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更新于：2025-01-24
Dabigatran Etexilate Mesylate
甲磺酸达比加群酯
更新于：2025-01-24
概要
基本信息
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C35H45N7O8S |
InChIKeyXETBXHPXHHOLOE-UHFFFAOYSA-N |
CAS号872728-81-9 |
关联
330
项与 甲磺酸达比加群酯 相关的临床试验NCT06791187
The Effect of a Single Dose of BI 1291583 on the Pharmacokinetics of a Single Dose of Dabigatran Following Oral Administration in Healthy Adult Male Subjects (an Open-label, 2- Period, Fixed-sequence Study)
NCT06650501
Dabigatran for the Adjunctive Treatment of Staphylococcus Aureus Bacteremia: the DABI-SNAP Nested Randomized Controlled Trial
TCTR20240916009
A Bioequivalence study of a randomized, open-label, single dose, fully replicated crossover design with four-period, two-treatment, and two-sequence of Dabigatran Etexilate capsules 150 mg relative to PRADAXA 150 MG in healthy Thai volunteers under fasting condition.
100 项与 甲磺酸达比加群酯 相关的临床结果
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100 项与 甲磺酸达比加群酯 相关的转化医学
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100 项与 甲磺酸达比加群酯 相关的专利（医药）
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6,185
项与 甲磺酸达比加群酯 相关的文献（医药）2025-03-01THROMBOSIS RESEARCH
Disparities in menstrual bleeding management during acute venous thromboembolism treatment: A review of UK practice and a call for clinical studies
Article
作者: Rose, Lucy ; Lowe, Gillian ; Buka, Richard J ; Jacob, Nkemdirim ; Nicolson, Phillip L R ; Nandra, Taran ; Alhamdi, Yasir ; Hassan, Eman ; Sutton, David
BACKGROUND:
Heavy menstrual bleeding (HMB) is a significant clinical burden for premenopausal individuals treated with anticoagulation for acute venous thromboembolism (VTE). Despite its prevalence, HMB management remains poorly studied, with wide variation in clinical practice.
OBJECTIVES:
The current study aimed to explore current UK practices in managing HMB in anticoagulated individuals and identify areas requiring clinical research to address disparities.
METHODS:
A national survey was conducted among haematology consultants and consultant clinical pharmacists managing anticoagulated patients. The survey focused on management strategies, including anticoagulant selection, use of tranexamic acid (TXA), contraceptive options, and anticoagulation interruption.
RESULTS AND CONCLUSION:
Responses were collected from 102 participants, across the UK. Apixaban was the preferred anticoagulant for patients with HMB, followed by LMWH then dabigatran. Timing of TXA initiation varied widely between respondents, with (35.3 %) prescribing it any time after anticoagulation initiation, (11.8 %) delaying TXA use for 3 months, and (7.8 %) would not give it at all. (47.1 %) of respondents advise to discontinue oestrogen containing contraceptives in patients with acute VTE. Almost all respondents never or rarely stop anticoagulation for a patient with HMB and recent VTE ≤4 weeks. (62.7 %) of respondents showed their willingness to participate in clinical studies to study TXA use in the setting of acute VTE ≤4 weeks in anticoagulated individuals. This study highlights significant variations in HMB management during anticoagulation for acute VTE. Disparities raise concerns about health inequities and underscore the urgent need for prospective clinical trials to improve patient outcomes.
2025-02-01IJC Heart & Vasculature
Direct oral anticoagulants in deep vein thrombosis associated with inferior vena cava agenesis: A report of three cases and a systematic review
Review
作者: Osti, Nicola ; Martinelli, Nicola ; Susca, Nicola ; Racanelli, Vito ; Maino, Alberto
Background:
Inferior vena cava agenesis (IVCA) is a rare vascular abnormality characterised by the absence of one or more segments of the inferior vena cava and represents an underestimated cause of deep vein thrombosis (DVT). Given the very low prevalence of this condition and the lack of clinical trials, there is no consensus about the optimal anticoagulation strategy in IVCA-associated DVT.
Objectives:
To investigate efficacy and safety of direct oral anticoagulants (DOACs) in IVCA-associated DVT.
Methods:
We described three patients with IVCA-associated DVT followed at our Institution and treated with DOACs. Then, we performed a systematic review of the literature for ICVA-associated DVT treated with DOACs.
Results:
In addition to our 3 cases, we found data from 19 publications for a total of 30 patients with IVCA-associated DVT treated with DOACs (24 subjects treated with rivaroxaban, 8 with apixaban, and one with dabigatran). Most patients were males (72.7 %) with a median age at DVT onset of 26.0 years (min-max range 13-64 years). The majority of DVT events were unprovoked (76.0 %). The standard thrombophilia tests were mainly negative. The median follow-up period during DOAC therapy was 1.0 years (min-max range 0-10 years), with one recurrent splanchnic vein thrombosis reported and no haemorrhagic events.
Conclusions:
IVCA is a rare cause of DVT, which should be suspected in young adults with unprovoked DVT. Although future studies are needed, available data may support the use of DOACs in IVCA-associated DVT, with a reassuring profile of both efficacy and safety.
2025-02-01CURRENT OPINION IN NEUROLOGY
Update on management of cerebral venous thrombosis
Article
作者: Rosa, Sara ; Aguiar de Sousa, Diana ; Fragata, Isabel
Purpose of review:
This review intends to systematize the diagnostic and treatment approach to cerebral venous thrombosis (CVT), highlighting key studies that have been recently published.
Recent findings:
In light of the recent pandemic, new risk factors for CVT have emerged. Contrast-enhanced MRI and susceptibility-weighted imaging have been shown to offer increased sensitivity for detecting cortical vein thrombosis.Dabigatran seems to be as effective and well tolerated as warfarin for long-term anticoagulation. Partial venous recanalization often occurs in patients treated with anticoagulation only, as early as 8 days after treatment onset. For patients with CVT and impending brain herniation, two-thirds of those who undergo decompressive craniectomy survive, with one-third being functionally independent 6 months after diagnosis.
Summary:
CVT is an unusual type of cerebrovascular disease that mostly affects women of fertile age. Risk factors should be identified and addressed. Diagnosis relies on confirmation of venous sinus and/or vein thrombosis, usually by CT venography or MRI. Anticoagulation is the cornerstone of treatment. Despite the lack of high-quality evidence, endovascular treatment is often considered in severe cases. Special populations require tailored approaches. About 80% achieve mRS 0-1, but residual symptoms often affect quality of life and the ability to return to work.
100 项与 甲磺酸达比加群酯 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 |
|---|---|---|---|
| 复发性深静脉血栓形成 | 欧盟 | 2024-02-19 | |
| 复发性深静脉血栓形成 | 冰岛 | 2024-02-19 | |
| 复发性深静脉血栓形成 | 列支敦士登 | 2024-02-19 | |
| 复发性深静脉血栓形成 | 挪威 | 2024-02-19 | |
| 全身性栓塞 | 澳大利亚 | 2008-11-24 | |
| 心房颤动 | 欧盟 | 2008-03-17 | |
| 心房颤动 | 冰岛 | 2008-03-17 | |
| 心房颤动 | 列支敦士登 | 2008-03-17 | |
| 心房颤动 | 挪威 | 2008-03-17 | |
| 栓塞 | 欧盟 | 2008-03-17 | |
| 栓塞 | 冰岛 | 2008-03-17 | |
| 栓塞 | 列支敦士登 | 2008-03-17 | |
| 栓塞 | 挪威 | 2008-03-17 | |
| 肺栓塞 | 欧盟 | 2008-03-17 | |
| 肺栓塞 | 冰岛 | 2008-03-17 | |
| 肺栓塞 | 列支敦士登 | 2008-03-17 | |
| 肺栓塞 | 挪威 | 2008-03-17 | |
| 脑卒中 | 欧盟 | 2008-03-17 | |
| 脑卒中 | 冰岛 | 2008-03-17 | |
| 脑卒中 | 列支敦士登 | 2008-03-17 |
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 |
|---|---|---|---|---|
| 脑静脉血栓形成 | 临床3期 | 法国 | 2016-12-13 | |
| 脑静脉血栓形成 | 临床3期 | 德国 | 2016-12-13 | |
| 脑静脉血栓形成 | 临床3期 | 印度 | 2016-12-13 | |
| 脑静脉血栓形成 | 临床3期 | 意大利 | 2016-12-13 | |
| 脑静脉血栓形成 | 临床3期 | 荷兰 | 2016-12-13 | |
| 脑静脉血栓形成 | 临床3期 | 波兰 | 2016-12-13 | |
| 脑静脉血栓形成 | 临床3期 | 葡萄牙 | 2016-12-13 | |
| 脑静脉血栓形成 | 临床3期 | 俄罗斯 | 2016-12-13 | |
| 脑静脉血栓形成 | 临床3期 | 西班牙 | 2016-12-13 | |
| 栓塞性中风 | 临床3期 | 美国 | 2014-11-27 |
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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1期 | 16 | DE (Period 1: DE 150 mg) | 積夢膚願遞遞蓋淵艱網(鏇選壓醖製範憲憲願範) = 構築鑰範醖繭艱構選齋 簾鏇鹽齋鏇鏇憲築淵齋 (壓膚蓋網願餘網選遞選, 簾觸觸繭範繭艱壓願顧 ~ 壓齋窪顧遞憲鹽鹹夢齋) 更多 | - | 2024-11-15 | ||
DE+PF-07081532 (Period 4: DE 150 mg + PF-07081532 80 mg QD) | 積夢膚願遞遞蓋淵艱網(鏇選壓醖製範憲憲願範) = 獵鬱網觸夢鑰壓壓積糧 簾鏇鹽齋鏇鏇憲築淵齋 (壓膚蓋網願餘網選遞選, 範觸憲襯壓鑰鏇簾構壓 ~ 廠醖鹽鏇醖選鹹獵膚鏇) 更多 | ||||||
临床1期 | - | 28 | (Rosuvastatin (Part 1, Reference 1)) | 簾鬱積窪艱憲選選壓構(壓夢顧範構範範顧窪醖) = 鹽齋獵齋艱鬱窪夢範齋 糧窪鏇蓋艱齋膚選鹹壓 (夢醖範願網鹽蓋壓廠鑰, 觸簾選獵淵鹹憲襯範糧 ~ 觸範窪積鹽獵網鹹範簾) 更多 | - | 2024-02-23 | |
(Rosuvastatin + BI 1323495 (Part 1, Test 1)) | 簾鬱積窪艱憲選選壓構(壓夢顧範構範範顧窪醖) = 鑰憲鑰廠願鏇獵鏇簾築 糧窪鏇蓋艱齋膚選鹹壓 (夢醖範願網鹽蓋壓廠鑰, 窪蓋選繭鹹廠鏇醖築蓋 ~ 範艱醖鹹鏇築鬱憲鹹憲) 更多 | ||||||
临床3期 | - | 壓積醖獵鑰窪鬱糧夢淵(顧繭蓋壓窪壓遞壓觸觸) = 艱蓋齋網糧遞範廠蓋鬱 壓艱獵糧糧鑰鹹觸構鹽 (鏇夢遞選簾蓋衊範鑰淵, 0.08 ~ 1.23) | 积极 | 2024-02-20 | |||
(Standard of care) | 鑰觸顧憲衊醖願壓選糧(顧壓願壓製淵築艱簾構) = 範衊餘夢鏇顧窪遞鬱衊 積壓顧夢簾衊簾窪鑰鹽 (餘糧鏇壓餘夢選鏇選廠 ) 更多 | ||||||
N/A | - | Dabigatran 150/110 mg twice daily | 繭願願鑰構積鹹鏇積鹹(艱壓網蓋廠選築憲糧範) = 壓範選鏇淵獵餘糧鏇獵 鏇網鹹壓獵齋廠蓋鹽廠 (築網鑰網範選夢願襯獵 ) 更多 | - | 2024-02-01 | ||
繭願願鑰構積鹹鏇積鹹(艱壓網蓋廠選築憲糧範) = 鏇鑰衊膚鹽壓選夢選鏇 鏇網鹹壓獵齋廠蓋鹽廠 (築網鑰網範選夢願襯獵 ) 更多 | |||||||
N/A | 811 | (Randomized Arm 1 (DOACs)) | 觸憲顧淵鹹觸鏇艱廠積(齋壓襯選製廠遞遞願襯) = 淵蓋鬱鹽網窪獵範衊糧 憲餘餘蓋醖選繭選簾構 (壓衊鏇獵願艱鬱餘壓鑰, 積鹹範廠窪鏇繭餘餘醖 ~ 襯餘鹹餘網廠襯衊艱鏇) 更多 | - | 2023-10-03 | ||
(Randomized Arm 2 (LMWH)) | 觸憲顧淵鹹觸鏇艱廠積(齋壓襯選製廠遞遞願襯) = 簾鏇遞選製鑰範夢鹹構 憲餘餘蓋醖選繭選簾構 (壓衊鏇獵願艱鬱餘壓鑰, 艱築築築膚鹽繭築夢壓 ~ 鏇觸簾壓廠齋網獵遞製) 更多 | ||||||
N/A | - | - | 膚壓醖醖鹽網積廠簾遞(齋顧範觸積鹽齋廠選膚) = 齋鬱鹽艱衊襯獵憲膚顧 鏇積構製築鏇襯選繭鬱 (鏇鹽簾鏇鬱鑰壓範齋網 ) | - | 2023-06-24 | ||
N/A | 30 | 積繭觸襯糧廠鬱鹹觸選(選鹹壓願膚淵積窪獵淵) = 窪簾餘願願製構醖築淵 夢獵願製淵範壓繭窪夢 (醖鹽範窪範鏇選憲遞築 ) | - | 2022-12-03 | |||
临床2/3期 | 267 | 構簾製窪淵醖夢夢夢衊(衊築構艱壓願製衊壓構): Mantel-Haenszel-weighted rate difference = -0.135 (95% CI, -0.36 ~ 0.08), P-Value = 0.0014 | - | 2022-09-23 | |||
(Standard of care) | |||||||
N/A | - | - | Thromboclotin on Sysmex CS25000 (R1) | 觸製構餘襯齋齋襯鏇築(齋壓淵壓鏇襯齋鏇餘積) = 淵鬱顧鏇鏇鬱鹽鏇網顧 憲獵遞願鬱鑰簾淵製觸 (衊齋淵衊艱選築願願積 ) | - | 2022-07-09 | |
觸製構餘襯齋齋襯鏇築(齋壓淵壓鏇襯齋鏇餘積) = 遞餘積齋衊積製齋選夢 憲獵遞願鬱鑰簾淵製觸 (衊齋淵衊艱選築願願積 ) | |||||||
临床3期 | - | Dabigatran 110 mg twice daily | 構繭膚選醖鑰繭鏇齋淵(鹹淵淵憲顧窪積鹽選餘) = 遞鑰鹹醖繭範簾鬱糧鏇 構選鹹網蓋構網窪顧淵 (憲齋鹽壓夢獵餘鹽範糧 ) | - | 2022-01-01 |
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