Boehringer Ingelheim Pharmaceuticals, Inc., announced that the FDA approved Pradaxa (dabigatran etexilate mesylate) for the prophylaxis of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have undergone hip-replacement surgery.
There are an estimated 300,000 total hip replacement surgeries performed in the U.S. each year. Without preventive anticoagulant treatment, the incidence of DVT ranges from 40 to 60 percent for primary elective hip surgery patients.
“This milestone represents the fourth FDA-approved indication for PRADAXA in five years—a testament to the company’s continued leadership in the evolution of anticoagulation care for patients and clinicians,” said Sabine Luik, MD, senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim. “PRADAXA has the longest real-world experience of any novel oral anticoagulant, and we are dedicated to ongoing research. Physicians and patients choosing PRADAXA may have added assurance knowing that it is the only novel oral anticoagulant with more than five years of use in clinical practice and a specific reversal agent.”
The FDA approval is based on the results of two randomized, double-blind, phase III trials in patients undergoing total hip replacement, RE-NOVATET and RE-NOVATE IIT. In RE-NOVATE, 3,494 patients were randomized to three groups receiving prophylactic treatment with one of two doses of PRADAXA (220 mg or 150 mg) once daily or enoxaparin 40 mg once daily for 28 to 35 days. The results of RE-NOVATE showed patients taking PRADAXA 220 mg had a lower composite total of venous thromboembolism (VTE, which comprises DVT and PE) and all-cause death (6.0 percent) than those on enoxaparin 40 mg (6.7 percent). In RE-NOVATE II, the composite total of VTE and all-cause death occurred in 7.7 percent of patients in the PRADAXA group vs. 8.8 percent of patients in the enoxaparin group.