Pradaxa dabigatran etexilate cardiovascular data

Researchers at the Cleveland Clinic reported data from a meta-analysis of 30,514 subjects in 7 randomized controlled trials conducted by Boehringer showing that Pradaxa was associated with a significantly increased risk of MI or unstable angina vs. control therapies (1.19% vs. 0.79%, respectively, p=0.03). Control therapies included warfarin, Lovenox enoxaparin and placebo. The association remained the same in an analysis that excluded 3 short-term trials <=1 month (p=0.03). In the 6 studies that reported on overall mortality, Pradaxa was associated with a significantly lower overall mortality rate vs. control therapies (4.83% vs. 5.02%; p=0.04). The authors concluded that the overall risk-benefit ratio of Pradaxa appears to be favorable in patients with AF because of stroke reduction, but cardiac risk of the drug should be investigated further.

The meta-analysis included data from the Phase III RE-LY trial in 18,113 patients with non-valvular AF at moderate to high risk of stroke; the Phase III RE-NOVATE and RE-NOVATE II trials in patients undergoing total hip replacement surgery; the Phase III RE-MODEL trial in patients undergoing primary knee replacement surgery; the Phase III RE-COVER trial in patients with VTE; the Phase II PETRO trial in patients with AF; and the Phase II RE-DEEM trial in patients with ACS. Re-LY made up 59% of the cohort and 74% of the events. Data were published in Archives of Internal Medicine. ...