
Results from a late-stage, non-inferiority study demonstrated that Boehringer Ingelheim's Pradaxa (dabigatran) was as effective as warfarin in reducing recurrent venous thromboembolism (VTE) and deaths related to VTE, the drugmaker announced.
The findings, presented at the annual meeting of American Society of Hematology, also showed that patients with acute VTE treated with Pradaxa had a significant reduction in episodes of bleeding, compared with those who received warfarin.
The randomised RE-COVER trial, which had a primary efficacy outcome of six-month incidence of recurrent VTE and related deaths, involved 1274 patients with acute VTE who received Pradaxa twice daily and 1265 patients who were treated with dose-adjusted warfarin.
Data showed that 30 patients in the Pradaxa arm had recurrent VTE, compared with 27 in the warfarin group, while the numbers of deaths were similar in the two arms.
In addition, Boehringer Ingelheim noted that compared with patients treated with warfarin, those who took Pradaxa had "a significant 37-percent reduction in major or clinically relevant non-major bleeding" and a significant 29-percent reduction in episodes of any bleeding
. The study's principal investigator, Sam Schulman, commented: "With dabigatran, we have a therapy that protects our patients effectively and safely, without need for frequent laboratory monitoring and dose changes."
A spokesman for Boehringer Ingelheim, Reinhard Malin, stated that the drugmaker's goal is to file the drug for approval in the US and Europe by the end of the year for the prevention of stroke in atrial fibrillation.
Earlier this year results from the RE-LY trial demonstrated that Pradaxa significantly reduced the risk of
stroke and systemic embolism in patients with atrial fibrillation, compared with warfarin, and did not increase the risk of major bleeding.
Pradaxa is currently approved in over 40 countries for the primary prevention of VTE in adults who undergo certain hip- or knee-replacement surgeries.