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The Impact of Generic Clopidogrel Bisulfate on Platelet Inhibition in Patients with Coronary Artery Stents: Results of the ACCEL-GENERIC Study

BACKGROUND/AIMS: In patients with coronary artery stents, the cost of clopidogrel has been cited as a factor in the premature discontinuation of therapy. Thus, the introduction of lower-cost generic clopidogrel may increase patient compliance. However, platelet inhibition by generic clopidogrel has...

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Detalles Bibliográficos
Autores principales: Jeong, Young-Hoon, Koh, Jin-Sin, Kang, Min-Kyung, Ahn, Yeon-Jeong, Kim, In-Suk, Park, Yongwhi, Hwang, Seok-Jae, Kwak, Choong Hwan, Hwang, Jin-Yong
Formato: Texto
Lenguaje:English
Publicado: The Korean Association of Internal Medicine 2010
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2880688/
https://www.ncbi.nlm.nih.gov/pubmed/20526388
http://dx.doi.org/10.3904/kjim.2010.25.2.154
Descripción
Sumario:BACKGROUND/AIMS: In patients with coronary artery stents, the cost of clopidogrel has been cited as a factor in the premature discontinuation of therapy. Thus, the introduction of lower-cost generic clopidogrel may increase patient compliance. However, platelet inhibition by generic clopidogrel has not been compared to the original clopidogrel formulation in patients with coronary artery stents. METHODS: We prospectively enrolled 20 patients receiving chronic therapy with the original clopidogrel bisulfate (Plavix®). After assessing patient compliance with Plavix®, maintenance therapy was switched to generic clopidogrel bisulfate (Plavitor®). Platelet reactivity was assessed at baseline and 30-day after the switch using conventional aggregometry and the VerifyNow P2Y12 assay. RESULTS: All patients completed maintenance therapy with Plavitor®. Before and after switching therapy maximal (36.5 ± 7.9% vs. 39.8 ± 16.2%, p = 0.280) and late platelet aggregation (23.5 ± 10.9% vs. 29.1 ± 18.3%, p = 0.156) with 5 µmol/L adenosine diphosphate (ADP) stimulus did not differ. Likewise, 20 µmol/L ADP-induced platelet aggregation and P2Y12 reaction unit in patients on Plavitor® therapy was comparable to that in patients on Plavix® therapy. However, Bland-Altman analysis showed wide limits of agreement between measured platelet reactivity on Plavix® vs. Plavitor® therapies. CONCLUSIONS: Among patients on Plavix® maintenance therapy with coronary stents, replacement with Plavitor® shows a comparable inhibition of ADP-induced platelet aggregation. However, due to poor inter-therapy agreement, between two regimens, physicians may be cautious when introducing generic clopidogrel bisulfate.