Switching Therapy to the Second Brand of Generic Atorvastatin: A 6-Month Retrospective Cohort, Real-World Study

Abstract Introduction High levels of low-density lipoprotein-cholesterol (LDL) is a major risk factor for cardiovascular diseases. While treatment with atorvastatin is beneficial, the original atorvastatin may be cost prohibitive to some patients. Currently, a second brand of generic atorvastatin is...

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Main Authors: Panisa Manasirisuk, Somsak Tiamkao, Chaiyasith Wongvipaporn, Nanthaphan Chainirun, Kittisak Sawanyawisuth
Format: Article
Language:English
Published: Adis, Springer Healthcare 2025-05-01
Series:Drugs - Real World Outcomes
Online Access:https://doi.org/10.1007/s40801-025-00491-0
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author Panisa Manasirisuk
Somsak Tiamkao
Chaiyasith Wongvipaporn
Nanthaphan Chainirun
Kittisak Sawanyawisuth
author_facet Panisa Manasirisuk
Somsak Tiamkao
Chaiyasith Wongvipaporn
Nanthaphan Chainirun
Kittisak Sawanyawisuth
author_sort Panisa Manasirisuk
collection DOAJ
description Abstract Introduction High levels of low-density lipoprotein-cholesterol (LDL) is a major risk factor for cardiovascular diseases. While treatment with atorvastatin is beneficial, the original atorvastatin may be cost prohibitive to some patients. Currently, a second brand of generic atorvastatin is available on the market. This study aimed to evaluate the effectiveness of the second generic brand of atorvastatin. Methods This was a retrospective cohort study conducted at Khon Kaen University Hospital, Thailand. The inclusion criteria were adult patients who received either Xarator® (original atorvastatin; Pfizer Pharmaceuticals, Puerto Rico) or Atorvastatin Sandoz® (Lek Pharmaceuticals, Slovenia) for at least 3 months prior to switching therapy to the second brand: Lipostat® (Siam Pharmaceutical, Thailand). The study period was between 1 April 2022 and 30 June 2023. The primary outcome of this study was a change in LDL 6 months after switching therapy from either the original (Xarator®) or generic atorvastatin (Atorvastatin Sandoz®). Results There were 683 patients who switched therapy from the original atorvastatin (Xarator®), and 1044 patients who switched therapy from generic atorvastatin (Atorvastatin Sandoz®), for a total of 1727 patients. Regarding LDL levels, switching therapy from original atorvastatin (Xarator®) resulted in a slightly lower but not significant decrease in LDL at 6 months (− 0.96 mg/dL; 95% CI of − 3.20, 1.28), while switching therapy from generic atorvastatin (Atorvastatin Sandoz®) led to significantly lower LDL at − 3.30 mg/dL (95% CI of − 5.25, − 1.36). The original (Xarator®) and generic atorvastatin (Atorvastatin Sandoz®) group also resulted in a significantly lower estimated glomerular filtration rate at − 0.90 and − 1.21 mL/min/1.73 m2, respectively, from baseline. Conclusions The second generic atorvastatin (Lipostat®) resulted in comparable outcomes on LDL compared with the original (Xarator®), but significantly lower LDL levels than another generic atorvastatin (Atorvastatin Sandoz®) 6 months after switching therapy. However, renal function should be closely monitored.
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spelling doaj-art-33e8d7b977f947e29b2db6bb7452bbac2025-08-20T02:10:38ZengAdis, Springer HealthcareDrugs - Real World Outcomes2199-11542198-97882025-05-0112226727910.1007/s40801-025-00491-0Switching Therapy to the Second Brand of Generic Atorvastatin: A 6-Month Retrospective Cohort, Real-World StudyPanisa Manasirisuk0Somsak Tiamkao1Chaiyasith Wongvipaporn2Nanthaphan Chainirun3Kittisak Sawanyawisuth4Department of Pharmacy Service, Faculty of Medicine, Srinagarind Hospital, Khon Kaen UniversityDivision of Neurology, Department of Medicine, Faculty of Medicine, Khon Kaen UniversityDivision of Cardiology, Department of Medicine, Faculty of Medicine, Khon Kaen UniversityDepartment of Pharmacy Service, Faculty of Medicine, Srinagarind Hospital, Khon Kaen UniversityDivision of Ambulatory Medicine, Department of Medicine, Faculty of Medicine, Khon Kaen UniversityAbstract Introduction High levels of low-density lipoprotein-cholesterol (LDL) is a major risk factor for cardiovascular diseases. While treatment with atorvastatin is beneficial, the original atorvastatin may be cost prohibitive to some patients. Currently, a second brand of generic atorvastatin is available on the market. This study aimed to evaluate the effectiveness of the second generic brand of atorvastatin. Methods This was a retrospective cohort study conducted at Khon Kaen University Hospital, Thailand. The inclusion criteria were adult patients who received either Xarator® (original atorvastatin; Pfizer Pharmaceuticals, Puerto Rico) or Atorvastatin Sandoz® (Lek Pharmaceuticals, Slovenia) for at least 3 months prior to switching therapy to the second brand: Lipostat® (Siam Pharmaceutical, Thailand). The study period was between 1 April 2022 and 30 June 2023. The primary outcome of this study was a change in LDL 6 months after switching therapy from either the original (Xarator®) or generic atorvastatin (Atorvastatin Sandoz®). Results There were 683 patients who switched therapy from the original atorvastatin (Xarator®), and 1044 patients who switched therapy from generic atorvastatin (Atorvastatin Sandoz®), for a total of 1727 patients. Regarding LDL levels, switching therapy from original atorvastatin (Xarator®) resulted in a slightly lower but not significant decrease in LDL at 6 months (− 0.96 mg/dL; 95% CI of − 3.20, 1.28), while switching therapy from generic atorvastatin (Atorvastatin Sandoz®) led to significantly lower LDL at − 3.30 mg/dL (95% CI of − 5.25, − 1.36). The original (Xarator®) and generic atorvastatin (Atorvastatin Sandoz®) group also resulted in a significantly lower estimated glomerular filtration rate at − 0.90 and − 1.21 mL/min/1.73 m2, respectively, from baseline. Conclusions The second generic atorvastatin (Lipostat®) resulted in comparable outcomes on LDL compared with the original (Xarator®), but significantly lower LDL levels than another generic atorvastatin (Atorvastatin Sandoz®) 6 months after switching therapy. However, renal function should be closely monitored.https://doi.org/10.1007/s40801-025-00491-0
spellingShingle Panisa Manasirisuk
Somsak Tiamkao
Chaiyasith Wongvipaporn
Nanthaphan Chainirun
Kittisak Sawanyawisuth
Switching Therapy to the Second Brand of Generic Atorvastatin: A 6-Month Retrospective Cohort, Real-World Study
Drugs - Real World Outcomes
title Switching Therapy to the Second Brand of Generic Atorvastatin: A 6-Month Retrospective Cohort, Real-World Study
title_full Switching Therapy to the Second Brand of Generic Atorvastatin: A 6-Month Retrospective Cohort, Real-World Study
title_fullStr Switching Therapy to the Second Brand of Generic Atorvastatin: A 6-Month Retrospective Cohort, Real-World Study
title_full_unstemmed Switching Therapy to the Second Brand of Generic Atorvastatin: A 6-Month Retrospective Cohort, Real-World Study
title_short Switching Therapy to the Second Brand of Generic Atorvastatin: A 6-Month Retrospective Cohort, Real-World Study
title_sort switching therapy to the second brand of generic atorvastatin a 6 month retrospective cohort real world study
url https://doi.org/10.1007/s40801-025-00491-0
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