxbind, Boehringer Ingelheim) to reverse the effects of Pradaxa.
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Cite this: FDA OKs Pradaxa for Thromboprophylaxis After Hip Surgery - Medscape - Nov 24, 2015.