FIGURE 2 Efficacy and safety outcomes of HIT patients, with and without TEC: comparison of danaparoid with lepirudin. Patients in the prospective lepirudin-treatment studies were compared with contemporaneous patients treated with danaparoid who met the identical inclusion and exclusion criteria as in the lepirudin trials. Also shown is the number of patients at risk on the starting day and at subsequent 7-day intervals. (A) Efficacy: time-to-event analysis of the incidences of a combined endpoint (new TECs, limb amputation, death; maximum, one endpoint per patient) up to day 42. Among patients without TEC at baseline (most of whom were treated with a prophylactic-dose regimen), there was a significantly higher incidence of the combined endpoint among patients treated with danaparoid, compared with lepirudin (p = 0.02, log-rank test). This suggests that a prophylactic-dose regimen for danaparoid (750 U b.i.d. or t.i.d. by sc injection, without anticoagulant monitoring) may be relatively less effective for managing patients with isolated HIT compared with a "prophylactic" regimen of lepirudin in which aPTT-adjusted monitoring occurs (Warkentin, 2001). In marked contrast, the combined endpoint did not differ significantly between danaparoid and lepirudin for patients with TEC at baseline (most of whom received therapeutic-dose danaparoid), suggesting that therapeutic (treatment) doses of danaparoid (Table 1) has similar efficacy as does therapeutic-dose lepirudin. (B) Safety: Time-to-event analysis of the incidences of major bleeding. Major bleeding was defined as overt bleeding requiring transfusion of two or more red blood cell concentrates or intracerebral bleeding. The bleeding rate was significantly lower in patients treated with danaparoid (p = 0.012, log-rank test). This indicates that the therapeutic window of lepirudin is rather narrow. Abbreviations: aPTT, activated partial thromboplastin time; HIT, heparin-induced thrombocytopenia; TEC, thromboembolic complications. Source: From Farner et al., 2001.

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