Subcutaneous Enoxaparin Once or Twice Daily Compared with Intravenous Unfractionated Heparin for Treatment of Venous Thromboembolic Disease - Enoxaparin Compared with Intravenous Unfractionated Heparin for Treatment of Venous Thromboembolic Disease

Mar 07, 2002
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Date Presented:
01/01/2001
Date Published:
01/01/2001
Date Updated:
03/07/2002
Original Posted Date:
03/07/2002
References

Description:

Subcutaneous Enoxaparin Once or Twice Daily Compared with Intravenous Unfractionated Heparin for Treatment of Venous Thromboembolic Disease

Hypothesis:

Is subcutaneous enoxaparin administered once or twice daily as effective as continuously infused unfractionated heparin in acute symptomatic venous thromboembolic disease?

Study Design

Study Design:

Patients Enrolled: 900

Drug/Procedures Used:

900 patients at 74 hospitals in 16 countries with symptomatic lower-extremity deep venous thrombosis (32% with confirmed pulmonary embolism) were randomized in a controlled, partially blinded clinical trail to receive one of the following three initial treatments: dose-adjusted intravenous unfractionated heparin or subcutaneous enoxaparin at fixed dosages of 1.0 mg/kg of body weight twice daily or 1.5 mg/kg once daily. Long-term oral anticoagulation was started in all patients within 72 hours of randomization. Clinical end points assessed during a 3-month follow-up period to evaluate equivalent efficacy of the three intervention strategies.

Principal Findings:

Recurrence of symptomatic venous thromboembolism was similar for the three treatment groups (12/290 [4.1%] unfractionated heparin group; 13/298 [4.4%] once-daily enoxaparin group; and 9/312 [2.9%] twice-daily enoxaparin group. Compared with unfractionated heparin, the treatment difference was 0.2% (95% CI, -3.04% to 3.49%) for once-daily enoxaparin and −1.2% (CI, -4.2% to 1.7%) for twice-daily enoxaparin. The incidence of major hemorrhage did not differ among the three treatment groups (2.1% in the unfractionated heparin group, 1.7% in the once-daily enoxaparin group and 1.3% in the twice-daily enoxaparin group).

The safety and efficacy of subcutaneous enoxaparin once or twice daily is similar to dose-adjusted, continuously infused unfractionated heparin in the prevention of recurrent symptomatic venous thromboembolic disease.

Interpretation:

This study provides further evidence that enoxaparin has similar efficacy and safety to unfractionated heparin in the prevention of recurrent symptomatic venous thromboembolic disease. Similar results have been reported for other low–molecular-weight heparins. Subcutaneous heparin regimens facilitate the outpatient treatment of deep-vein thrombosis and have obvious resource utilization implications.

References:

1. Merli G, Spiro TE, Olsson CG, et al., for the Enoxaparin Clinical Trial Group. Ann Intern Med 2001;134:191-202.

Keywords: Enoxaparin, Heparin, Low-Molecular-Weight, Pulmonary Embolism, Body Weight, Heparin, Venous Thromboembolism, Venous Thrombosis


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