title: Generic versus branded enoxaparin in prophylaxis and treatment of vein thrombosis.
abstract: OBJECTIVE
  to compare the biological efficacy of generic enoxaparin (HeptronTM) versus branded Sanofi-Aventis enoxaparin for prophylaxis and treatment of lower-extremity deep venous thrombosis (DVT) in a prospective, randomized, open-label study.
  
  
  METHODS
  patients with diagnosed lower-extremity DVT (therapeutic branch, n=57) and patients requiring venous thromboembolism (VTE) prophylaxis after arterial vascular surgery or major lower-extremity amputations (prophylactic branch, n=57) were randomized to receive generic or branded enoxaparin for up to seven days. Enoxaparin activity was measured by estimating blood anti-factor Xa levels at the peak plasma concentration. As secondary outcomes, development or progression of VTE events, major adverse events and major bleeding events were considered for efficacy and safety comparisons.
  
  
  RESULTS
  DVT therapy: twenty-five patients received generic enoxaparin while 32 received branded enoxaparin (subcutaneous, 1 mg/kg BID). Mean percentages of anti-factor Xa levels within the target ranges were 62 ± 35.4% and 67.5 ± 24.7%, respectively (p= .035 for non-inferiority). No patient presented DVT progression, clinically detectable pulmonary embolism, or major bleeding events in any subgroup. DVT prophylaxis: Thirty patients received generic enoxaparin and 27 received branded enoxaparin (subcutaneous, 40 mg/day). Mean percentages of anti-factor Xa levels within the target ranges were 77.9 ± 30.9% and 77.8 ± 32.9%, respectively (p = .009 for non-inferiority). There were no cases of VTE or major bleeding events in any subgroup.
  
  
  CONCLUSIONS
  generic and branded enoxaparins exhibited similar in vivo responses as measured by the anti-factor Xa activity, as well as similar clinical efficacy and safety outcomes.
authors.affiliation: Faculty of Medicine, University of São Paulo, São Paulo, SP, Brazil.
authors.forename: Ivan Benaduce
authors.initials: IB
authors.lastname: Casella
authors.affiliation: FM, USP, São Paulo, SP, Brazil.
authors.forename: Pedro
authors.initials: P
authors.lastname: Puech-Leão
mesh_terms: D000368:Aged; D000925:Anticoagulants / Q000627:therapeutic use*; D016568:Drugs, Generic / Q000627:therapeutic use*; D017984:Enoxaparin / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D011446:Prospective Studies; D016896:Treatment Outcome; D054556:Venous Thromboembolism / Q000188:drug therapy* / Q000517:prevention & control
chemical_list: D000925:Anticoagulants; D016568:Drugs, Generic; D017984:Enoxaparin