COMPARISON OF A ONCE-DAILY WITH A TWICE-DAILY SUBCUTANEOUS LOW-MOLECULAR-WEIGHT HEPARIN REGIMEN IN THE TREATMENT OF DEEP-VEIN THROMBOSIS

Background: Clinical trials have been performed to compare with standa rd heparin a once or a twice daily regimen of low-molecular-weight hep arin but no direct comparison has been done between these two low-mole cular-weight heparin regimens in terms of efficacy and safety with a l ong-term clinical evaluation. Methods: Patients with proximal deep vei n thrombosis, confirmed by venography were randomly assigned to either nadroparin (10,250 AXa IU/ml) twice daily or nadroparin (20,500 AXa I U/ml) once daily for at least 5 days. Regimens were adjusted to bodywe ight. Oral anticoagulants were starred on day 1 or 2 and continued for 3 months. Patients were followed up for 3 months. The composite outco me of venous thromboembolism and death possibly related to pulmonary e mbolism was the primary measure of efficacy. Major bleeding was the pr incipal 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 patie nts in the once daily group (4.1%) and in 24 patients of the twice dai ly group (7.2%): (absolute difference 3.1% in favor of the once daily regimen; 95% confidence interval -6.6%, +0.5%). Major bleeding episode s during nadroparin treatment occurred in 4 (1.3%) and 4 patients (1.2 %) in the once and twice daily groups, respectively. Conclusions: A na droparin 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.