Clinical Studies With Lepirudin In Hit A Three Prospective Clinical Trials Heparin Associated Thrombocytopenias 2 and

Three prospective studies with lepirudin for HIT were designated heparin-asso-ciated thrombocytopenia (HAT)-l, -2, and -3 (Greinacher et al., 1999a,b, 2000; Lubenow and Greinacher, 2002; Lubenow et al., 2005). There was no approved non-heparin alternative anticoagulant during the 3 yr in which the HAT studies were conducted (March 1994-April 1996), and thus for ethical reasons, a placebo control was not appropriate. The HAT studies therefore included comparisons of clinical outcomes with a historical control group treated before lepirudin became available.

A meta-analysis of HAT-1 and -2 was performed to evaluate patients given lepirudin for treatment of HIT with thrombosis (Greinacher et al., 2000). A second meta-analysis of the HAT-1, -2, and -3 studies was performed to evaluate the effects of lepirudin in patients with HIT and isolated thrombocytopenia ("isolated HIT") (Lubenow et al., 2004). In addition, an observational study termed the drug-monitoring program (DMP) was carried out to determine the effects of lepirudin in a large cohort of patients treated in routine clinical settings (Lubenow et al., 2000).

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