Xing Xiaoxuan, Wang Zhizhou, Wang Ke, Hua Yiming, Li Xiaoxi, Le Kejia, Ma Wenbing, Guan Yingyun, Deng Aiping, Yun Xiong, Cai Hongfu, Lyu Yongning, Xiong Guoying, Yang Min, Wang Siyang, Xue Chaojun, Zhang Jing, Guo Qiushi, Hu Song, Li Jing, Dong Xianzhe, Zhang Lan
Department of Pharmacy, Xuanwu Hospital of Capital Medical University, 45 Changchun Street, Xicheng District, Beijing, 100053, China.
Department of Pharmacy, Renji Hospital, Shanghai JiaoTong University School of Medicine, Shanghai, China.
Lipids Health Dis. 2025 Jul 22;24(1):248. doi: 10.1186/s12944-025-02673-9.
To evaluate and compare the treatment patterns, effectiveness, and safety of generic and branded atorvastatin in China.
This multicenter, retrospective cohort study collected and analyzed data from patients who initiated atorvastatin therapy for the first time across 16 hospitals between 2020 and 2022. Treatment patterns included adherence, persistence, switching, augmentation. Absolute reductions of low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol, total cholesterol, and triglycerides, LDL-C reduction ≥ 50%, and adverse events were assessed to measure efficacy and safety. Propensity score matching was utilized to control for potential confounding variables.
Data of 359,159 patients were reviewed. The results indicated a greater proportion of patients the generic atorvastatin group (5772/39742 [14.5%]) exhibited good adherence compared to those in the branded atorvastatin group (3157/39742 [7.9%]; P < 0.001) with an odds ratio of 1.97 (95% CI 1.88-2.06; P < 0.001). In the generic atorvastatin group, a smaller proportion of patients discontinued treatment (35,621/39,742 [89.6%]) compared to the branded group (36,390/39742 [91.6%]; P < 0.001) This difference in treatment persistence was further reflected in the calculated hazard ratio, which was 0.85 (95% CI 0.84-0.86; P < 0.001), indicating a reduced risk of discontinuation in the generic group. Efficacy outcomes were comparable between two groups (all P > 0.05). Both groups exhibited a comparable incidence of most adverse events. Less fasting plasma glucose increase and fewer new-onset diabetes were observed in the generic group (0.01 mmol/L [IQR 0-0.58] vs 0.16 mmol/L [IQR 0-0.73]; P = 0.009; 664/28640 [2.3%] vs 1244/28640 [4.3%]; P < 0.001).
Generic atorvastatin had higher adherence and persistence and lower costs vs the branded drug, with no significant differences in efficacy and safety. Generic atorvastatin can be considered a viable option for dyslipidemia and atherosclerotic cardiovascular disease.
评估和比较中国国产阿托伐他汀与原研阿托伐他汀的治疗模式、有效性和安全性。
这项多中心回顾性队列研究收集并分析了2020年至2022年间在16家医院首次开始阿托伐他汀治疗的患者的数据。治疗模式包括依从性、持续性、换药、加药。评估低密度脂蛋白胆固醇（LDL-C）、非高密度脂蛋白胆固醇、总胆固醇和甘油三酯的绝对降低值、LDL-C降低≥50%以及不良事件，以衡量疗效和安全性。采用倾向得分匹配法控制潜在的混杂变量。
共审查了359159例患者的数据。结果表明，与原研阿托伐他汀组（3157/39742 [7.9%]）相比，国产阿托伐他汀组（5772/39742 [14.5%]）有更高比例的患者表现出良好的依从性（P < 0.001），比值比为1.97（95%CI 1.88 - 2.06；P < 0.001）。在国产阿托伐他汀组中；与原研组（36390/39742 [91.6%]）相比，停药的患者比例较小（35621/39742 [89.6%]；P < 0.001）。这种治疗持续性的差异在计算出的风险比中进一步体现，风险比为0.85（95%CI 0.84 - 0.86；P < 0.001），表明国产组停药风险降低。两组的疗效结果相当（所有P > 0.05）。两组大多数不良事件的发生率相当。在国产组中观察到空腹血糖升高较少且新发糖尿病较少（0.01 mmol/L [四分位间距0 - （此处原文有误，应为0.58）] 对比0.16 mmol/L [四分位间距0 - 0.73]；P = 0.009；664/28640 [2.3%] 对比1244/28640 [4.3%]；P < 0.001）。
与原研药物相比，国产阿托伐他汀具有更高的依从性和持续性，且成本更低，在疗效和安全性方面无显著差异。国产阿托伐他汀可被视为治疗血脂异常和动脉粥样硬化性心血管疾病的一个可行选择。
