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[使用氯吡格雷原研药与仿制药起始治疗的患者的临床和经济后果:一项真实世界回顾性研究]

[Clinical and economic consequences in patients initiating therapy with clopidogrel brand-name vs. generic: A real-life retrospective study].

作者信息

Sicras-Mainar A, Escobar-Cervantes C, Micó-Pérez R M, Llisterri-Caro J L

机构信息

Dirección Científica, HEOR, Real Life Data, Madrid, España.

Servicio de Cardiología, Hospital Universitario La Paz, Madrid, España.

出版信息

Semergen. 2020 Jan-Feb;46(1):16-26. doi: 10.1016/j.semerg.2019.05.004. Epub 2019 Jul 22.

DOI:10.1016/j.semerg.2019.05.004
PMID:31345684
Abstract

OBJECTIVE

To evaluate the adherence to treatment, resource use, and costs in subjects initiating treatment with brand-name versus generic clopidogrel for acute coronary syndrome (ACS) and peripheral arterial disease (PAD).

PATIENTS AND METHODS

Observational, retrospective study based on the medical records of patients aged ≥18 years who initiated treatment with clopidogrel (brand-name vs. generic) between 4 April 2015 and 31 March 2017. Four study groups were compared, and the follow-up was one year. The main measurements were: comorbidity, treatment adherence, medication possession ratio (MPR), resource use, and costs. The results were analysed using multivariate analysis. The level of statistical significance was P<.05.

RESULTS

Four groups were compared: a) ACS: brand-name clopidogrel (N=1,067) vs. generic (N=3,504), and b) PAD: brand-name clopidogrel (N=425) vs. generic (N=994). In the ACS comparison (mean age: 69.7 years, 61.4% male), adherence (65.3% vs. 61.0%, P<.001), adjusted hazard ratio 0.85 and MPR (89.8% vs. 86.7%, P=.045) were more superior with brand-name clopidogrel than with the generic and with a lower mean cost per unit (€2,890 vs. €3,865, P=.001). In the PAD comparison, similar results were observed: persistence (64.7% vs. 58.9%, P=.039); adjusted hazard-ratio 0.86 and MPR (88.6% vs. 81.7%; P=.013) were more superior with brand-name clopidogrel than for the generic, with a lower mean cost per unit (€2,880 vs. €3,532, P=.044).

CONCLUSIONS

There was better treatment adherence in patients initiating treatment with brand-name compared with generic clopidogrel for ACS and PAD, resulting in lower health costs for the Spanish National Health System.

摘要

目的

评估使用品牌氯吡格雷与通用氯吡格雷治疗急性冠状动脉综合征(ACS)和外周动脉疾病(PAD)的患者的治疗依从性、资源使用情况和成本。

患者与方法

基于2015年4月4日至2017年3月31日期间开始使用氯吡格雷(品牌与通用)治疗的≥18岁患者的病历进行观察性回顾性研究。比较了四个研究组,随访时间为一年。主要测量指标包括:合并症、治疗依从性、药物持有率(MPR)、资源使用情况和成本。使用多变量分析对结果进行分析。统计学显著性水平为P<0.05。

结果

比较了四组:a)ACS:品牌氯吡格雷(N=1067)与通用氯吡格雷(N=3504),以及b)PAD:品牌氯吡格雷(N=425)与通用氯吡格雷(N=994)。在ACS组比较中(平均年龄:69.7岁,男性占61.4%),品牌氯吡格雷的依从性(65.3%对61.0%,P<0.001)、调整后的风险比0.85和MPR(89.8%对86.7%,P=0.045)均优于通用氯吡格雷,且单位平均成本更低(2890欧元对3865欧元,P=0.001)。在PAD组比较中,观察到类似结果:持续性(64.7%对58.9%,P=0.039);品牌氯吡格雷的调整后风险比0.86和MPR(88.6%对81.7%;P=0.

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