Key result
Generic clopidogrel resulted in comparable plasma concentrations of clopidogrel active metabolite compared with Plavix (ratio 0.83; 90% CI 0.80-1.25).
Why the study?
Does generic clopidogrel provide comparable active metabolite concentrations and platelet inhibition compared to Plavix in healthy cats?
RCT (n=4)
double-blind
randomized
Does generic clopidogrel provide comparable active metabolite concentrations and platelet inhibition compared to Plavix in healthy cats?
Generic clopidogrel results in comparable plasma concentrations of the active metabolite compared to Plavix in healthy cats, though platelet aggregation response is variable.
Answers are grounded in this paper and cite their sources.
Supports generic clopidogrel substitution to lower costs; confirms bioequivalence in this RCT.
OBJECTIVES: This pilot study sought to assess the metabolism of Plavix (Bristol-Myers Squibb/Sanofi) and generic clopidogrel in cats, using a novel assay for the measurement of clopidogrel, clopidogrel carboxylic acid (CCA) and clopidogrel active metabolite (CAM-D). METHODS: This was a prospective, randomized, double-blind study. Four healthy, skeletally mature cats were enrolled into the study. There were two treatment phases during which cats received either Plavix or generic clopidogrel at a dosage of 18.75 mg PO q24h for 7 days with a 2 week washout between phases. During each phase, plasma concentrations of parent drug and active and inactive metabolites were measured along with impedance platelet aggregometry in response to adenosine diphosphate (ADP). RESULTS: The ratio of CAM-D between generic clopidogrel and Plavix was 0.83 (equivalence reference 1.00, 90% confidence interval 0.80-1.25). Inhibition of ADP-induced platelet aggregation was variable, with two cats classified as non-responders in both treatment phases. The concentrations of CAM-D were not predictive of aggregometry-based responsiveness to either formulation of clopidogrel. CONCLUSIONS AND RELEVANCE: This is the first study comparing Plavix and generic clopidogrel in cats. Administration of the generic formulation resulted in comparable plasma concentrations of clopidogrel active metabolite when compared with Plavix.
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Malkawi et al. (2018) conducted an RCT in healthy cats (n=4). Generic clopidogrel vs. Plavix was evaluated on Ratio of clopidogrel active metabolite (CAM-D) between generic clopidogrel and Plavix (Ratio 0.83, 95% CI 0.80-1.25). Generic clopidogrel resulted in comparable plasma concentrations of clopidogrel active metabolite compared with Plavix (ratio 0.83; 90% CI 0.80-1.25).
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