Why the study?
Given clopidogrel's significant pharmacokinetic and pharmacodynamic variability, data were needed on whether generic clopidogrel bisulfate is as efficacious as brand name Plavix for inhibiting platelet aggregation.
Does generic clopidogrel bisulfate improve inhibition of platelet aggregation compared to brand name Plavix in patients on clopidogrel monotherapy?
Does generic clopidogrel bisulfate improve inhibition of platelet aggregation compared to brand name Plavix in patients on clopidogrel monotherapy?
Generic clopidogrel bisulfate appears to be associated with lower rates of antiplatelet resistance compared to brand name Plavix, suggesting it is at least as efficacious for platelet inhibition.
Answers are grounded in this paper and cite their sources.
Generic clopidogrel was associated with lower resistance rates than Plavix; leaves open questions on formulation variability before practice change.
BACKGROUND: Following the expiration of brand name exclusivity of Plavix® in 2012, generic clopidogrel bisulfate was approved. As a widely prescribed medication with significant inter-patient pharmacokinetic and pharmacodynamic variability, data regarding the impact of switching to generic clopidogrel bisulfate on patients is needed. OBJECTIVE: The objective of this study was to determine whether generic clopidogrel bisulfate is as efficacious as Plavix® for the inhibition of platelet aggregation. METHODS: Patients treated with Plavix® monotherapy (n = 254) or generic clopidogrel bisulfate monotherapy (n = 185) were included in this retrospective review. Confounding factors previously found to affect clopidogrel responsiveness (diabetes, female sex, and smoking) were assessed, as well as medications classified as substrates, inducers, and inhibitors of enzymes involved in clopidogrel metabolism. Whole blood impedance aggregometry was used to measure platelet aggregation in response to adenosine diphosphate. Patients were tested after ≥2 weeks of treatment and designated as non-responders if aggregation response exceeded sensitivity thresholds of 6 ohms of impedance. RESULTS: The introduction of generic clopidogrel bisulfate was associated with a decrease in antiplatelet resistance (44% to 31%, p < 0.01) and decreased mean ohms of resistance (5.06 ± 4.55 to 3.32 ± 4.03, p < 0.01). Prior to analysis of secondary outcomes, 217 patients were eliminated due to antiplatelet usage for longer than 3 years (n = 123 for Plavix® and n = 118 for clopidogrel). There was no statistically significant finding in prevalence of secondary events. CONCLUSION: Resistance rates to the antiplatelet, clopidogrel are significantly lower since the switch to generic formulations. Further investigation into the impact of variability between clopidogrel bisulfate formulations is needed.
No takes yet. Share an insight, caveat, or question.
Westphal et al. (2021) studied this question.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: