Boehringer Ingelheim’s anticoagulant Pradaxa (dabigatran etexilate) has been shown by a phase III clinical trial to be safer than warfarin, the standard stroke prevention drug.
The global 18,000-patient RE-LY trial showed significantly lower rates of fatal and traumatic intracranial haemorrhage (ICH) in patients treated with Pradaxa rather than with well-controlled warfarin.
The new findings suggest that Pradaxa may offer an alternative to warfarin in patients with atrial fibrillation (AF), easing the burden of dosage adjustment.
AF is experienced by one in four adults over the age of 40, and is a major risk factor for strokes. Anticoagulation therapy is widely used as a preventative measure – but ICF is a widespread side-effect, causing disability and death.
Warfarin (first introduced in 1948 as a rodent poison) is the standard treatment for prevention of strokes. However, very careful dosage adjustment is needed to minimise the risk of ICF.
The RE-LY trial evaluated 154 intracranial haemorrhages that occurred in 153 patients during the trial period, comparing the effects of Pradaxa and well-controlled warfarin:
• Pradaxa 110mg and 150mg doses were associated with significantly fewer fatal ICH events (11 and 13 respectively vs. 32) than warfarin.
• Pradaxa was associated with significantly fewer traumatic ICH events (11 vs. 24) than warfarin.
• The rate of ICH with Pradaxa was similar to the rate in patients receiving antiplatelet therapy.
Dr Stuart Connolly, Director of the Division of Cardiology at McMaster University, Hamilton, Ontario, said: “In our hospital, we see patients frequently presenting with intracranial haemorrhage as a result of warfarin and unfortunately, this complication is associated with a high mortality rate.
“These data show us that not only is Pradaxa associated with lower rates of intracranial haemorrhage overall, but that fatal and traumatic intracranial bleeding is also reduced, highlighting the favourable safety profile of Pradaxa.”