Safety Outcomes

In the DMP, the incidence of bleeding was greatly decreased when compared to the HAT clinical trials. In the group of 496 patients with HIT plus thrombosis, there were 27 (5.4%) major bleeding episodes, and among the 612 patients with isolated HIT, 36 (5.9%) had major bleeding. Allergic reactions were reported in four (0.8%) patients in the HIT plus thrombosis group and in 1 (0.2%) patient with isolated HIT. No anaphylaxis was reported.

The decreased incidence of bleeding events in the DMP can most likely be attributed to physicians' greater experience with administering lepirudin and monitoring its effects.

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