Postmarketing Drug Monitoring Program

Preliminary results from 1329 patients treated with lepirudin in a DMP are reported (Lubenow et al., 2002): 496 patients had HIT and thrombosis and 612 patients had isolated HIT. This postmarketing study evaluated the same clinical endpoints as were used in HAT-1, -2, and -3. In this DMP, lepirudin could be started immediately upon clinical diagnosis of HIT, thus avoiding the inherent delay awaiting laboratory confirmation. A total of 382 (77.0%) of the 496 patients with HIT and thrombosis were positive in the HIPA test, while 406 (66.3%) of the 612 patients with isolated HIT were positive in the HIPA test.

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