Experience with Lepirudin in a Large Case Series in France

Tardy and colleagues (2006) reported a retrospective observational analysis involving 181 patients (median age, 67 yr) with HIT, in whom the diagnosis was confirmed in 89.5% by a laboratory assay. The mean treatment dose was only 0.06 ± 0.04 mg/kg/h, which was much less than the approved dose (0.15 mg/kg/h), as well as the mean doses given in the HAT studies (0.11 mg/kg/h for HIT with thrombosis and 0.07 mg/kg/h for isolated thrombocytopenia). Whereas in the HAT 1-3 studies the rate of new thrombosis was 7.4%, it was somewhat greater (13.8%) in the French cohort. The rate of major bleeding, however, was similar in both studies: 20.4% in the French cohort and 17.6% in HAT 1-3 (although a somewhat broader definition of major bleeding was used in the French study). As in the HAT studies, Tardy et al. also found that moderate to severe impairment of renal function strongly enhanced bleeding risk (p < 0.001). They also found that prolonged treatment with lepirudin and a mean dose exceeding 0.07 mg/kg/h were independent risk factors for bleeding. In the context of the HAT 1-3 studies, this is further evidence that the approved dose for lepirudin is too high and that especially in elderly patients, initial lepirudin dosing should be reduced to 0.05-0.10 mg/kg/h iv. In patients with known impairment of renal function, dosing should be reduced even further (Table 2).

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