The US Food and Drug Administration (US FDA) Medicare analysis of 134,000 atrial fibrillation (AF) patients treated with either Pradaxa (dabigatran etexilate) or warfarin in a general practice setting, was published in Circulation. The FDA authors conclude that dabigatran was associated with a significantly reduced risk of ischaemic stroke and intracranial bleeding, a significantly increased risk of major gastrointestinal bleeding and a significant survival benefit compared with warfarin in elderly patients with non-valvular AF.1 The FDA study confirms findings of the RE-LY study in 18,000 patients, which led to the approval of Pradaxa for stroke prevention in AF worldwide.
The FDA Medicare analysis is based on patient data from elderly patients enrolled in Medicare.1 The FDA study included patients who started treatment for dabigatran or warfarin for non-valvular AF between October 2010 and December 2012 and were older than 65 years. The detailed results of the analysis showed: a fewer ischaemic strokes due to blood clots with Pradaxa (20 per cent less than with warfarin). Fewer intracranial bleeds with Pradaxa (66 per cent less than warfarin)
Survival benefit with Pradaxa (14 per cent better than warfarin). No difference in major bleeding between Pradaxa and warfarin, no difference in acute myocardial infarction between Pradaxa and warfarin, more gastrointestinal bleeding with Pradaxa (28 per cent more than warfarin).
The US FDA had already communicated part of its analysis in a Drug Safety Communication on its website in May 2014 and explicitly stated that, “Pradaxa provides an important health benefit when used as directed.”
“The results of the US FDA Medicare analysis clearly confirm that the positive safety and efficacy profile observed in the clinical RE-LY study was also achieved in real world general practice”, commented Professor Jörg Kreuzer, vice president medicine Therapeutic Area Cardiovascular, Boehringer Ingelheim. “The results of this study, which is by far the largest of its kind, further reinforce the quality and reliability of RE-LY study results and the value Pradaxa can bring to patients with atrial fibrillation at risk of stroke.”