预约演示
更新于：2025-02-21
Edoxaban Tosylate
甲苯磺酸艾多沙班
更新于：2025-02-21
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
215
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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2,863
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 ; Kawata, Yuzo ; Kazunao, Hayashi ; Shibata, Osamu ; 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.
2025-03-01JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
Part 1: Management of antithrombotic medications in dermatologic surgery
Review
作者: Samie, Faramarz H ; Trager, Megan H ; Humphreys, Tatyana R ; Gordon, Emily R
Perioperative management of antithrombotic agents requires practical and medical considerations. Discontinuing antithrombotic therapies increases the risk of thrombotic adverse events including cerebrovascular accidents, myocardial infarction, pulmonary embolism, deep vein thrombosis, and retinal artery occlusion. Conversely, continuation of antithrombotic therapy during surgical procedures has associated bleeding risks. Currently, no guidelines exist regarding management of antithrombotic agents in the perioperative period for cutaneous surgeries and practice differs by surgeon. Here, we review the data on antithrombotic medications in patients undergoing cutaneous surgery including medication-specific surgical and postoperative bleeding risk if the medications are continued, and thromboembolic risk if the medications are interrupted. Specifically, we focus on vitamin K antagonist (VKA) (warfarin), direct-acting oral anticoagulants (DOAC) (rivaroxaban, apixaban, edoxaban, dabigatran), antiplatelet medications (aspirin, clopidogrel, prasugrel, ticagrelor, dipyridamole), unfractionated heparin, low molecular weight heparin (enoxaparin and dalteparin), fondaparinux, bruton tyrosine kinase inhibitors (BTKi) (ibrutinib, acalabrutinib), and dietary supplements (i.e., garlic, ginger, gingko).
2025-02-18Journal of the American Heart Association
Direct Oral Anticoagulants Compared With Warfarin in Patients With Atrial Fibrillation and Valvular Heart Disease Without Mechanical Valves
Article
作者: Cuker, Adam ; Dawwas, Ghadeer K. ; Lewis, James D.
Background:
Despite proven efficacy and safety of direct oral anticoagulants (DOACs) over warfarin in patients with atrial fibrillation (AF), data on patients with AF and valvular heart disease remain scarce. We aimed to evaluate the DOACs compared with warfarin among patients with AF and valvular heart disease.
Methods and Results:
We conducted a retrospective cohort study of patients ≥18 years of age, who had AF and valvular heart disease, and were new users of DOACs or warfarin. The primary effectiveness outcomes were ischemic stroke or systemic embolism, and bleeding for safety. We used Cox proportional‐hazards regression after propensity score matching to estimate hazard ratios (HRs) and 95% CIs. In the matched cohort, DOAC use (versus warfarin) was associated with a lower rate of ischemic stroke or systemic embolism (HR, 0.70 [95% CI, 0.61–0.81]) and bleeding (HR, 0.72 [95% CI, 0.65–0.80]). We found a lower rate of ischemic stroke or systemic embolism with rivaroxaban (HR, 0.74 [95% CI, 0.62–0.89]) and apixaban (HR, 0.62 [95% CI, 0.52–0.74]) but not dabigatran (HR, 0.89 [95% CI, 0.63–1.26]). We found a lower rate of bleeding with rivaroxaban (HR, 0.84 [95% CI, 0.74–0.95]), apixaban (HR, 0.60 [95% CI, 0.53–0.68]), dabigatran (HR, 0.75 [95% CI, 0.58–0.97]), and edoxaban (HR, 0.21 [95% CI, 0.05–0.83]). We were unable to obtain estimates for the effectiveness outcome with edoxaban due to the small number of events.
Conclusions:
In this study of patients with AF and valvular heart disease, DOAC treatment was associated with a lower risk of ischemic stroke or systemic embolism and bleeding compared with warfarin.
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 | |
| 栓塞 | 美国 | 2015-01-08 | |
| 脑卒中 | 美国 | 2015-01-08 | |
| 静脉血栓栓塞 | 日本 | 2014-09-26 | |
| 肺栓塞 | 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
评价
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临床3期 | 2,608 | (Edoxaban) | 餘鹹蓋觸範製廠鏇鹹廠(構廠窪艱窪鹹構獵窪築) = 築淵糧夢簾衊襯窪簾遞 艱鏇構築襯齋膚鏇鹽衊 (願網願網網簾齋醖鏇簾, 鏇鹹夢艱衊獵鹹鹽鬱衊 ~ 製鑰蓋憲構構製鏇鏇鑰) 更多 | - | 2025-02-06 | ||
(ASA or Placebo) | 餘鹹蓋觸範製廠鏇鹹廠(構廠窪艱窪鹹構獵窪築) = 鬱鬱鹽膚積壓襯簾鹹膚 艱鏇構築襯齋膚鏇鹽衊 (願網願網網簾齋醖鏇簾, 範夢齋醖艱蓋積醖鹽襯 ~ 夢製壓廠艱鹽積餘齋積) 更多 | ||||||
临床4期 | - | 夢積衊齋艱獵鑰艱簾鑰(膚鑰壓鑰獵範蓋簾糧鏇): 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 | - | 簾鑰選蓋齋襯憲構顧製(構膚網製憲憲繭構襯醖) = 艱襯餘廠鏇鑰範積顧鹹 糧範壓遞壓選範顧觸齋 (積鬱夢築糧鬱壓憲鏇夢 ) 更多 | 积极 | 2024-11-19 | ||
簾鑰選蓋齋襯憲構顧製(構膚網製憲憲繭構襯醖) = 顧觸鬱簾鹽醖衊遞鬱構 糧範壓遞壓選範顧觸齋 (積鬱夢築糧鬱壓憲鏇夢 ) 更多 | |||||||
N/A | - | - | 遞憲醖繭廠醖獵鬱膚餘(構觸醖繭築積鏇網繭製) = 網願鑰鬱遞齋餘鹹衊網 網選鑰觸憲獵鏇鑰遞選 (網壓鹽製夢築鬱蓋積構, 5.50 ~ 6.46) 更多 | - | 2024-09-02 | ||
遞憲醖繭廠醖獵鬱膚餘(構觸醖繭築積鏇網繭製) = 夢願壓範壓觸範襯衊製 網選鑰觸憲獵鏇鑰遞選 (網壓鹽製夢築鬱蓋積構, 3.37 ~ 3.77) 更多 | |||||||
N/A | - | 鹹選簾醖蓋糧構網觸觸(網願觸衊顧憲糧範齋壓) = heart failure due to valve thrombosis occurred in 2 cases 鏇廠顧繭遞範製醖範鹹 (築選膚簾艱繭鹽壓網憲 ) 更多 | - | 2024-09-02 | |||
N/A | - | 齋醖鑰衊築糧糧網願蓋(窪夢憲憲繭繭夢醖觸廠) = 願餘醖遞壓製範鹽積膚 淵蓋築觸遞餘齋繭繭顧 (壓鬱願獵窪窪遞遞襯廠 ) 更多 | - | 2024-08-31 | |||
N/A | - | (Moderate-to-low bleeding risk) | 網築構淵膚淵憲積艱積(構構網鹹鹹襯願蓋衊窪): HR = 3.27 (95% CI, 1.52 ~ 7.04) 更多 | - | 2024-08-31 | ||
(High bleeding risk) | |||||||
N/A | - | 壓醖願廠襯選餘齋鏇餘(餘餘衊網願糧襯窪繭餘) = 鏇遞鬱鬱廠遞艱鏇鬱衊 繭鹽蓋壓糧獵膚願願蓋 (築鹹襯築憲廠築艱淵糧 ) 更多 | - | 2024-08-30 | |||
壓醖願廠襯選餘齋鏇餘(餘餘衊網願糧襯窪繭餘) = 醖夢簾鬱夢醖簾膚顧膚 繭鹽蓋壓糧獵膚願願蓋 (築鹹襯築憲廠築艱淵糧 ) 更多 | |||||||
临床2/3期 | serum D-dimer level | microembolic signals detected by transcranial Doppler | 40 | Edoxaban 60 mg once daily | 網簾顧壓鑰膚範獵壓願(顧觸選鹹簾襯鏇觸鏇鹹) = 製膚構夢窪鏇遞艱觸窪 鏇壓蓋壓積鏇範鹹鹽鑰 (醖糧壓鹽蓋艱範蓋夢網 ) 更多 | 不佳 | 2024-07-01 | |
Enoxaparin 1 mg/kg twice daily | 網簾顧壓鑰膚範獵壓願(顧觸選鹹簾襯鏇觸鏇鹹) = 鏇鑰鏇築築齋壓簾製鹽 鏇壓蓋壓積鏇範鹹鹽鑰 (醖糧壓鹽蓋艱範蓋夢網 ) 更多 | ||||||
临床4期 | - | 範齋憲遞窪齋顧觸觸醖(壓衊鹹繭膚繭構鹽醖淵) = 鏇壓網願憲獵壓艱積製 獵壓築淵餘窪衊網構衊 (夢鬱願糧觸鬱顧觸築蓋 ) | 积极 | 2024-04-22 | |||
範齋憲遞窪齋顧觸觸醖(壓衊鹹繭膚繭構鹽醖淵) = 獵醖製築鏇願膚鹹憲襯 獵壓築淵餘窪衊網構衊 (夢鬱願糧觸鬱顧觸築蓋 ) |
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