Key result
Generic eurofarma-enoxaparin was as safe and effective as branded enoxaparin for VTE prophylaxis after major abdominal surgery, with DVT occurring in 0% vs 2.1% of patients.
Why the study?
Does generic enoxaparin prevent venous thromboembolism as effectively and safely as branded enoxaparin in patients following major abdominal surgery?
RCT (n=200)
1:1
Does generic enoxaparin prevent venous thromboembolism as effectively and safely as branded enoxaparin in patients following major abdominal surgery?
Absolute Event Rate: 0% vs 2.1%
Generic enoxaparin appears to be as safe and effective as branded enoxaparin for VTE prophylaxis following major abdominal surgery.
Supports generic enoxaparin substitution to lower costs in postoperative VTE prophylaxis; confirms equivalence to branded in this RCT population.
INTRODUCTION: 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.
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Gomes et al. (2011) conducted an RCT in Venous thromboembolism following major abdominal surgery (n=200). Generic eurofarma-enoxaparin vs. Branded Sanofi-Aventis enoxaparin was evaluated on Deep vein thrombosis (DVT). Generic eurofarma-enoxaparin was as safe and effective as branded enoxaparin for VTE prophylaxis after major abdominal surgery, with DVT occurring in 0% vs 2.1% of patients.
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