Dabigatran bleeding data encouraging

The Food and Drug Administration (FDA) mini-sentinel program found the rate of GI tract bleeding with dabigatran was 1.6 per 100,000 days at risk compared with 3.5 for warfarin.

However, a meta-analysis of dabigatran trial data had the opposite finding, that dabigatran had a 41% increased risk of GI bleeding over warfarin.

Associate Professor John Amerena, director of the Geelong cardiology research department at Deakin University, said the discrepancy was due to excess GI bleeding in patients over 75 years