Ingelheim, Germany, 18 April 2012 – A new analysis of the 18,113 patient, RE-LY® trial highlights significantly lower rates of both fatal and traumatic intracranial haemorrhage (ICH) in patients treated with dabigatran etexilate (Pradaxa®) 110mg and 150mg bid compared to those treated with well-controlled warfarin. 1 As part of the primary safety endpoint, the analysis evaluated 154 intracranial haemorrhages that occurred in153 patients during the trial, including bleeding sites, rates, risk factors, associated trauma, and outcomes. Results of this safety analysis were recently published online in Stroke: The Journal of the American Heart Association.
Intracranial haemorrhage is mostly seen in older patients with atrial fibrillation (AF), and is one of the most devastating complications of anticoagulation therapy. Intracranial haemorrhage, which comprises intracerebral haemorrhage, subdural haematoma and subarachnoid haemorrhage, 1 is responsible for the majority of disability and death from bleeding related to treatment with the long time standard of care warfarin. 2