KMID : 0338420100250020154
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The Korean Journal of Internal Medicine 2010 Volume.25 No. 2 p.154 ~ p.161
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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
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Jeong Young-Hoon
Koh Jin-Sin Kang Min-Kyung Ahn Yeon-Jeong Kim In-Suk Park Yong-Whi Hwang Seok-Jae Kwak Choong-Hwan Hwang Jin-Yong
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Abstract
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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¢ç). After assessing patient compliance with Plavix¢ç, maintenance therapy was switched to generic clopidogrel bisulfate (Plavitor¢ç). 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¢ç. Before and after switching therapy maximal (36.5 ¡¾ 7.9% vs. 39.8 ¡¾ 16.2%, p = 0.280) and late platelet aggregation (23.5 ¡¾ 10.9% vs. 29.1 ¡¾ 18.3%, p = 0.156) with 5 ¥ìmol/L adenosine diphosphate (ADP) stimulus did not differ. Likewise, 20 ¥ìmol/L ADP-induced platelet aggregation and P2Y12 reaction unit in patients on Plavitor¢ç therapy was comparable to that in patients on Plavix¢ç therapy. However, Bland-Altman analysis showed wide limits of agreement between measured platelet reactivity on Plavix¢ç vs. Plavitor¢ç therapies.
Conclusions: Among patients on Plavix¢ç maintenance therapy with coronary stents, replacement with Plavitor¢ç 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.
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KEYWORD
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Clopidogrel, Drugs, generic, Blood platelets, Purinoceptor P2Y12
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