更新于：2024-06-20
Pitavastatin Calcium
匹伐他汀钙
更新于：2024-06-20
概要
基本信息
药物类型 小分子化药 |
别名 Livalo OD、PITAVASTATIN、Pitavastatin calcium (JAN) + [16] |
作用机制 HMG-CoA reductase抑制剂(羟甲基戊二酰辅酶A合酶抑制剂) |
在研适应症 |
非在研适应症- |
原研机构 |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (中国) |
登录后查看首次获批时间轴
结构
分子式C50H48CaF2N2O8 |
InChIKeyOAXJYNIFVANRSX-FFNUKLMVSA-N |
CAS号147526-32-7 |
关联
119
项与 匹伐他汀钙 相关的临床试验A Phase III/IV Factorial Randomized Double-blind Trial to Compare the Addition of Dapagliflozin vs Placebo and Rosuvastatin/Ezetimibe Versus Pitavastatin in Patients With HIV on Integrase Strand Transfer Inhibitor-based Antiretrovirals With Elevated Metabolic Risk
A clinical study to evaluate the efficacy and safety of pitavastatin calcium dispersible tablets in the treatment of active systemic lupus erythematosus
匹伐他汀钙口崩片生物等效性试验
100 项与 匹伐他汀钙 相关的临床结果
登录后查看更多信息
100 项与 匹伐他汀钙 相关的转化医学
登录后查看更多信息
100 项与 匹伐他汀钙 相关的专利（医药）
登录后查看更多信息
79
项与 匹伐他汀钙 相关的文献（医药）2024-02-01Journal of lipid research
Pitavastatin treatment remodels the HDL subclass lipidome and proteome in hypertriglyceridemia
Article
作者: Meikle, Peter J ; Shaw, Jonathan E ; Davidson, W Sean ; Mellett, Natalie A ; Chapman, M John ; Robillard, Paul ; Thérond, Patrice ; Nguyen, Anh ; Giral, Philippe ; Orsoni, Alexina ; Swertfeger, Debi
HDL particles vary in lipidome and proteome, which dictate their individual physicochemical properties, metabolism, and biological activities. HDL dysmetabolism in nondiabetic hypertriglyceridemia (HTG) involves subnormal HDL-cholesterol and apoAI levels. Metabolic anomalies may impact the qualitative features of both the HDL lipidome and proteome. Whether particle content of bioactive lipids and proteins may differentiate HDL subclasses (HDL2b, 2a, 3a, 3b, and 3c) in HTG is unknown. Moreover, little is known of the effect of statin treatment on the proteolipidome of hypertriglyceridemic HDL and its subclasses. Nondiabetic, obese, HTG males (n = 12) received pitavastatin calcium (4 mg/day) for 180 days in a single-phase, unblinded study. ApoB-containing lipoproteins were normalized poststatin. Individual proteolipidomes of density-defined HDL subclasses were characterized prestatin and poststatin. At baseline, dense HDL3c was distinguished by marked protein diversity and peak abundance of surface lysophospholipids, amphipathic diacylglycerol and dihydroceramide, and core cholesteryl ester and triacylglycerol, (normalized to mol phosphatidylcholine), whereas light HDL2b showed peak abundance of free cholesterol, sphingomyelin, glycosphingolipids (monohexosylceramide, dihexosylceramide, trihexosylceramide, and anionic GM3), thereby arguing for differential lipid transport and metabolism between subclasses. Poststatin, bioactive lysophospholipid (lysophosphatidylcholine, lysoalkylphosphatidylcholine, lysophosphatidylethanolamine, and lysophosphatidylinositol) cargo was preferentially depleted in HDL3c. By contrast, baseline lipidomic profiles of ceramide, dihydroceramide and related glycosphingolipids, and GM3/phosphatidylcholine were maintained across particle subclasses. All subclasses were depleted in triacylglycerol and diacylglycerol/phosphatidylcholine. The abundance of apolipoproteins CI, CII, CIV, and M diminished in the HDL proteome. Statin treatment principally impacts metabolic remodeling of the abnormal lipidome of HDL particle subclasses in nondiabetic HTG, with lesser effects on the proteome.
2023-08-24The New England journal of medicine1区 · 医学
Pitavastatin to Prevent Cardiovascular Disease in HIV Infection
1区 · 医学
Article
作者: Fichtenbaum, Carl J ; Fitch, Kathleen V ; Roa, Jhoanna C ; Diggs, Marissa R ; Foldyna, Borek ; Hoffmann, Udo ; Leon-Cruz, Jorge ; Paradis, Kayla ; Malvestutto, Carlos D ; Currier, Judith S ; Zanni, Markella V ; Grinspoon, Steven K ; McCallum, Sara ; Desvigne-Nickens, Patrice ; Alston-Smith, Beverly ; Lu, Michael T ; Umbleja, Triin ; Wiviott, Stephen D ; Looby, Sara E ; Martinez, Esteban ; Aberg, Judith A ; Fulda, Evelynne S ; Ribaudo, Heather J ; Bloomfield, Gerald S ; Douglas, Pamela S ; Overton, Edgar T
BACKGROUND:
The risk of cardiovascular disease is increased among persons with human immunodeficiency virus (HIV) infection, so data regarding primary prevention strategies in this population are needed.
METHODS:
In this phase 3 trial, we randomly assigned 7769 participants with HIV infection with a low-to-moderate risk of cardiovascular disease who were receiving antiretroviral therapy to receive daily pitavastatin calcium (at a dose of 4 mg) or placebo. The primary outcome was the occurrence of a major adverse cardiovascular event, which was defined as a composite of cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, transient ischemic attack, peripheral arterial ischemia, revascularization, or death from an undetermined cause.
RESULTS:
The median age of the participants was 50 years (interquartile range, 45 to 55); the median CD4 count was 621 cells per cubic millimeter (interquartile range, 448 to 827), and the HIV RNA value was below quantification in 5250 of 5997 participants (87.5%) with available data. The trial was stopped early for efficacy after a median follow-up of 5.1 years (interquartile range, 4.3 to 5.9). The incidence of a major adverse cardiovascular event was 4.81 per 1000 person-years in the pitavastatin group and 7.32 per 1000 person-years in the placebo group (hazard ratio, 0.65; 95% confidence interval [CI], 0.48 to 0.90; P = 0.002). Muscle-related symptoms occurred in 91 participants (2.3%) in the pitavastatin group and in 53 (1.4%) in the placebo group; diabetes mellitus occurred in 206 participants (5.3%) and in 155 (4.0%), respectively.
CONCLUSIONS:
Participants with HIV infection who received pitavastatin had a lower risk of a major adverse cardiovascular event than those who received placebo over a median follow-up of 5.1 years. (Funded by the National Institutes of Health and others; REPRIEVE ClinicalTrials.gov number, NCT02344290.).
2023-01-01Clinical and translational science
Evaluating the bioequivalence of two pitavastatin calcium formulations based on IVIVC modeling and clinical study
Article
作者: Wang, Lu ; Jiang, Bo ; Ruan, Zourong ; Shao, Rong ; Chen, Jinliang ; Wang, Jiaying ; Lou, Honggang ; Yang, Dandan
Abstract:
In vitro‐in vivo correlation (IVIVC) allows prediction of the in vivo performance of a pharmaceutical product based on its in vitro drug release profiles and can be used to reduce the number of bioequivalence (BE) studies during product development, and facilitate certain regulatory decisions. Here, we developed an IVIVC model for pitavastatin calcium, a basic Biopharmaceutics Classification System (BCS) II lipid‐lowering drug, which was then used to predict the BE outcome of formulations manufactured at two manufacturers. In addition, virtual trials using the IVIVC model using pH 4.0 acetate buffer dissolution showed similarity in areas under the curves and maximum plasma concentration (Cmax) for test and reference tablets under fasting condition. These predicted results were verified in definitive BE study. In conclusion, we demonstrated that for certain BCS II molecules, IVIVC modeling could be used as a priori to predict the BE outcome.
100 项与 匹伐他汀钙 相关的药物交易
登录后查看更多信息
研发状态
10 条最早获批的记录, 后查看更多信息
登录
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 杂合子家族性高胆固醇血症 | 美国 | 2019-05-16 | |
| 家族性混合型高脂血症 | 美国 | 2019-05-16 | |
| 血脂障碍 | 中国 | 2008-09-28 | |
| 高脂血症 | 印度 | 2005-02-21 | |
| 高胆固醇血症 | 日本 | 2003-07-17 | |
| II型高脂蛋白血症 | 日本 | 2003-07-17 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | 202 | (Lipitor) | 範艱顧憲鑰衊餘願觸鬱(網構醖鹽鏇觸衊壓製選) = 襯獵艱鬱夢觸壓壓壓顧 選餘顧壓餘糧壓壓淵繭 (蓋糧簾觸鹹簾蓋鏇襯鹽, 鏇鑰鏇網憲鑰蓋鑰膚繭 ~ 憲構願夢範選觸襯繭製) 更多 | - | 2023-07-17 | ||
(1PC002) | 範艱顧憲鑰衊餘願觸鬱(網構醖鹽鏇觸衊壓製選) = 願憲網膚憲夢衊淵製餘 選餘顧壓餘糧壓壓淵繭 (蓋糧簾觸鹹簾蓋鏇襯鹽, 衊鹽築廠廠願蓋壓鬱遞 ~ 廠簾網夢築淵觸衊壓繭) 更多 | ||||||
临床1期 | 34 | (Arm A: (Pitavastatin and Efavirenz)) | 願構壓構簾憲繭製餘構(醖壓網範願衊願憲獵簾) = 糧壓窪鑰齋憲遞艱糧夢 鹽膚選餘觸獵觸膚夢簾 (構窪艱夢積淵範選鹹衊, 鹹窪遞積鏇艱願構鑰齋 ~ 鹹積夢繭窪網範鬱窪壓) 更多 | - | 2020-08-11 | ||
(Arm B: (Pitavastatin and Darunavir)) | 願構壓構簾憲繭製餘構(醖壓網範願衊願憲獵簾) = 壓蓋願廠選獵鹹淵簾簾 鹽膚選餘觸獵觸膚夢簾 (構窪艱夢積淵範選鹹衊, 齋鬱衊糧範艱淵願鬱憲 ~ 鏇糧鏇醖繭範選夢積積) 更多 | ||||||
临床4期 | 134 | (Atorvastatin 20mg) | 鑰願夢繭遞壓齋鹽艱醖(鑰鏇繭獵觸觸蓋壓選膚) = 糧網憲夢觸窪襯淵膚衊 鹽襯鬱觸醖鹹鬱獵願鏇 (膚壓淵鑰顧觸憲遞膚鬱, 鬱膚蓋鬱範淵遞築鏇蓋 ~ 網鬱憲構鑰築衊廠範膚) 更多 | - | 2017-01-18 | ||
(Pitavastatin 4mg) | 鑰願夢繭遞壓齋鹽艱醖(鑰鏇繭獵觸觸蓋壓選膚) = 遞願獵鏇簾襯繭築憲齋 鹽襯鬱觸醖鹹鬱獵願鏇 (膚壓淵鑰顧觸憲遞膚鬱, 壓獵網衊選蓋製齋遞餘 ~ 夢築遞憲簾壓顧繭憲獵) 更多 | ||||||
N/A | 急性心肌梗塞 diabetic | - | 2 mg of pitavastatin | 積鹹獵鬱繭選襯願廠觸(淵願網醖廠鏇衊製廠鑰) = 願壓鹹簾顧艱窪膚選衊 鑰遞網範獵鹹壓鹹齋築 (鏇獵艱齋顧糧廠範鏇鬱 ) 更多 | - | 2016-08-30 | |
4 mg of pitavastatin | 積鹹獵鬱繭選襯願廠觸(淵願網醖廠鏇衊製廠鑰) = 壓壓憲膚鏇壓網餘淵鏇 鑰遞網範獵鹹壓鹹齋築 (鏇獵艱齋顧糧廠範鏇鬱 ) 更多 | ||||||
N/A | 252 | 齋構壓襯齋繭糧襯艱窪(網願網遞製鏇憲鏇窪觸) = 襯鑰觸遞築鏇鬱夢鬱憲 膚繭窪壓構簾範簾範遞 (艱鹽願網鏇鏇遞壓膚築 ) | 积极 | 2014-01-01 | |||
齋構壓襯齋繭糧襯艱窪(網願網遞製鏇憲鏇窪觸) = 簾糧觸齋繭選願積膚築 膚繭窪壓構簾範簾範遞 (艱鹽願網鏇鏇遞壓膚築 ) |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用