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 View Full-text : Current Issue |
| Original articles |
Korean J Intern Med. 2010
June;25(2):154-161.
DOI: 10.3904/kjim.2010.25.2.154
The Impact of Generic Clopidogrel Bisulfate on Platelet Inhibition in Patients with Coronary Artery Stents: Results of the ACCEL-GENERIC Study
Young-Hoon Jeong1, Jin-Sin Koh1, Min-Kyung Kang1, Yeon-Jeong Ahn1, In-Suk Kim2, Yongwhi Park1, Seok-Jae Hwang1, Choong Hwan Kwak1, and Jin-Yong Hwang1
Departments of 1Internal Medicine and 2Laboratory Medicine, Gyeongsang National University Hospital, Jinju, Korea |
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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¡Ëc). After assessing patient compliance with Plavix¡Ëc, maintenance therapy was switched to generic clopidogrel bisulfate (Plavitor¡Ëc). 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¡Ëc. Before and after switching therapy maximal (36.5 ¢®¨ú 7.9% vs. 39.8 ¢®¨ú 16.2%, p = 0.280) and late platelet aggregation (23.5 ¢®¨ú 10.9% vs. 29.1 ¢®¨ú 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¡Ëc therapy was comparable to that in patients on Plavix¡Ëc therapy. However, Bland-Altman analysis showed wide limits of agreement between measured platelet reactivity on Plavix¡Ëc vs. Plavitor¡Ëc therapies.
Conclusions: Among patients on Plavix¡Ëc maintenance therapy with coronary stents, replacement with Plavitor¡Ëc 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. (Korean J Intern Med 2010;25:154-161)
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Keywords : Clopidogrel; Drugs, generic; Blood platelets; Purinoceptor P2Y12 |
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eISSN 2005-6648
