A Randomized Trial Comparing 2 Low-Molecular-Weight Heparins for the Outpatient Treatment of Deep Vein Thrombosis and Pulmonary Embolism

SummaryBackground: Clinical trials have been performed to compare with standard heparin a once or a twice daily regimen of low-molecular-weight heparin but no direct comparison has been done between these two low-molecular-weight heparin regimens in terms of efficacy and safety with a long-term clinical evaluation.Methods: Patients with proximal deep vein thrombosis, confirmed by venography were randomly assigned to either nadroparin (10,250 AXa IU/ml) twice daily or nadroparin (20,500 AXa IU/ml) once daily for at least 5 days. Regimens were adjusted to bodyweight. Oral anticoagulants were started on day 1 or 2 and continued for 3 months. Patients were followed up for 3 months. The composite outcome of venous thromboembolism and death possibly related to pulmonary embolism was the primary measure of efficacy. Major bleeding was the principal measure of safety. The study was designed to show equivalence between the two regimens.Results: Recurrent thromboembolic events or death possibly related to pulmonary embolism were reported in 13 patients in the once daily group (4.1%) and in 24 patients of the twice daily group (7.2%): (absolute difference 3.1% in favor of the once daily regimen; 95% confidence interval -6.6%, +0.5%). Major bleeding episodes during nadroparin treatment occurred in 4 (1.3%) and 4 patients (1.2%) in the once and twice daily groups, respectively.Conclusions: A nadroparin regimen of one injection per day is at least as effective and safe as the same total daily dose divided over two injections for the treatment of acute deep vein thrombosis.

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Assessment of Outpatient Treatment of Deep-Vein Thrombosis With Low-Molecular-Weight Heparin

Archives of Internal Medicine ◽

10.1001/archinte.158.18.2001 ◽

1998 ◽

Vol 158 (18) ◽

pp. 2001 ◽

Cited By ~ 133

Author(s):

Linda Harrison ◽

Joanne McGinnis ◽

Mark Crowther ◽

Jeffrey Ginsberg ◽

Jack Hirsh

Keyword(s):

Molecular Weight ◽

Deep Vein Thrombosis ◽

Outpatient Treatment ◽

Low Molecular Weight Heparin ◽

Low Molecular Weight ◽

Vein Thrombosis ◽

Deep Vein

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A DOUBLE BLIND RANDOMIZED TRIAL OF ORG 10172 LOW MOLECULAR WEIGHT HEPARINOID IN THE PREVENTION OF DEEP VEIN THROMBOSIS IN PATIENTS WITH THROMBOTIC STROKE

10.1055/s-0038-1643239 ◽

1987 ◽

Author(s):

A G G Turple ◽

M N Levin ◽

J Hirish ◽

C J Carter ◽

R M Jay ◽

...

Keyword(s):

Molecular Weight ◽

Deep Vein Thrombosis ◽

Placebo Group ◽

Venous Thrombosis ◽

Randomized Trial ◽

Thrombosis Prophylaxis ◽

Low Molecular Weight ◽

Double Blind ◽

Vein Thrombosis ◽

Deep Vein

The optimal method of venous thrombosis prophylaxis in patients with stroke is uncertain. ORG 10172 is a low molecular weight heparinoid consisting principally of heparan and dermatan sulphates. In animal studies, ORG 10172 is as effective as unfractionated heparin in preventing venous thrombosis but produces less bleeding. There have been a limited number of descriptive studies on its use in humans, but to date randomized efficacy trials of ORG 10172 in the prevention of venous thrombosis have not been reported. A double blind randomized trial was carried out to compare ORG 10172 with placebo in the prevention of deep vein thrombosis in patients with thrombotic stroke. Seventy-five patients were randomized to receive ORG 10172 (50 patients) in a loading dose of 1,000 anti-Xa units intravenously followed by 750 anti-Xa units subcutaneously 12 hourly or placebo (25 patients). Prophylaxis was commenced within 7 days of stroke onset, continued for 14 days or until discharge from hospital, if earlier. Venous thrombosis surveillance was carried out with 125-1 fibrinogen leg scanning and impedance plethysmography. Venous thrombosis was confirmed by venography which occurred in 2 of 50 (4%) in the ORG 10172 group and 7 of 25 (28%) in the placebo group (p=0.005). The corresponding rates for proximal vein thrombosis were 0% and 16%, respectively (p=0.01). There was one major haemorrhage in the treated group and one minor haemorrhage in the placebo group. The anti-factor Xa levels (units/ml; mean ± SE) gradually rose from 0.18 ± 0.001 and 0.06 ± 0.01 six and 12 hours after injection on the first day to 0.24 ± 0.02 and 0.12 ± 0.01 after 11 days treatment. The results of this study indicate that ORG 10172 heparinoid is effective prophylaxis against deep vein thrombosis in patients with acute thrombotic stroke.

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Low-Molecular-Weight Heparins in the Treatment of Deep-Vein Thrombosis

Annals of Pharmacotherapy ◽

10.1345/aph.16450 ◽

1998 ◽

Vol 32 (5) ◽

pp. 588-601 ◽

Cited By ~ 17

Author(s):

Pierre Martineau ◽

Nadine Tawil

Keyword(s):

Molecular Weight ◽

Deep Vein Thrombosis ◽

Clinical Efficacy ◽

Total Mortality ◽

Bleeding Complications ◽

Low Molecular Weight ◽

Laboratory Monitoring ◽

Low Molecular Weight Heparins ◽

Vein Thrombosis ◽

Deep Vein

OBJECTIVE: To compare the characteristics and clinical efficacy of low-molecular-weight heparins (LMWHs) and unfractionated heparin (UFH) in the treatment of deep-vein thrombosis (DVT). Adverse effects, dosing, and cost issues are also discussed. DATA SOURCES: A MEDLINE search (January 1984–October 1997) was used to identify pertinent French and English literature, including clinical trials and reviews on LMWHs and their use in DVT. STUDY SELECTION: Trials comparing dalteparin, enoxaparin, tinzaparin, and nadroparin with UFH were selected. As studies were numerous, only randomized trials including more than 50 patients were reviewed. Moreover, all patients studied had a first episode of symptomatic DVT confirmed by objective tests (i.e., venography, duplex ultrasonography, impedance plethysmography). Clinical efficacy and safety of LMWHs were assessed in these trials. DATA EXTRACTION: Results pertaining to venographic assessment, recurrent thromboembolism, total mortality, and bleeding complications were extracted from the selected studies. DATA SYNTHESIS: Compared with UFH, LMWHs have a longer plasma half-life, better subcutaneous bioavailability, more predictable anticoagulant response, and require less intense laboratory monitoring. Most trials demonstrate comparable effects on thrombus extension and incidence of recurrent thromboembolism. Compared with UFH, LMWHs do not alter total mortality. Although animal trials predict a lower hemorrhagic potential for LMWHs, the incidence of bleeding complications is generally similar to that observed with UFH. Outpatient management of DVT with LMWHs has shown comparable safety and efficacy with inpatient UFH use but a shorter hospital stay. CONCLUSIONS: Because LMWHs are as safe and as effective as UFH, and because of their more convenient method of administration, they can be considered valuable alternatives for the treatment of DVT. Savings generated by less intensive laboratory monitoring and the possibility of early hospital discharge and outpatient therapy may outweigh the higher acquisition cost of LMWHs.

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