Info

p=0.0473

days after start of selected treatment

days after start of selected treatment

Cumulative incidences of new TEC

days after start of selected treatment

days after start of selected treatment

Cumulative incidences of limb amputation

Cumulative incidences of death

Cumulative incidences of limb amputation

Cumulative incidences of death

days after start of selected treatment days after start of selected treatment

Cumulative incidences of major bleeding

Cumulative incidences of major bleeding

FIGURE 5 Time-to-event analyses of efficacy and safety endpoints in the HAT-1, -2, and -3 studies (combined) in comparison with the historical control group. (A) Composite endpoint (new thromboembolic complication, limb amputation, or death); (B) new thromboembolic complication; (C) limb amputation; (D) death; and (E) major bleeding. Abbreviation: HAT, heparin-associated thrombocytopenia. Source: From Lubenow et al., 2005.

- Hist. control n=120 - Lepirudin n=399

FIGURE 5 Time-to-event analyses of efficacy and safety endpoints in the HAT-1, -2, and -3 studies (combined) in comparison with the historical control group. (A) Composite endpoint (new thromboembolic complication, limb amputation, or death); (B) new thromboembolic complication; (C) limb amputation; (D) death; and (E) major bleeding. Abbreviation: HAT, heparin-associated thrombocytopenia. Source: From Lubenow et al., 2005.

analysis of HAT-1 and -2 showed that lepirudin was effective in patients with HIT plus thrombosis (Greinacher et al., 2000). In a meta-analysis of HAT-1, -2, and -3, the safety and efficacy of lepirudin in patients with HIT in the absence of known thrombosis was demonstrated (Lubenow et al., 2004). This meta-analysis included 91 patients treated according to dosing regimen B; of these, 20 had a history of HIT (not acute HIT). Patients with recent thrombosis at baseline were excluded from this analysis. Mean duration of treatment was 11.0 days (range 1-68 days). The mean steady state dose was 0.062 ± 0.037 mg/kg/h.

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