Comparison of a once Daily with a twice Daily Subcutaneous Low Molecular Weight Heparin Regimen in the Treatment of Deep Vein Thrombosis

Abstract

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.

Effects of a Low-Molecular-Weight Heparin on Thrombus Regression and Recurrent Thromboembolism in Patients with Deep-Vein Thrombosis

“…I Because of their greater bioavailability, low-molecular-weight heparins can be administered subcutaneously without the need for laboratory monitoring. Randomized, controlled trials of treatment for acute deep-vein thrombosis [5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20] or pulmonary embolism 21 have demonstrated that low-molecular-weight heparins are at least as effective and safe as unfractionated heparin. In addition to the assessments of clinical outcome, repeated venography has revealed a tendency for the thrombus to regress in the groups receiving a low-molecular-weight heparin.…”

Major bleeding risks of different low‐molecular‐weight heparin agents: a cohort study in 12 934 patients treated for acute venous thrombosis

“…gave higher rates of bleeding complications as compared with o.d. (relative risk, 1.64; 95% CI, 0.74–3.57) . When combining results from our study and the latter study in a post hoc meta‐analysis with a random effects model, the OR of the meta‐analysis indicates a 1.77 increased risk (95% CI, 0.97–3.23) for patients using b.i.d.…”

Low-molecular-weight heparins in the treatment of venous thromboembolism

“…Once daily dosing is attractive because it may be more acceptable to the patient and involves less nursing time. In one controlled study [20], once daily nadroparin was shown to have equal efficacy and safety as twice daily nadroparin. The primary end-point of a combination of venous thromboembolism and mortality was reported in 13 patients (4.1%) in the group that received daily nadroparin and in 24 patients (7.2%) who received twice daily nadroparin.…”