The incidence of recurrent cardiovascular events among acute coronary syndrome patients treated with generic or original clopidogrel in relation to their sociodemographic and clinical characteristics. The Aegean study

Nikolaos G. Patsourakos, Matina Kouvari, Apostolos Kotidis, Kallirroi I. Kalantzi, Maria E. Tsoumani, Filippos Anastasiadis, Panagiotis Andronikos, Theano Aslanidou, Petros Efraimidis, Anastasios Georgiopoulos, Kalliopi Gerakiou, Eleni Grigoriadou-Skouta, Panagiotis Grigoropoulos, Dionysios Hatzopoulos, Athanasios Kartalis, Anastasios Lyras, Gerasimos Markatos, Aristeidis Mikrogeorgiou, Ioannis Myroforou, Anestis OrkopoulosPavlos Pavlidis, Charalampos Petras, Maria Riga, Marina Skouloudi, Nikolaos Smyrnioudis, Konstantinos Thomaidis, Grammatiki E. Tsikouri, Emmanuel I. Tsikouris, Konstantinos Zisimos, Panagiotis Vavoulis, Maria Gabriella Vitali, George Vitsas, Constantinos Vogiatzidis, Stylianos Chantanis, Stefanos Fousas, Demosthenes B. Panagiotakos, Alexandros D. Tselepis

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2 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)1013-1021
Number of pages9
JournalArchives of Medical Science
Volume16
Issue number5
DOIs
Publication statusPublished - 30 May 2020
Externally publishedYes

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