title: Generic versus branded enoxaparin in the prevention of venous thromboembolism following major abdominal surgery: report of an exploratory clinical trial.
abstract: BACKGROUND
  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.
authors.affiliation: Loyola University Medical Center, Maywood, IL, USA.
authors.forename: Marise
authors.initials: M
authors.lastname: Gomes
authors.forename: Eduardo
authors.initials: E
authors.lastname: Ramacciotti
authors.forename: Alexandre Cruz
authors.initials: AC
authors.lastname: Henriques
authors.forename: Gilson Roberto
authors.initials: GR
authors.lastname: Araujo
authors.forename: Luiz Arnaldo
authors.initials: LA
authors.lastname: Szultan
authors.forename: Fausto
authors.initials: F
authors.lastname: Miranda
authors.forename: Indermohan
authors.initials: I
authors.lastname: Thethi
mesh_terms: D000005:Abdomen / Q000601:surgery*; D000925:Anticoagulants / Q000627:therapeutic use*; D016568:Drugs, Generic / Q000627:therapeutic use*; D017984:Enoxaparin / Q000627:therapeutic use*; D005260:Female; D006495:Heparin, Low-Molecular-Weight / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome; D054556:Venous Thromboembolism / Q000188:drug therapy / Q000517:prevention & control*
chemical_list: D000925:Anticoagulants; D016568:Drugs, Generic; D017984:Enoxaparin; D006495:Heparin, Low-Molecular-Weight