{"title":"切换到第二品牌阿托伐他汀：一个6个月的回顾性队列，现实世界研究。","authors":"Panisa Manasirisuk, Somsak Tiamkao, Chaiyasith Wongvipaporn, Nanthaphan Chainirun, Kittisak Sawanyawisuth","doi":"10.1007/s40801-025-00491-0","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>This was a retrospective cohort study conducted at Khon Kaen University Hospital, Thailand. The inclusion criteria were adult patients who received either Xarator<sup>®</sup> (original atorvastatin; Pfizer Pharmaceuticals, Puerto Rico) or Atorvastatin Sandoz<sup>®</sup> (Lek Pharmaceuticals, Slovenia) for at least 3 months prior to switching therapy to the second brand: Lipostat<sup>®</sup> (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<sup>®</sup>) or generic atorvastatin (Atorvastatin Sandoz<sup>®</sup>).</p><p><strong>Results: </strong>There were 683 patients who switched therapy from the original atorvastatin (Xarator<sup>®</sup>), and 1044 patients who switched therapy from generic atorvastatin (Atorvastatin Sandoz<sup>®</sup>), for a total of 1727 patients. Regarding LDL levels, switching therapy from original atorvastatin (Xarator<sup>®</sup>) 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<sup>®</sup>) led to significantly lower LDL at - 3.30 mg/dL (95% CI of - 5.25, - 1.36). The original (Xarator<sup>®</sup>) and generic atorvastatin (Atorvastatin Sandoz<sup>®</sup>) group also resulted in a significantly lower estimated glomerular filtration rate at - 0.90 and - 1.21 mL/min/1.73 m<sup>2</sup>, respectively, from baseline.</p><p><strong>Conclusions: </strong>The second generic atorvastatin (Lipostat<sup>®</sup>) resulted in comparable outcomes on LDL compared with the original (Xarator<sup>®</sup>), but significantly lower LDL levels than another generic atorvastatin (Atorvastatin Sandoz<sup>®</sup>) 6 months after switching therapy. However, renal function should be closely monitored.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":1.9000,"publicationDate":"2025-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Switching Therapy to the Second Brand of Generic Atorvastatin: A 6-Month Retrospective Cohort, Real-World Study.\",\"authors\":\"Panisa Manasirisuk, Somsak Tiamkao, Chaiyasith Wongvipaporn, Nanthaphan Chainirun, Kittisak Sawanyawisuth\",\"doi\":\"10.1007/s40801-025-00491-0\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>This was a retrospective cohort study conducted at Khon Kaen University Hospital, Thailand. The inclusion criteria were adult patients who received either Xarator<sup>®</sup> (original atorvastatin; Pfizer Pharmaceuticals, Puerto Rico) or Atorvastatin Sandoz<sup>®</sup> (Lek Pharmaceuticals, Slovenia) for at least 3 months prior to switching therapy to the second brand: Lipostat<sup>®</sup> (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<sup>®</sup>) or generic atorvastatin (Atorvastatin Sandoz<sup>®</sup>).</p><p><strong>Results: </strong>There were 683 patients who switched therapy from the original atorvastatin (Xarator<sup>®</sup>), and 1044 patients who switched therapy from generic atorvastatin (Atorvastatin Sandoz<sup>®</sup>), for a total of 1727 patients. Regarding LDL levels, switching therapy from original atorvastatin (Xarator<sup>®</sup>) 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<sup>®</sup>) led to significantly lower LDL at - 3.30 mg/dL (95% CI of - 5.25, - 1.36). The original (Xarator<sup>®</sup>) and generic atorvastatin (Atorvastatin Sandoz<sup>®</sup>) group also resulted in a significantly lower estimated glomerular filtration rate at - 0.90 and - 1.21 mL/min/1.73 m<sup>2</sup>, respectively, from baseline.</p><p><strong>Conclusions: </strong>The second generic atorvastatin (Lipostat<sup>®</sup>) resulted in comparable outcomes on LDL compared with the original (Xarator<sup>®</sup>), but significantly lower LDL levels than another generic atorvastatin (Atorvastatin Sandoz<sup>®</sup>) 6 months after switching therapy. However, renal function should be closely monitored.</p>\",\"PeriodicalId\":11282,\"journal\":{\"name\":\"Drugs - Real World Outcomes\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":1.9000,\"publicationDate\":\"2025-05-11\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Drugs - Real World Outcomes\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1007/s40801-025-00491-0\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Drugs - Real World Outcomes","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1007/s40801-025-00491-0","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
Switching Therapy to the Second Brand of Generic Atorvastatin: A 6-Month Retrospective Cohort, Real-World Study.
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.
期刊介绍：
Drugs - Real World Outcomes targets original research and definitive reviews regarding the use of real-world data to evaluate health outcomes and inform healthcare decision-making on drugs, devices and other interventions in clinical practice. The journal includes, but is not limited to, the following research areas: Using registries/databases/health records and other non-selected observational datasets to investigate: drug use and treatment outcomes prescription patterns drug safety signals adherence to treatment guidelines benefit : risk profiles comparative effectiveness economic analyses including cost-of-illness Data-driven research methodologies, including the capture, curation, search, sharing, analysis and interpretation of ‘big data’ Techniques and approaches to optimise real-world modelling.
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