Interim analysis shows benefits of Pradaxa (dabigatran etexilate mesylate) in reducing stroke- Boehringer Ingelheim

Results of a new interim analysis from a long-term study evaluating the safety and effectiveness of Pradaxa (dabigatran etexilate mesylate), from Boehringer Ingelheim, relative to warfarin showed that patients with non-valvular atrial fibrillation (NVAF) treated with dabigatran had fewer strokes and fewer major bleeding events compared to NVAF patients treated with warfarin. Researchers identified 65 strokes for dabigatran-treated patients (0.73 incidence rate per 100 patient years) and 78 strokes for warfarin-treated patients (1.08 incidence rate per 100 patient years), representing a 28% reduction in stroke risk for dabigatran compared to warfarin.

In addition, researchers reported 395 major bleeding events for dabigatran-treated patients (4.47 events per 100 patient years), compared to 459 events for warfarin-treated patients (6.42 events per 100 patient years), representing a 26% reduction in the risk of major bleeding events with dabigatran compared to warfarin. There were 238 major gastrointestinal bleeding events for dabigatran-treated patients (2.69 events per 100 patient years) and 213 for warfarin treated patients (2.97 events per 100 patient years). The findings were presented at the American Heart Association (AHA) Scientific Session.

Comment: dabigatran is facing strong competition from a number of drugs, including Eliquis (apixaban) from BMS/Pfizer. Other treatments available to treat DVT and/or PE include: warfarin, heparin, and Xarelto (rivaroxaban) from Bayer/Johnson & Johnson.