Li Jinshuang, Fan Yuansheng, Zhu Tiantian, Chen Jun, Kong Deyu, Meng Haoyu, Zhang Jing, Xu Ke, Ye Sen, Ji Yuqin, Li Chunjian
Department of Cardiology, The First Affiliated Hospital of Nanjing Medical University, 300 Guangzhou Road, Nanjing, 210029, Jiangsu, China.
Department of Cardiology, Suqian Hospital Affiliated of Xuzhou Medical University, Suqian, 223800, Jiangsu, China.
Eur J Clin Pharmacol. 2018 Nov;74(11):1397-1403. doi: 10.1007/s00228-018-2532-3. Epub 2018 Aug 20.
Form II clopidogrel bisulfate (Plavix) has been extensively used in patients with acute coronary syndrome. However, the efficacy of form I clopidogrel bisulfate (Talcom) was less investigated. The aim of this study was to investigate the efficacy and safety of Talcom compared with Plavix.
Two hundred and forty-eight patients were recruited after receiving percutaneous coronary intervention (PCI). Participants were randomly assigned to Talcom or Plavix group, and administered with Talcom or Plavix 75 mg od respectively in combination with aspirin 100 mg od for 12 months. Primary endpoints were set as levels of adenosine diphosphate-induced platelet aggregation (PL) on the 5th day and at 1 month after randomization. Patients were followed-up for 5 years. Bleeding events and major adverse cardiovascular events (MACE) including cardiac death, non-fatal myocardial infarction, ischemic stroke, target lesion revascularization (TLR), and cardiogenic re-admission were recorded.
On the 5th day and at 1 month after randomization, the antiplatelet effect of Talcom was non-inferior to that of Plavix [PL (5th day): 30% (22%, 43%) vs. 33% (22%, 44%), p = 0.007; PL (1 month): 29% (19%, 43%) vs. 31% (22%, 43%), p = 0.005]. A total of 208 patients completed the follow-up, the incidences of MACE and bleeding were both comparable, and the MACE-free survival did not differ between the two groups. However, the expenditure was 32% lower for Talcom compared to Plavix during the treatment period.
The antiplatelet effect of Talcom is non-inferior to Plavix, and the clinical efficacy and safety of Talcom and Plavix at 5 years were not significantly different in this study.
硫酸氢氯吡格雷II型（波立维）已广泛应用于急性冠脉综合征患者。然而，硫酸氢氯吡格雷I型（泰嘉）的疗效研究较少。本研究旨在探讨泰嘉与波立维相比的疗效和安全性。
248例接受经皮冠状动脉介入治疗（PCI）的患者被纳入研究。参与者被随机分配到泰嘉组或波立维组，分别给予泰嘉或波立维75mg每日一次，并联合阿司匹林100mg每日一次，持续12个月。主要终点设定为随机分组后第5天和1个月时二磷酸腺苷诱导的血小板聚集（PL）水平。患者随访5年。记录出血事件和主要不良心血管事件（MACE），包括心源性死亡、非致命性心肌梗死、缺血性中风、靶病变血管重建（TLR）和心源性再入院。
随机分组后第5天和1个月时，泰嘉的抗血小板作用不劣于波立维[PL（第5天）：30%（22%，43%）对33%（22%，44%），p = 0.007；PL（1个月）：29%（19%，43%）对31%（22%，43%），p = 0.005]。共有208例患者完成随访，MACE和出血的发生率相当，两组间无MACE生存情况无差异。然而，治疗期间泰嘉的费用比波立维低32%。
泰嘉的抗血小板作用不劣于波立维，本研究中泰嘉和波立维在5年时的临床疗效和安全性无显著差异。
