Abstract
Clopidogrel is a thienopyridine that selectively and irreversibly inhibits the ADP purinergic receptor P2Y12 and the subsequent ADP-mediated platelet activation. Clopidogrel has been approved for clinical use as clopidogrel hydrogen sulfate (bisulfate) salt. The clinical usefulness of clopidogrel bisulfate salt has been proved in a wide variety of large scale clinical trials, thus clopidogrel bisulfate has been extensively used in a large spectrum of patients been under thrombotic risk. Recently, several generic clopidogrel formulations have been approved for clinical use. Consequently, clopidogrel is currently a cost-effective antiplatelet agent. Only small studies have compared the pharmacokinetic and pharmacodynamic properties of various clopidogrel generic salt formulations with the innovator bisulfate salt. In addition few data are available concerning the clinical efficacy and safety of these generic clopidogrel formulations in order to guide clinicians in deciding when generic substitution is appropriate. The aim of this review is to summarize the physicochemical properties as well as the pharmacokinetic and pharmacodynamic characteristics of the generic clopidogrel salts. We also critically present existing data on the clinical efficacy and safety of the generic clopidogrel formulations compared with the innovator clopidogrel bisulfate salt in patients with cardiovascular disease.
Keywords: Bioequivalence, cardiovascular disease, clopidogrel, generic clopidogrel, pharmacokinetics, pharmacodynamics, platelets.
Current Vascular Pharmacology
Title:Clopidogrel Generic Formulations in the Era of New Antiplatelets: A Systematic Review
Volume: 12 Issue: 5
Author(s): Maria E. Tsoumani, Kallirroi I. Kalantzi, Ioannis A. Goudevenos and Alexandros D. Tselepis
Affiliation:
Keywords: Bioequivalence, cardiovascular disease, clopidogrel, generic clopidogrel, pharmacokinetics, pharmacodynamics, platelets.
Abstract: Clopidogrel is a thienopyridine that selectively and irreversibly inhibits the ADP purinergic receptor P2Y12 and the subsequent ADP-mediated platelet activation. Clopidogrel has been approved for clinical use as clopidogrel hydrogen sulfate (bisulfate) salt. The clinical usefulness of clopidogrel bisulfate salt has been proved in a wide variety of large scale clinical trials, thus clopidogrel bisulfate has been extensively used in a large spectrum of patients been under thrombotic risk. Recently, several generic clopidogrel formulations have been approved for clinical use. Consequently, clopidogrel is currently a cost-effective antiplatelet agent. Only small studies have compared the pharmacokinetic and pharmacodynamic properties of various clopidogrel generic salt formulations with the innovator bisulfate salt. In addition few data are available concerning the clinical efficacy and safety of these generic clopidogrel formulations in order to guide clinicians in deciding when generic substitution is appropriate. The aim of this review is to summarize the physicochemical properties as well as the pharmacokinetic and pharmacodynamic characteristics of the generic clopidogrel salts. We also critically present existing data on the clinical efficacy and safety of the generic clopidogrel formulations compared with the innovator clopidogrel bisulfate salt in patients with cardiovascular disease.
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Cite this article as:
Tsoumani E. Maria, Kalantzi I. Kallirroi, Goudevenos A. Ioannis and Tselepis D. Alexandros, Clopidogrel Generic Formulations in the Era of New Antiplatelets: A Systematic Review, Current Vascular Pharmacology 2014; 12 (5) . https://dx.doi.org/10.2174/15701611113119990135
DOI https://dx.doi.org/10.2174/15701611113119990135 |
Print ISSN 1570-1611 |
Publisher Name Bentham Science Publisher |
Online ISSN 1875-6212 |
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