Prevention of Deep Vein Thrombosis

Bivalirudin (given as sc injection) has been evaluated for prevention of deep vein thrombosis (DVT) in patients undergoing hip or knee surgery. In a phase II, open-label, dose-optimization study of 222 patients, sc bivalirudin was given beginning 12-24 h postoperatively for up to 14 days or until hospital discharge (Ginsberg et al., 1994b). Five dose regimens were used, ranging from 0.3mg/kg twice a day to 1.0mg/kg three times a day (Table 4). Patients were evaluated for the occurrence of symptomatic DVT or pulmonary embolism (PE) within 72 h of discontinuing bivalirudin, and assessment of distal or proximal DVT by venography was performed on day 14 or just prior to discharge. Two patients suffered PE while three patients had major bleeding. The rate of DVT ranged from 59% in the lowest-dose regimen to only 17% in the highest-dose regimen (1.0mg/kg three

TABLE 4 Efficacy and Safety of Bivalirudin in Preventing Deep Vein Thrombosis After Major Hip or Knee Surgery

Bivalirudin dosing regimen

1.0 mg/kg every 12 h

TABLE 4 Efficacy and Safety of Bivalirudin in Preventing Deep Vein Thrombosis After Major Hip or Knee Surgery

1.0 mg/kg every 12 h

Efficacy or safety

0.3 mg/kg

0.6 mg/kg

for 3 d,

1.0 mg/kg

1.0 mg/kg

endpoint

every 12 h

every 12 h

then 0.6 mg/kg

every 12 h

every 8 h

n

0 0

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