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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.
Archives of Medical Science ( IF 3.8 ) Pub Date : 2020-05-30 , DOI: 10.5114/aoms.2020.95878 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
Archives of Medical Science ( IF 3.8 ) Pub Date : 2020-05-30 , DOI: 10.5114/aoms.2020.95878 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
Affiliation
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.
中文翻译：
使用通用或原始氯吡格雷治疗的急性冠状动脉综合征患者中复发性心血管事件的发生率与其社会人口学和临床特征有关。爱琴海研究。
引言
仿制药的使用不断增长；然而，关于每种原始药物制剂与其仿制药对应物的治疗等效性的流行病学数据有限。我们评估了接受原始氯吡格雷或通用氯吡格雷制剂治疗的急性冠状动脉综合征 (ACS) 患者的复发性急性心肌梗死、缺血性卒中、心脏死亡或因大出血住院的 12 个月复合终点与社会人口学和临床特征。
材料与方法
在爱琴海群岛和阿提卡地区住院的连续希腊 ACS 患者 (n = 1194) 被纳入研究。氯吡格雷治疗记录为原始氯吡格雷硫酸氢盐 (Plavix®/Iscover®) 或通用氯吡格雷苯磺酸盐制剂 (Clovelen®)。在 12 个月的随访中记录了复合终点。
结果
12 个月的复合终点为 3.9%（爱琴海群岛为 4.6%，阿提卡地区为 3.5%，p > 0.05）。男性的发病率为 4.0%，女性为 3.8%（p > 0.05）。总体而言，通用和原始氯吡格雷的使用率分别为 87% 和 13% 的患者。原始和通用氯吡格雷使用与 12 个月复合终点发生率之间未观察到显着差异。以性别、居住地区以及临床和生活方式因素为分层的亚组分析未显示任何显着结果。总样本中的出血发生率不超过 1%。
结论
在希腊的城市和岛屿地区，苯磺酸氯吡格雷仿制制剂的使用率很高，并且与原始氯吡格雷盐具有相似的疗效和安全性，支持这种低成本仿制氯吡格雷在心血管疾病患者管理中的常规使用.
更新日期：2020-05-30
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.
中文翻译：
使用通用或原始氯吡格雷治疗的急性冠状动脉综合征患者中复发性心血管事件的发生率与其社会人口学和临床特征有关。爱琴海研究。
引言
仿制药的使用不断增长；然而，关于每种原始药物制剂与其仿制药对应物的治疗等效性的流行病学数据有限。我们评估了接受原始氯吡格雷或通用氯吡格雷制剂治疗的急性冠状动脉综合征 (ACS) 患者的复发性急性心肌梗死、缺血性卒中、心脏死亡或因大出血住院的 12 个月复合终点与社会人口学和临床特征。
材料与方法
在爱琴海群岛和阿提卡地区住院的连续希腊 ACS 患者 (n = 1194) 被纳入研究。氯吡格雷治疗记录为原始氯吡格雷硫酸氢盐 (Plavix®/Iscover®) 或通用氯吡格雷苯磺酸盐制剂 (Clovelen®)。在 12 个月的随访中记录了复合终点。
结果
12 个月的复合终点为 3.9%（爱琴海群岛为 4.6%，阿提卡地区为 3.5%，p > 0.05）。男性的发病率为 4.0%，女性为 3.8%（p > 0.05）。总体而言，通用和原始氯吡格雷的使用率分别为 87% 和 13% 的患者。原始和通用氯吡格雷使用与 12 个月复合终点发生率之间未观察到显着差异。以性别、居住地区以及临床和生活方式因素为分层的亚组分析未显示任何显着结果。总样本中的出血发生率不超过 1%。
结论
在希腊的城市和岛屿地区，苯磺酸氯吡格雷仿制制剂的使用率很高，并且与原始氯吡格雷盐具有相似的疗效和安全性，支持这种低成本仿制氯吡格雷在心血管疾病患者管理中的常规使用.
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