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Trials & Filings

Pradaxa Hits VTE Endpoint

BI drug demonstrates non-inferiority against warfarin in DVT, PE

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Boehringer Ingelheim Pharmaceuticals has posted results from the Phase III RE-COVER II study evaluating Pradaxa (dabigatran) compared to warfarin in patients diagnosed with acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE). In this study, dabigatran met the primary endpoint of non-inferiority to warfarin for recurrent, symptomatic, objectively-confirmed DVT and/or PE and related deaths during six months of treatment.

DVT and PE are collectively referred to as venous thromboembolism (VTE), which is the third most common cardiovascular disorder after coronary artery disease and stroke. A DVT occurs when a blood clot develops in a deep vein, usually in the leg or pelvis, and either partially or totally blocks the flow of blood through the vein. A PE occurs when a DVT, or part of it, breaks off and travels through the bloodstream to the lungs, blocking a vessel. This is considered a life-threatening condition.

RE-COVER II was a randomized, double-blind, double-dummy study in 2,589 patients with acute symptomatic DVT and/or PE recruited at 208 study sites in 31 countries. The trial was designed to determine if dabigatran 150 mg twice daily is non-inferior to warfarin for the primary endpoint of preventing a recurrence of DVT and/or PE and related deaths, and to compare the safety of the two drug regimens during six months of treatment. In the trial, patients were treated with either dabigatran or warfarin after initial parenteral anticoagulation therapy (approximately 9 to 10 days). Patients in the warfarin group had their doses adjusted to maintain an International Normalized Ratio (INR) of 2.0-3.0.

The trial also showed that dabigatran was associated with a 31% reduction in the risk of major bleeding, which did not reach statistical significance. Additionally, the study demonstrated significantly less overall bleeding (33% reduced risk) and major or clinically relevant non-major bleeding (38% reduced risk).

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