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.