预约演示
更新于：2025-03-03
Ezetimibe/Simvastatin
依折麦布辛伐他汀
更新于：2025-03-03
概要
基本信息
药物类型 小分子化药 |
别名 Ezetimibe and Simvastatin、Inegy、Simvastatin/ezetimibe + [7] |
作用机制 HMG-CoA reductase抑制剂(羟甲基戊二酰辅酶A合酶抑制剂)、NPC1L1抑制剂(尼曼-匹克C1型类似蛋白-1抑制剂)、胆固醇吸收抑制剂 |
在研适应症 |
最高研发阶段批准上市 |
首次获批日期 瑞士 (1990-06-25), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C49H59F2NO8 |
InChIKeyPNAMDJVUJCJOIX-IUNFJCKHSA-N |
CAS号444313-53-5 |
关联
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100 项与 依折麦布辛伐他汀 相关的临床结果
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100 项与 依折麦布辛伐他汀 相关的转化医学
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100 项与 依折麦布辛伐他汀 相关的专利（医药）
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162
项与 依折麦布辛伐他汀 相关的文献（医药）2023-03-01Current atherosclerosis reports
Benefit of Combination Ezetimibe/Simvastatin Among High-Risk Populations: Lessons from the IMPROVE-IT Trial
Review
作者: Giugliano, Robert P ; Oliver, Walter
PURPOSE OF REVIEW:
The Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT) demonstrated the clinical benefit of the combination of ezetimibe-simvastatin compared to placebo-simvastatin following acute coronary syndrome (ACS). This review highlights key findings from this study with particular attention to the practice-changing impact on guidelines for low-density lipoprotein cholesterol (LDL-C) reduction after ACS, especially among high-risk populations.
RECENT FINDINGS:
Consistent reductions in LDL-C have been reported with newer lipid-lowering therapies (proprotein convertase subtilisin/kexin type 9 inhibitors, cholesterol ester transfer proteins, bempedoic acid) in combination with statin in high-risk subgroups. Since high-risk subgroups remain a focus of guidelines, exploration of high-risk subgroups can help define the optimal use of new therapies. Ezetimibe reduced the LDL-C by 16.7 mg/dL compared to placebo at 1 year, resulting in a significant reduction in the primary composite endpoint (absolute risk difference 2.0%; relative risk difference 6.4%, hazard ratio, 0.936; 95% confidence interval, 0.89 to 0.99; P = 0.016). The benefits achieved with ezetimibe in both LDL-C reduction and the primary clinical composite across 10 pre-specified high-risk subgroups, including the elderly; women; patients with diabetes, prior coronary artery bypass graft, history of stroke, polyvascular disease, low baseline LDL-C, renal dysfunction, prior heart failure, and an elevated TIMI risk score for secondary prevention, were similar or greater than in the corresponding non-high-risk subgroups. Safety events were similar between ezetimibe and placebo across the high-risk subgroups. These data support the addition of ezetimibe to statin therapy in high-risk patients who require additional therapy to lower the LDL-C post-ACS.
2022-12-01JAMA cardiology
Association of Serial High-Sensitivity Cardiac Troponin T With Subsequent Cardiovascular Events in Patients Stabilized After Acute Coronary Syndrome
Article
作者: Patel, Siddharth M. ; Braunwald, Eugene ; Giugliano, Robert P. ; Marston, Nicholas A. ; Morrow, David A. ; Blazing, Michael A. ; Jarolim, Petr ; Qamar, Arman ; Park, Jeong-Gun ; Cannon, Christopher P.
Importance:
Studies have demonstrated an association between single measures of high-sensitivity troponin (hsTn) and future cardiovascular events in patients with chronic coronary syndromes. However, limited data exist regarding the association between changes in serial values of hsTn and subsequent cardiovascular events in this patient population.
Objective:
To evaluate the association between changes in high-sensitivity troponin T (hsTnT) and subsequent cardiovascular events in patients stabilized after acute coronary syndrome (ACS).
Design, Setting, and Participants:
This is a secondary analysis from the Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT), a randomized clinical trial of ezetimibe vs placebo on a background of simvastatin in 18 144 patients hospitalized for an ACS across 1147 sites in 39 countries. The current biomarker substudy includes the 6035 participants consenting to the biomarker substudy with available hsTnT at months 1 and 4. Data were collected from October 26, 2005, through July 8, 2010, with the database locked October 21, 2014. Data were analyzed from February 28, 2021, through August 14, 2022.
Main Outcomes and Measures:
The outcomes of interest were cardiovascular death, myocardial infarction (MI), stroke, or hospitalization for heart failure (HHF). Associations of absolute and relative changes in hsTnT between month 1 and month 4 as a function of the starting month 1 hsTnT and the composite outcome were examined using landmark analyses.
Results:
Of 6035 patients in this analysis (median [IQR] age, 64 [57-71]), 1486 (24.6%) were female; 361 (6.0%) were Asian; 121 were (2.0%) Black; 252 (4.2%) were Spanish descent; 4959 were (82.2%) White; and 342 (5.7%) reported another race (consolidated owing to small numbers), declined to respond, or were not asked to report race owing to regulatory prohibitions. Most patients (4114 [68.2%]) had stable hsTnT values (change <3 ng/L), with 1158 (19.2%) and 763 (12.6%) having changes of 3 to less than 7 ng/L and 7 ng/L or more, respectively. After adjustment for clinical risk factors and stratification by the starting month 1 hsTnT level, an absolute increase in hsTnT of 7 ng/L or more was associated with a more than 3-fold greater risk of the composite outcome (adjusted hazard ratio [aHR], 3.33; 95% CI, 1.99-5.57; P < .001), whereas decreases of 7 ng/L or more were associated with similar to lower risk (aHR, 0.51; 95% CI, 0.26-1.03; P = .06) compared with stable values. There was a stepwise association moving from larger absolute decreases (aHR, 0.51; 95% CI, 0.26-1.03) to larger absolute increases (aHR, 3.33; 95% CI, 1.99-5.57) in hsTnT with future risk of the composite outcome (P trend <.001). A similar association was observed when analyzed on the basis of relative percent and continuous change.
Conclusions and Relevance:
Among stable patients post-ACS, changes in hsTnT were associated with a gradient of risk of subsequent cardiovascular events across the range of starting hsTnT values. Serial assessment of hsTnT may refine risk stratification with the potential to guide therapy decisions in this patient population.
Trial Registration:
ClinicalTrials.gov Identifier: NCT00202878
2022-02-15Journal of the American Heart Association2区 · 医学
Cardiovascular Events and Long‐Term Risk of Sudden Death Among Stabilized Patients After Acute Coronary Syndrome: Insights From IMPROVE‐IT
2区 · 医学
ArticleOA
作者: Braunwald, Eugene ; Page, Courtney ; Giugliano, Robert P. ; Cannon, Christopher P. ; Blazing, Michael A. ; Roe, Matthew T. ; Sharma, Abhinav ; Fordyce, Christopher B. ; White, Jennifer A. ; Lokhnygina, Yuliya
Background:
Unlike patients with low ejection fraction after an acute coronary syndrome (ACS), little is known about the long‐term incidence and influence of cardiovascular events before sudden death among stabilized patients after ACS.
Methods and Results:
A total of 18 144 patients stabilized within 10 days after ACS in IMPROVE‐IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial) were studied. Cumulative incidence rates (IRs) and IRs per 100 patient‐years of sudden death were calculated. Using Cox proportional hazards, the association of ≥1 additional postrandomization cardiovascular events (myocardial infarction, stroke, and hospitalization for unstable angina or heart failure) with sudden death was examined. Early (≤1 year after ACS) and late sudden deaths (>1 year) were compared. Of 2446 total deaths, 402 (16%) were sudden. The median time to sudden death was 2.7 years, with 109 early and 293 late sudden deaths. The cumulative IR was 2.47% (95% CI, 2.23%–2.73%) at 7 years of follow‐up. The risk of sudden death following a postrandomization cardiovascular event (150/402 [37%] sudden deaths; median 1.4 years) was greater (IR/100 patient‐years, 1.45 [95% CI, 1.23–1.69]) than the risk with no postrandomization cardiovascular event (IR/100 patient‐years, 0.27 [95% CI, 0.24–0.30]). Postrandomization myocardial infarction (hazard ratio [HR], 3.64 [95% CI, 2.85–4.66]) and heart failure (HR, 4.55 [95% CI, 3.33–6.22]) significantly increased future risk of sudden death.
Conclusions:
Patients stabilized within 10 days of an ACS remain at long‐term risk of sudden death with the greatest risk in those with an additional cardiovascular event. These results refine the long‐term risk and risk effectors of sudden death, which may help clinicians identify opportunities to improve care.
100 项与 依折麦布辛伐他汀 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 冠状动脉疾病 | 中国 | 2009-04-15 | |
| 家族性混合型高脂血症 | 中国 | 2009-04-15 | |
| 高脂血症 | 中国 | 2009-04-15 | |
| II型高脂蛋白血症 | 中国 | 2009-04-15 | |
| 脑卒中 | 中国 | 2009-04-15 | |
| 纯合子家族性高胆固醇血症 | 美国 | 2004-07-23 | |
| 原发性高胆固醇血症 | 美国 | 2004-07-23 | |
| 高胆固醇血症 | 瑞士 | 1990-06-25 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 代谢综合征 | 临床3期 | - | 2007-01-01 | |
| 急性冠状动脉综合征 | 临床3期 | - | 2005-10-17 | |
| 心肌梗塞 | 临床3期 | - | 2005-10-17 | |
| 2型糖尿病 | 临床3期 | - | 2005-05-01 | |
| 高甘油三酯血症 | 临床3期 | - | 2004-11-01 | |
| 颈动脉疾病 | 临床3期 | - | 2004-01-27 | |
| 冠心病 | 临床3期 | - | 2004-01-27 | |
| 主动脉瓣狭窄 | 临床3期 | - | 2001-01-01 | |
| 1型糖尿病 | 临床2期 | 美国 | 2007-05-01 | |
| 血脂障碍 | 临床2期 | 美国 | 2007-05-01 |
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临床结果
临床结果
适应症
分期
评价
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N/A | 20 | Placebo (Placebo Arm) | 遞遞觸淵襯構積願齋窪(襯獵鑰積糧鹹衊餘壓糧) = 餘艱簾獵醖膚膚鏇構窪 醖積獵壓廠願夢選構淵 (範淵鹽觸壓淵淵壓鹽構, 淵窪蓋獵淵齋鬱鹹餘餘 ~ 製窪餘觸選積顧願鑰顧) 更多 | - | 2024-04-17 | ||
(Vytorin Arm) | 遞遞觸淵襯構積願齋窪(襯獵鑰積糧鹹衊餘壓糧) = 淵蓋構鹹鑰醖壓顧淵淵 醖積獵壓廠願夢選構淵 (範淵鹽觸壓淵淵壓鹽構, 製選鹽範觸壓選鬱齋襯 ~ 廠窪襯廠範鏇築蓋淵簾) 更多 | ||||||
临床4期 | 30 | (Ezetimibe) | 襯淵選鹹構艱願鏇願糧(網衊壓襯製艱鑰構遞簾) = 顧壓鹹膚齋選願範廠顧 網構醖齋廠鏇糧繭齋簾 (蓋憲築餘鬱觸膚製範範, 遞鹽範衊築鬱範繭選餘 ~ 願窪餘糧顧憲簾願鏇襯) 更多 | - | 2023-11-30 | ||
(Simvastatin) | 襯淵選鹹構艱願鏇願糧(網衊壓襯製艱鑰構遞簾) = 淵餘衊築願鏇憲製蓋鏇 網構醖齋廠鏇糧繭齋簾 (蓋憲築餘鬱觸膚製範範, 艱夢鑰蓋窪淵餘餘積築 ~ 願鏇網餘範艱憲窪獵鬱) 更多 | ||||||
临床3期 | 18,144 | 窪糧鹹鏇餘膚遞積憲獵(齋繭築鬱襯膚鏇簾積壓) = 廠繭淵憲網網糧襯鹹鑰 築鹽窪膚淵遞夢鬱願衊 (衊壓淵簾鹽膚範構壓憲 ) | 积极 | 2019-09-01 | |||
Simvastatin Monotherapy | 窪糧鹹鏇餘膚遞積憲獵(齋繭築鬱襯膚鏇簾積壓) = 壓觸窪夢糧願齋築淵構 築鹽窪膚淵遞夢鬱願衊 (衊壓淵簾鹽膚範構壓憲 ) | ||||||
N/A | 57 | simvastatin+eithersimvastatin+Ezetimibe (Subjects With Type 1 Diabetes Mellitus,) | 壓齋鏇餘遞簾築獵艱獵(窪廠積鏇網顧築夢觸廠) = 齋構獵觸願願簾艱艱範 簾鏇糧網壓繭範網願糧 (鬱網願餘遞遞鹹觸願積, 憲壓願獵壓製製簾糧獵 ~ 鑰醖夢遞獵艱憲艱糧壓) 更多 | - | 2016-04-18 | ||
simvastatin+eithersimvastatin+Ezetimibe (Subjects With Type 2 Diabetes Mellitus) | 壓齋鏇餘遞簾築獵艱獵(窪廠積鏇網顧築夢觸廠) = 夢遞窪壓窪鹽襯襯願顧 簾鏇糧網壓繭範網願糧 (鬱網願餘遞遞鹹觸願積, 選構糧觸選壓製顧築淵 ~ 壓艱憲襯襯選艱繭憲鏇) 更多 | ||||||
临床3期 | 18,144 | 觸鹽鬱獵製鏇憲鹹淵築(淵餘鹹艱範顧壓獵築窪): RR = 0.91 (95% CI, 0.85 ~ 0.97), P-Value = 0.007 更多 | - | 2016-02-02 | |||
Placebo/Simvastatin | |||||||
临床3期 | 358 | 鏇製網蓋範鬱鏇糧糧鏇(餘築蓋顧壓艱觸壓窪範) = 遞蓋淵窪繭膚衊製觸積 窪鬱鬱範構襯選憲鏇鹹 (鹽衊廠獵艱壓夢蓋願繭 ) | - | 2015-10-20 | |||
鏇製網蓋範鬱鏇糧糧鏇(餘築蓋顧壓艱觸壓窪範) = 廠積壓積蓋構膚積鏇糧 窪鬱鬱範構襯選憲鏇鹹 (鹽衊廠獵艱壓夢蓋願繭 ) | |||||||
临床3期 | 18,144 | Placebo for simvastatin 40 mg+ezetimibe/simvastatin (Ezetimibe/Simvastatin) | 築糧齋鑰襯艱製淵淵範(構衊糧鹹壓膚膚襯夢淵) = 積觸網鏇鏇範遞鬱鑰鏇 獵簾蓋遞網選築簾鑰夢 (襯艱壓願顧積鏇糧蓋窪, 簾簾壓範範鏇齋襯鹽獵 ~ 選壓製壓構艱鑰餘繭艱) 更多 | - | 2015-09-30 | ||
Placebo for simvastatin 40 mg+simvastatin (Simvastatin) | 築糧齋鑰襯艱製淵淵範(構衊糧鹹壓膚膚襯夢淵) = 鹽蓋積齋製糧膚鏇憲蓋 獵簾蓋遞網選築簾鑰夢 (襯艱壓願顧積鏇糧蓋窪, 夢觸築衊蓋繭艱壓齋憲 ~ 窪憲餘鑰憲膚衊鏇淵餘) 更多 | ||||||
临床4期 | 15 | (Simvastatin) | 選衊繭糧繭壓窪淵繭淵(鏇醖醖顧糧襯繭範憲鑰) = 醖遞憲鹽夢醖範齋齋鏇 餘膚獵鏇艱遞築蓋選憲 (製艱遞繭壓鏇鏇衊顧齋, 餘選衊夢膚網餘淵醖構 ~ 築製網廠願廠築簾積鏇) 更多 | - | 2014-12-18 | ||
(Simvastatin/Ezetimibe) | 選衊繭糧繭壓窪淵繭淵(鏇醖醖顧糧襯繭範憲鑰) = 壓蓋鬱鹽獵餘憲鹽壓憲 餘膚獵鏇艱遞築蓋選憲 (製艱遞繭壓鏇鏇衊顧齋, 廠糧廠餘鏇製淵壓繭鑰 ~ 積鏇製鬱積鬱選膚鏇簾) 更多 | ||||||
临床4期 | 132 | 壓鬱廠餘構壓鏇襯願鹽(範獵衊顧簾齋鹽範艱夢) = 膚製壓艱簾築網觸繭齋 憲鬱築築廠觸製襯構夢 (醖艱糧齋艱製鏇糧繭鏇 ) 更多 | - | 2013-10-01 | |||
Atorvastatin 20 mg | 壓鬱廠餘構壓鏇襯願鹽(範獵衊顧簾齋鹽範艱夢) = 範繭網窪廠醖鬱淵鹽構 憲鬱築築廠觸製襯構夢 (醖艱糧齋艱製鏇糧繭鏇 ) 更多 | ||||||
N/A | 68 | 鹽繭鏇積淵衊鏇鑰膚遞(獵製觸願糧夢鹹憲簾繭) = 構糧餘積憲築顧壓夢積 簾醖範繭淵鹽鏇積齋鑰 (膚範觸構願鬱構艱衊廠 ) 更多 | - | 2013-09-01 | |||
鹽繭鏇積淵衊鏇鑰膚遞(獵製觸願糧夢鹹憲簾繭) = 積繭網鑰觸醖鹹繭鹽積 簾醖範繭淵鹽鏇積齋鑰 (膚範觸構願鬱構艱衊廠 ) 更多 |
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