J Med Assoc Thai 2012; 95 (12):1495

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Comparison of Original and Generic Clopidogrel 600 mg Loading Dose in the Patients Who Planned Undergoing Coronary Angiography
Srimahachota S Mail, Rojnuckarin P , Udayachalerm W , Buddhari W , Chaipromprasit J , Lertsuwunseri V , Akkawat B , Jirapattrathamrong S

Objective: To compare the efficacy and safety of original (Plavix®) and generic (Apolets®) clopidogrel 600 mg loading in patients planning to undergo coronary angiography.

Material and Method: This is an experimental design, parallel, randomized-controlled study. Coronary artery disease patients planned for cardiac catheterization were recruited. Patients were randomized to receive either original or generic clopidogrel 600 mg loading dose. Platelet aggregation induced by 5 μmol/L and 20 μmol/L adenosine diphosphate (ADP) was measured by light transmission aggregometry (LTA) at baseline and 6 hours after clopidogrel 600 mg administration.

Results: Forty-nine patients were enrolled, 24 patients received original clopidogrel, and 25 patients received generic clopidogrel. After six hours of loading, there was significantly reduction in platelet aggregation induced by adenosine 5 μmol/L from 41.08 ± 3.04% to 19.50 ± 1.68% (p < 0.001) in original group compared to 36.76 ± 2.66% to 21.32 ± 2.60% (p < 0.001) in generic group. When induced by 20 μmol/L, the platelet aggregation was reduced from 58.50 ± 2.09% to 32.25 ± 2.30% (p < 0.001) in original group and from 61.12 ± 2.54% to 30.04 ± 3.14% (p < 0.001) in generic group. There was no significant difference between original and generic clopidogrel in reducing platelet aggregation induced by both adenosine 5 and 20 μmol/L. Groin hematoma was found in one case (4.2%) in the original clopidogrel group.

Conclusion: Generic clopidogrel (Apolets®) 600 mg loading dose is as effective as original clopidogrel (Plavix®) in term of platelet aggregation inhibition.

Keywords: Original clopidogrel, Generic clopidogrel, Coronary artery disease, Platelet aggregation, Adenosine diphosphate, Light transmission aggregometry


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