Major bleeding occurred in 6.9% (21/304) of argatroban-treated patients, compared with 6.7% (13/193) of historical controls. In each group, there were two fatal bleeding events. One patient experienced a fatal intracranial hemorrhage 4 days after discontinuation of argatroban and following urokinase and warfarin therapy; one historical control also experienced a fatal intracranial hemorrhage. Minor bleeding rates were similar between the groups (41%). The most common adverse events among argatroban-treated patients with HIT or HITTS, respectively, were diarrhea (11%) and pain (9%).

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