State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing 100037, China.
Research Center of Clinical Epidemiology, Peking University Third Hospital, Beijing 100191, China.
Chin Med J (Engl). 2021 Jan 19;134(3):292-301. doi: 10.1097/CM9.0000000000001360.
Generic drugs are bioequivalent to their brand-name counterparts; however, concerns still exist regarding the effectiveness and safety of generic drugs because of small sample sizes and short follow-up time in most studies. The purpose of this study was to evaluate the long-term antihypertensive efficacy, cost-effectiveness and cardiovascular outcomes of generic drugs compared with brand-name drugs.
In a multicenter, community-based study including 7955 hypertensive patients who were prospectively followed up for an average of 2.5 years, we used the propensity-score-matching method to match the patients using brand-name drugs to those using generic drugs in a ratio of 1:2, 2176 patients using brand-name drugs and 4352 patients using generic drugs.
There were no significant differences between generic drugs and brand-name drugs in blood pressure (BP)-lowering efficacy, BP control rate, and cardiovascular outcomes including coronary heart disease and stroke. The adjusted mean (95% confidence interval [CI]) of systolic BP (SBP)-lowering was -7.9 mmHg (95% CI, -9.9 to -5.9) in the brand-name drug group and -7.1 mmHg (95% CI, -9.1 to -5.1) in the generic drug group after adjusting for age, sex, body mass index, number of antihypertensive drugs and traditionally cardiovascular risk factors. Among patients aged <60 years, brand-name drugs had a higher BP control rate (47% vs. 41%; P = 0.02) and a greater effect in lowering SBP compared with generic drugs, with the between-group difference of 1.5 mmHg (95% CI, 0.2-2.8; P = 0.03). BP control rate was higher in male patients using brand-name drugs compared with those using generic drugs (46% vs. 40%; P = 0.01). Generic drugs treatment yielded an average annual incremental cost-effectiveness ratio of $315.4 per patient per mmHg decrease in SBP compared with brand-name drugs treatment.
Our data suggested that generic drugs are suitable and cost-effective in improving hypertension management and facilitating public health benefits, especially in low- and middle-income areas.
仿制药与品牌药具有生物等效性；然而，由于大多数研究的样本量小且随访时间短，人们仍然对仿制药的有效性和安全性存在担忧。本研究旨在评估与品牌药相比，仿制药的长期降压疗效、成本效益和心血管结局。
在一项多中心、社区为基础的研究中，我们纳入了 7955 名高血压患者，前瞻性随访平均 2.5 年。我们使用倾向评分匹配方法，将使用品牌药的患者与使用仿制药的患者按 1:2 的比例进行匹配，共匹配了 2176 名使用品牌药的患者和 4352 名使用仿制药的患者。
在降压疗效、血压控制率以及包括冠心病和卒中等心血管结局方面，仿制药与品牌药之间没有显著差异。在调整年龄、性别、体重指数、降压药物种类和传统心血管危险因素后，品牌药组收缩压（SBP）降低的平均（95%置信区间[CI]）为-7.9mmHg（95%CI，-9.9 至-5.9），仿制药组为-7.1mmHg（95%CI，-9.1 至-5.1）。在年龄<60 岁的患者中，品牌药的血压控制率（47% vs. 41%；P=0.02）更高，SBP 降低幅度更大，两组间差异为 1.5mmHg（95%CI，0.2-2.8；P=0.03）。与使用仿制药的患者相比，使用品牌药的男性患者血压控制率更高（46% vs. 40%；P=0.01）。与品牌药治疗相比，使用仿制药治疗可使 SBP 每降低 1mmHg 平均每年增加的成本-效果比为 315.4 美元。
我们的数据表明，仿制药在改善高血压管理和促进公共卫生效益方面是合适且具有成本效益的，特别是在中低收入地区。
