Dabigatran for stroke prevention in atrial fibrillation.

Dabigatran is a novel direct thrombin inhibitor that has recently been approved for primary and secondary stroke prevention and prevention of systemic embolism in patients with atrial fibrillation. In the pivotal RE-LY study, dabigatran 110 mg BID was demonstrated to be associated with a stroke rate similar to that observed with warfarin (INR target 2.0 to 3.0), but with a lower rate of major haemorrhage. Dabigatran administered at a dose of 150 mg BID was significantly more effective in stroke prevention than warfarin and showed a similar rate of major hemorrhages. Of note, both dosages resulted in an approximately 60-70% relative risk reduction of haemorrhagic stroke. The dosage of 110 mg BID should be preferably used in patients aged 75-80 years or older as the rate of extracranial bleeding events tends to increase with dabigatran 150 mg BID above this age limit. In RE-LY, myocardial infarcts occurred at a very low incidence. There were numerically more myocardial infarcts in dabigatran-treated patients than in warfarin patients; however, other myocardial ischaemic events were similar in the three treatment arms.