Comparison of Original and Generic Clopidogrel 600 mg Loading Dose in the Patients Who Planned Undergoing Coronary Angiography
Suphot Srimahachota MD*, Ponlapat Rojnuckarin MD**, Wasan Udayachalerm MD*, Wacin Buddhari MD*, Jarkarpun Chaipromprasit MD*, Vorarit Lertsuwunseri MD*, Benjaporn Akkawat BSc**, Somboon Jirapattrathamrong MD*
Affiliation : * Cardiac Center and Division of Cardiology, Department of Internal Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand ** Division of Hematology, Department of Internal Medicine, Faculty of Medicine, Chulalongkorn University Bangkok, Thailand
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
