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After an initial course of treatment for venous thromboembolism (VTE), extended warfarin therapy lowers risk for recurrent VTE — but at the expense of excess risk for bleeding. Dabigatran (Pradaxa) now has been examined for this indication in two placebo-controlled, industry-sponsored trials.
One trial included nearly 2900 VTE patients at especially high risk for recurrence; after initial treatment (mean, 7 months), they were randomized to receive either dabigatran or warfarin. During extended treatment that averaged 16 months, the incidence of symptomatic or fatal VTE was 1.8% with dabigatran and 1.3% with warfarin, a result that met criteria for “noninferiority” of dabigatran. Major or clinically relevant bleeding was significantly less co…