Enoxaparin Sodium (Page 11 of 16)

Extended Prophylaxis of Deep Vein Thrombosis following Hip Replacement Surgery

In a study of extended prophylaxis for patients undergoing hip replacement surgery, patients were treated, while hospitalized, with enoxaparin sodium injection 40 mg subcutaneously, initiated up to 12 hours prior to surgery for the prophylaxis of postoperative DVT. At the end of the peri-operative period, all patients underwent bilateral venography. In a double-blind design, those patients with no venous thromboembolic disease were randomized to a post-discharge regimen of either enoxaparin sodium injection 40 mg (n = 90) once a day subcutaneously or to placebo (n = 89) for 3 weeks. A total of 179 patients were randomized in the double-blind phase of the study and all patients were treated. Patients ranged in age from 47 to 87 years (mean age 69.4 years) with 57% men and 43% women. In this population of patients, the incidence of DVT during extended prophylaxis was significantly lower for enoxaparin sodium injection compared to placebo. The efficacy data are provided below (see Table 19).

Table 19: Efficacy of Enoxaparin Sodium Injection in the Extended Prophylaxis of Deep Vein Thrombosis following Hip Replacement Surgery
Post-discharge Dosing Regimen
Indication (Post-discharge) Enoxaparin Sodium Injection 40 mg daily subcutaneously n (%) Placebo daily subcutaneously n (%)
*
p value versus placebo = 0.008
CI= Confidence Interval
p value versus placebo = 0.537

All Treated Extended Prophylaxis Patients

90 (100)

89 (100)

Treatment Failures

Total DVT (%)

6 (7)*(95% CI : 3 to 14)

18 (20)(95% CI: 12 to 30)

Proximal DVT (%)

5 (6)(95% CI: 2 to 13)

7 (8)(95% CI: 3 to 16)

In a second study, patients undergoing hip replacement surgery were treated, while hospitalized, with enoxaparin sodium injection 40 mg subcutaneously, initiated up to 12 hours prior to surgery. All patients were examined for clinical signs and symptoms of venous thromboembolic (VTE) disease. In a double-blind design, patients without clinical signs and symptoms of VTE disease were randomized to a post-discharge regimen of either enoxaparin sodium injection 40 mg (n = 131) once a day subcutaneously or to placebo (n = 131) for 3 weeks. A total of 262 patients were randomized in the study double-blind phase and all patients were treated. Patients ranged in age from 44 to 87 years (mean age 68.5 years) with 43.1% men and 56.9% women. Similar to the first study the incidence of DVT during extended prophylaxis was significantly lower for enoxaparin sodium injection compared to placebo, with a statistically significant difference in both total DVT (enoxaparin sodium injection 21 [16%] versus placebo 45 [34%]; p = 0.001) and proximal DVT (enoxaparin sodium injection 8 [6%] versus placebo 28 [21%]; p = <0.001).

14.3 Prophylaxis of Deep Vein Thrombosis in Medical Patients with Severely Restricted Mobility during Acute Illness

In a double blind multicenter, parallel group study, enoxaparin sodium injection 20 mg or 40 mg once a day subcutaneously was compared to placebo in the prophylaxis of deep vein thrombosis (DVT) in medical patients with severely restricted mobility during acute illness (defined as walking distance of <10 meters for ≤3 days). This study included patients with heart failure (NYHA Class III or IV); acute respiratory failure or complicated chronic respiratory insufficiency (not requiring ventilatory support): acute infection (excluding septic shock); or acute rheumatic disorder (acute lumbar or sciatic pain, vertebral compression [due to osteoporosis or tumor], acute arthritic episodes of the lower extremities). A total of 1102 patients were enrolled in the study, and 1073 patients were treated. Patients ranged in age from 40 to 97 years (mean age 73 years) with equal proportions of men and women. Treatment continued for a maximum of 14 days (median duration 7 days). When given at a dose of 40 mg once a day subcutaneously, enoxaparin sodium injection significantly reduced the incidence of DVT as compared to placebo. The efficacy data are provided below (see Table 20).

Table 20: Efficacy of Enoxaparin Sodium Injection in the Prophylaxis of Deep Vein Thrombosis in Medical Patients with Severely Restricted Mobility during Acute Illness
Dosing Regimen
Indication Enoxaparin Sodium Injection 20 mg daily subcutaneously n (%) Enoxaparin Sodium Injection 40 mg daily subcutaneously n (%) Placebo n (%)
*
Treatment failures during therapy, between Days 1 and 14.
VTE = Venous thromboembolic events which included DVT, PE, and death considered to be thromboembolic in origin.
CI = Confidence Interval

All Treated Medical Patients during Acute Illness

351 (100)

360 (100)

362 (100)

Treatment Failure *

Total VTE (%)

43 (12.3)

16 (4.4)

43 (11.9)

Total DVT (%)

43 (12.3)(95% CI : 8.8 to 15.7)

16 (4.4)(95% CI : 2.3 to 6.6)

41 (11.3)(95% CI : 8.1 to 14.6)

Proximal DVT (%)

13 (3.7)

5 (1.4)

14 (3.9)

At approximately 3 months following enrollment, the incidence of venous thromboembolism remained lower in the enoxaparin sodium injection 40 mg treatment group versus the placebo treatment group.

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