Pradaxa Now Approved for Hip Replacement Patients

The FDA has approved Boehringer Ingelheim’s oral direct thrombin inhibitor dabigatran etexilate mesylate (Pradaxa) for the prophylaxis of deep vein thrombosis (DVT) and pulmonary embolism in patients who have had hip replacement surgery.

This expanded approval was based on the results of 2 phase 3 trials involving more than 5500 patients. These studies showed superior efficacy and safety of Pradaxa compared with enoxaparin (Lovenox).

The RE-NOVATE studies demonstrated that patients who took Pradaxa had a lower composite total of venous thromboembolism and all-cause death than the patients who took Lovenox.

While major gastrointestinal bleed rates were the same (0.1%) in the Pradaxa and Lovenox groups, any gastrointestinal bleed rates were more common in the Pradaxa group (1.4% compared with 0.9%).

The most common adverse event was gastrointestinal disorders, and incidence was the same in both groups. Dyspepsia was more common among the Pradaxa patients, but gastritis-like symptoms were more common among the Lovenox patients.

Each year, around 300,000 hip replacement surgeries are completed, Boehringer Ingelheim noted in a press release.

DVT prevalence increases 40% to 60% without preventive anticoagulant treatment among patients who undergo primary elective hip surgery.

“Physicians and patients choosing Pradaxa may have added assurance knowing that it is the only novel oral anticoagulant with more than 5 years of use in clinical practice and a specific reversal agent,” said Sabine Luik, MD, senior vice president of Medicine and Regulatory Affairs at Boehringer Ingelheim, in a press release. “…Pradaxa has the longest real-world experience of any novel oral anticoagulant, and we are dedicated to ongoing research.”

The FDA approved Praxbind as a rapid reversal agent for Pradaxa in October 2015.

Pradaxa was originally approved in 2010 as a treatment to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

In 2014, it was approved for 2 more indications: to treat DVT and pulmonary embolism in patients who have been treated with a parenteral anticoagulant for 5 to 10 days and to reduce the risk of recurrent DVT and pulmonary embolism in patients who have been previously treated.