@article{Junpanichjaroen_Piyayothai_Mongkolsomlit_Wattanavijitkul_2022, title={Comparison of the Lipid-lowering Effects of Generic Atorvastatin between Generic and Originator Brands}, volume={47}, url={https://he02.tci-thaijo.org/index.php/JDMS/article/view/250985}, abstractNote={<p><strong>Background:</strong> Generic drugs have the same therapeutic effect as original drugs. Generic drug substitution aimed at increasing opportunity of patients access to drugs and reducing drug expenditure. <br />At present, generic drugs of Atorvastatin manufactured by both originator company and generic company <br />as original-brand and generic-brand. Confidence in efficacy and safety of generic-brand substitution has limitation by health-care workers perception.<strong>Objective:</strong> This study was to compare lipid lowering effects of generic Atorvastatin between generic-brand and originator-brand with non-inferiority testing and was to report adverse drug events.<strong>Methods:</strong> A retrospective cohort study was conducted, and data collected from medical records. All patients were taking originator-brand of generic Atorvastatin at least 3 months and then divided into two groups, changed to generic-brand and continue originator-brand. Low-density lipoprotein cholesterols (LDL-C) was followed at 6 months and 1 year. The percent reduction from baseline in LDL-C was evaluated by multivariable Gaussian regression analysis. Non-inferiority hypothesis was evaluated at -5.94 mg/dL (non-inferiority margin).<strong>Results:</strong> Among 365 patients divided to generic-brand group (n=248) and originator-brand group (n=117). The percent reduction from baseline in LDL-C of  generic-brand and originator-brand was not significant, 1.60 mg/dL (95%CI: -4.92 to 8.13) at 6 months and 2.20 mg/dL (95%CI: -4.67 to 9.07) at 1 year. The 95% confidence interval was on the right side of non-inferiority margin, generic-brand was not inferior to originator-brand can be accepted. Adverse drug events needed to be confirmed because lack of report validity.<strong>Conclusion:</strong> Generic-brand substitution was accepted for efficacy. Adverse drug events should be monitored after generic drugs substitution.</p>}, number={1}, journal={Journal of The Department of Medical Services}, author={Junpanichjaroen, Athirat and Piyayothai, Dilok and Mongkolsomlit, Sirima and Wattanavijitkul, Thitima}, year={2022}, month={Mar.}, pages={49–56} }