Efficacy and Safety of Generic Atorvastatin in Patients with Hyperlipidemia: A Multicenter Retrospective Cohort Study

doi:10.19546/j.issn.1674-3830.2024.9.006

China Health Insurance ›› 2024, Vol. 0 ›› Issue (9) : 44-52. DOI: 10.19546/j.issn.1674-3830.2024.9.006

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Efficacy and Safety of Generic Atorvastatin in Patients with Hyperlipidemia: A Multicenter Retrospective Cohort Study

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Abstract

Objective: The paper compares the clinical efficacy and safety differences between generic and original atorvastatin to provide real-world evidence for the rational use of selected generic drugs in clinical practice and the implementation of national volume-based procurement policy. Methods: This is a multicenter retrospective cohort study. The data was collected from the outpatient electronic information systems of 10 medical institutions in China. Patients prescribed with atorvastatin, either original or generic, for the first time between April 1, 2020 and March 31, 2023 were included. Propensity score matching was used to adjust the baseline characteristics of the generic drug group and original drug group. The improvement of blood lipid tests, the occurrence of drug-induced liver injury and muscle symptoms were compared between the groups. Results: No significant differences were observed between the generic drug group and the original drug group in terms of reduction in LDL-C, non HDL-C, TC and TG levels from baseline within 6 months after enrollment. Compared to the original drug group, the generic drug group exhibited significantly lower occurrence of drug-induced liver injury and the the proportions of patients diagnosed with new muscle symptoms were not significantly different. Conclusion: In this study, the generic and the original atorvastatin were basically equivalent in terms of clinical lipid-lowering efficacy and safety. They are replaceable in clinical practice.

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atorvastatin / generic drug / real-world study / efficacy / safety

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Efficacy and Safety of Generic Atorvastatin in Patients with Hyperlipidemia: A Multicenter Retrospective Cohort Study[J]. China Health Insurance. 2024, 0(9): 44-52 https://doi.org/10.19546/j.issn.1674-3830.2024.9.006

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