Efficacy Outcomes

When outcomes were assessed from the start of lepirudin treatment, the combined endpoint for new thrombosis, limb amputation, and death was significantly lower in the lepirudin-treated patients (n = 235) than in the controls (n = 75) (19.1% vs. 40.0%; p = 0.002). This difference was primarily due to a reduction in the number of new thrombosis (6.8% vs. 25.3%; p = 0.001). Incidences of limb amputation

TABLE 4a Outcomes from Diagnosis of HIT

HAT-1, n = 82 HAT-2, n = 116 HAT-3, n = 205 All HAT-studies, n = 403 Hist, control n = 120 p*= Risk reductlon%

Treatment A1 A2 B C Total A1 A2 B C Total A1 A2 B C Total A1 A2 B C Total 120

n= 51 5 18 8 82 65 4 43 4b'° 116 98 12 84 10 205 214 21 145 22 403

Death 3 - 3 - 6(7.3) 8 1 2 - 11(9.5) 14 2 11 3 30(14.6) 25 3 16 3 47(11.2) 21(17.5) 0.095 36.0

Limb amputation 2 - 2 - 4(4.9) 4 1 5 - 10(8.6) 7 - 5 - 12(5.9) 13 1 12 - 26(6.5) 8(6.7) 0.933 3.0

New TEC 3 - 5 - 8(9.8) 8 1 3 - 12(10.3) 15 4 9 28(13.7) 26 5 17 - 48(11.9) 37(30.8) <0.0001 61.4

Composite0 7 - 8 - 15(18.3) 17 2 7 26(22.4) 29 6 23 3 61(29.8) 53 8 38 3 102(25.3) 3(44.2) 0.0001 42.8

Major bleeding 7 - 2 2 11(13.4) 6 1 11 2 20(17.2) 20 1 12 7 40(19.5) 33 2 25 11 71(17.6) 7(5.8) 0.0015 -67.0

Note: Details of treatment regimens A1, A2, B, and C are given in Table 1.

aComparing all patients in the HAT 1-3 studies with the historical control group by categorical analysis. bThe four patients receiving regimen C were not reported in the HAT-2 publication. "Composite of death, limb amputation, and new TEC (maximum, one event per patient). Abbreviations: HAT, heparin-associated thrombocytopenia; TEC, thromboembolic complication.

TABLE 4b Outcomes from Start of Treatment

HAT-1, n = 82 HAT-2, n=116 HAT-3, n = 205 All HAT-studies, n = 403 Hist, control n = 120 pa= Risk reduction %

TABLE 4b Outcomes from Start of Treatment

HAT-1, n = 82 HAT-2, n=116 HAT-3, n = 205 All HAT-studies, n = 403 Hist, control n = 120 pa= Risk reduction %

Treatment

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