急性冠状动脉综合征患者使用氯吡格雷仿制药或原研药治疗后的心血管事件复发率与社会人口统计学及临床特征的关系。爱琴海研究。
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.
作者信息
Patsourakos Nikolaos G, Kouvari Matina, Kotidis Apostolos, Kalantzi Kallirroi I, Tsoumani Maria E, Anastasiadis Filippos, Andronikos Panagiotis, Aslanidou Theano, Efraimidis Petros, Georgiopoulos Anastasios, Gerakiou Kalliopi, Grigoriadou-Skouta Eleni, Grigoropoulos Panagiotis, Hatzopoulos Dionysios, Kartalis Athanasios, Lyras Anastasios, Markatos Gerasimos, Mikrogeorgiou Aristeidis, Myroforou Ioannis, Orkopoulos Anestis, Pavlidis Pavlos, Petras Charalampos, Riga Maria, Skouloudi Marina, Smyrnioudis Nikolaos, Thomaidis Konstantinos, Tsikouri Grammatiki E, Tsikouris Emmanuel I, Zisimos Konstantinos, Vavoulis Panagiotis, Vitali Maria-Gabriella, Vitsas George, Vogiatzidis Constantinos, Chantanis Stylianos, Fousas Stefanos, Panagiotakos Demosthenes B, Tselepis Alexandros D
机构信息
Cardiology Department, Tzaneio Hospital of Piraeus, Piraeus, Greece.
School of Health Science and Education, Harokopio University of Athens, Athens, Greece.
出版信息
Arch Med Sci. 2020 May 30;16(5):1013-1021. doi: 10.5114/aoms.2020.95878. eCollection 2020.
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 ( = 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, > 0.05). The respective incidence in men was 4.0% and in women 3.8% ( > 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.
引言
仿制药的使用量持续增长；然而，关于每种原研药物制剂与其仿制药等效性的流行病学数据有限。我们评估了接受原研氯吡格雷或氯吡格雷仿制药治疗的急性冠状动脉综合征（ACS）患者复发性急性心肌梗死、缺血性中风、心源性死亡或因大出血住院的12个月综合终点，以及社会人口学和临床特征。
材料与方法
纳入在爱琴海诸岛和阿提卡地区住院的连续希腊ACS患者（n = 1194）。氯吡格雷治疗记录为原研硫酸氢氯吡格雷（波立维/易倍申）或仿制药氯吡格雷苯磺酸盐制剂（可立宁）。在12个月随访时记录综合终点。
结果
12个月综合终点为3.9%（爱琴海诸岛为4.6%，阿提卡地区为3.5%，P>0.05）。男性的相应发生率为4.0%，女性为3.8%（P>0.05）。总体而言，使用氯吡格雷仿制药和原研药的患者分别占87%和13%。原研氯吡格雷和仿制药的使用与12个月综合终点发生率之间未观察到显著差异。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著结果。总样本中的出血发生率未超过1%。
结论
氯吡格雷苯磺酸盐仿制药在希腊城市和岛屿地区的使用比例都很高，并且与原研氯吡格雷盐具有相似的疗效和安全性，支持在心血管疾病患者管理中常规使用这种低成本的氯吡格雷仿制药。
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