Pooled analysis shows safety profile of Pradaxa (Boehringer) for AF
A new pooled analysis comprising data gathered from five Phase III trials, including the pivotal RE-LY trial which enrolled more than 18,000 patients with non-valvular Atrial Fibrillation (NVAF), showed that patients treated with Pradaxa/Rendix (dabigatran) 150 mg, from Boehringer, twice daily experienced fewer intracranial hemorrhages, but more gastrointestinal hemorrhages. Major bleeding in patients treated with dabigatran 150 mg twice daily was associated with more frequent treatment with blood transfusions, but fewer plasma transfusions, compared to patients treated with warfarin.
Overall, patients treated with dabigatran 150 mg twice daily had shorter stays in an intensive care unit and reduced odds for mortality than patients treated with warfarin. In this study investigators assessed 1,121 reports of major bleeds from 1,034 patients (627 of 16,755 dabigatran patients, and 407 of 10,002 warfarin patients). Data were published in the journal Circulation. See: "Management and Outcomes of Major Bleeding during Treatment with Dabigatran or Warfarin" Ammar Majeed et al. Circulation, 30, 2013, doi: 10.1161/CIRCULATIONAHA.113.002332
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.