Background Warfarin reduces the risk of stroke in patients withatrial fibrillation but increases the risk of hemorrhage andis difficult to use. Dabigatran is a new oral direct thrombininhibitor.
http://content.nejm.org/cgi/content/short/NEJMoa0905561v1
Methods In this noninferiority trial, we randomly assigned 18,113patients who had atrial fibrillation and a risk of stroke toreceive, in a blinded fashion, fixed doses of dabigatran —110 mg or 150 mg twice daily — or, in an unblinded fashion,adjusted-dose warfarin. The median duration of the follow-upperiod was 2.0 years. The primary outcome was stroke or systemicembolism.
Results Rates of the primary outcome were 1.69% per year inthe warfarin group, as compared with 1.53% per year in the groupthat received 110 mg of dabigatran (relative risk with dabigatran,0.91; 95% confidence interval [CI], 0.74 to 1.11; P<0.001for noninferiority) and 1.11% per year in the group that received150 mg of dabigatran (relative risk, 0.66; 95% CI, 0.53 to 0.82;P<0.001 for superiority). The rate of major bleeding was3.36% per year in the warfarin group, as compared with 2.71%per year in the group receiving 110 mg of dabigatran (P=0.003)and 3.11% per year in the group receiving 150 mg of dabigatran(P=0.31). The rate of hemorrhagic stroke was 0.38% per yearin the warfarin group, as compared with 0.12% per year with110 mg of dabigatran (P<0.001) and 0.10% per year with 150mg of dabigatran (P<0.001). The mortality rate was 4.13%per year in the warfarin group, as compared with 3.75% per yearwith 110 mg of dabigatran (P=0.13) and 3.64% per year with 150mg of dabigatran (P=0.051).
Conclusions In patients with atrial fibrillation, dabigatran given at a dose of 110 mg was associated with rates of stroke and systemic embolism that were similar to those associated with warfarin, as well as lower rates of major hemorrhage. Dabigatran administered at a dose of 150 mg, as compared with warfarin, was associated with lower rates of stroke and systemic embolism but similar rates of major hemorrhage. (ClinicalTrials.gov number,NCT00262600[ClinicalTrials.gov] .)
other sources:
http://www.vancouversun.com/health/seniors/blood+thinner+safer+better+cutting+stroke+risk/1946543/story.html?id=1946543
http://www.warfarinfo.com/dabigatran.htm
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