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® (test formulation, n=211) or Plavix® (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® group vs. 7.4% (16/217, 4 deaths, 1 MI, 2 strokes, and 9 TVRs) in Plavix® group (p=0.66). The incidence of 1-year ST was 0.5% (1 definite and subacute ST) in Platless® group vs. 0% in Plavix® 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.
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® (test formulation, n=211) or Plavix® (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® group vs. 7.4% (16/217, 4 deaths, 1 MI, 2 strokes, and 9 TVRs) in Plavix® group (p=0.66). The incidence of 1-year ST was 0.5% (1 definite and subacute ST) in Platless® group vs. 0% in Plavix® 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.
Authors: Robert J Applegate; Mark A Grabarczyk; William C Little; Timothy Craven; Michael Walkup; Frederic R Kahl; Gregory A Braden; Kevin M Rankin; Michael A Kutcher Journal: J Am Coll Cardiol Date: 2002-07-03 Impact factor: 24.094
Authors: Sidney C Smith; Jerilyn Allen; Steven N Blair; Robert O Bonow; Lawrence M Brass; Gregg C Fonarow; Scott M Grundy; Loren Hiratzka; Daniel Jones; Harlan M Krumholz; Lori Mosca; Richard C Pasternak; Thomas Pearson; Marc A Pfeffer; Kathryn A Taubert Journal: Circulation Date: 2006-05-16 Impact factor: 29.690
Authors: Donald E Cutlip; Stephan Windecker; Roxana Mehran; Ashley Boam; David J Cohen; Gerrit-Anne van Es; P Gabriel Steg; Marie-angèle Morel; Laura Mauri; Pascal Vranckx; Eugene McFadden; Alexandra Lansky; Martial Hamon; Mitchell W Krucoff; Patrick W Serruys Journal: Circulation Date: 2007-05-01 Impact factor: 29.690
Authors: Steven R Steinhubl; Peter B Berger; J Tift Mann; Edward T A Fry; Augustin DeLago; Charles Wilmer; Eric J Topol Journal: JAMA Date: 2002-11-20 Impact factor: 56.272
Authors: S R Mehta; S Yusuf; R J Peters; M E Bertrand; B S Lewis; M K Natarajan; K Malmberg; H Rupprecht; F Zhao; S Chrolavicius; I Copland; K A Fox Journal: Lancet Date: 2001-08-18 Impact factor: 79.321
Authors: Govinda J Weerakkody; John T Brandt; Christopher D Payne; Joseph A Jakubowski; Hideo Naganuma; Kenneth J Winters Journal: Platelets Date: 2007-09 Impact factor: 3.862