School of Pharmacy, Sungkyunkwan University, Suwon, Gyeonggi-Do, South Korea.
Lipids Health Dis. 2023 Sep 13;22(1):151. doi: 10.1186/s12944-023-01903-2.
Although generic drugs have been approved with the assurance of interchangeable applications with original drugs, some physicians, and patients still view their efficacy and interchangeability negatively. Using real-world data, we aimed to determine factors that impact switching between drugs that contain the same active ingredient, i.e., atorvastatin, and, in turn, whether this 'switch' could alter clinical outcomes.
Using the National Health Insurance Service senior cohort, a retrospective cohort study was conducted to assess patients who had newly started atorvastatin 10 mg and had at least two records of national health examinations from 2010 to 2014. Drug switching, which was defined as a change in the atorvastatin product administered 90 days before the first and second examinations, was assessed. Greedy propensity score matching (1:2) was performed between switchers and non-switchers to control for potential confounders. Factors influencing switching were analyzed using multivariate logistic regression to estimate odds ratios and 95% confidence intervals (CIs). Changes in low-density lipoprotein-cholesterol (LDL-C) levels attributable to drug switching were evaluated using difference-in-differences regression.
A total of 1,588 patients were included, of whom 25.3% switched drugs (1,187 non-switchers and 401 switchers). Compared to patients taking generics before the first examination, those taking the original drugs had a lower odds ratio (0.31; 95% CI [0.21, 0.46]) for subsequent drug switching. A change in medical institution was associated with a significantly higher odds ratio (6.83; 95% CI [4.66, 10.02]). There were no significant differences in LDL-C alterations between switchers and non-switchers (0.42 mg/dL; 95% CI [-2.29, 3.13]).
The type of first-time drug administered and changes in medical institution can influence drug switching. No significant changes in LDL-C values were observed in the various switching scenarios between the original and generic drugs, suggesting their interchangeable application in real-world clinical practice.
尽管仿制药已获得与原研药可互换应用的批准，但一些医生和患者仍对其疗效和可互换性持负面看法。本研究使用真实世界数据，旨在确定影响含相同活性成分药物（即阿托伐他汀）转换的因素，并由此探讨这种“转换”是否会改变临床结局。
利用国家健康保险服务高级队列，进行了一项回顾性队列研究，评估了 2010 年至 2014 年期间新开始使用阿托伐他汀 10mg 且至少有两次国民健康检查记录的患者。评估了 90 天前在第一次和第二次检查前改变阿托伐他汀产品的药物转换情况。采用贪婪倾向评分匹配（1:2）在转换者和非转换者之间进行匹配，以控制潜在混杂因素。采用多变量逻辑回归分析影响转换的因素，以估计优势比和 95%置信区间（CI）。采用差值法回归评估药物转换引起的低密度脂蛋白胆固醇（LDL-C）水平变化。
共纳入 1588 例患者，其中 25.3%的患者（1187 例非转换者和 401 例转换者）转换了药物。与第一次检查前服用仿制药的患者相比，服用原研药的患者后续药物转换的优势比（OR）较低（0.31；95%CI [0.21, 0.46]）。医疗机构的变化与显著更高的 OR（6.83；95%CI [4.66, 10.02]）相关。转换者和非转换者的 LDL-C 变化无显著差异（0.42mg/dL；95%CI [-2.29, 3.13]）。
首次给药的药物类型和医疗机构的变化会影响药物转换。在原研药和仿制药之间的各种转换情况下，LDL-C 值没有观察到显著变化，这表明它们在真实临床实践中可互换应用。
