Last year Boehringer Ingelheimannounced the launch of the RE-ALIGN trial, a phase 2, open-label, 12-week randomized comparison of warfarin and dabigatran (Pradaxa) in 400 patients who received a mechanical valve. There were two arms in the trial. The first arm randomized patients during their initial hospital stay. The second arm randomized patients more than 3 months after their surgery.
Now, following the advice of the trial’s Data Safety Monitoring Board, Boehringer Ingelheim said it had discontinued the first arm of the trial, the post-surgery arm, due to "lower than projected plasma levels of dabigatran in this population, and an imbalance in reports of thromboembolic events (primarily strokes)." The trial’s second arm with patients who received a valve more than 3 months before enrollment in the trial is unaffected by this decision and will continue as planned.
An "imabalance in reports of thromboembolic events" means that there were higher numbers of patients having strokes after taking Pradaxa than was reported in the initial study used to gain FDA approval. Now, new data is coming out about the initial study, called the RE-LY study, which shows that there more adverse events in that study than originally reported to the FDA.