Real-world data show lower risk of stroke and major bleeding for Pradaxa compared with warfarin

Compared with warfarin, Pradaxa was associated with a 26% reduced risk of stroke and a 20% reduced risk of major bleeding.

Boehringer Ingelheim Pharmaceuticals has announced results from a real-world analysis showing that Pradaxa (dabigatran etexilate mesylate) was associated with an improvement in safety and efficacy outcomes compared with warfarin in patients with non-valvular atrial fibrillation (NVAF). The results were presented at the International Stroke Conference.

The study analysed 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 1 October 2010 to 30 April 2014. The patients were mostly male (56%), with a mean age of 74 years, and mean CHADS2 stroke risk score of 2.2.

Compared with warfarin, Pradaxa was associated with a 26% reduced risk of stroke and a 20% reduced risk of major bleeding. Pradaxa was also associated with a lower risk for serious secondary outcomes, including a 68% reduced risk of hemorrhagic stroke, an 18% reduced risk of major extracranial bleeding, a 48% reduced risk of venous thromboembolism, and a 27% reduced risk of death.

"By combining our deep understanding of the patient journey with access to robust real-world data, we are improving the understanding of treatment for patients with chronic conditions such as NVAF," said Sabine Luik, senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals. "These data offer valuable real-world insights on patient outcomes, and are an important complement to our robust clinical trial program, in which Pradaxa demonstrated superior efficacy and a favorable risk-benefit profile compared to warfarin."