背景:仿制药的替代可以有效缓解药品成本的快速增长;然而,在中国,原始产品和仿制药的临床有效性和医疗成本几乎没有研究。目的:比较鄞州地区原药和仿制药之间抗高血压药物的有效性和与高血压相关的医疗费用。中国。方法:我们使用中国电子健康档案研究在鄞州(CHERRY)进行了一项基于人群的回顾性队列研究,从2011年7月1日至2018年12月31日。将开始使用原始产品的高血压患者与开始使用通用产品的患者进行比较。我们使用1:1的倾向得分匹配,根据社会人口统计学将两组配对,临床,和卫生服务利用率变量。采用Cox比例回归比较匹配的发起者和普通发起者之间高血压相关心血管疾病的住院率。使用Wilcoxon配对对符号秩检验来比较与高血压相关的年度医疗费用。结果:配对对(10,535)患者被纳入原创产品和仿制药的比较研究,对应于包括氨氯地平在内的七种降压药物,非洛地平,硝苯地平,厄贝沙坦,氯沙坦,缬沙坦,还有美托洛尔.纳入分析的患者平均年龄约为60岁(发起人与泛型启动:从59.0vs.氯沙坦59.1年至62.9年vs.硝苯地平63.6年)。对于三种钙通道阻滞剂,在始发者中观察到较高的住院率(危害比[95%CI]:氨氯地平,3.18[1.43,7.11];非洛地平,3.60[1.63,7.98];和硝苯地平,3.86[1.26、11.81];分别)。临床终点估计的7种药物中的其余4种显示出原始产品和仿制药之间的可比结果(风险比[95%CI]:厄贝沙坦,1.19[0.50,2.84];氯沙坦,1.84[0.84,4.07];缬沙坦,2.04[0.72,5.78];和美托洛尔,1.25[0.56,2.80];分别)。在发起人中观察到较高的与高血压相关的年度医疗费用中位数(所有p<0.001),美托洛尔除外(p=0.646)。结论:与原始药物相比,我们观察到与使用抗高血压药物相关的临床结果相当甚至更好,医疗成本更低。这可以帮助提高患者和提供者对仿制药治疗高血压疾病的有效性的信心。
Background: The substitution of generic drugs can effectively alleviate the rapid growth of drug costs; however, the clinical effectiveness and medical costs of
originator products and generics were barely studied in
China. Objectives: To compare the effectiveness of antihypertensive drugs and hypertension-related medical costs between originator and generic initiators in Yinzhou,
China. Methods: We conducted a population-based retrospective cohort study using the Chinese Electronic Health Records Research in Yinzhou (CHERRY), from July 1, 2011, to December 31, 2018. Hypertension patients initiating with
originator products were compared with patients initiating with generic counterparts. We used 1:1 propensity score matching to pair the two groups based on sociodemographic, clinical, and health service utilization variables. Cox proportional regression was adopted to compare the rate of hospitalization for hypertension-related cardiovascular disease between matched originator and generic initiators. Wilcoxon matched-pairs signed-rank test was used to compare annual hypertension-related medical costs. Results: Matched pairs (10,535) of patients were included in the comparative study of originator products and generics, corresponding to seven antihypertensive drugs including amlodipine, felodipine, nifedipine, irbesartan, losartan, valsartan, and metoprolol. The average age of patients included in the analysis was around 60 years (originator vs. generics initiators: from 59.0 vs. 59.1 years in losartan to 62.9 vs. 63.6 years in nifedipine). Higher hospitalization rates among originator initiators were observed for three calcium channel blockers (hazard ratio[95% CI]: amlodipine, 3.18[1.43, 7.11]; felodipine, 3.60[1.63, 7.98]; and nifedipine, 3.86[1.26, 11.81]; respectively). The remaining four out of seven drugs of the clinical endpoint estimates showed comparable outcomes between originator products and generics (hazard ratio[95% CI]: irbesartan, 1.19[0.50, 2.84]; losartan, 1.84[0.84, 4.07]; valsartan, 2.04[0.72, 5.78]; and metoprolol, 1.25[0.56, 2.80]; respectively). Higher median annual hypertension-related medical costs were observed in
originator initiators (all p < 0.001), except for metoprolol (p = 0.646). Conclusion: We observed comparable or even better clinical outcomes and less medical cost associated with the use of antihypertensive generics compared to originator counterparts. This could help increase patient and provider confidence in the efficacy of generic medicines to manage hypertension diseases.