Korean Circ J.  2012 Jul;42(7):458-463. 10.4070/kcj.2012.42.7.458.

A Comparison of Two Brands of Clopidogrel in Patients With Drug-Eluting Stent Implantation

• Park YM
• Ahn T
• Lee K
• Shin KC
• Jung ES
• Shin DS
• Kim MG
• Kang WC
• Han SH
• Choi IS
• Shin EK

• KMID: 2094117
• DOI: http://doi.org/10.4070/kcj.2012.42.7.458

Abstract

BACKGROUND AND OBJECTIVES
Although generic clopidogrel is widely used, clinical efficacy and safety between generic and original clopidogrel had not been well evaluated. The aim of this study was to evaluate the clinical outcomes of 2 oral formulations of clopidogrel 75 mg tablets in patients with coronary artery disease (CAD) undergoing drug-eluting stent (DES) implantation.
SUBJECTS AND METHODS
Between July 2006 and February 2009, 428 patients that underwent implantation with DES for CAD and completed >1 year of clinical follow-up were enrolled in this study. Patients were divided into the following 2 groups based on treatment formulation, Platless(R) (test formulation, n=211) or Plavix(R) (reference formulation, n=217). The incidence of 1-year major adverse cardiovascular and cerebrovascular event (MACCE) and stent thrombosis (ST) were retrospectively reviewed.
RESULTS
The baseline demographic and procedural characteristics were not significantly different between two treatment groups. The incidence of 1-year MACCEs was 8.5% {19/211, 2 deaths, 4 myocardial infarctions (MIs), 2 strokes, and 11 target vessel revascularizations (TVRs)} in Platless(R) group vs. 7.4% (16/217, 4 deaths, 1 MI, 2 strokes, and 9 TVRs) in Plavix(R) group (p=0.66). The incidence of 1-year ST was 0.5% (1 definite and subacute ST) in Platless(R) group vs. 0% in Plavix(R) group (p=0.49).
CONCLUSION
In this study, the 2 tablet preparations of clopidogrel showed similar rates of MACCEs, but additional prospective randomized studies with pharmacodynamics and platelet reactivity are needed to conclude whether generic clopidgrel may replace original clopidogrel.

Keyword

Generic drug; Treatment outcome clopidogrel; Stent thrombosis

MeSH Terms

Blood Platelets
Coronary Artery Disease
Drug-Eluting Stents
Follow-Up Studies
Glycosaminoglycans
Humans
Incidence
Myocardial Infarction
Retrospective Studies
Stents
Stroke
Tablets
Thrombosis
Ticlopidine
Glycosaminoglycans
Tablets
Ticlopidine

Figure

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  Fig. 1 Diagram showing the number of screened, enrolled, and excluded patients in the study. DES: drug-eluting stent.

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  Fig. 2 The incidence of in-hospital MACCE between the 2 treatment groups (p=0.62). MI: myocardial infarction, TVR: target vessel revascularization, MACCE: major adverse cardiovascular and cerebrovascular event.

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  Fig. 3 The incidence of 1-year MACCEs between the 2 treatment groups (p=0.66). MI: myocardial infarction, TVR: target vessel revascularization, MACCEs: major adverse cardiovascular and cerebrovascular events.

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