Real-world analysis of Pradaxa (dabigatran etexilate mesylate) shows benefits over warfarin in non-valvular atrial fibrillation- Boehringer

Boehringer announced results from a real-world analysis showing that Pradaxa (dabigatran etexilate mesylate) was associated with an improvement in safety and efficacy outcomes compared to warfarin in patients with non-valvular atrial fibrillation (NVAF). The study analyzed 7,245 Pradaxa and 14,490 warfarin patients with NVAF who had no prior use of an oral anticoagulant (OAC), using data from an administrative claims database from October 1, 2010, to April 30, 2014. The patients were mostly male (56%), with a mean age of 74 years, and mean CHADS2 stroke risk score of 2.2.

Compared to warfarin, Pradaxa was associated with a 26 percent reduced risk of stroke and a 20 percent reduced risk of major bleeding. Pradaxa was also associated with a lower risk for serious secondary outcomes, including a 68 percent reduced risk of hemorrhagic stroke, an 18 percent reduced risk of major extracranial bleeding, a 48 percent reduced risk of venous thromboembolism, and a 27 percent reduced risk of death. The results were presented at the International Stroke Conference.