Pradaxa, an oral anticoagulant, has been approved for the prevention of stroke in AF in more than 50 countries across the globe.
RE-LY was a global, Phase III, prospective, randomized, open-label with blinded endpoint evaluation (PROBE) trial of 18,113 patients, which compared two fixed doses of the oral direct thrombin inhibitor dabigatran (110mg and 150mg bid) each administered in a blinded manner, with well controlled (INR 2.0-3.0, median TTR 67%1) open label warfarin.
The data showed that the rates of intracranial bleeding were lower with both doses of Pradaxa compared to well-controlled warfarin, irrespective of whether patients had sHF or not.
In addition, annual rates of stroke or systemic embolism were higher overall for patients with sHF (Pradaxa 110mg bid: 1.90%, Pradaxa® 150mg bid: 1.44%, warfarin: 1.92%) than those without sHF (Pradaxa 110mg bid: 1.41%, Pradaxa®150mg bid: 1.00%, warfarin: 1.64%).