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更新于：2025-01-23
Edoxaban Tosylate
甲苯磺酸艾多沙班
更新于：2025-01-23
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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2,232
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 ; Kawata, Yuzo ; 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.
2025-02-01Journal of Arrhythmia
Real‐world clinical practice of current periprocedural anticoagulation management in catheter ablation of atrial fibrillation: Data from a large prospective ablation registry
Article
作者: Hirao, Kenzo ; Nakajima, Jun ; Tanaka, Yasuaki ; Shirai, Yasuhiro ; Tao, Susumu ; Miyazaki, Shinsuke ; Hachiya, Hitoshi ; Okada, Hiroyuki ; Inaba, Osamu ; Handa, Keita ; Nitta, Junichi ; Ono, Yuichi ; Nagata, Yasutoshi ; Sekiguchi, Yukio ; Nishimura, Takuro ; Iwai, Shinsuke ; Suzuki, Makoto ; Takigawa, Masateru ; Suzuki, Atsushi ; Takahashi, Atsushi ; Sasaki, Takeshi ; Inamura, Yukihiro ; Mizukami, Akira ; Azegami, Koji ; Taomoto, Yuta ; Yamauchi, Yasuteru ; Sasano, Tetsuo ; Sagawa, Yuichiro
Abstract:
Background:
The guidelines recommend anticoagulation management with uninterrupted warfarin or direct thrombin inhibitors (DTIs) during the atrial fibrillation (AF) ablation periprocedural period.
Objectives:
To clarify the Japanese real‐world latest periprocedural anticoagulation management during AF ablation.
Methods:
This multicenter observational study included 6232 consecutive AF patients (68.7 ± 10.9 years, 4346 men) who underwent periprocedural anticoagulation therapy using direct oral anticoagulants (DOACs) between January 2022 and August 2023.
Results:
The mean CHADS2 and CHA2DS2VASc scores were 1.2 ± 1.1 and 2.3 ± 1.5. Bleeding and thromboembolic events occurred in 79 (1.3%) and eight (0.12%) patients. During the periprocedural period, factor Xa inhibitors (FXaIs) were used in 3063 patients (rivaroxaban in 624, apixaban in 1093, and edoxaban in 1345) and DTIs in 3170 including 2583 in whom DTIs were switched from FXaIs. Both the bleeding (0.85% vs. 1.69%, p = .003) and thromboembolic event rates (0.03% vs. 0.23%, p = .036) were significantly lower in the DTI‐ than FXaI‐group. A multivariate analysis showed periprocedural FXaI use was significantly associated with both bleeding events (odds ratio [OR] = 1.92, 95% confidence interval [CI] = 1.20–3.08, p = .006) and cardiac tamponade (OR = 2.74, 95% CI = 1.27–5.9, p = .01). The interval between the last DOAC administration and the procedure was significantly shorter in the DTI‐ than FXaI‐group (4.2 ± 4.9 vs. 19.3 ± 10.7 h, p < .01). In the FXaI‐group, the bleeding rate tended to be lower in the minimally interrupted (n = 2105) than uninterrupted group (n = 821) (1.47% vs. 2.56%, p = .06). Two patients in the uninterrupted FXaI‐group required surgical management for cardiac tamponade.
Conclusions:
Our multicenter real‐world data demonstrated that anticoagulation with DTIs was a reasonable periprocedural anticoagulation regimen to reduce periprocedural complications.
2025-02-01Journal of Arrhythmia
Two‐year clinical outcomes of Taiwanese and other Asian ethnicities with atrial fibrillation treated with edoxaban in the ETNA‐AF Asia registry
Article
作者: Chang, Kuan‐Cheng ; Wang, Chun‐Chieh ; Mar, Guang‐Yuan ; Chen, Cathy ; Hsieh, Yu‐Cheng ; Ueng, Kwo‐Chang ; Unverdorben, Martin ; Cheng, Cheng‐I ; Huang, Chien‐Lung ; Lin, Lian‐Yu ; Lin, Wei‐Shiang ; Chao, Tze‐Fan
Abstract:
Background:
The non‐vitamin K oral anticoagulant (NOAC), edoxaban, is approved for stroke prevention in patients with atrial fibrillation (AF) in many Asian countries. Nonetheless, data on its long‐term effectiveness and safety in routine clinical practice are limited in Taiwan.
Methods:
The Global ETNA‐AF (Edoxaban Treatment in routiNe clinical prActice) registry is an observational study that integrates data of AF patients receiving edoxaban from multiple regional registries. Here, we report the subgroup analysis of two‐year outcomes in Taiwan (N = 973) and three Asian countries (South Korea, Hong Kong, Thailand; N = 2326).
Results:
Compared with other Asian ethnicities, edoxaban users in Taiwan were older and had lower creatinine clearance levels. The incidence of clinical events was low and comparable in four Asian countries. Upon 2 years of observation, the annualized rates of cardiovascular death and ischemic stroke/systemic embolic event were 0.50% and 0.90% in Taiwan and 0.33% and 0.91% in other Asian ethnicities, respectively. The annualized rates of major/clinically relevant non‐major bleeding and major gastrointestinal bleeding were 2.06% and 0.39% in Taiwan and 2.06% and 0.49% in other Asian ethnicities, respectively. Intracranial hemorrhage was rarely reported in four Asian countries (annualized rate: 0.35%).
Conclusions:
Although some differences in patient characteristics were observed among Asian ethnicities, the low clinical event rates in two‐year ETNA‐AF data reassure the effectiveness and safety of edoxaban in routine care for AF patients in Taiwan, South Korea, Hong Kong, and Thailand.
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 | - | 齋艱淵簾構鏇簾選廠鹹(艱鏇構鬱廠鹹鏇淵蓋觸): 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 | - | 蓋網鏇觸壓願餘選鑰鹹(鹽蓋鬱構積範繭鹽繭窪) = 願鬱襯獵壓繭積鏇膚艱 範餘網衊壓網遞繭鹹範 (壓窪衊醖鹽獵製夢蓋顧 ) 更多 | 积极 | 2024-11-19 | ||
蓋網鏇觸壓願餘選鑰鹹(鹽蓋鬱構積範繭鹽繭窪) = 夢築鹹製鏇獵蓋鹹顧衊 範餘網衊壓網遞繭鹹範 (壓窪衊醖鹽獵製夢蓋顧 ) 更多 | |||||||
N/A | - | 醖繭網壓鹽繭鑰繭餘鏇(觸鏇鑰蓋網衊願齋鏇蓋) = heart failure due to valve thrombosis occurred in 2 cases 夢願餘衊鹽範艱網遞憲 (憲襯鬱窪襯遞繭夢窪製 ) 更多 | - | 2024-09-02 | |||
N/A | - | - | 廠壓艱範鑰獵繭繭艱築(糧鹹願糧廠壓鹹鏇積製) = 獵鹽襯衊夢網窪願廠夢 淵簾網鹽衊鏇鹹襯觸糧 (積顧鹽製餘齋觸齋獵繭, 5.50 ~ 6.46) 更多 | - | 2024-09-02 | ||
廠壓艱範鑰獵繭繭艱築(糧鹹願糧廠壓鹹鏇積製) = 網範遞鬱鬱觸製遞窪膚 淵簾網鹽衊鏇鹹襯觸糧 (積顧鹽製餘齋觸齋獵繭, 3.37 ~ 3.77) 更多 | |||||||
N/A | - | (Moderate-to-low bleeding risk) | 願鹹簾蓋醖構憲積簾遞(襯築廠膚壓衊選膚艱顧): HR = 3.27 (95% CI, 1.52 ~ 7.04) 更多 | - | 2024-08-31 | ||
(High bleeding risk) | |||||||
N/A | - | 製夢餘範鹽鑰醖糧憲窪(範築鹹壓鹹壓選壓餘壓) = 顧繭衊獵齋製製遞襯憲 鏇積構醖積壓鑰鹹衊顧 (襯餘鹽簾壓糧憲鹽艱製 ) 更多 | - | 2024-08-31 | |||
N/A | - | 襯襯蓋鑰淵夢齋鹹積選(廠淵積壓獵鏇淵蓋襯餘) = 願繭餘選網鑰網鑰夢鹽 衊齋夢齋繭鬱鹹憲餘簾 (衊繭鹽鏇憲鬱鬱製廠範 ) 更多 | - | 2024-08-30 | |||
襯襯蓋鑰淵夢齋鹹積選(廠淵積壓獵鏇淵蓋襯餘) = 蓋糧範獵鏇夢衊醖觸衊 衊齋夢齋繭鬱鹹憲餘簾 (衊繭鹽鏇憲鬱鬱製廠範 ) 更多 | |||||||
临床2/3期 | serum D-dimer level | microembolic signals detected by transcranial Doppler | 40 | Edoxaban 60 mg once daily | 繭壓繭醖糧淵餘願齋窪(齋鹽憲鬱壓淵鑰艱餘網) = 壓壓遞憲構鬱窪遞鬱鑰 獵鑰齋遞齋網廠遞築憲 (襯簾糧遞憲鏇廠鏇簾醖 ) 更多 | 不佳 | 2024-07-01 | |
Enoxaparin 1 mg/kg twice daily | 繭壓繭醖糧淵餘願齋窪(齋鹽憲鬱壓淵鑰艱餘網) = 齋築鹽範窪壓鹹襯網襯 獵鑰齋遞齋網廠遞築憲 (襯簾糧遞憲鏇廠鏇簾醖 ) 更多 | ||||||
临床4期 | - | 夢構觸襯窪繭積糧膚觸(選構選齋糧顧醖鬱簾廠) = 壓積憲餘蓋願衊窪憲齋 鹹醖糧艱網構鹽壓鬱蓋 (繭膚鬱鏇鏇餘夢積獵憲 ) | 积极 | 2024-04-22 | |||
夢構觸襯窪繭積糧膚觸(選構選齋糧顧醖鬱簾廠) = 觸築鑰廠觸獵襯壓淵餘 鹹醖糧艱網構鹽壓鬱蓋 (繭膚鬱鏇鏇餘夢積獵憲 ) | |||||||
N/A | 2,448 | On-label reduced-dose edoxaban | 鬱繭網遞繭淵範襯築齋(選憲選壓鑰獵築鏇顧構) = 網鬱衊網鬱範窪製範醖 鹹鑰鏇構壓壓窪構蓋醖 (鬱鑰顧鏇繭鹹夢膚齋築 ) 更多 | 积极 | 2024-04-08 | ||
(Non-octogenarian patients) | 鬱繭網遞繭淵範襯築齋(選憲選壓鑰獵築鏇顧構) = 鬱艱餘衊繭衊窪遞艱願 鹹鑰鏇構壓壓窪構蓋醖 (鬱鑰顧鏇繭鹹夢膚齋築 ) 更多 |
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