Thromboelastographic evaluation of blood coagulation in the presence of branded and generic enoxaparins Journal Article


Authors: Walenga, J. M.; Jeske, W. P.; Escalante, V; Hoppensteadt, D; Fareed, J; Bakhos, M.
Article Title: Thromboelastographic evaluation of blood coagulation in the presence of branded and generic enoxaparins
Abstract: AIM: Enoxaparin is the most widely used low-molecular-weight heparin (LMWH) in the USA and has been approved for clinical use in multiple indications. Enoxaparin is a complex biological product with multiple known activities relevant to its antithrombotic effects, and variations in different forms of enoxaparin may have important clinical implications. This study aimed to compare the physiological anticoagulant activity of branded and a generic enoxaparin, using thromboelastography (TEG) to evaluate their effect on the dynamic formation of the blood clot as quantitated by interactions between coagulation factors and inhibitors, fibrinogen, platelets and the fibrinolytic system. METHODS: Whole native (no preservative) blood was obtained from 7 healthy volunteers. Samples were immediately mixed with various concentrations of branded or generic enoxaparin and TEG was performed to assess anticoagulant activity. Five different batches of each enoxaparin (branded and generic) were tested. RESULTS: Generic enoxaparin showed more variation in anticoagulation response with a less predictable concentration-dependent and linear response compared with branded enoxaparin. There was also an apparent batch-to-batch variation for generic enoxaparin. The results demonstrated a lower overall anticoagulant effect (P=0.05; no overlap of 95% confidence intervals) with a wider inter-individual variation for generic enoxaparin in comparison with branded enoxaparin. Some individuals responded with a higher than expected anticoagulant response to the given concentration of the generic enoxaparin. CONCLUSION: The findings of this study suggest that other pre-clinical and clinical studies should be done to validate the clinical interchangeability between branded and generic enoxaparin.
Keywords: Humans; Thoracic and Cardiovascular Surgery; Time Factors; Analysis of Variance; Quality Control; Linear Models; Dose-Response Relationship, Drug; Anticoagulants/pharmacology/standards; Blood Coagulation/drug effects; Drugs, Generic/pharmacology/standards; Enoxaparin/pharmacology/standards; Thrombelastography
Journal Title: International angiology : a journal of the International Union of Angiology
Volume: 31
Issue: 6
ISSN: 1827-1839; 0392-9590
Publisher: Unknown  
Journal Place: Italy
Date Published: 2012
Start Page: 517
End Page: 525
Language: eng
Notes: JID: 8402693; 0 (Anticoagulants); 0 (Drugs, Generic); 0 (Enoxaparin); ppublish