Going high and low against warfarin

While previous attempts to replace warfarin to prevent stroke in patients with atrial fibrillation have fallen short due to inferior efficacy or toxicity issues, data published last week from Boehringer Ingelheim GmbH show that Pradaxa dabigatran may have both the efficacy and safety necessary to supplant warfarin as the treatment of choice. Doctors contacted by BioCentury were cautiously optimistic that Pradaxa would not only provide a safer alternative to warfarin, but would likely replace it as standard of care over time.

Data from the Phase III RE-LY trial in 18,113 patients with non-valvular AF who were at moderate to high risk of stroke showed that both the low (110 mg) and high (150 mg) dose of Pradaxa met the primary endpoint of non-inferiority to warfarin in reducing stroke and systemic embolism. Not only was Pradaxa non-inferior to warfarin, but the high dose was superior on the primary efficacy endpoint, while the low dose was superior on the primary safety endpoint of annual rate of major bleeding versus warfarin...