ONCE-DAILY SUBCUTANEOUS DALTEPARIN, A LOW-MOLECULAR-WEIGHT HEPARIN, FOR THE INITIAL TREATMENT OF ACUTE DEEP-VEIN THROMBOSIS

The aim of the study was to compare the efficacy and safety of once-da ily subcutaneous injection of dalteparin, a low molecular weight hepar in, with that of intravenous unfractionated heparin in the treatment o f deep venous thrombosis (DVT). Patients were included if they had dee p venous thrombosis distal to inguinal ligament and were randomised ei ther before, if it was considered necessary, or after phlebographic ve rification of the diagnosis. There was no pre-inclusion treatment with unfractionated heparin. One hundred and twenty patients received dalt eparin, administered subcutaneously once-daily at a fixed dose of 200 IU anti-factor Xa/kg, and 133 patients received a continuous intraveno us infusion of unfractionated heparin (UFH). Oral anticoagulation was started on the first or second day, and initial treatment with daltepa rin or UFH discontinued when the prothrombin time was in the therapeut ic range (2<INR<3) on two consecutive days. Control phlebograms were t aken within 4 days, thereafter. There were no significant differences between the two initial treatment groups in improvements in Marder sco re. Two major bleeding events occurred in the UFH group versus none in the dalteparin group. One patient in each group experienced clinicall y significant pulmonary embolism. During a mean follow-up period of 6. 9 +/- 1.5 months, recurrent DVT occurred in four patients in the dalte parin group and in two of the UFH group. These results confirm those o f a previous study on dalteparin in the initial treatment of DVT, and suggest that dalteparin administered once-daily at a fixed dose of 200 UI/kg is as effective and well-tolerated as UFH in patients with DVT below the inguinal ligament. The present study also demonstrates that dalteparin can be started as soon as the diagnosis of DVT is suspected and without pre-treatment with UFH. Given that the administration of once-daily subcutaneous injections needs not require a patient to be h ospitalised: studies to investigate the possibility of using daltepari n for the initial treatment of DVT in the outpatient setting are warra nted.