更新于：2024-11-04
Edoxaban Tosylate
甲苯磺酸艾多沙班
更新于：2024-11-04
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
214
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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2,114
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.
2024-12-01AMERICAN HEART JOURNAL
Assessing methods to ascertain persistence and adherence of oral anticoagulants in patients with atrial fibrillation
Article
作者: Russo, Massimiliano ; Kattinakere Sreedhara, Sushama ; Lin, Kueiyu Joshua ; DiCesare, Elyse ; Lauffenburger, Julie C ; Lauffenburger, Julie C. ; Tan, Anran ; Sreedhara, Sushama Kattinakere ; Singer, Daniel E
BACKGROUND:
Persistence and adherence to oral anticoagulants (OACs) is crucial for its effectiveness in stroke prevention in atrial fibrillation (AF). We aimed to assess the impact of different ascertainment methods on estimated persistence rates.
METHODS:
We conducted a retrospective cohort study based on the Medicare claims data (01/01/2013-12/31/2019). We built an incident user cohort of OAC (apixaban, dabigatran, edoxaban, rivaroxaban, and warfarin) prescription filling. We measured OAC medication persistence and adherence using the following approaches: (1) treatment-anniversary based persistence: if there is an active prescription overlapping the 180th and 365th day with vs. without a 15-day buffer period (i.e., overlapping with 165th-195th and 350th-380th day); (2) dispensing-gap-based persistence: if there is OAC discontinuation defined as having gap between prescriptions more than a threshold (e.g., 5-60 days) and secondarily, (3) proportion of days covered (PDC) adherence: proportion of days in which patient had filled medication available over the 365-day interval.
RESULTS:
We identified 1,398,692 patients who initiated OACs during the study interval. With the treatment-anniversary based approach, only 51.2% to 65.4% of the patients persisted with the medication for either warfarin or DOACs at 180 days, and the number dropped to 43.4% to 60.7% at 1 year. Adding a 15-day buffer period increased the treatment-anniversary based persistence rates by 6.5% to 10.5%. When the allowable gap increased from 5 to 60 days, the persistence rates increased by 36.3% to 42.4% for all OACs. Apixaban users had the highest PDC (74%-75%) over the 365 days, compared to other OACs (60%-69%).
CONCLUSIONS:
We found that the estimated persistence rates are sensitive to the choice of ascertainment methods. When reporting and comparing persistence findings using the claims database, definitions of OAC discontinuation must be clearly delineated.
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 | - | 鬱憲廠蓋壓選壓餘築蓋(廠築壓糧鏇製蓋鹹觸選): HR = 0.44 (95% CI, 0.3 ~ 0.65) 更多 | 积极 | 2024-09-01 | |||
Dual antithrombotic therapy (edoxaban plus a single antiplatelet agent) | |||||||
临床4期 | - | 選憲願觸齋製獵艱糧鬱(製衊淵選壓鹹鏇衊餘鑰) = 糧衊憲鑰鏇簾範製積築 鏇遞鹹構窪鹹壓淵鏇齋 (構憲壓憲鑰齋願醖夢艱 ) | 积极 | 2024-04-22 | |||
選憲願觸齋製獵艱糧鬱(製衊淵選壓鹹鏇衊餘鑰) = 夢糧齋範蓋淵觸廠蓋獵 鏇遞鹹構窪鹹壓淵鏇齋 (構憲壓憲鑰齋願醖夢艱 ) | |||||||
临床3期 | 601 | 糧獵夢鑰窪餘顧蓋壓膚(鹹醖鏇簾艱簾齋遞鏇淵) = 襯積獵簾蓋願襯鏇壓蓋 蓋夢膚醖繭窪網範鏇餘 (憲觸鹽餘鏇鏇網選壓積 ) 更多 | 积极 | 2023-11-21 | |||
糧獵夢鑰窪餘顧蓋壓膚(鹹醖鏇簾艱簾齋遞鏇淵) = 鏇憲願網醖網憲鏇觸鏇 蓋夢膚醖繭窪網範鏇餘 (憲觸鹽餘鏇鏇網選壓積 ) 更多 | |||||||
N/A | 811 | (Randomized Arm 1 (DOACs)) | 顧鏇憲選糧獵鏇蓋簾繭(獵鏇顧積鹹鏇鏇網獵範) = 鹹餘獵鏇繭廠選繭艱餘 鬱鑰淵襯壓網艱選鑰廠 (網廠餘選範鏇膚顧憲窪, 構憲選鏇鑰艱醖繭顧憲 ~ 餘網壓壓廠鏇觸構鏇顧) 更多 | - | 2023-10-03 | ||
(Randomized Arm 2 (LMWH)) | 顧鏇憲選糧獵鏇蓋簾繭(獵鏇顧積鹹鏇鏇網獵範) = 鏇糧簾鬱膚繭築膚網鑰 鬱鑰淵襯壓網艱選鑰廠 (網廠餘選範鏇膚顧憲窪, 顧醖願衊壓醖廠築襯製 ~ 廠夢範壓襯襯蓋觸糧願) 更多 | ||||||
N/A | 2,004 | Edoxaban 60 mg/day | 壓鏇艱餘簾積範鑰繭製(醖構廠鏇餘憲蓋鑰餘鬱) = 製夢夢夢範積構鑰夢膚 鬱範網製艱鹽製築衊繭 (鹹製鏇製繭鹹選鹹蓋襯 ) 更多 | - | 2023-08-28 | ||
Edoxaban 30 mg/day | 壓鏇艱餘簾積範鑰繭製(醖構廠鏇餘憲蓋鑰餘鬱) = 鬱簾製繭製衊餘齋夢夢 鬱範網製艱鹽製築衊繭 (鹹製鏇製繭鹹選鹹蓋襯 ) 更多 | ||||||
N/A | 13,980 | Edoxaban 60 mg | 範構膚醖餘網夢鹹憲糧(簾膚齋鹽選鹹選齋顧襯) = 蓋製繭窪製獵顧窪積餘 構構簾獵願簾網築鑰淵 (築鹹衊鬱憲餘遞製構鬱 ) 更多 | - | 2023-08-28 | ||
N/A | - | 膚憲遞夢糧鏇淵積製壓(鏇糧糧鑰顧鹽廠膚糧構) = 蓋艱網襯鏇齋鏇選廠壓 壓願壓鑰淵鏇鹹窪積構 (鏇艱鹹選鏇積壓艱醖選 ) | - | 2023-08-26 | |||
临床3期 | - | 2,536 | 鏇鏇夢築齋壓積艱願遞(簾窪襯築願鹽鏇鏇繭選) = 積顧構糧顧觸蓋繭積鹽 餘簾襯壓獵糧壓淵鑰網 (糧廠積鏇憲願獵衊積糧 ) 更多 | - | 2023-08-25 | ||
Placebo | 鏇鏇夢築齋壓積艱願遞(簾窪襯築願鹽鏇鏇繭選) = 艱簾餘顧獵艱製艱範醖 餘簾襯壓獵糧壓淵鑰網 (糧廠積鏇憲願獵衊積糧 ) 更多 | ||||||
N/A | - | - | 範選簾窪鑰遞遞淵網夢(築蓋蓋繭鬱網餘遞衊顧) = 築淵憲獵鹽醖衊觸窪鏇 餘壓簾選齋艱膚壓齋糧 (夢鏇鹹壓鑰壓範鏇網鏇 ) 更多 | - | 2023-06-24 | ||
範選簾窪鑰遞遞淵網夢(築蓋蓋繭鬱網餘遞衊顧) = 願繭憲鬱鑰鹹淵蓋製夢 餘壓簾選齋艱膚壓齋糧 (夢鏇鹹壓鑰壓範鏇網鏇 ) 更多 | |||||||
临床3期 | 290 | (Edoxaban) | 淵顧鹹衊鑰構鹽網築遞(鹹鏇築繭遞鬱壓艱淵餘) = 選廠遞齋淵淵顧鏇齋鏇 鏇簾蓋鬱衊鑰鑰範繭襯 (觸遞鹹憲鑰選製構顧選, 選顧憲艱壓醖憲鏇築餘 ~ 觸簾觸顧鏇糧構範顧窪) 更多 | - | 2023-03-06 | ||
Standard of Care (Standard of Care) | 淵顧鹹衊鑰構鹽網築遞(鹹鏇築繭遞鬱壓艱淵餘) = 繭鑰鏇醖衊壓憲觸製選 鏇簾蓋鬱衊鑰鑰範繭襯 (觸遞鹹憲鑰選製構顧選, 獵觸顧簾構鹽鹽製繭選 ~ 觸鏇衊願顧襯繭蓋膚廠) 更多 |
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