TY - JOUR
T1 - 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
AU - Patsourakos, Nikolaos G.
AU - Kouvari, Matina
AU - Kotidis, Apostolos
AU - Kalantzi, Kallirroi I.
AU - Tsoumani, Maria E.
AU - Anastasiadis, Filippos
AU - Andronikos, Panagiotis
AU - Aslanidou, Theano
AU - Efraimidis, Petros
AU - Georgiopoulos, Anastasios
AU - Gerakiou, Kalliopi
AU - Grigoriadou-Skouta, Eleni
AU - Grigoropoulos, Panagiotis
AU - Hatzopoulos, Dionysios
AU - Kartalis, Athanasios
AU - Lyras, Anastasios
AU - Markatos, Gerasimos
AU - Mikrogeorgiou, Aristeidis
AU - Myroforou, Ioannis
AU - Orkopoulos, Anestis
AU - Pavlidis, Pavlos
AU - Petras, Charalampos
AU - Riga, Maria
AU - Skouloudi, Marina
AU - Smyrnioudis, Nikolaos
AU - Thomaidis, Konstantinos
AU - Tsikouri, Grammatiki E.
AU - Tsikouris, Emmanuel I.
AU - Zisimos, Konstantinos
AU - Vavoulis, Panagiotis
AU - Vitali, Maria Gabriella
AU - Vitsas, George
AU - Vogiatzidis, Constantinos
AU - Chantanis, Stylianos
AU - Fousas, Stefanos
AU - Panagiotakos, Demosthenes B.
AU - Tselepis, Alexandros D.
N1 - Funding Information:
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.
Publisher Copyright:
Copyright © 2020 Termedia & Banach
PY - 2020/5/30
Y1 - 2020/5/30
N2 - 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.
AB - 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.
KW - Acute coronary syndrome
KW - Cardiovascular disease
KW - Clopidogrel besylate
KW - Gender
KW - Generic clopidogrel
KW - Secondary prevention
UR - http://www.scopus.com/inward/record.url?scp=85090913075&partnerID=8YFLogxK
U2 - 10.5114/AOMS.2020.95878
DO - 10.5114/AOMS.2020.95878
M3 - Article
AN - SCOPUS:85090913075
SN - 1734-1922
VL - 16
SP - 1013
EP - 1021
JO - Archives of Medical Science
JF - Archives of Medical Science
IS - 5
ER -
