Generic and Branded Enoxaparin Bioequivalence: A Clinical and Experimental Study
Hamdi Boubaker MD1,8, Mohamed Habib Grissa MD1,8, Mouna Sassi MD2,8, Taher Chakroun MD3, Kaouthar Beltaief MD1,8, Mohsen Hassine MD4,8, Grigoris T Gerotziafas MD5, Rabie Razgallah MD6, Wahid Bouida MD1,8, Riadh Boukef MD7,8, Ismail Elalamy MD5 and Semir Nouira MD1,8*
- *Corresponding Author:
- Semir Nouira, MD
Emergency Department, Fattouma
Bourguiba University Hospital Monastir
and Research Laboratory (LR12SP18)
University of Monastir 5000 Tunisia
Tel : +216 73 532 014
Fax : +216 73 460 678
E-mail: [email protected]
Received Date: June 16, 2015 Accepted Date: July 14, 2015 Published Date: July 21, 2015
Citation: Boubaker H MD, Grissa MH MD, Sassi M MD, Chakroun T MD, Beltaief K MD, et al. (2015) Generic and Branded Enoxaparin Bioequivalence: A Clinical and Experimental Study. J Bioequiv Availab 7:225-228. doi:10.4172/jbb.1000244
Copyright: © 2015 Boubaker H MD, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Our aim is to compare a new generic version of enoxaparin (Enoxa®) with the parent brand (Lovenox®). We included patients with acute coronary syndrome (ACS) for the clinical study and healthy volunteers for the experimental study. ACS patients randomly assigned to receive a bolus of Enoxa® (n=86) or Lovenox® (n=83) and serum anti-Xa activity was measured 4 hours thereafter. For experimental study, blood from healthy volunteers was used to compare the effect of both formulations on thrombin generation in citrated platelet-poor plasma (PPP). The half maximal inhibitory concentration of the drug (IC50) that is required to inhibit 50% in-vitro thrombin generation parameters, mean rate index (MRI) and endogenous thrombin potential (ETP). Both IC50 MRI and IC50 ETP were calculated in PPP. In ACS patients, serum anti-Xa activity was found not different between Enoxa® and Lovenox®. Median anti Xa activity measured 4 hours after the initial bolus was 0.39 IU anti-Xa/ml [95 % CI 0.31-0.53] and 0.34 IU anti-Xa/ml [95% CI 0.27-0.53], for the Enoxa® group and Lovenox® group respectively. No difference in major cardiovascular events was observed during hospital stay. In healthy volunteers, IC50 MRI and IC50 ETP were similar between Lovenox® and Enoxa® in PPP [(2.5 μg/ml ± 0.2 μg/ml) versus (2.3 μg/ml ± 0.1μg/ml) respectively for IC50 MRI; (p=0.2)] and [(4.8 μg/ml ± 0.8 μg/ml) versus (4.1 μg/ml ± 0.1 μg/ml) respectively for IC50 ETP; (p=0.2)]. With both formulations, anti-Xa activity and anti-Xa/anti-IIa ratio were similar. The generic enoxaparin Enoxa® met the main regulatory criteria of bioequivalence with the branded product.