Generic Versus Branded Enoxaparin in the Prevention of Venous Thromboembolism Following Major Abdominal Surgery: Report of an Exploratory Clinical Trial

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dc.contributor.authorGomes, Marise
dc.contributor.authorRamacciotti, Eduardo
dc.contributor.authorHenriques, Alexandre Cruz
dc.contributor.authorAraujo, Gilson Roberto
dc.contributor.authorSzultan, Luiz Arnaldo
dc.contributor.authorMiranda, Fausto [UNIFESP]
dc.contributor.authorThethi, Indermohan
dc.contributor.institutionLoyola Univ
dc.contributor.institutionHosp Base Brasilia
dc.contributor.institutionIrmandade Santa Casa Misericordia São Paulo
dc.contributor.institutionUniversidade Federal de São Paulo (UNIFESP)
dc.contributor.institutionAurora Mem Hosp
dc.date.accessioned2016-01-24T14:17:26Z
dc.date.available2016-01-24T14:17:26Z
dc.date.issued2011-11-01
dc.description.abstractIntroduction: Several generic low-molecular-weight heparins (LMWHs) have recently become available worldwide, including the United States. Companies have filed for regulatory approval of generic versions in many countries, based only on compound biochemical characteristics or its immunogenicity. Methods: Prospective study to evaluate the comparative effect of 2 enoxaparins (Sanofi-Aventis branded enoxaparin [SAe] vs eurofarma-enoxaparin [Ee], a generic version) as prophylaxis for venous thromboembolism (VTE) following major abdominal surgery. A total of 200 patients were randomized in a 1:1 ratio either to receive 40 mg of SAe or Ee subcutaneously (sc) once daily (od) postoperatively for 7 to 10 days. Compressive ultrasound was performed on day 10 + 4. Results: No statistically significant differences between the 2 groups were detected. in all, 2 SAe patients presented deep vein thrombosis ([DVT] 2.1%), none of the Ee group. No major bleeding events occurred. Conclusions: This exploratory trial suggests that the generic LMWH is probably as safe and as effective as the branded enoxaparin (Lovenox, Brazil) in the prophylaxis of VTE in this population.en
dc.description.affiliationLoyola Univ, Med Ctr, Maywood, IL 60153 USA
dc.description.affiliationHosp Base Brasilia, Brasilia, DF, Brazil
dc.description.affiliationIrmandade Santa Casa Misericordia São Paulo, São Paulo, SP, Brazil
dc.description.affiliationEscola Paulista Med, São Paulo, SP, Brazil
dc.description.affiliationAurora Mem Hosp, Burlington, WI USA
dc.description.affiliationUnifespEscola Paulista Med, São Paulo, SP, Brazil
dc.description.sourceWeb of Science
dc.description.sponsorshipEurofarma laboratories
dc.format.extent633-639
dc.identifierhttp://dx.doi.org/10.1177/1076029611418967
dc.identifier.citationClinical and Applied Thrombosis-hemostasis. Thousand Oaks: Sage Publications Inc, v. 17, n. 6, p. 633-639, 2011.
dc.identifier.doi10.1177/1076029611418967
dc.identifier.issn1076-0296
dc.identifier.urihttp://repositorio.unifesp.br/handle/11600/34217
dc.identifier.wosWOS:000300376400053
dc.language.isoeng
dc.publisherSage Publications Inc
dc.relation.ispartofClinical and Applied Thrombosis-hemostasis
dc.rightsinfo:eu-repo/semantics/restrictedAccess
dc.rights.licensehttp://www.uk.sagepub.com/aboutus/openaccess.htm
dc.subjectenoxaparinen
dc.subjectgeneric low-molecular-weight heparinsen
dc.subjectrandomized controlled trialen
dc.subjectabdominal surgeryen
dc.subjectprophylaxisen
dc.subjectvenous thromboembolismen
dc.titleGeneric Versus Branded Enoxaparin in the Prevention of Venous Thromboembolism Following Major Abdominal Surgery: Report of an Exploratory Clinical Trialen
dc.typeinfo:eu-repo/semantics/article
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