Pitavastatin
證據等級: L5 | 預測適應症: 10 個
## 藥師評估報告
Pitavastatin 藥師筆記
一句話總結
Pitavastatin 為 HMG-CoA 還原酶抑制劑，TxGNN 預測對家族性高膽固醇血症等脂質代謝疾病有療效，已有豐富臨床試驗及文獻支持，部分預測與現有適應症重疊。
快速總覽
| 項目 | 內容 |
|---|---|
| 藥品學名 | Pitavastatin (匹伐他汀/環丙烯脂汀) |
| DrugBank ID | DB08860 |
| 原核准適應症 | 原發性高膽固醇血症、混合型血脂異常、兒童家族性高膽固醇血症 |
| TxGNN 預測新適應症 | obsolete familial combined hyperlipidemia、homozygous familial hypercholesterolemia、hyperlipoproteinemia、hyperlipidemia, familial combined, LPL related、familial hypercholesterolemia、cholesterol-ester transfer protein deficiency、hypercholesterolemia, autosomal dominant、hypercholesterolemia due to cholesterol 7alpha-hydroxylase deficiency、HIV infectious disease、neurodevelopmental disorder with ataxic gait, absent speech, and decreased cortical white matter |
| 台灣許可證數 | 46 張 |
| 最高證據等級 | L1-L2 (RCT) |
預測適應症詳細分析
1. homozygous familial hypercholesterolemia L4 100.00% 主要分析
2. hyperlipoproteinemia L1 100.00%
臨床試驗（12 項）
| 試驗編號 | 階段 | 狀態 | 人數 | 主要發現 |
|---|---|---|---|---|
| NCT02799758 | PHASE3 | WITHDRAWN | 0 | Efficacy & Long-term Safety Comparison Study of NK-104-CR & Livalo® IR With Prim... |
| NCT01256476 | PHASE4 | COMPLETED | 328 | A RANDOMIZED, DOUBLE-BLIND, ACTIVE CONTROLLED, PARALLEL GROUP STUDY OF PITAVASTA... |
| NCT01386853 | PHASE3 | UNKNOWN | 200 | A 12-week, Randomized, Multicenter, Double-blind, Active-controlled, Non-inferio... |
| NCT01695954 | PHASE1 | COMPLETED | 34 | The Effect of Efavirenz and Ritonavir-boosted Darunavir on the Pharmacokinetics ... |
| NCT04608474 | PHASE4 | UNKNOWN | 120 | Lipid Management in Renal Transplant Recipients: A Pilot Study Evaluating the Us... |
| NCT01166633 | PHASE4 | COMPLETED | 200 | A Randomized , Open Label, Dose Titration Study to Evaluate the Effect of Pitava... |
| NCT02634034 | PHASE1 | COMPLETED | 18 | A Comparison Study to Evaluate the Pharmacokinetics and Safety of NK-104-CR in H... |
| NCT01764178 | PHASE1 | COMPLETED | 52 | A Single Dose, Sequence-randomized, Open-label, 2x2 Crossover Study to Compare P... |
| NCT02670434 | PHASE3 | WITHDRAWN | 0 | Safety and Efficacy Comparison Study of NK-104-CR (Controled Release) in Patient... |
| NCT02056847 | PHASE4 | COMPLETED | 313 | Randomized, Open-label, Multi-centered Study to Evaluate the Safety and Efficacy... |
| NCT01406431 | PHASE1 | COMPLETED | 48 | A Single Dose, Sequence-randomized, Open-label, 2x2 Crossover Study to Compare P... |
| NCT00711919 | NA | UNKNOWN | 300 | Pitavastatin Evaluation of Atherosclerosis Regression by Intensive Cholesterol-L... |
相關文獻（15 篇）
| PMID | 年份 | 類型 | 期刊 | 主要發現 |
|---|---|---|---|---|
| 29187694 | 2018 | Article | Journal of atherosclerosis and | Efficacy and Safety of Pitavastatin in Children and Adolescents with Familial Hy... |
| 25891210 | 2016 | Article | Journal of atherosclerosis and | Efficacy and Safety of Pitavastatin in Japanese Male Children with Familial Hype... |
| 12822207 | 2003 | Article | Therapie | [New antilipemics: prospects]. |
| 17957184 | 2008 | Article | Clinical pharmacology and ther | Comparison of effects of pitavastatin and atorvastatin on plasma coenzyme Q10 in... |
| 23672789 | 2013 | Article | Journal of cardiology | Comparison of pitavastatin with atorvastatin in increasing HDL-cholesterol and a... |
| 31965805 | 2020 | Article | Journal of proteome research | Lipid Profiling of Serum and Lipoprotein Fractions in Response to Pitavastatin U... |
| 12442637 | 2002 | Article | Arzneimittel-Forschung | Metabolic fate of pitavastatin (NK-104), a new inhibitor of 3-hydroxy-3-methyl-g... |
| 35361995 | 2022 | Article | The pharmacogenomics journal | Combining familial hypercholesterolemia and statin genetic studies as a strategy... |
| 32084003 | 2020 | Article | Journal of pediatric endocrino | Nine-year overview of dyslipidemia management in children with heterozygous fami... |
| 12048134 | 2002 | Article | Atherosclerosis | Long-term treatment with pitavastatin (NK-104), a new HMG-CoA reductase inhibito... |
| 21951922 | 2011 | Article | Hepatology research : the offi | Efficacy of pitavastatin for the treatment of non-alcoholic steatohepatitis with... |
| 26510755 | 2016 | Article | Journal of atherosclerosis and | Effect of Statin Therapy in 4-Year-Old Dichorionic Diamniotic Twins with Familia... |
| 16733299 | 2006 | Article | Journal of atherosclerosis and | Efficacy of a low dose of pitavastatin compared with atorvastatin in primary hyp... |
| 10955373 | 2000 | Article | The American journal of cardio | Effects of NK-104, a new hydroxymethylglutaryl-coenzyme reductase inhibitor, on ... |
| 39532566 | 2025 | Article | Journal of clinical lipidology | Rapid lipid-lowering response in two cases of autosomal recessive hypercholester... |
3. familial hypercholesterolemia L2 99.99%
臨床試驗（2 項）
| 試驗編號 | 階段 | 狀態 | 人數 | 主要發現 |
|---|---|---|---|---|
| NCT02107898 | PHASE3 | COMPLETED | 216 | A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Stud... |
| NCT01890967 | PHASE2 | COMPLETED | 527 | A Phase 2 Efficacy and Safety Dose-Ranging Study of LY3015014 in Patients With P... |
相關文獻（19 篇）
| PMID | 年份 | 類型 | 期刊 | 主要發現 |
|---|---|---|---|---|
| 29187694 | 2018 | Article | Journal of atherosclerosis and | Efficacy and Safety of Pitavastatin in Children and Adolescents with Familial Hy... |
| 35361995 | 2022 | Article | The pharmacogenomics journal | Combining familial hypercholesterolemia and statin genetic studies as a strategy... |
| 25891210 | 2016 | Article | Journal of atherosclerosis and | Efficacy and Safety of Pitavastatin in Japanese Male Children with Familial Hype... |
| 36928267 | 2023 | Article | Journal of atherosclerosis and | Achievement Rates for Low-Density Lipoprotein Cholesterol Goals in Patients at H... |
| 31965805 | 2020 | Article | Journal of proteome research | Lipid Profiling of Serum and Lipoprotein Fractions in Response to Pitavastatin U... |
| 41036155 | 2025 | Article | Clinical case reports | Two Cases of Heterozygous Familial Hypercholesterolemia in Children Effectively ... |
| 12931254 | 2003 | Article | Cardiovascular drug reviews | Pitavastatin: efficacy and safety profiles of a novel synthetic HMG-CoA reductas... |
| 17957184 | 2008 | Article | Clinical pharmacology and ther | Comparison of effects of pitavastatin and atorvastatin on plasma coenzyme Q10 in... |
| 40874855 | 2025 | Article | Journal of clinical research i | Real-World Experience from Türkiye: Genetic and Therapeutic Insights in Pediatri... |
| 28416195 | 2017 | Article | The lancet. HIV | Pitavastatin versus pravastatin in adults with HIV-1 infection and dyslipidaemia... |
| 18603821 | 2008 | Article | Journal of atherosclerosis and | Effects of statin on small dense low-density lipoprotein cholesterol and remnant... |
| 22152282 | 2011 | Article | Atherosclerosis. Supplements | Pitavastatin: novel effects on lipid parameters. |
| 12048134 | 2002 | Article | Atherosclerosis | Long-term treatment with pitavastatin (NK-104), a new HMG-CoA reductase inhibito... |
| 32084003 | 2020 | Article | Journal of pediatric endocrino | Nine-year overview of dyslipidemia management in children with heterozygous fami... |
| 40552191 | 2025 | Article | Frontiers in cardiovascular me | Familial hypercholesterolaemia with early-onset coronary artery disease and recu... |
| 12486415 | 2002 | Article | American heart journal | Management of dyslipidemia in the high-risk patient. |
| 10955373 | 2000 | Article | The American journal of cardio | Effects of NK-104, a new hydroxymethylglutaryl-coenzyme reductase inhibitor, on ... |
| 26510755 | 2016 | Article | Journal of atherosclerosis and | Effect of Statin Therapy in 4-Year-Old Dichorionic Diamniotic Twins with Familia... |
| 15178557 | 2004 | Article | Arteriosclerosis, thrombosis, | Statins upregulate PCSK9, the gene encoding the proprotein convertase neural apo... |
4. cholesterol-ester transfer protein deficiency L5 99.98%
目前尚無針對此適應症的專門臨床研究。此為 TxGNN 模型預測結果，需進一步驗證。
5. hypercholesterolemia, autosomal dominant L2 99.97%
臨床試驗（2 項）
| 試驗編號 | 階段 | 狀態 | 人數 | 主要發現 |
|---|---|---|---|---|
| NCT02107898 | PHASE3 | COMPLETED | 216 | A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Stud... |
| NCT01890967 | PHASE2 | COMPLETED | 527 | A Phase 2 Efficacy and Safety Dose-Ranging Study of LY3015014 in Patients With P... |
相關文獻（12 篇）
| PMID | 年份 | 類型 | 期刊 | 主要發現 |
|---|---|---|---|---|
| 29187694 | 2018 | Article | Journal of atherosclerosis and | Efficacy and Safety of Pitavastatin in Children and Adolescents with Familial Hy... |
| 25891210 | 2016 | Article | Journal of atherosclerosis and | Efficacy and Safety of Pitavastatin in Japanese Male Children with Familial Hype... |
| 31965805 | 2020 | Article | Journal of proteome research | Lipid Profiling of Serum and Lipoprotein Fractions in Response to Pitavastatin U... |
| 17957184 | 2008 | Article | Clinical pharmacology and ther | Comparison of effects of pitavastatin and atorvastatin on plasma coenzyme Q10 in... |
| 35361995 | 2022 | Article | The pharmacogenomics journal | Combining familial hypercholesterolemia and statin genetic studies as a strategy... |
| 39532566 | 2025 | Article | Journal of clinical lipidology | Rapid lipid-lowering response in two cases of autosomal recessive hypercholester... |
| 26510755 | 2016 | Article | Journal of atherosclerosis and | Effect of Statin Therapy in 4-Year-Old Dichorionic Diamniotic Twins with Familia... |
| 15178557 | 2004 | Article | Arteriosclerosis, thrombosis, | Statins upregulate PCSK9, the gene encoding the proprotein convertase neural apo... |
| 32084003 | 2020 | Article | Journal of pediatric endocrino | Nine-year overview of dyslipidemia management in children with heterozygous fami... |
| 12048134 | 2002 | Article | Atherosclerosis | Long-term treatment with pitavastatin (NK-104), a new HMG-CoA reductase inhibito... |
| 10955373 | 2000 | Article | The American journal of cardio | Effects of NK-104, a new hydroxymethylglutaryl-coenzyme reductase inhibitor, on ... |
| 16733299 | 2006 | Article | Journal of atherosclerosis and | Efficacy of a low dose of pitavastatin compared with atorvastatin in primary hyp... |
6. hypercholesterolemia due to cholesterol 7alpha-hydroxylase deficiency L5 99.97%
目前尚無針對此適應症的專門臨床研究。此為 TxGNN 模型預測結果，需進一步驗證。
7. HIV infectious disease L1 99.97%
臨床試驗（2 項）
| 試驗編號 | 階段 | 狀態 | 人數 | 主要發現 |
|---|---|---|---|---|
| NCT06317051 | PHASE3 | ACTIVE_NOT_RECRUITING | 300 | A Phase III/IV Factorial Randomized Double-blind Trial to Compare the Addition o... |
| NCT02344290 | PHASE3 | COMPLETED | 7769 | Randomized Trial to Prevent Vascular Events in HIV - REPRIEVE |
相關文獻（20 篇）
| PMID | 年份 | 類型 | 期刊 | 主要發現 |
|---|---|---|---|---|
| 37486775 | 2023 | Article | The New England journal of med | Pitavastatin to Prevent Cardiovascular Disease in HIV Infection. |
| 38381407 | 2024 | Article | JAMA cardiology | Effects of Pitavastatin on Coronary Artery Disease and Inflammatory Biomarkers i... |
| 37991867 | 2023 | Article | The New England journal of med | Pitavastatin and Cardiovascular Disease in HIV. |
| 37991865 | 2023 | Article | The New England journal of med | Pitavastatin and Cardiovascular Disease in HIV. |
| 37991866 | 2023 | Article | The New England journal of med | Pitavastatin and Cardiovascular Disease in HIV. |
| 37991864 | 2023 | Article | The New England journal of med | Pitavastatin and Cardiovascular Disease in HIV. |
| 37991868 | 2023 | Article | The New England journal of med | Pitavastatin and Cardiovascular Disease in HIV. Reply. |
| 38198667 | 2023 | Article | Topics in antiviral medicine | Prevention and treatment of cardiovascular disease in HIV: practical insights in... |
| 40482662 | 2025 | Article | The lancet. HIV | Effects of antiretrovirals on major adverse cardiovascular events in the REPRIEV... |
| 39374532 | 2024 | Article | Annals of internal medicine | Diabetes Risk Factors in People With HIV Receiving Pitavastatin Versus Placebo f... |
| 38294226 | 2025 | Article | Cardiology in review | Pitavastatin in the Prevention of Cardiovascular Disease in People Living with H... |
| 26713505 | 2015 | Article | Topics in antiviral medicine | HIV-Related Cardiovascular Disease, Statins, and the REPRIEVE Trial. |
| 28252528 | 2017 | Article | AIDS (London, England) | Effects of pitavastatin and pravastatin on markers of immune activation and arte... |
| 30928823 | 2019 | Article | American heart journal | Rationale and design of the Mechanistic Substudy of the Randomized Trial to Prev... |
| 37503623 | 2023 | Article | AIDS (London, England) | Hepatic steatosis and nonalcoholic fatty liver disease are common and associated... |
| 39661372 | 2025 | Article | JAMA cardiology | Pitavastatin, Procollagen Pathways, and Plaque Stabilization in Patients With HI... |
| 35642121 | 2023 | Article | Current reviews in clinical an | A Systematic Review of Randomized Clinical Trials on the Efficacy and Safety of ... |
| 28416195 | 2017 | Article | The lancet. HIV | Pitavastatin versus pravastatin in adults with HIV-1 infection and dyslipidaemia... |
| 37931263 | 2023 | Article | Annals of internal medicine | In adults with HIV and low-to-moderate CV risk, pitavastatin reduced MACE over a... |
| 36849967 | 2023 | Article | AIDS research and therapy | Effects of pitavastatin on atherosclerotic-associated inflammatory biomarkers in... |
8. neurodevelopmental disorder with ataxic gait, absent speech, and decreased cortical white matter L5 99.95%
目前尚無針對此適應症的專門臨床研究。此為 TxGNN 模型預測結果，需進一步驗證。
9. hyperlipidemia due to hepatic triglyceride lipase deficiency L5 99.94%
目前尚無針對此適應症的專門臨床研究。此為 TxGNN 模型預測結果，需進一步驗證。
10. simian immunodeficiency virus infection L5 99.93%
目前尚無針對此適應症的專門臨床研究。此為 TxGNN 模型預測結果，需進一步驗證。
台灣上市資訊
上市狀態
台灣已核准上市，共有 46 張許可證，目前有效許可證超過 20 張。
代表性產品
| 許可證字號 | 商品名 | 劑型 | 許可證持有者 | 效期 |
|---|---|---|---|---|
| 衛部藥輸字第027002號 | 力清之口溶錠2毫克 (LIVALO) | 口溶錠 | 台田藥品股份有限公司 | 2027/01/19 |
| 衛部藥製字第059192號 | 庇脂清膜衣錠4毫克 | 膜衣錠 | 瑩碩生技醫藥股份有限公司 | 2026/05/23 |
| 衛部藥製字第060290號 | 好脂定膜衣錠4毫克 | 膜衣錠 | 永信藥品工業股份有限公司 | 2029/05/09 |
| 衛署藥製字第057372號 | 必抑脂膜衣錠2毫克 | 膜衣錠 | 友霖生技醫藥股份有限公司 | 2027/09/26 |
| 衛部藥製字第061165號 | 同抑脂膠囊2/10毫克 | 膠囊劑 | 友霖生技醫藥股份有限公司 | 2027/10/28 |
核准適應症
- 原發性高膽固醇血症
- 混合型血脂異常
- 10 歲以上兒童家族性高膽固醇血症
安全性考量
藥物交互作用
DDInter 資料庫顯示 Pitavastatin 與多種藥物有交互作用：
中度交互作用 (Moderate)：
- Eluxadoline
- Naltrexone
- Metronidazole
注意事項
- 肌肉毒性：監測肌肉疼痛、無力，定期檢測 CK 值
- 肝功能：開始治療前及治療期間定期監測肝功能
- 藥物交互作用：Pitavastatin 主要經 CYP2C9 代謝，與 CYP3A4 無明顯交互作用，較其他 statin 藥物交互作用風險低
- HIV 患者：可用於接受抗病毒治療的 HIV 患者（INTREPID 試驗支持）
藥物-疾病注意事項 (DDSI)
資料來源：DDInter 2.0（原文內容請參閱該網站）
糖尿病 🟡 Moderate
- 應謹慎使用本藥物。需定期監測。
腎臟疾病 🟡 Moderate
- 應謹慎使用本藥物。需定期監測。可能需要降低劑量。可能有嚴重不良反應。
肝臟疾病 🟢 Minor
- 本藥物在此情況下禁用。需定期監測。
Rhabdomyolysis 🟢 Minor
- 需定期監測。可能有嚴重不良反應。
藥物-食物交互作用 (DFI)
資料來源：DDInter 2.0（原文內容請參閱該網站）
酒精 🟡 Moderate
- 影響：產生協同作用。
- 建議：建議避免併用。
結論與下一步
預測價值評估
| 預測適應症 | 證據等級 | 文獻支持 | 臨床試驗 | 總評 |
|---|---|---|---|---|
| 同型合子 FH | L3 | 2 篇 | 間接 | 中度支持 |
| 高脂蛋白血症 | L2 | 15+ 篇 | 12 | 強力支持 |
| 家族性高膽固醇血症 | L1-L2 | 18+ 篇 | 2 | 已為核准適應症 |
建議
- 高脂蛋白血症及家族性高膽固醇血症預測與現有適應症高度重疊，證實模型預測準確
- 同型合子 FH：雖文獻支持較少，但基於作用機轉，Pitavastatin 可作為綜合治療方案的一部分
- Pitavastatin 較其他 statin 藥物交互作用風險低，適合多重用藥患者
本筆記由 TwTxGNN 系統自動產生，僅供研究參考，不構成醫療建議。 產生日期：2026-02-11
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引用本報告
如需引用本報告，請使用以下格式：
APA 格式：
TwTxGNN. (2026). Pitavastatin老藥新用驗證報告. https://twtxgnn.yao.care/drugs/pitavastatin/
BibTeX 格式：
@misc{twtxgnn_pitavastatin,
title = {Pitavastatin老藥新用驗證報告},
author = {TwTxGNN Team},
year = {2026},
url = {https://twtxgnn.yao.care/drugs/pitavastatin/}
}
免責聲明
本報告僅供學術研究參考，不構成醫療建議。藥物使用請遵循醫師指示，切勿自行調整用藥。任何老藥新用決策需經過完整的臨床驗證與法規審查。
最後審核：2026-02-20 | 審核者：TwTxGNN Research Team
本報告僅供學術研究參考，不構成醫療建議。藥物使用請遵循醫師指示，切勿自行調整用藥。任何老藥新用決策需經過完整的臨床驗證與法規審查。
最後審核：2026-02-20 | 審核者：TwTxGNN Research Team
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