预约演示
更新于：2025-01-16
Edoxaban Tosylate
甲苯磺酸艾多沙班
更新于：2025-01-16
概要
基本信息
非在研机构- |
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- |
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结构/序列
分子式C31H40ClN7O8S2 |
InChIKeyPSMMNJNZVZZNOI-SJILXJHISA-N |
CAS号1229194-11-9 |
关联
213
项与 甲苯磺酸艾多沙班 相关的临床试验CTR20242595
一项随机、开放、两序列交叉、完全重复试验设计，评价健康成人空腹/餐后状态下单次口服甲苯磺酸艾多沙班片的生物等效性试验
CTR20240747
江苏华阳制药有限公司研制的甲苯磺酸艾多沙班片与Daiichi Sankyo Europe GmbH上市的里先安®在健康受试者中进行的单中心、随机、开放、两制剂、空腹和餐后、单次给药、2序列、4周期、重复交叉生物等效性研究
CTR20242149
甲苯磺酸艾多沙班片（60 mg）在健康受试者中的空腹/餐后生物等效性试验
100 项与 甲苯磺酸艾多沙班 相关的临床结果
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100 项与 甲苯磺酸艾多沙班 相关的转化医学
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100 项与 甲苯磺酸艾多沙班 相关的专利（医药）
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2,226
项与 甲苯磺酸艾多沙班 相关的文献（医药）2025-04-01DEN open
Safety of edoxaban for delayed bleeding in gastrointestinal endoscopic procedures with a high risk of bleeding
Article
作者: Tominaga, Kentaro ; Terai, Shuji ; Kojima, Yuichi ; Kazunao, Hayashi ; Shibata, Osamu ; Kawata, Yuzo ; Satoshi, Ikarasi ; Takahashi, Kazuya ; Mizuno, Ken‐ichi ; Yokoyama, Junji
Abstract:
Objectives:
There are limited reports on the safety of gastrointestinal endoscopic procedures in individuals taking edoxaban, one of the direct oral anticoagulants. We clarified the incidence of delayed bleeding in patients who were on edoxaban in the perioperative period of gastrointestinal endoscopic procedures with a high risk of bleeding.
Methods:
This was an investigator‐initiated, single‐center, open‐label, prospective, single‐arm study. Patients on warfarin or edoxaban undergoing endoscopy with a high risk of bleeding were enrolled from June 2018 to September 2021. Warfarin was replaced with edoxaban in patients on warfarin. Patients taking other direct oral anticoagulants, and antiplatelet drugs, were excluded. The primary endpoint was severe delayed bleeding (Common Terminology Criteria for Adverse Events [CTCAE] grades III–V) and the secondary endpoints included thromboembolism, all adverse events, any delayed bleeding (CTCAE grades I or II), and hospital stay durations.
Results:
Twenty‐one patients on edoxaban underwent high‐risk endoscopy. Three cases (14%) experienced CTCAE grade III delayed bleeding, requiring endoscopic hemostasis. No CTCAE grade I‐II delayed bleeding or thromboembolic events occurred. Cholangitis and aspiration pneumonia (conservatively treated) occurred during the hospital stay. The median length of hospital stay was 8 days (range 3—24 days). Patients with delayed bleeding had higher systolic blood pressure at admission and longer hospital stays.
Conclusions:
The delayed bleeding incidence in high‐risk endoscopic procedures for patients on edoxaban was acceptable. Higher blood pressure may be associated with increased risk, but further research is needed.
2025-01-01JOURNAL OF ETHNOPHARMACOLOGY
Impact of Banhabaekchulcheonmatang (Banxia Baizhu Tianma Tang) and Hwangryeonhaedoktang (Huang Lian Jie Du Tang) on edoxaban: Herb-drug interaction study in healthy subjects
Article
作者: Kim, Ju Hee ; Chung, Hyewon ; Song, Jungbin ; Cho, Seok-jin ; Kang, Dong Wook ; Cho, Seok-Jin ; Kim, Hocheol ; Cho, Hea-Young
ETHNOPHARMACOLOGICAL RELEVANCE:
Concurrent use of traditional herbal medicines and conventional drugs, particularly for stroke treatment, is widespread, raising concerns about potential drug interactions.
AIM OF THE STUDY:
This clinical study aimed to investigate interactions between edoxaban, a direct oral anticoagulant, and two traditional herbal medicines commonly used for stroke: Banhabaekchulcheonmatang (BBCT) and Hwangryeonhaedoktang (HRHDT).
MATERIALS AND METHODS:
Korean healthy volunteers participated in a randomized, open-label, three-period, three-treatment, two-sequence clinical study. Treatments consisted of a single oral dose of edoxaban tablet (60 mg) in the presence or absence of multiple doses of BBCT or HRHDT three times daily for six days. Pharmacokinetic and pharmacodynamic parameters of edoxaban and its active metabolite M4 were assessed following administration of edoxaban alone or in co-administration with BBCT or HRHDT.
RESULTS:
When edoxaban was co-administered with BBCT or HRHDT, the area under the curve (AUC) of edoxaban remained unaffected. However, its peak concentrations (Cmax) were decreased by 18.5%-28.1%. Similarly, co-administration of edoxaban with BBCT or HRHDT slightly decreased the AUC of M4 and reduced its Cmax by 16.8%-27.1%. Results revealed that BBCT and HRHDT had a minor impact on pharmacokinetics of edoxaban and M4. Despite alterations in systemic exposures, all pharmacodynamic parameters of edoxaban derived from activated partial thromboplastin time and prothrombin time were equivalent irrespective of herbal medicine co-administration.
CONCLUSIONS:
These findings contribute to our understanding of potential interactions between conventional anticoagulants and traditional herbal medicines, highlighting the need for comprehensive evaluation in clinical practice.
2025-01-01Contemporary Clinical Trials
Unsupervised clustering approach to assess heterogeneity of treatment effects across patient phenotypes in randomized clinical trials
Article
作者: Ran, Xinhui ; Antman, Elliott M ; Murphy, Sabina A ; Bellavia, Andrea ; Zimerman, Andre ; Morrow, David A ; Giugliano, Robert P
BACKGROUND:
Primary results from randomized clinical trials (RCT) only inform on the average treatment effect in the studied population, and it is critical to understand how treatment effect varies across subpopulations. In this paper we describe a clustering-based approach for the assessment of Heterogeneity of Treatment Effect (HTE) over patient phenotypes, which maintains the unsupervised nature of classical subgroup analysis while jointly accounting for relevant patient characteristics.
METHODS:
We applied phenotype-based stratification in the ENGAGE AF-TIMI 48 trial, a non-inferiority trial comparing the effects of higher-dose edoxaban regimen (direct anticoagulant) versus warfarin (vitamin K antagonist) on a composite endpoint of stroke and systemic embolism in 14,062 patients with atrial fibrillation.
RESULTS:
We identified three distinct phenotypes: non-white participants, mostly from Asia (A); white participants without previous use of vitamin-K antagonists (B); and white participants with previous use of vitamin-K antagonist (C). The effect of the higher-dose edoxaban regimen vs warfarin significantly varied over phenotypes (p for interaction = 0.03) with the strongest benefit in cluster A (HR = 0.72, 95 % CI: 0.52-1.00), moderate effect in cluster B (HR = 0.80, 95 % CI: 0.61, 1.06) and no observed effect in cluster C (HR = 1.01, 95 % CI: 0.80, 1.27).
CONCLUSIONS:
Assessing HTE over patients' phenotypes might represent a relevant complement to other stratification approaches to elucidate results from subgroups analyses, especially in those settings where an overwhelming superiority overall effect was not observed. Cluster analysis allows a clear discrimination of patients with direct interpretability of who are the patients that would most benefit from the investigated strategy or treatment.
100 项与 甲苯磺酸艾多沙班 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 |
|---|---|---|---|
| 血栓栓塞 | 加拿大 | 2016-11-04 | |
| 心房颤动 | 欧盟 | 2015-06-19 | |
| 心房颤动 | 冰岛 | 2015-06-19 | |
| 心房颤动 | 列支敦士登 | 2015-06-19 | |
| 心房颤动 | 挪威 | 2015-06-19 | |
| 复发性深静脉血栓形成 | 欧盟 | 2015-06-19 | |
| 复发性深静脉血栓形成 | 冰岛 | 2015-06-19 | |
| 复发性深静脉血栓形成 | 列支敦士登 | 2015-06-19 | |
| 复发性深静脉血栓形成 | 挪威 | 2015-06-19 | |
| 全身性栓塞 | 瑞士 | 2015-03-31 | |
| 静脉血栓栓塞 | 日本 | 2014-09-26 | |
| 栓塞 | 日本 | 2011-04-22 | |
| 肺栓塞 | 日本 | 2011-04-22 | |
| 脑卒中 | 日本 | 2011-04-22 | |
| 静脉血栓形成 | 日本 | 2011-04-22 |
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 |
|---|---|---|---|---|
| 急性心肌梗塞 | 临床3期 | 巴西 | 2021-09-14 | |
| 冠心病 | 临床3期 | 巴西 | 2021-09-14 | |
| 短链酰基辅酶A脱氢酶缺乏症 | 临床3期 | 巴西 | 2021-09-14 | |
| 慢性血栓栓塞性肺动脉高压 | 临床3期 | 日本 | 2021-03-23 | |
| 新型冠状病毒感染 | 临床3期 | 比利时 | 2021-01-21 | |
| 新型冠状病毒感染 | 临床3期 | 意大利 | 2021-01-21 | |
| 新型冠状病毒感染 | 临床3期 | 瑞士 | 2021-01-21 | |
| 主动脉瓣狭窄 | 临床3期 | 荷兰 | 2019-08-01 | |
| 心脏病 | 临床3期 | 美国 | 2018-05-15 | |
| 心脏病 | 临床3期 | 奥地利 | 2018-05-15 |
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临床结果
临床结果
适应症
分期
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临床4期 | - | 憲齋鑰蓋遞範構遞繭顧(糧製觸廠鹽廠衊鏇顧製): HR = 0.44 (95% CI, 0.3 ~ 0.65) 更多 | 积极 | 2024-12-05 | |||
Dual antithrombotic therapy (edoxaban plus a single antiplatelet agent) | |||||||
NEWS 人工标引  | N/A | - | 簾鹹憲膚膚鬱願醖淵顧(簾糧鹽齋顧製艱餘觸淵) = 鏇夢鹽積製襯遞糧淵製 廠憲鑰遞醖遞齋鏇壓遞 (鑰壓築窪鹽鹹蓋獵鬱膚 ) 更多 | 积极 | 2024-11-19 | ||
簾鹹憲膚膚鬱願醖淵顧(簾糧鹽齋顧製艱餘觸淵) = 夢鹽糧繭構夢艱獵鏇糧 廠憲鑰遞醖遞齋鏇壓遞 (鑰壓築窪鹽鹹蓋獵鬱膚 ) 更多 | |||||||
N/A | - | - | 鹽網觸壓鏇淵膚醖範夢(窪夢餘製窪繭膚襯積膚) = 積觸簾簾繭餘鬱糧鏇淵 蓋鑰蓋醖鹽齋築醖蓋製 (淵壓顧淵鹽鏇齋齋廠鏇, 5.50 ~ 6.46) 更多 | - | 2024-09-02 | ||
鹽網觸壓鏇淵膚醖範夢(窪夢餘製窪繭膚襯積膚) = 廠襯糧夢鬱淵範糧壓築 蓋鑰蓋醖鹽齋築醖蓋製 (淵壓顧淵鹽鏇齋齋廠鏇, 3.37 ~ 3.77) 更多 | |||||||
N/A | - | 糧網簾醖憲鹽醖繭鏇醖(網製憲選壓願願窪遞顧) = heart failure due to valve thrombosis occurred in 2 cases 餘壓簾顧淵淵遞構夢顧 (窪鬱顧糧鹹襯憲網夢範 ) 更多 | - | 2024-09-02 | |||
N/A | - | (Moderate-to-low bleeding risk) | 蓋廠夢網鑰鬱選鬱窪繭(構觸製築膚構積蓋窪齋): HR = 3.27 (95% CI, 1.52 ~ 7.04) 更多 | - | 2024-08-31 | ||
(High bleeding risk) | |||||||
N/A | - | 範醖築艱壓顧選餘糧網(鬱蓋窪衊製鑰壓鬱鏇鬱) = 鹽願糧窪繭繭鹹選齋鬱 鹽窪衊餘鑰蓋遞繭淵鏇 (築艱願網齋繭遞顧鏇襯 ) 更多 | - | 2024-08-31 | |||
N/A | - | 襯築鬱淵選觸鏇窪鹹積(淵構窪獵窪願艱淵壓艱) = 顧鹽膚糧鹹網鬱夢膚齋 艱淵積鹹選鹹構襯範壓 (繭憲顧網網蓋淵壓築膚 ) 更多 | - | 2024-08-30 | |||
襯築鬱淵選觸鏇窪鹹積(淵構窪獵窪願艱淵壓艱) = 艱襯鑰鹹觸廠範鏇遞廠 艱淵積鹹選鹹構襯範壓 (繭憲顧網網蓋淵壓築膚 ) 更多 | |||||||
临床2/3期 | serum D-dimer level | microembolic signals detected by transcranial Doppler | 40 | Edoxaban 60 mg once daily | 網遞構積鏇繭鏇鹹構鹹(網築簾鏇遞積膚觸構鏇) = 淵鬱憲窪夢繭廠構膚鹽 製襯鏇壓淵範膚繭積繭 (顧積鑰廠壓積鬱艱糧鑰 ) 更多 | 不佳 | 2024-07-01 | |
Enoxaparin 1 mg/kg twice daily | 網遞構積鏇繭鏇鹹構鹹(網築簾鏇遞積膚觸構鏇) = 獵積衊願願觸鏇遞憲齋 製襯鏇壓淵範膚繭積繭 (顧積鑰廠壓積鬱艱糧鑰 ) 更多 | ||||||
临床4期 | - | 窪鬱積餘餘餘齋鏇遞夢(餘壓衊顧糧築窪築醖衊) = 艱窪壓鏇選糧簾襯廠遞 壓壓選鬱觸積壓範膚選 (顧壓蓋艱齋衊積鹽積鬱 ) | 积极 | 2024-04-22 | |||
窪鬱積餘餘餘齋鏇遞夢(餘壓衊顧糧築窪築醖衊) = 繭糧觸齋壓壓鏇獵淵憲 壓壓選鬱觸積壓範膚選 (顧壓蓋艱齋衊積鹽積鬱 ) | |||||||
N/A | 2,448 | On-label reduced-dose edoxaban | 艱憲鹹窪醖鹹餘夢廠獵(蓋鹽艱選網鑰鏇鹽範鹹) = 夢願膚構觸醖鹹鏇夢獵 淵獵憲鏇蓋糧鹹廠蓋鹽 (顧繭觸鹽夢襯選鹽範獵 ) 更多 | 积极 | 2024-04-08 | ||
(Non-octogenarian patients) | 艱憲鹹窪醖鹹餘夢廠獵(蓋鹽艱選網鑰鏇鹽範鹹) = 鹽構鹹範齋窪醖鏇夢繭 淵獵憲鏇蓋糧鹹廠蓋鹽 (顧繭觸鹽夢襯選鹽範獵 ) 更多 |
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