Once-daily enoxaparin in the outpatient setting versus unfractionated heparin in hospital for the treatment of symptomatic deep-vein thrombosis.
BACKGROUND
Once- and twice-daily low-molecular-weight heparin administered in hospital have been shown to be effective and safe for treating deep-vein thrombosis. The aim of this study was to compare the efficacy and safety of deep-vein thrombosis treatment using once-daily subcutaneous enoxaparin in the outpatient setting with intravenous unfractionated heparin in hospital.


METHODS
This randomized, parallel-group, open-label study was conducted in 18 centers in 4 countries. In total, 298 patients with symptomatic deep-vein thrombosis who were eligible for home treatment were randomized to treatment with enoxaparin in the outpatient setting (1.5 mg/kg subcutaneously once-daily) or unfractionated heparin in hospital (5000 IU bolus and 1250 IU/hour intravenous infusion) for > or =5 days. Clinical endpoints were assessed during a 6-month follow-up period.


RESULTS
Among all patients treated with enoxaparin, there was a trend towards fewer recurrent deep-vein thromboses (1.3% vs. 5.4%; p = 0.060) and pulmonary emboli (1.3% vs. 4.1%; p = 0.17) compared with patients treated with unfractionated heparin. When considering a post-hoc combined endpoint of deep-vein thrombosis and pulmonary embolism, significantly fewer events occurred in the enoxaparin group than in the unfractionated-heparin group (2.7% vs. 8.8%; p = 0.026). The incidences of bleeding events and adverse events in the enoxaparin and unfractionated-heparin groups were similar.


CONCLUSIONS
Once-daily subcutaneous enoxaparin in the outpatient setting is at least as effective and as well tolerated as in-hospital intravenous unfractionated heparin for treatment of deep-vein thrombosis.
Chong
Beng H
BH
Prince of Wales Hospital, Randwick, New South Wales, Australia. beng.chong@unsw.edu.au
Brighton
Tim A
TA
Baker
Ross I
RI
Thurlow
Peter
P
Lee
Choon H
CH
D000328:Adult; D000368:Aged; D000553:Ambulatory Care; D004334:Drug Administration Schedule; D017984:Enoxaparin / Q000008:administration & dosage* / Q000633:toxicity; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006493:Heparin / Q000008:administration & dosage* / Q000633:toxicity; D006760:Hospitalization; D006801:Humans; D008297:Male; D008875:Middle Aged; D011655:Pulmonary Embolism / Q000517:prevention & control; D020246:Venous Thrombosis / Q000188:drug therapy* / Q000517:prevention & control
D017984:Enoxaparin; D006493:Heparin