预约演示
更新于：2025-05-07
Apixaban
阿哌沙班
更新于：2025-05-07
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 |
特殊审评快速通道 (美国)、优先审评 (中国) |
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结构/序列
分子式C25H25N5O4 |
InChIKeyQNZCBYKSOIHPEH-UHFFFAOYSA-N |
CAS号503612-47-3 |
关联
417
项与 阿哌沙班 相关的临床试验NCT06953726
CSP #2037T - Veterans Affairs Learning Health System Initiative to Assess Novel Screening vs. Usual Care and Treatment With Apixaban vs. Rivaroxaban in Veterans With Atrial Fibrillation (VALIANT-AF-T) Trial
NCT06933056
Comparison of Antiplatelet Effects of Sotagliflozin to FDA-approved Antiplatelet Drugs: an Interventional Study
CTIS2024-519660-40-00
- 02API2024
100 项与 阿哌沙班 相关的临床结果
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100 项与 阿哌沙班 相关的转化医学
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100 项与 阿哌沙班 相关的专利（医药）
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6,961
项与 阿哌沙班 相关的文献（医药）2025-12-31JOURNAL OF MEDICAL ECONOMICS
Decision model to evaluate the cost of clinical events associated with switching from apixaban to rivaroxaban among patients with non-valvular atrial fibrillation in the United States and Germany
Article
作者: Dworatzek, Elke ; Kongnakorn, Thitima ; Duan, Cecilia ; Shah, Anshul ; Kisser, Agnes ; Subash, Rupesh ; Hines, Dionne M. ; Hagan, Melissa ; Zhang, Michelle
AIMS:
Direct-acting oral anticoagulants (DOACs) have emerged as the preferred treatment for nonvalvular atrial fibrillation (NVAF). However, evidence concerning the economic outcomes of DOAC switching remains limited. This study aimed to assess the economic outcomes of DOAC switching in the US and Germany, two countries with a high AF prevalence and DOAC utilization.
METHODS:
A decision model was developed to assess the incidence and cost of stroke/systemic embolism (SE) and major bleeding (MB) associated with switching from apixaban to rivaroxaban in patients with NVAF. The model compared two scenarios: continuers (patients continuing apixaban) and switchers (patients switching from apixaban to rivaroxaban). Model inputs on clinical event rates were sourced from a published real-world study, cost inputs were from a standard costing database and published literature. The analysis was conducted over a 1-year time horizon from US Medicare fee-for-service and German public healthcare payer perspectives.
RESULTS:
Over one year, 47,036 patients among a hypothetical plan size of 1,000,000 US Medicare fee-for-service members and 1,019,079 patients among the German adult population size of 70,107,122 were estimated to be treated for NVAF with apixaban. Switching all patients from apixaban to rivaroxaban resulted in 1,498 and 32,447 additional clinical events (stroke/SE and MB) and deaths in the US and Germany, respectively, compared to continuing with apixaban. This led to a total incremental cost of $17.3 million and €153 million from Medicare fee-for-service and German public healthcare perspectives, respectively.
LIMITATIONS:
The incidence and hazard ratios of clinical events informing this analysis were based on a US commercial and Medicare Advantage population and may not be generalizable to other populations.
CONCLUSIONS:
Switching from apixaban to rivaroxaban was associated with increased clinical events, deaths, and higher medical care costs, potentially representing a less favorable strategy economically compared to continuing apixaban among patients with NVAF.
2025-05-01JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
Simultaneous quantification of eighteen therapeutic oral anticoagulants, rodenticides, and antiplatelet agents by LC-MS/MS and its application in post-mortem forensic cases
Article
作者: Bidat, Carolyne ; Feliu, Catherine ; Duband, Sébastien ; Escal, Jean ; Dellinger, Sandrine ; Hodin, Sophie ; Drague, Angélique ; Delavenne, Xavier
Anticoagulants and antiplatelet agents, which interfere with blood coagulation, can lead to fatal bleeding. Moreover, their widespread use as drugs or rodenticides poses a high risk of accidental or intentional poisoning. Therefore, quantifying these substances is essential in forensic investigations. This research aimed to develop and validate a liquid chromatography-tandem mass spectrometry method capable of quantifying eighteen anticoagulant or antiplatelet compounds (apixaban, rivaroxaban, dabigatran, warfarin, acenocoumarol, fluindione, brodifacoum, bromadiolone, difenacoum, difethialone, chlorophacinone, coumatetralyl, flocoumafen, acetylsalicylic acid, clopidogrel, dipyridamole, ticagrelor, and ticlopidine) in a single run with simple sample preparation. The method was validated according to the FDA recommendations for all compounds, with an eight-min run time in human whole blood, the gold standard in toxicological forensic investigation. The method was also validated for therapeutic compounds and most rodenticides in bile and vitreous humor. Following validation, the method was applied to seven forensic cases with a known history of anticoagulant or antiplatelet agent use to prove the validity of the method. This method provides a valuable tool for legal contexts where precise determination of anticoagulant compound presence and concentration is required.
2025-05-01PEDIATRIC DRUGS
Adverse Events of Factor Xa Inhibitors in Pediatric Patients: A Meta-analysis and Pharmacovigilance Study
Article
作者: Hua, Manqi ; Xiang, Qian ; Chong, Shan ; Sun, Lan ; Cui, Yimin ; Mu, Guangyan
BACKGROUND:
This study aimed to provide a comprehensive review of adverse events (AEs) associated with factor Xa (FXa) inhibitors in pediatric patients.
METHODS:
We searched PubMed, Embase, Cochrane Library, ClinicalTrials.gov, and the European Union Clinical Trials Register for English-language records from the establishment of the database up to October 17, 2023. Both randomized controlled trials and single-arm trials were included. AEs were analyzed using a Bayesian hierarchical model. For the pharmacovigilance study, data from the US Food and Drug Administration Adverse Event Reporting System from January 1, 2007, to December 31, 2023, were obtained. The proportional imbalance method and the Medicines and Healthcare products Regulatory Agency method were used to detect AE signals. Further characterization of patients presenting with AEs was performed.
RESULTS:
Of 451 records identified, 12 eligible studies were included. A total of 50.6% (95% Bayesian credible interval [CrI] 33.1-67.2, τ = 0.796) of patients experienced at least one AE, and 9.9% (95% CrI 3.9-19.5, τ = 0.552) developed at least one serious AE. Major and clinically relevant non-major bleeding occurred in 2.4% (95% CrI 0.8-4.8, τ = 1.61) of patients. The most common bleeding AEs were epistaxis (8.4% [95% CrI 3.9-14.9, τ = 1.96]), subcutaneous hematoma (6.4% [95% CrI 0.5-26.2, τ = 0.54]), and wound hemorrhage (3.7% [95% CrI 0.4-13.3, τ = 0.55]). Non-hemorrhagic AEs were pyrexia (9.2% [95% CrI 4.6-15.3, τ = 1.18]), vomiting (7.8% [95% CrI 4.0-12.3, τ = 0.08]), and abdominal pain (7.4% [95% CrI 1.5-19.4, τ = 0.84]). A total of 39 AE signals were detected in the pharmacovigilance study. The top three highest overall relative odds ratio (ROR) for AEs were observed for haemorrhoidal hemorrhage at 1211.82 (95% CI, 312.69-4696.29), thrombophlebitis at 134.64 (95% CI, 42.18-429.81), and deep vein thrombosis at 68.3 (95% CI, 42.53-109.68). Patients experiencing bleeding AEs had received a mean dosage of rivaroxaban 0.16 mg/kg and apixaban 0.08 mg/kg.
CONCLUSIONS:
Systematically quantified AEs of FXa inhibitors in clinical trials and real-world studies provide an important guide for clinicians. The use of FXa inhibitors in pediatric patients is associated with an acceptable rate of AEs. The most common bleeding AE was epistaxis. Pediatric patients treated with FXa inhibitors were more prone to hemorrhoidal hemorrhage. A safe approach may involve prior use of other anticoagulants followed by careful administration of FXa inhibitors, with a dosing regimen tailored to age and weight. Close monitoring is recommended for peri-procedural anticoagulation and vomiting.
100 项与 阿哌沙班 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 |
|---|---|---|---|
| 复发性深静脉血栓形成 | 欧盟 | 2020-07-23 | |
| 复发性深静脉血栓形成 | 冰岛 | 2020-07-23 | |
| 复发性深静脉血栓形成 | 列支敦士登 | 2020-07-23 | |
| 复发性深静脉血栓形成 | 挪威 | 2020-07-23 | |
| 血栓形成 | 中国 | 2013-01-22 | |
| 缺血性卒中 | 日本 | 2012-12-25 | |
| 全身性栓塞 | 澳大利亚 | 2011-07-21 | |
| 心房颤动 | 欧盟 | 2011-05-18 | |
| 心房颤动 | 冰岛 | 2011-05-18 | |
| 心房颤动 | 列支敦士登 | 2011-05-18 | |
| 心房颤动 | 挪威 | 2011-05-18 | |
| 栓塞 | 欧盟 | 2011-05-18 | |
| 栓塞 | 冰岛 | 2011-05-18 | |
| 栓塞 | 列支敦士登 | 2011-05-18 | |
| 栓塞 | 挪威 | 2011-05-18 | |
| 肺栓塞 | 欧盟 | 2011-05-18 | |
| 肺栓塞 | 冰岛 | 2011-05-18 | |
| 肺栓塞 | 列支敦士登 | 2011-05-18 | |
| 肺栓塞 | 挪威 | 2011-05-18 | |
| 脑卒中 | 欧盟 | 2011-05-18 |
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 |
|---|---|---|---|---|
| 慢性肢体威胁性缺血 | 临床3期 | 巴西 | 2020-01-09 | |
| 脑梗塞 | 临床3期 | 美国 | 2018-12-19 | |
| 脑梗塞 | 临床3期 | 美国 | 2018-12-19 | |
| 认知功能障碍 | 临床3期 | 美国 | 2018-12-19 | |
| 认知功能障碍 | 临床3期 | 美国 | 2018-12-19 | |
| 基底细胞癌 | 临床3期 | 奥地利 | 2018-10-11 | |
| 基底细胞癌 | 临床3期 | 比利时 | 2018-10-11 | |
| 基底细胞癌 | 临床3期 | 加拿大 | 2018-10-11 | |
| 基底细胞癌 | 临床3期 | 法国 | 2018-10-11 | |
| 基底细胞癌 | 临床3期 | 希腊 | 2018-10-11 |
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临床结果
临床结果
适应症
分期
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临床3期 | 1,015 | (Active Agent: Apixaban) | 鑰範製遞構艱構糧壓衊 = 餘觸糧願窪鑰衊鏇夢鬱 窪艱顧壓網繭獵蓋艱醖 (鏇齋廠製廠膚齋築構夢, 蓋膚鹹壓範簾築構遞夢 ~ 廠製鹽積憲鹹鑰網願繭) 更多 | - | 2025-04-09 | ||
(Active Control: Aspirin) | 鑰範製遞構艱構糧壓衊 = 網鹽襯築獵醖遞網構廠 窪艱顧壓網繭獵蓋艱醖 (鏇齋廠製廠膚齋築構夢, 壓鏇廠顧蓋鹽餘顧網顧 ~ 膚艱齋衊鏇艱獵廠鹽觸) 更多 | ||||||
N/A | - | (Favorable PRFP) | 膚蓋淵壓壓憲膚簾築蓋(積選衊淵範鹽鏇齋衊獵) = 製醖齋壓網範衊衊鏇鏇 夢糧憲憲繭淵鏇構獵齋 (製糧簾製鬱齋鏇顧餘餘, 1.00 ~ 2.20) | 积极 | 2025-04-07 | ||
(Adverse PRFP) | - | ||||||
临床4期 | - | 淵鏇廠鏇艱餘獵窪艱窪(鬱鬱憲顧衊鹽願獵醖築) = 壓選鏇鏇選廠窪夢憲獵 夢衊艱網夢遞獵選積獵 (餘壓艱衊艱淵繭選鹽壓 ) | 积极 | 2025-04-01 | |||
Apixaban 5.0 mg | 淵鏇廠鏇艱餘獵窪艱窪(鬱鬱憲顧衊鹽願獵醖築) = 淵鬱夢鹹艱鹽醖簾糧衊 夢衊艱網夢遞獵選積獵 (餘壓艱衊艱淵繭選鹽壓 ) | ||||||
临床3期 | 1,291 | Placebo (Placebo) | 築醖窪糧糧醖艱積構鹽 = 顧簾膚簾淵夢簾鬱衊糧 積憲範糧窪齋觸遞製築 (觸選艱餘遞顧遞獵獵製, 獵製繭選鏇鬱鹽繭築遞 ~ 壓構製醖醖餘蓋鏇顧鏇) 更多 | - | 2025-02-25 | ||
(Apixaban) | 築醖窪糧糧醖艱積構鹽 = 襯簾構衊窪鹹鬱膚鬱鹹 積憲範糧窪齋觸遞製築 (觸選艱餘遞顧遞獵獵製, 襯淵願遞築網齋觸願廠 ~ 鹽網顧顧窪壓構窪壓築) 更多 | ||||||
临床2期 | 48 | 鬱壓夢觸鹹獵鹽艱襯積(糧醖鹽鬱顧構襯鏇網鹹) = 在监管机构认可的范围(80-125%)内 襯遞醖襯艱餘艱鏇膚遞 (範鹽膚製選淵膚鬱範構 ) 更多 | 积极 | 2025-02-18 | |||
临床4期 | 4,614 | Apixaban + Placebo | 築觸衊夢膚範範顧蓋醖(鏇築餘齋鹹糧鑰夢鹹壓) = 醖憲網窪衊鏇簾網願繭 選範獵夢鏇衊鏇積憲獵 (艱顧餘鏇襯糧憲憲獵積, 28) | 不佳 | 2025-02-01 | ||
築觸衊夢膚範範顧蓋醖(鏇築餘齋鹹糧鑰夢鹹壓) = 糧夢鑰選廠築醖壓餘夢 選範獵夢鏇衊鏇積憲獵 (艱顧餘鏇襯糧憲憲獵積, 29) | |||||||
N/A | - | (Favorable Polygenic Profile) | 簾顧築鏇遞選獵鬱築遞(夢範構獵網鏇繭夢製憲) = cumulative incidence:1.5%[95%CI:1.00–2.20] 願憲襯願窪壓窪夢壓憲 (淵窪選鬱糧觸獵鬱醖繭 ) | 积极 | 2025-01-30 | ||
(Adverse Polygenic Profile) | |||||||
N/A | - | 淵繭構蓋遞衊範膚網鏇(淵繭網遞壓齋廠壓選糧) = 廠膚蓋糧鹽廠繭齋鹹鑰 製艱淵願選餘遞醖願淵 (範遞齋壓膚夢齋積夢範, 0.29 ~ 0.81) 更多 | 积极 | 2025-01-30 | |||
N/A | - | 膚淵窪鹹壓構壓夢鏇願(遞憲網蓋構鏇觸鹹觸積): HR = 0.92 (95% CI, 0.83 ~ 1.03), P-Value = 0.13 更多 | 积极 | 2025-01-30 | |||
Standard of Care (SOC) | |||||||
N/A | - | 鏇顧築夢鹹艱積夢壓憲(夢鹹糧選蓋壓鏇選鬱衊) = 鹽鹽範夢艱觸鏇憲襯顧 糧艱構齋糧鹹遞醖製憲 (餘夢膚糧簾積構獵襯衊, ±5.4) 更多 | - | 2024-12-08 |
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