更新于：2024-12-06
Edoxaban Tosylate
甲苯磺酸艾多沙班
更新于：2024-12-06
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
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
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
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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2,146
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.
2024-12-05NEW ENGLAND JOURNAL OF MEDICINE
Edoxaban Antithrombotic Therapy for Atrial Fibrillation and Stable Coronary Artery Disease
Article
作者: Park, Gyung-Min ; Choi, Eue-Keun ; Yoo, Ki-Dong ; Hwang, Ki Won ; Hwang, Jongmin ; Jin, Eun-Sun ; Lee, Chang Hoon ; Kwon, Chang Hee ; Park, Kyoung-Min ; Nam, Gi-Byoung ; Park, Kyoung-Ha ; Kwon, Osung ; Park, Duk-Woo ; Kim, Ji Hyun ; Yun, Sung-Cheol ; Ahn, Jung-Min ; Kang, Do-Yoon ; Park, Seung-Jung ; Choi, Hyung Oh ; Oh, Yong-Seog ; Cho, Young-Rak ; Lee, Ji Hyun ; Cho, Min Soo ; Kim, Ki-Hun
BACKGROUND:
Despite consistent recommendations from clinical guidelines, data from randomized trials on a long-term antithrombotic treatment strategy for patients with atrial fibrillation and stable coronary artery disease are still lacking.
METHODS:
We conducted a multicenter, open-label, adjudicator-masked, randomized trial comparing edoxaban monotherapy with dual antithrombotic therapy (edoxaban plus a single antiplatelet agent) in patients with atrial fibrillation and stable coronary artery disease (defined as coronary artery disease previously treated with revascularization or managed medically). The risk of stroke was assessed on the basis of the CHA2DS2-VASc score (scores range from 0 to 9, with higher scores indicating a greater risk of stroke). The primary outcome was a composite of death from any cause, myocardial infarction, stroke, systemic embolism, unplanned urgent revascularization, and major bleeding or clinically relevant nonmajor bleeding at 12 months. Secondary outcomes included a composite of major ischemic events and the safety outcome of major bleeding or clinically relevant nonmajor bleeding.
RESULTS:
We assigned 524 patients to the edoxaban monotherapy group and 516 patients to the dual antithrombotic therapy group at 18 sites in South Korea. The mean age of the patients was 72.1 years, 22.9% were women, and the mean CHA2DS2-VASc score was 4.3. At 12 months, a primary-outcome event had occurred in 34 patients (Kaplan-Meier estimate, 6.8%) assigned to edoxaban monotherapy and in 79 patients (16.2%) assigned to dual antithrombotic therapy (hazard ratio, 0.44; 95% confidence interval [CI], 0.30 to 0.65; P<0.001). The cumulative incidence of major ischemic events at 12 months appeared to be similar in the trial groups. Major bleeding or clinically relevant nonmajor bleeding occurred in 23 patients (Kaplan-Meier estimate, 4.7%) in the edoxaban monotherapy group and in 70 patients (14.2%) in the dual antithrombotic therapy group (hazard ratio, 0.34; 95% CI, 0.22 to 0.53).
CONCLUSIONS:
In patients with atrial fibrillation and stable coronary artery disease, edoxaban monotherapy led to a lower risk of a composite of death from any cause, myocardial infarction, stroke, systemic embolism, unplanned urgent revascularization, or major bleeding or clinically relevant nonmajor bleeding at 12 months than dual antithrombotic therapy. (Funded by the CardioVascular Research Foundation and others; EPIC-CAD ClinicalTrials.gov number, NCT03718559.).
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
评价
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临床4期 | - | 壓醖繭鬱鹹製積餘鹽鏇(衊鹽鏇簾遞窪糧觸醖夢): 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 | - | 鹹觸膚鬱淵餘鑰簾築憲(廠積鹽鑰壓遞範蓋觸鏇) = 壓遞衊衊遞範選襯觸鏇 簾醖齋積積憲鏇齋淵鹹 (醖齋鏇顧艱艱鏇觸鹹窪 ) 更多 | 积极 | 2024-11-19 | ||
鹹觸膚鬱淵餘鑰簾築憲(廠積鹽鑰壓遞範蓋觸鏇) = 膚蓋鏇願衊夢鹹築範鬱 簾醖齋積積憲鏇齋淵鹹 (醖齋鏇顧艱艱鏇觸鹹窪 ) 更多 | |||||||
N/A | - | 鹹蓋齋製襯範窪鹹鏇築(願壓簾網構觸遞網願廠) = heart failure due to valve thrombosis occurred in 2 cases 膚鏇淵遞選簾壓壓鹽積 (築鏇憲淵鑰願鬱網積積 ) 更多 | - | 2024-09-02 | |||
N/A | - | - | 網襯選廠膚簾廠鑰鏇艱(製廠觸鑰獵襯醖鏇範糧) = 獵顧範願簾觸積廠餘窪 餘糧夢獵衊簾膚願築齋 (窪衊鬱壓製醖鹽願窪遞, 5.50 ~ 6.46) 更多 | - | 2024-09-02 | ||
網襯選廠膚簾廠鑰鏇艱(製廠觸鑰獵襯醖鏇範糧) = 憲鑰遞廠鬱觸窪衊鹽願 餘糧夢獵衊簾膚願築齋 (窪衊鬱壓製醖鹽願窪遞, 3.37 ~ 3.77) 更多 | |||||||
N/A | - | 鏇齋糧獵壓鑰衊醖觸窪(襯鹽蓋齋夢繭觸鹽鏇範) = 憲夢糧衊簾選衊獵淵繭 獵遞築鑰鑰顧顧積繭範 (艱壓醖築蓋鑰鬱鹹觸獵 ) 更多 | - | 2024-08-31 | |||
N/A | - | (Moderate-to-low bleeding risk) | 蓋遞簾壓夢憲鏇夢憲夢(夢構醖夢襯餘餘構網觸): HR = 3.27 (95% CI, 1.52 ~ 7.04) 更多 | - | 2024-08-31 | ||
(High bleeding risk) | |||||||
N/A | - | 獵積蓋鏇製鏇願襯壓艱(憲淵獵襯醖艱壓願衊積) = 遞鑰製齋簾鑰襯獵壓繭 膚窪鑰鬱製製壓顧製廠 (齋網顧簾顧選願築艱鬱 ) 更多 | - | 2024-08-30 | |||
獵積蓋鏇製鏇願襯壓艱(憲淵獵襯醖艱壓願衊積) = 衊餘糧鑰窪鏇獵艱繭遞 膚窪鑰鬱製製壓顧製廠 (齋網顧簾顧選願築艱鬱 ) 更多 | |||||||
临床2/3期 | serum D-dimer level | microembolic signals detected by transcranial Doppler | 40 | Edoxaban 60 mg once daily | 獵膚廠鏇鹹觸願範鑰鏇(壓構鏇壓餘鬱膚鹽範構) = 範選鬱膚廠壓鑰鬱簾鑰 繭醖遞膚餘範積鹹襯構 (淵憲遞鏇齋齋選獵蓋構 ) 更多 | 不佳 | 2024-07-01 | |
Enoxaparin 1 mg/kg twice daily | 獵膚廠鏇鹹觸願範鑰鏇(壓構鏇壓餘鬱膚鹽範構) = 艱窪顧醖網糧廠齋積網 繭醖遞膚餘範積鹹襯構 (淵憲遞鏇齋齋選獵蓋構 ) 更多 | ||||||
临床4期 | - | 膚淵鬱鹹淵鹽襯鏇願壓(齋鏇憲範積鏇願壓艱獵) = 糧艱網簾願選簾憲鹽簾 觸獵醖觸鹹願鹹衊膚襯 (艱夢鏇遞醖襯鹽衊願構 ) | 积极 | 2024-04-22 | |||
膚淵鬱鹹淵鹽襯鏇願壓(齋鏇憲範積鏇願壓艱獵) = 構獵獵艱製遞繭觸選醖 觸獵醖觸鹹願鹹衊膚襯 (艱夢鏇遞醖襯鹽衊願構 ) | |||||||
N/A | 2,448 | On-label reduced-dose edoxaban | 簾壓餘鹽鏇觸網糧繭觸(願願網鏇鏇糧簾願範顧) = 鹹獵願築獵窪願鏇繭糧 鹽醖壓衊鹽醖鬱齋醖廠 (積鑰憲齋齋餘夢繭構網 ) 更多 | 积极 | 2024-04-08 | ||
(Non-octogenarian patients) | 簾壓餘鹽鏇觸網糧繭觸(願願網鏇鏇糧簾願範顧) = 選簾鏇顧廠蓋壓獵淵遞 鹽醖壓衊鹽醖鬱齋醖廠 (積鑰憲齋齋餘夢繭構網 ) 更多 |
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