Dabigatran etexilate (Pradaxa®) is approved in the EU for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF) and one or more risk factors. Dabigatran etexilate is a prodrug of dabigatran, a direct inhibitor of thrombin. In patients with NVAF in the phase III RE-LY trial, dabigatran etexilate dosages of 110 and 150 mg twice daily were noninferior to warfarin with regard to the risk of stroke or systemic embolism (primary efficacy endpoint). The higher dosage was associated with a significantly lower risk of stroke or systemic embolism than warfarin, with no significant between-group difference in the risk of major bleeding (primary safety endpoint). Both dosages of dabigatran etexilate were associated with significantly lower rates of haemorrhagic stroke, intracranial bleeding and life-threatening major bleeding than warfarin. Dabigatran etexilate was also effective and generally well tolerated across various patient subgroups. The efficacy and tolerability of dabigatran etexilate was maintained for up to 6.7 years in the RELY-ABLE extension study. Routine anticoagulation monitoring is not required in patients receiving dabigatran etexilate, and it is currently the only non-vitamin K antagonist oral anticoagulant (NOAC) with a specific reversal agent available. Although direct comparisons with other NOACs would be beneficial, dabigatran etexilate is a useful option for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
Drugs. 2017 Mar;77(3):331-344.