Real world study on the comparison of efficacy and safety of the generic and original sertraline tablets
10.3760/cma.j.cn114015-20221031-01011
- VernacularTitle:仿制与原研舍曲林片疗效和安全性比较的真实世界研究
- Author:
Wei GUO
1
;
Fei JIA
;
Shanshan LIU
;
Hongyan ZHUANG
Author Information
1. 首都医科大学附属北京安定医院药事部，国家精神心理疾病临床医学研究中心，精神疾病诊断与治疗北京市重点实验室，北京 100088
- Publication Type:Journal Article
- Keywords:
Sertraline;
Validation study;
Safety;
Volume-based procurement;
Real world study
- From:
Adverse Drug Reactions Journal
2023;25(3):159-164
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To compare the efficacy and safety between the generic sertraline tablets, which was selected in the national centralized volume-based procurement of drugs (trade name: Weitating), and the original sertraline tablets (trade name: Levofloxacin) in the treatment for depressive disorder, and to provide a basis for promoting the rational use of the generic drugs. Methods:Real world study using retrospective mirror-image comparison was adopted. The outpatient data of patients who were prescribed sertraline tablets one year after the implementation of the national centralized volume-based procurement policy in Beijing Anding Hospital, Capital Medical University were collected. The patients were divided into the generic drug group and the original drug group. After the propensity score matching, the daily dose of prescription, blood concentration of sertraline, and incidence of abnormal laboratory test items (prolactin, liver and kidney function, blood lipids, etc.) of patients in the 2 groups were analyzed.Results:A total of 13 659 patients with depression, generalized anxiety disorder, and obsessive-compulsive disorder were enrolled in the study, including 5 973 (43.73%) patients in the generic drug group and 7 686 (56.27%) patients in the original drug group. Among the 5 973 patients in the generic drug group, 2 167 (36.28%) were male and 3 806 (63.72%) were female, aged (34±18) years, ranging from 6 to 94 years. Among the 7 686 (56.27%) patients in the original drug group, 2 709 (35.24%) were male and 4 977 (64.75%) were female, aged (35±19) years, ranging from 6 to 95 years. The difference between the daily dose of sertraline in prescription in the generic drug group and the original drug group was statistically significant [(161.00±46.58) mg vs. (166.34±43.67) mg, t=6.614, P<0.001]. The difference of blood concentration of sertraline in patients between the generic drug group and the original drug group was statistically significant [(50.41±39.49) μg/L vs. (53.80±39.62) μg/L, t=2.616, P=0.009]. The differences in incidence of prolactin elevation and liver and kidney dysfunction between the 2 groups were not statistically significant (all P>0.05). The difference in the proportion of patients with high-density lipoprotein cholesterol lower than limit of the reference value between the generic drug group and the original drug group was statistically significant [41.75% (734/1 758) vs. 38.28% (673/1 758), χ 2=4.409, P=0.039]. The difference in the proportion of patients with low-density lipoprotein cholesterol higher than the upper limit of the reference value between the 2 groups was statistically significant [41.75% (734/1 758) vs. 45.39% (798/1 758), χ2=4.738, P=0.032]. Conclusion:In this study, no clinically significant differences in efficacy and safety of the generic and original sertraline tablets were found.
