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

dc.contributor.authorRamacciotti, E.
dc.contributor.authorAraujo, G. R.
dc.contributor.authorLastoria, S.
dc.contributor.authorMaffei, Francisco Humberto de Abreu [UNESP]
dc.contributor.authorde Moura, L. K.
dc.contributor.authorMichaelis, W.
dc.contributor.authorSandri, J. L.
dc.contributor.authorDietrich-Neto, F.
dc.contributor.institutionHosp Cristovao Gama
dc.contributor.institutionHosp Base Brasilia
dc.contributor.institutionUniversidade Estadual Paulista (Unesp)
dc.contributor.institutionHosp Sao Rafael
dc.contributor.institutionHosp Evangel
dc.contributor.institutionVitoria Apart Hosp
dc.contributor.institutionAventis Pharma
dc.date.accessioned2014-05-20T15:30:44Z
dc.date.available2014-05-20T15:30:44Z
dc.date.issued2004-01-01
dc.description.abstractBackground: 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. (C) 2004 Elsevier Ltd. All rights reserved.en
dc.description.affiliationHosp Cristovao Gama, BR-09070720 Santo Andre, SP, Brazil
dc.description.affiliationHosp Base Brasilia, Brasilia, DF, Brazil
dc.description.affiliationUniv Estadual Paulista, Botucatu, SP, Brazil
dc.description.affiliationHosp Sao Rafael, Salvador, BA, Brazil
dc.description.affiliationHosp Evangel, Curitiba, Parana, Brazil
dc.description.affiliationVitoria Apart Hosp, Vitoria, Brazil
dc.description.affiliationAventis Pharma, Bridgewater, MA USA
dc.description.affiliationUnespUniv Estadual Paulista, Botucatu, SP, Brazil
dc.format.extent149-153
dc.identifierhttp://dx.doi.org/10.1016/j.thromres.2004.05.009
dc.identifier.citationThrombosis Research. Oxford: Pergamon-Elsevier B.V., v. 114, n. 3, p. 149-153, 2004.
dc.identifier.doi10.1016/j.thromres.2004.05.009
dc.identifier.issn0049-3848
dc.identifier.urihttp://hdl.handle.net/11449/40060
dc.identifier.wosWOS:000223936100001
dc.language.isoeng
dc.publisherElsevier B.V.
dc.relation.ispartofThrombosis Research
dc.relation.ispartofjcr2.779
dc.relation.ispartofsjr1,096
dc.rights.accessRightsAcesso restrito
dc.sourceWeb of Science
dc.subjectenoxaparinpt
dc.subjectvenous thromboembolismpt
dc.subjectlow-molecular-weight heparinpt
dc.subjecttreatmentpt
dc.titleAn 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 thrombosisen
dc.typeArtigo
dcterms.licensehttp://www.elsevier.com/about/open-access/open-access-policies/article-posting-policy
dcterms.rightsHolderElsevier B.V.
unesp.campusUniversidade Estadual Paulista (Unesp), Faculdade de Medicina, Botucatupt

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