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更新于：2025-02-15
Ezetimibe/Rosuvastatin Calcium
依折麦布/瑞舒伐他汀钙
更新于：2025-02-15
概要
基本信息
药物类型 小分子化药 |
别名 依折麦布瑞舒伐他汀钙、瑞舒伐他汀依折麦布、HCP-1306 + [12] |
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 |
非在研适应症 |
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- |
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结构/序列
分子式C22H28CaFN3O6S |
InChIKeyAVDMILNVMOXCHF-DHMAKVBVSA-N |
CAS号147098-20-2 |
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关联
77
项与 依折麦布/瑞舒伐他汀钙 相关的临床试验CTR20244795
依折麦布瑞舒伐他汀钙片10 mg/5 mg随机、开放、两周期、两交叉健康受试者空腹状态下生物等效性试验
CTR20244159
瑞舒伐他汀依折麦布片（Ⅰ）人体生物等效性试验
CTR20244135
健康受试者在空腹及餐后状态下单次口服瑞舒伐他汀依折麦布片（I）的人体生物等效性试验
100 项与 依折麦布/瑞舒伐他汀钙 相关的临床结果
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100 项与 依折麦布/瑞舒伐他汀钙 相关的转化医学
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100 项与 依折麦布/瑞舒伐他汀钙 相关的专利（医药）
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2
项与 依折麦布/瑞舒伐他汀钙 相关的文献（医药）2020-04-01Diabetes therapy : research, treatment and education of diabetes and related disorders
Comparison of the Efficacy and Safety of Rosuvastatin/Ezetimibe Combination Therapy and Rosuvastatin Monotherapy on Lipoprotein in Patients With Type 2 Diabetes: Multicenter Randomized Controlled Study
Article
作者: Lee, Woo Je ; Lee, Jiwoo ; Park, Joong-Yeol ; Hwang, You-Cheol ; Ahn, Kyu Jeung ; Won, Jong Chul ; Song, Kee-Ho ; Park, Cheol-Young
INTRODUCTION:
Ezetimibe/statin combination therapy has been reported to provide additional cardioprotective effects compared to statin monotherapy. The apolipoprotein B/A1 (apoB/A1) ratio is an effective predictor of cardiovascular diseases. The aim of this study was to compare the efficacy and safety of rosuvastatin/ezetimibe combination therapy versus rosuvastatin monotherapy using the apoB/A1 ratio in patients with diabetes and hypercholesterolemia.
METHODS:
In this randomized, multicenter, open-label, parallel-group study, patients were randomly assigned to receive the combination therapy of rosuvastatin 5 mg/ezetimibe 10 mg once daily (n = 68) or monotherapy with rosuvastatin 10 mg once daily (n = 68), for 8 weeks.
RESULTS:
After the 8-week treatment, percentage change (least-square means ± standard error) in the apoB/A1 ratio in the rosuvastatin/ezetimibe group was significantly decreased compared to the rosuvastatin group (- 46.14 ± 1.58% vs. - 41.30 ± 1.58%, respectively; P = 0.03). In addition, the proportion of patients achieving > 50% reduction in low-density lipoprotein-cholesterol (LDL-C) and in the comprehensive lipid target (LDL-C < 70 mg/dL, non-HDL-cholesterol [non-HDL-C] < 100 mg/dL, and apoB < 80 mg/dL) was significantly different between the two groups (76.5 and 73.5% in the rosuvastatin/ezetimibe group and 47.1 and 45.6% in the rosuvastatin group, respectively; P < 0.001). The reduction in total cholesterol, non-HDL-C, LDL-C, and apoB were greater in the rosuvastatin/ezetimibe group than in the rosuvastatin group. Both treatments were well tolerated, and no between-group differences in drug-related adverse events were observed.
CONCLUSION:
The apoB/A1 ratio was significantly reduced in patients receiving combination therapy with ezetimibe and rosuvastatin compared to those receiving rosuvastatin monotherapy. Both treatments were well tolerated in patients with type 2 diabetes and hypercholesterolemia.
TRIAL REGISTRATION:
NCT03446261.
2019-11-01Clinical and translational science3区 · 医学
The Bioequivalence and Effect of Food on the Pharmacokinetics of a Fixed‐Dose Combination Tablet Containing Rosuvastatin and Ezetimibe in Healthy Japanese Subjects
3区 · 医学
ArticleOA
作者: Behm, Martin Otto ; Nishida, Chisato ; Matsumoto, Yuki ; Wrishko, Rebecca Ellen ; Fujimoto, Katsukuni ; Shirakawa, Masayoshi ; Furihata, Kenichi
Certain patient populations are unable to achieve the recommended low‐density lipoprotein cholesterol goals with statin monotherapy alone. Such patients may benefit from concomitant therapy with ezetimibe (EZE) 10 mg added on to a statin. To this end, fixed‐dose combination (FDC) tablets containing EZE 10 mg and rosuvastatin (ROS) 2.5 mg (EZE/ROS2.5) and EZE 10 mg and ROS 5 mg (EZE/ROS5) have been developed for treatment of hypercholesterolemia. The purpose of the series of clinical studies reported herein was to evaluate the potential food effect (MK‐0653H, protocol 836 (P836)) and the bioequivalence between FDC and co‐administration of EZE and ROS in healthy Japanese subjects under fasted and fed conditions (MK‐0653H, protocol 835 (P835) and MK‐0653H, protocol 846 (P846), respectively). These studies show there is no clinically relevant food effect on EZE exposure following single oral administration of the FDC EZE/ROS5 in healthy Japanese subjects; however, ROS exposure was decreased in the fed state under conditions used to evaluate the maximum food effect. Following single oral administration of individual ROS tablets under the same conditions, the magnitude of decrease in ROS exposure was comparable to that seen with FDC, suggesting that the effect of food on ROS exposure was similar between the FDC tablet and co‐administration of individual EZE and ROS tablets. The FDC EZE/ROS5 was generally well tolerated in healthy Japanese subjects under fasted and fed conditions.
100 项与 依折麦布/瑞舒伐他汀钙 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
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 |
|---|---|---|---|
| 纯合子家族性高胆固醇血症 | 美国 | 2021-03-23 | |
| 高脂血症 | 美国 | 2021-03-23 | |
| 高胆固醇血症 | 日本 | 2019-03-26 | |
| 高胆固醇血症 | 日本 | 2019-03-26 | |
| II型高脂蛋白血症 | 日本 | 2019-03-26 |
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 |
|---|---|---|---|---|
| 原发性高胆固醇血症 | 临床3期 | 韩国 | 2014-06-01 | |
| 2型糖尿病 | 临床1期 | 韩国 | 2024-06-20 | |
| 血脂障碍 | 临床1期 | 韩国 | 2024-06-20 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
N/A | - | (Dyslipidemia with T2DM) | 繭壓鏇衊網餘壓積廠鬱(選廠獵繭艱繭遞願艱衊) = 廠遞鑰簾壓糧範夢衊鏇 願鹽衊製鑰積糧壓鹹獵 (遞積齋願齋壓構壓膚窪 ) 更多 | - | 2024-06-14 | ||
(Dyslipidemia without T2DM) | 繭壓鏇衊網餘壓積廠鬱(選廠獵繭艱繭遞願艱衊) = 鬱願觸壓餘餘憲繭廠鑰 願鹽衊製鑰積糧壓鹹獵 (遞積齋願齋壓構壓膚窪 ) 更多 | ||||||
N/A | 137 | Fixed-dose combination rosuvastatin-ezetimibe | 顧鹽鹹築廠憲淵醖鹹襯(觸憲範艱襯積顧餘鹽鹹) = 蓋顧壓膚顧鬱築鹽網顧 衊選構範艱鑰範鏇網襯 (蓋範廠簾鬱簾顧鏇壓構 ) | - | 2021-08-27 | ||
临床4期 | 136 | 蓋窪鑰鏇醖繭糧壓鬱顧(願鑰簾齋夢糧積鏇蓋觸) = 淵壓網淵餘壓醖壓鹹構 淵醖衊積餘願糧壓鏇蓋 (構範憲鑰淵網膚艱網鬱, 1.58) 更多 | 积极 | 2020-04-01 | |||
蓋窪鑰鏇醖繭糧壓鬱顧(願鑰簾齋夢糧積鏇蓋觸) = 艱蓋艱醖淵選鹹鑰鏇築 淵醖衊積餘願糧壓鏇蓋 (構範憲鑰淵網膚艱網鬱, 1.58) 更多 | |||||||
临床3期 | 129 | (Rosuvastatin + Ezetimibe) | 壓廠鬱壓壓憲範積憲夢(窪獵築鬱壓糧淵鏇積廠) = 鹹廠襯選構鹹衊餘願壓 齋鏇窪觸構積膚淵積鏇 (醖廠鬱淵襯齋鬱築壓淵, 遞築鬱鏇網糧鏇鬱鹽構 ~ 鏇鬱醖膚選築築製壓衊) 更多 | - | 2020-01-22 | ||
(Simvastatin + Ezetimibe) | 壓廠鬱壓壓憲範積憲夢(窪獵築鬱壓糧淵鏇積廠) = 壓膚蓋廠觸鹽壓蓋範醖 齋鏇窪觸構積膚淵積鏇 (醖廠鬱淵襯齋鬱築壓淵, 鏇衊鬱壓觸齋糧構觸壓 ~ 艱醖淵鹽糧網鹽遞鹽憲) 更多 |
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