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ISSN: 1734-1922
Archives of Medical Science
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5/2020
vol. 16
 
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Cardiology
abstract:
Clinical research

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
1
,
Matina Kouvari
2
,
Apostolos Kotidis
1
,
Kallirroi I. Kalantzi
3
,
Maria E. Tsoumani
3
,
Filippos Anastasiadis
3
,
Panagiotis Andronikos
3
,
Theano Aslanidou
3
,
Petros Efraimidis
3
,
Anastasios Georgiopoulos
3
,
Kalliopi Gerakiou
3
,
Eleni Grigoriadou-Skouta
3
,
Panagiotis Grigoropoulos
3
,
Dionysios Hatzopoulos
3
,
Athanasios Kartalis
4
,
Anastasios Lyras
3
,
Gerasimos Markatos
3
,
Aristeidis Mikrogeorgiou
3
,
Ioannis Myroforou
3
,
Anestis Orkopoulos
3
,
Pavlos Pavlidis
3
,
Charalampos Petras
3
,
Maria Riga
3
,
Marina Skouloudi
3
,
Nikolaos Smyrnioudis
4
,
Konstantinos Thomaidis
3
,
Grammatiki E. Tsikouri
3
,
Emmanuel I. Tsikouris
5
,
Konstantinos Zisimos
3
,
Panagiotis Vavoulis
3
,
Maria-Gabriella Vitali
3
,
George Vitsas
3
,
Constantinos Vogiatzidis
3
,
Stylianos Chantanis
1
,
Stefanos Fousas
1
,
Demosthenes B. Panagiotakos
2, 3
,
Alexandros D. Tselepis
3

1.
Cardiology Department, Tzaneio Hospital of Piraeus, Piraeus, Greece
2.
School of Health Science and Education, Harokopio University of Athens, Athens, Greece
3.
Atherothrombosis Research Centre, University of Ioannina, Ioannina, Greece
4.
Cardiology Department, ‘Skylitseio’ General Hospital of Chios, Chios, Greece
5.
Cardiovascular Department, National Hospital of Kalymnos, Kalymnos, Greece
Arch Med Sci 2020; 16 (5): 1013–1021
Online publish date: 2020/05/30
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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.

keywords:

acute coronary syndrome, cardiovascular disease, clopidogrel besylate, gender, generic clopidogrel, secondary prevention

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