Enoxaparin Sodium (Page 8 of 11)

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

Indication

Dosing Regimen

Enoxaparin Sodium Injection

Enoxaparin Sodium Injection

Placebo

20 mg daily subcutaneously

40 mg daily subcutaneously

n (%)

n (%)

n (%)

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)

* 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

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.

14.4 Treatment of Deep Vein Thrombosis with or without Pulmonary Embolism

In a multicenter, parallel group study, 900 patients with acute lower extremity deep vein thrombosis (DVT) with or without pulmonary embolism (PE) were randomized to an inpatient (hospital) treatment of either (i) enoxaparin sodium injection 1.5 mg/kg once a day subcutaneously, (ii) enoxaparin sodium injection 1 mg/kg every 12 hours subcutaneously, or (iii) heparin intravenous bolus (5000 IU) followed by a continuous infusion (administered to achieve an aPTT of 55 to 85 seconds). A total of 900 patients were randomized in the study and all patients were treated. Patients ranged in age from 18 to 92 years (mean age 60.7 years) with 54.7% men and 45.3% women. All patients also received warfarin sodium (dose adjusted according to PT to achieve an International Normalization Ratio [INR] of 2.0 to 3.0), commencing within 72 hours of initiation of enoxaparin sodium injection or standard heparin therapy, and continuing for 90 days. Enoxaparin sodium injection or standard heparin therapy was administered for a minimum of 5 days and until the targeted warfarin sodium INR was achieved. Both enoxaparin sodium injection regimens were equivalent to standard heparin therapy in reducing the risk of recurrent venous thromboembolism (DVT and/or PE). The efficacy data are provided below (see Table 21).

Table 21: Efficacy of Enoxaparin Sodium Injection in Treatment of Deep Vein Thrombosis with or without Pulmonary Embolism

Indication

Dosing Regimen*

Enoxaparin Sodium Injection

Enoxaparin Sodium Injection

Heparin

1.5 mg/kg daily subcutaneously

1 mg/kg q12h subcutaneously

aPTT Adjusted Intravenous Therapy

n (%)

n (%)

n (%)

All Treated DVT Patients with or without PE

298 (100)

312 (100)

290 (100)

Patient Outcome

Total VTE (%)

13 (4.4)

9 (2.9)

12 (4.1)

DVT Only (%)

11 (3.7)

7 (2.2)

8 (2.8)

Proximal DVT (%)

9 (3.0)

6 (1.9)

7 (2.4)

PE (%)

2 (0.7)

2 (0.6)

4 (1.4)

* All patients were also treated with warfarin sodium commencing within 72 hours of enoxaparin sodium injection or standard heparin therapy.
† VTE = venous thromboembolic event (DVT and/or PE)
‡ The 95% Confidence Intervals for the treatment differences for total VTE were:
Enoxaparin sodium injection once a day versus heparin (-3.0 to 3.5)
Enoxaparin sodium injection every 12 hours versus heparin (-4.2 to 1.7)

Similarly, in a multicenter, open-label, parallel group study, patients with acute proximal DVT were randomized to enoxaparin sodium injection or heparin. Patients who could not receive outpatient therapy were excluded from entering the study. Outpatient exclusion criteria included the following: inability to receive outpatient heparin therapy because of associated co-morbid conditions or potential for non-compliance and inability to attend follow-up visits as an outpatient because of geographic inaccessibility. Eligible patients could be treated in the hospital, but ONLY enoxaparin sodium injection patients were permitted to go home on therapy (72%). A total of 501 patients were randomized in the study and all patients were treated. Patients ranged in age from 19 to 96 years (mean age 57.8 years) with 60.5% men and 39.5% women. Patients were randomized to either enoxaparin sodium injection 1 mg/kg every 12 hours subcutaneously or heparin intravenous bolus (5000 IU) followed by a continuous infusion administered to achieve an aPTT of 60 to 85 seconds (in-patient treatment). All patients also received warfarin sodium as described in the previous study. Enoxaparin sodium injection or standard heparin therapy was administered for a minimum of 5 days. Enoxaparin sodium injection was equivalent to standard heparin therapy in reducing the risk of recurrent venous thromboembolism. The efficacy data are provided below (see Table 22).

Table 22: Efficacy of Enoxaparin Sodium Injection in Treatment of Deep Vein Thrombosis

Indication

Dosing Regimen*

Enoxaparin Sodium Injection

Heparin

1 mg/kg q12h subcutaneously

aPTT Adjusted Intravenous Therapy

n (%)

n (%)

All Treated DVT Patients

247 (100)

254 (100)

Patient Outcome

Total VTE (%)

13 (5.3)

17 (6.7)

DVT Only (%)

11 (4.5)

14 (5.5)

Proximal DVT (%)

10 (4.0)

12 (4.7)

PE (%)

2 (0.8)

3 (1.2)

* All patients were also treated with warfarin sodium commencing on the evening of the second day of enoxaparin sodium injection or standard heparin therapy.
† VTE = venous thromboembolic event (deep vein thrombosis [DVT] and/or pulmonary embolism [PE]).
‡ The 95% Confidence Intervals for the treatment difference for total VTE was: Enoxaparin sodium injection versus heparin (-5.6 to 2.7).

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