Patsourakos NG, Kouvari M, Kotidis A, Kalantzi KI, Tsoumani ME, Anastasiadis F, Andronikos P, Aslanidou T, Efraimidis P, Georgiopoulos A, Gerakiou K, Grigoriadou-Skouta E, Grigoropoulos P, Hatzopoulos D, Kartalis A, Lyras A, Markatos G, Mikrogeorgiou A, Myroforou I, Orkopoulos A, Pavlidis P, Petras C, Riga M, Skouloudi M, Smyrnioudis N, Thomaidis K, Tsikouri GE, Tsikouris EI, Zisimos K, Vavoulis P, Vitali MG, Vitsas G, Vogiatzidis C, Chantanis S, Fousas S, Panagiotakos DB, and Tselepis AD
Introduction: The use of generic drugs is continuously growing; however, there are limited epidemiological data regarding the therapeutic equivalence of each original drug formulation with its generic counterparts. We evaluated the 12-month composite endpoint of recurrent acute myocardial infarction, ischaemic stroke, cardiac deaths, or hospitalisation due to a major bleeding in acute coronary syndrome (ACS) patients treated with original clopidogrel or a generic clopidogrel formulation, in relation to sociodemographic and clinical characteristics., Material and Methods: Consecutive Greek ACS patients ( n = 1194) hospitalised in the Aegean islands and the Attica region were enrolled. Clopidogrel treatment was recorded either as original clopidogrel hydrogen sulphate (Plavix ® /Iscover ® ) or as a generic clopidogrel besylate formulation (Clovelen ® ). The composite endpoint was recorded at 12-month follow-up., Results: The 12-month composite endpoint was 3.9% (4.6% in the Aegean islands and 3.5% in the Attica area, p > 0.05). The respective incidence in men was 4.0% and in women 3.8% ( p > 0.05). Overall, generic and original clopidogrel use was 87% and 13% of patients, respectively. No significant differences were observed between original and generic clopidogrel use and 12-month composite endpoint incidence. Subgroup analysis with gender, region of residence, and clinical and lifestyle factors as strata did not reveal any significant outcomes. Haemorrhage incidence did not exceed 1% in the total sample., Conclusions: The use of a generic clopidogrel besylate formulation was quite high in both urban and insular areas of Greece and had similar efficacy and safety profile with the original clopidogrel salt, supporting the routine use of this low-cost generic clopidogrel in the management of cardiovascular disease patients., Competing Interests: This study was partially supported by grants from ELPEN (Greece), manufacturer of the clopidogrel besylate generic formulation (Clovelen®) used in the present study. However, the study was investigator initiated, and the sponsor had no involvement in the design and conduct of the study, in the collection, management, analysis, and interpretation of the data or in the preparation, review or approval of the manuscript. The corresponding author had full access to all the data in the study and had the final responsibility for the decision to submit for publication. The authors have indicated that they have no other conflicts of interest regarding the content of this article., (Copyright: © 2020 Termedia & Banach.)