Boehringer has announced that Pradaxa (dabigatran etexilate mesylate) has failed to meet its primary endpoint in its Phase 3 study, proving unable to show superiority over acetylsalicylic acid (ASA) in preventing recurrent stroke in patients with embolic stroke of undetermined source (ESUS).
The drug particularly failed to present a statistically significant difference in the risk of recurrent stroke. The manufacturer did, however, note that after one year of treatment, a trend emerged showing Pradaxa to improve this very metric over ASA.
