An open-label, comparative study of the efficacy and safety of once-daily dose of enoxaparin versus unfractionated heparin in the treatment of proximal lower limb deep-vein thrombosis.
BACKGROUND
Treatment of deep-vein thrombosis (DVT) with a once-daily regimen of enoxaparin, rather than a continuous infusion of unfractionated heparin (UFH) is more convenient and allows for home care in some patients. This study was designed to compare the efficacy and safety of these two regimens for the treatment of patients with proximal lower limb DVT.


METHODS
201 patients with proximal lower limb DVT from 13 centers in Brazil were randomized in an open manner to receive either enoxaparin [1.5 mg/kg subcutaneous (s.c.) OD] or intravenous (i.v.) UFH (adjusted to aPTT 1.5-2.5 times control) for 5-10 days. All patients also received warfarin (INR 2-3) for at least 3 months. The primary efficacy endpoint was recurrent DVT (confirmed by venography or ultrasonography), and safety endpoints included bleeding and serious adverse events. The rate of pulmonary embolism (PE) was also collected. Hospitalization was at the physician's discretion.


RESULTS
Baseline patient characteristics were comparable between groups. The duration of hospital stay was significantly shorter with enoxaparin than with UFH (3 versus 7 days). In addition, 36% of patients receiving enoxaparin did not need to be hospitalized, whereas all of the patients receiving UFH were hospitalized. The treatment duration was slightly longer with enoxaparin (8 versus 7 days). There was a nonsignificant trend toward a reduction in the rate of recurrent DVT with enoxaparin versus UFH, and similar safety.


CONCLUSIONS
A once-daily regimen of enoxaparin 1.5 mg/kg subcutaneous is at least as effective and safe as conventional treatment with a continuous intravenous infusion of UFH. However, the once daily enoxaparin regimen is easier to administer (subcutaneous versus intravenous), does not require aPTT monitoring, and leads to both a reduced number of hospital admissions and an average 4-day-shorter hospital stay.
Ramacciotti
Eduardo
E
Hospital Cristóvão da Gama, Rua Padre Vieira 326 Santo André SP 09070-720, Brazil. eramacciotti@yahoo.com
Araújo
Gilson R
GR
Lastoria
Sidnei
S
Maffei
Francisco H A
FH
Karaoglan de Moura
Liberato
L
Michaelis
Wilson
W
Sandri
João Luis
JL
Dietrich-Neto
Flávia
F
D000328:Adult; D000553:Ambulatory Care / Q000706:statistics & numerical data; D000925:Anticoagulants / Q000008:administration & dosage; D001938:Brazil / Q000453:epidemiology; D015984:Causality; D015897:Comorbidity; D017984:Enoxaparin / Q000008:administration & dosage*; D005260:Female; D006470:Hemorrhage / Q000453:epidemiology; D006495:Heparin, Low-Molecular-Weight / Q000008:administration & dosage*; D006801:Humans; D007902:Length of Stay / Q000706:statistics & numerical data; D008297:Male; D008875:Middle Aged; D018570:Risk Assessment / Q000379:methods*; D012307:Risk Factors; D055502:Secondary Prevention; D013924:Thrombophlebitis / Q000188:drug therapy* / Q000453:epidemiology* / Q000517:prevention & control; D016896:Treatment Outcome; D020246:Venous Thrombosis / Q000188:drug therapy / Q000453:epidemiology / Q000517:prevention & control
D000925:Anticoagulants; D017984:Enoxaparin; D006495:Heparin, Low-Molecular-Weight