Comparison of the Lipid-lowering Effects of Generic Atorvastatin between Generic and Originator Brands


  • Athirat Junpanichjaroen, Pharm.D. Pharmacy Department, Police General Hospital
  • Dilok Piyayothai, Ph.D. Faculty of Medicine, Thammasat University Rangsit Campus
  • Sirima Mongkolsomlit, Ph.D. Faculty of Public Health, Thammasat University Rangsit Campus
  • Thitima Wattanavijitkul, Ph.D. Faculty of Pharmaceutical Sciences, Chulalongkorn University


Atorvastatin, generic drug, generic-brand, originator-brand, lipid lowering effects


Background: 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.
At present, generic drugs of Atorvastatin manufactured by both originator company and generic company
as original-brand and generic-brand. Confidence in efficacy and safety of generic-brand substitution has limitation by health-care workers perception.Objective: 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.Methods: 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).Results: 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.Conclusion: Generic-brand substitution was accepted for efficacy. Adverse drug events should be monitored after generic drugs substitution.


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Straka RJ, Keohane DJ, Liu LZ. Potential Clinical and Economic Impact of Switching Branded Medications to Generics. American

journal of therapeutics. 2017;24(3):e278-e89.

Lexicomp. Atorvastatin: Drug information. In: UpToDate. [Internet]. Waltham (MA): UpToDate Inc; 2021. [cited 2021 Apr

. Available from:

สำนักงบประมาณ. บัญชีนวัตกรรมไทย ฉบับเพิ่มเติม สิงหาคม 2561.

Liu HH, Li JJ. Aging and dyslipidemia: a review of potentialmechanisms. Ageing research reviews. 2015;19:43-52.

Phan BAP, Toth PP. Dyslipidemia in women: etiology and management. International Journal of Women’s Health. 2014;6:185-94.

Klop B, Elte JWF, Cabezas MC. Dyslipidemia in obesity: mechanisms and potential targets. Nutrients. 2013;5(4):1218-40.

Rivellese AA, Vaccaro O, Patti L. The pathophysiology of lipid metabolism and diabetes. International Journal of Clinical Practice. 2004;58:32-5.

Mikolasevic I, Žutelija M, Mavrinac V, Orlic L. Dyslipidemia in patients with chronic kidney disease: etiology and management. Int J Nephrol Renovasc Dis. 2017;10:35-45.

Ross DS. Lipid abnormalities in thyroid disease 2017 [Available from:

Simha V. Drug-Induced Dyslipidemia. In: Garg A, editor. Dyslipidemias: Pathophysiology, Evaluation and Management. Totowa, NJ: Humana Press; 2015. p. 267-86.

Lee J-H, Kim S-H, Choi D-J, Tahk S-J, Yoon J-H, Choi SW, et al. Efficacy and tolerability of two different formulations of atorvastatin in Korean patients with hypercholesterolemia: a multicenter, prospective, randomized clinical trial. Drug Des Devel Ther. 2017;11:2277-85.

Non-Inferiority Clinical Trials to Establish Effectiveness: Guidance for Industry: U.S. Department of Health and Human Services Food and Drug Administration; 2016 [cited 2021, 23 January]. Available from:

Law MR, Wald NJ, Rudnicka AR. Quantifying effect of statins on low density lipoprotein cholesterol, ischaemic heart disease, and stroke: systematic review and meta-analysis. BMJ (Clinical research ed). 2003;326(7404):1423.

Medicines in Health Care Delivery Thailand: Situational Analysis 2015:[57 p.].

Howard JN, Harris I, Frank G, Kiptanui Z, Qian J, Hansen R. Influencers of generic drug utilization: A systematic review. Research in social & administrative pharmacy : RSAP. 2018;14(7):619-27.

Kim SH, Seo MK, Yoon MH, Choi DH, Hong TJ, Kim HS. Assessment of the efficacy and tolerability of 2 formulations of atorvastatin in Korean adults with hypercholesterolemia: a multicenter, prospective, open-label, randomized trial. Clin Ther. 2013;35(1): 77-86. doi: 10.1016/j.clinthera.2012.11.009. Epub Dec 28.

Kim SH, Park K, Hong SJ, Cho YS, Sung JD, Moon GW, et al. Efficacy and tolerability of a generic and a branded formulation of atorvastatin 20 mg/d in hypercholesterolemic Korean adults at high risk for cardiovascular disease: a multicenter, prospective, randomized, double-blind, double-dummy clinical trial. Clin Ther. 2010;32(11):1896-905. doi: 10.016/j.clinthera.2010.10.004.

Loch A, Bewersdorf JP, Kofink D, Ismail D, Abidin IZ, Veriah RS. Generic atorvastatin is as effective as the brand-name drug (LIPITOR(®)) in lowering cholesterol levels: a cross-sectional retrospective cohort study. BMC Res Notes. 2017;10(1):291.

Guidance for Industry, E 10 Choice of Control Group and Related Issues in Clinical Trials: U.S. Department of Health and Human Services Food and Drug Administration; 2001 [cited 2021, 25 January]. Available from:

Althunian TA, de Boer A, Groenwold RHH, Klungel OH. Defining the noninferiority margin and analysing noninferiority: An overview. British journal of clinical pharmacology. 2017; 83(8): 1636-42.



How to Cite

Junpanichjaroen A, Piyayothai D, Mongkolsomlit S, Wattanavijitkul T. Comparison of the Lipid-lowering Effects of Generic Atorvastatin between Generic and Originator Brands. j dept med ser [Internet]. 2022 Mar. 31 [cited 2022 Sep. 28];47(1):49-56. Available from:



Original Article