Division of Cardiology, Department of Internal Medicine, Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Taoyuan, Taiwan.
Institute of Stem Cell and Translational Cancer Research, Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Taoyuan, Taiwan.
Clin Transl Sci. 2023 Sep;16(9):1594-1605. doi: 10.1111/cts.13590. Epub 2023 Jul 23.
Skepticism exists among healthcare workers and patients regarding the efficacy and safety of generic medication, despite its potential to lower healthcare costs. This study aimed to compare the outcomes of a generic clopidogrel and its brand-name counterpart for secondary prevention in patients with acute myocardial infarction (AMI). Using the Taiwan National Health Insurance Research Database, we identified 49,325 patients who were hospitalized for AMI between January 1, 2008 and December 31, 2013 and prescribed either generic or brand-name clopidogrel. Among them, 2419 (4.9%) were prescribed the generic clopidogrel. After propensity score matching, both the generic and brand-name groups consisted of 2382 patients. The primary efficacy outcome was a composite of myocardial infarction, coronary revascularization, ischemic stroke, and all-cause death. The primary safety outcome was major bleeding requiring hospitalization. At a mean follow-up of 2.5 years, the generic and brand-name clopidogrel groups had comparable risks of primary efficacy outcome (41.9% vs. 42%; hazard ratio [HR] 0.96; 95% confidence interval [CI] 0.88-1.04), and the risks of the individual components were also similar. There were no significant differences between the two groups in major bleeding (7.9% vs. 7.9%; HR 0.99; 95% CI 0.81-1.21). Subgroup analyses also revealed no statistically significant interactions between the treatment effect and various subgroups. In this retrospective database analysis, the generic clopidogrel was comparable to its brand-name counterpart regarding cardiovascular and bleeding outcomes for the treatment of patients with AMI.
医护人员和患者对仿制药的疗效和安全性存在怀疑，尽管它有可能降低医疗成本。本研究旨在比较急性心肌梗死（AMI）患者使用通用氯吡格雷和其品牌药物进行二级预防的结果。我们使用台湾全民健康保险研究数据库，确定了 2008 年 1 月 1 日至 2013 年 12 月 31 日期间因 AMI 住院并开处通用或品牌氯吡格雷的 49325 名患者。其中，有 2419 名（4.9%）患者开处通用氯吡格雷。经过倾向评分匹配后，通用和品牌组各有 2382 名患者。主要疗效终点是心肌梗死、冠状动脉血运重建、缺血性卒中和全因死亡的复合终点。主要安全性终点是需要住院治疗的大出血。平均随访 2.5 年后，通用和品牌氯吡格雷组的主要疗效终点风险相当（41.9% vs. 42%；风险比[HR]0.96；95%置信区间[CI]0.88-1.04），且各组成部分的风险也相似。两组大出血（7.9% vs. 7.9%；HR 0.99；95% CI 0.81-1.21）风险无显著差异。亚组分析也显示治疗效果与各种亚组之间无统计学显著交互作用。在这项回顾性数据库分析中，通用氯吡格雷在治疗 AMI 患者的心血管和出血结局方面与品牌药物相当。
