DIAMOND study is a national, multicentre, randomized, parallel-group, open label study in patients (aged ≥18 years) with aortic bioprosthesis (excluding TAVI) at least 7 days after cardiac surgery.
Experimental group:
Patients treated with apixaban 5 mg twice daily (BID)
Active Comparator group:
Aspirin 75 to 100mg once a day
The primary objective is to demonstrate that antithrombotic treatment with apixaban is superior to aspirin in patients with recent surgical bioprosthetic aortic valve replacement for the primary composite efficacy endpoint of death from any cause, myocardial infarction, stroke, systemic embolism, deep vein thrombosis, or pulmonary embolism and valve thrombosis after 105 days of follow-up.

开始日期2025-09-01

申办/合作机构

Eske Corp. SAC

NCT06933056

/ Not yet recruiting早期临床1期IIT

Comparison of Antiplatelet Effects of Sotagliflozin to FDA-approved Antiplatelet Drugs: an Interventional Study

This study will identify the potential benefits of regulating platelet activation with sotagliflozin compared to other FDA-approved drugs known to limit platelet activation.

开始日期2025-08-01

申办/合作机构

University of Michigan

[+1]

NCT07005024

/ Not yet recruiting临床3期IIT

A Comparison of Anticoagulant Dosing Strategies to Reduce VTE and Mortality in Cancer Outpatients: A Randomized, Pragmatic Trial

Blood clots, also known as venous thromboembolism (VTE), are a common and serious complication for people with cancer. They can lead to pain, hospitalizations, delayed cancer treatment, and even death. Although national guidelines recommend using blood thinners (anticoagulants) to prevent clots in cancer patients who are at higher risk, these medications are not commonly prescribed due to concerns about bleeding and inconvenience.
This study will test different ways of using a commonly prescribed blood thinner called apixaban (brand name Eliquis) to see if it can safely and effectively reduce the risk of blood clots and death in cancer patients who are at moderate risk for VTE. The study focuses on people who have a "Khorana score" of 2, which puts them at intermediate risk for developing blood clots.
The study will include approximately 996 participants with solid tumors or lymphoma who are starting or recently started cancer-directed therapy. Participants will be randomly assigned to one of three groups:
Group 1: Apixaban 2.5 mg twice a day (standard prophylactic dose)
Group 2: Apixaban 5 mg once a day (an alternative, more convenient dose)
Group 3: No anticoagulant (standard care)
Participants will take the assigned treatment (if applicable) for 6 months. Researchers will monitor whether participants develop blood clots, experience serious bleeding events, or die from any cause during the study period.
By comparing these three groups, the researchers hope to learn whether a once-daily dose of apixaban can work as well as the standard twice-daily dose, and whether either dosing strategy is better than no anticoagulation at all. If successful, the study may help increase the safe use of VTE prevention in cancer patients and improve overall outcomes, especially in patients at intermediate risk.
This is a pragmatic trial, meaning it is designed to fit into real-world clinical practice with minimal extra procedures. The study drug is not provided by the sponsor and will be prescribed and filled through usual care channels. Participants and their doctors will decide whether to continue the medication after the study ends.

开始日期2025-08-01

申办/合作机构

University of Vermont

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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7,111

项与阿哌沙班相关的文献（医药）

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

Nationwide extrapolation of economic benefit of therapeutic innovation: a 10-year retrospective budget impact of direct oral anticoagulants introduction in France

Article

作者: Belhassen, M. ; Lesage, H. ; Moreau, R. ; Née, M. ; Cotté, F. E. ; Guilmet, C. ; Danchin, N. ; Marant Micallef, C. ; Guitard-Dehoux, D.

OBJECTIVES:

Patients with atrial fibrillation (AF) face increased risks of strokes and systemic thromboembolism (SE), traditionally managed with vitamin K antagonists (VKAs), which are associated with major bleeding (MB) risks. The nationwide real-life data-based NAXOS study, comparing Direct Oral Anticoagulants (DOACs: apixaban, dabigatran, rivaroxaban) to VKAs in over 400,000 AF patients in France, showed that DOACs are more effective, safer, and associated with lower total costs. This study evaluates the 10-year budget impact of DOACs in France, focusing on reductions in strokes/SE, MB, and monitoring costs (INRt).

METHODS:

A retrospective budget impact model from 2014 to 2023 compared scenarios with and without DOACs, using clinical and cost data from the NAXOS study. The target population of DOAC-eligible patients ranged from 725,000 in 2014 to 1.4 million in 2023. Market shares trends were derived from the public national drugs database, indicating that VKAs' use decreased from 67% to 11%, while DOACs, especially apixaban, rose sharply (2% to 55%) over the same period. Costs included treatment acquisition, strokes/SE, MB, and international normalized ratio testing (INRt) for VKAs.

RESULTS:

Over a 10-year horizon, the introduction of DOACs is estimated to have prevented 73,009 strokes, 97,234 major bleeding, and 19,567 stroke-related deaths among patients with NVAF. DOAC introduction increased treatment costs by €5.15 billion over 10 years, and reduced costs for strokes/SE (-€4.24 billion), MB (-€3.22 billion), and INRt (-€1.14 billion), leading to €3.45 billion of savings for National Insurance over 10 years, with apixaban contributing 55% of savings.

LIMITATIONS:

This analysis may not account for all contextual variables, such as indirect costs related to productivity losses.

CONCLUSION:

Over 10 years, the introduction of DOACs in France has generated substantial savings in AF-related costs, highlighting their clinical and economic benefits and the importance for authorities to valorise the external effects of therapeutic innovations.

2025-12-31·JOURNAL 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.

2025-12-01·Blood Research

Real-world apixaban concentration in Korean patients with atrial fibrillation

Article

作者: Choe, Jeongcheon ; Choi, Junghyun ; Ahn, Jinhee ; Kim, Hyerim ; Lee, Han Cheol ; Lee, Hyewon ; Cha, Kwang Soo ; Kim, Min Sun ; Kim, Mijin ; Lee, Sun Hack

Abstract:

Purpose:

Apixaban is recommended for patients with atrial fibrillation. Although routine monitoring of plasma concentrations is not typically advised, factors such as ethnicity, sex, and comorbidities can influence these levels. Our study analyzed the plasma apixaban concentrations (PAC) in patients to explore whether these levels, along with underlying conditions, offer enhanced insights for risk stratification.

Methods:

This study analyzed 49 patients with atrial fibrillation who had been taking apixaban for over a month, examined factor Xa levels within 6 h post-administration, and correlated PAC with clinical characteristics such as age, body weight, estimated glomerular filtration rate (eGFR), presence of heart failure, and bleeding events.

Results:

The mean plasma concentration of apixaban in all patients was 160.3 ± 77.5 ng/mL. Those taking apixaban 5 mg twice daily had higher plasma concentrations than those taking 2.5 mg twice daily (191.2 ± 75.3 ng/mL vs. 137.2 ± 72.0 ng/mL, p = 0.014). Among the patients receiving a reduced dose, renal function and heart failure were significantly associated with plasma concentrations. No factors were associated with the plasma concentrations in patients receiving the standard dose. Notably, reduced-dose patients with heart failure had plasma concentrations comparable to those of individuals receiving the standard dose and exhibited a higher incidence of bleeding than the other groups.

Conclusions:

PAC measurement revealed that apixaban dosages, classified based on age, body weight, and eGFR, were generally effective. Nonetheless, heart failure may increase plasma levels and correlate with an increased bleeding risk in Korean patients on reduced doses. Therefore, tailoring apixaban prescriptions to account for heart failure and other comorbidities may enhance treatment efficacy.

810

项与阿哌沙班相关的新闻（医药）

2025-07-14

·医药地理

111 亿美元！BMS 就 PD-L1/VEGF 双抗与 BioNTech 达成合作

6 月 2 日，百时美施贵宝（BMS）与 BioNTech 共同宣布达成一项全球性合作协议，双方将联合开发及商业化 BioNTech 旗下双特异性抗体候选药物 BNT327（原Biotheus的 PM8002），用于多种实体瘤治疗。根据协议内容，BioNTech 与 BMS 将协同推进这一临床候选药物的开发进程，这一合作动态在生物医药行业引发广泛关注。在合作的具体条款方面，BMS 将向 BioNTech 支付 15 亿美元的首付款，并在 2028 年前完成总计 20 亿美元的非或有性周年付款。此外，BioNTech 还有望获得最高达 76 亿美元的开发、监管及商业里程碑付款。在药物的开发与商业化模式上，双方将联合推进 BNT327 作为单药疗法及与其他产品联合疗法的开发工作。同时，两家企业均有权自主开展 BNT327 在更多适应症及联合疗法中的研究，包括将其与各自管线中的产品进行联合应用。值得关注的是，BNT327 是一款靶向 PD-L1 和 VEGF-A 的新一代双特异性抗体候选药物。该药物最初由中国 Biotech 企业Biotheus研发。2024 年，BioNTech 以最高9.5 亿美元的价格完成对普米斯生物 100% 股权的收购。当前正在进行的临床试验初步数据显示，将抗 PD-L1 和抗 VEGF-A 这两个经过充分验证的治疗靶点整合到一个分子中，在此前公布的1b/2期临床试验中，该药在治疗局部晚期或转移性三阴性乳腺癌取得了积极疗效，研究数据明显优于既往临床试验数据，证明其在乳腺癌治疗领域有很大潜力。接受BNT327治疗12个月、15个月和18个月的患者总生存率分别为80.8%、78.1%和69.7%。回顾 BMS 近年来的一系列交易举措，其动作频繁且规模庞大。作为全球知名的生物制药企业，BMS 始终致力于通过各类交易来扩充自身产品线，提升市场竞争力。BMS 的两大核心产品 Opdivo 和 Eliquis 即将面临 “专利悬崖” 的挑战，为此，BMS 正积极寻觅高潜力在研产品以填补这一缺口。自 2023 年至今，BMS 已投入巨额资金达成多项 BD 交易。2024 年，BMS 完成了多笔大额交易。其中包括以BMS 与 Repertoire Immune Medicines 达成合作协议，共同开发用于治疗自身免疫性疾病的疫苗，该交易总金额达 18.65 亿美元。以 41 亿美元收购核药公司 RayzeBio，通过此次收购，BMS 成功涉足核药领域，进一步拓展了其在肿瘤治疗领域的技术与产品布局；以 140 亿美元收购神经科学领域公司 Karuna，这一举措极大地增强了 BMS 在神经科学领域的实力，丰富了该领域的研发管线与产品储备；以 48 亿美元收购 Mirati，进一步夯实了 BMS 在肿瘤创新疗法领域的优势；以 84 亿美元引进百利天恒 HER3/EGFR 双抗 ADC，使 BMS 在双抗 ADC 领域占据了一席之地。这些交易充分体现了 BMS 在不同治疗领域广泛布局、积极寻求创新产品的战略意图。此次与 BioNTech 就 BNT327 达成合作，是 BMS 战略布局中的关键一步。2025 年 5 月，辉瑞以 12.5 亿美元首付款加 48 亿美元里程碑款的方式，获得三生制药 PD-1/VEGF 双抗 SSGJ-707 的全球权益（中国除外）；2024 年 11 月，默沙东以 5.88 亿美元首付款加 27 亿美元里程碑款的代价，获得礼新药业在研 PD-1/VEGF 双抗 LM-299 的全球权益。BMS 此次以高额首付款及潜在里程碑付款的投入参与到 PD-L1/VEGF 双抗领域的竞争，彰显了其对该领域的高度重视。图1 BNT327（PM-8002）已进入临床三期根据Pharma ONE数据库显示，目前 BNT327 已进入临床三期，并且在肺癌、乳腺癌等多种实体瘤的临床试验中表现出良好效果，这对 BMS 具有极大的吸引力。通过与 BioNTech 的合作，BMS 能够快速获取这一具有潜力的产品，加速其在相关肿瘤治疗市场的布局，有望在下一代免疫肿瘤疗法竞争中占据有利位置。从行业视角来看，BMS 的这些交易举措对整个生物医药行业产生了深远影响。一方面，其大额的资金投入推动了生物医药研发的进程。对于被收购公司及合作方而言，充足的资金支持能够加快研发项目的推进速度，促使更多创新药物有望更快进入临床阶段，最终使患者受益。另一方面，BMS 在不同领域的布局为行业发展提供了方向指引。其对免疫肿瘤疗法、神经科学等领域的重视，引导更多企业关注这些领域，促进了相关领域技术的交流与创新。此外，BMS 与众多企业的合作与交易，也加强了行业内企业间的联系与互动，有利于构建更为广泛的产业生态合作网络。此次 BMS 与 BioNTech 就 BNT327 达成的 111 亿美元合作，是 BMS 一系列交易动作中的重要组成部分。它不仅体现了 BMS 对创新产品的追求以及对市场趋势的精准把握，也将对全球生物医药行业的发展产生积极而深远的影响。未来 BNT327 能否能重塑实体瘤治疗标准，值得整个业界持续关注。END如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001

并购疫苗抗体药物偶联物申请上市引进/卖出

2025-07-13

·信狐药迅

两个1类新药：苏州亚盛力胜克拉片和苏州旺山旺水斯美瑞非片获批上市| 新获批(7.7-7.13）

每周药品注册获批数据，分门别类呈现，一目了然。(7.7-7.13）新药上市申请药品名称企业注册分类受理号力胜克拉片苏州亚盛药业有限公司1CXHS2400114力胜克拉片苏州亚盛药业有限公司1CXHS2400113力胜克拉片苏州亚盛药业有限公司1CXHS2400112斯美瑞非片苏州旺山旺水生物医药股份有限公司1CXHS2300087斯美瑞非片苏州旺山旺水生物医药股份有限公司1CXHS2300086斯美瑞非片苏州旺山旺水生物医药股份有限公司1CXHS2300085新药临床申请药品名称企业注册分类受理号DZD8586片迪哲(江苏)医药股份有限公司1CXHL2500453注射用JJH201601脂质体江苏吉贝尔药业股份有限公司1CXHL2500448CMS-D001片海南德镁医药科技有限责任公司1CXHL2500442CMS-D001片海南德镁医药科技有限责任公司1CXHL2500441注射用HRS8179北京盛迪医药有限公司1CXHL2500436MDI-1228_mesylate凝胶迈英诺医药科技(珠海)有限公司1CXHL2500435MDI-1228_mesylate凝胶迈英诺医药科技(珠海)有限公司1CXHL2500434MDI-1228_mesylate凝胶迈英诺医药科技(珠海)有限公司1CXHL2500433MDI-1228_mesylate凝胶迈英诺医药科技(珠海)有限公司1CXHL2500432SYN608片杭州圣域生物医药科技有限公司1CXHL2500430SYN608片杭州圣域生物医药科技有限公司1CXHL2500429G201-Na胶囊石家庄以岭药业股份有限公司1CXHL2500425G201-Na胶囊石家庄以岭药业股份有限公司1CXHL2500424PTT-621片北京炎明生物科技有限公司1CXHL2500399PTT-621片北京炎明生物科技有限公司1CXHL2500398GD-19乳状注射液天津谷堆生物医药科技有限公司2.1CXHL2500385OLP-210片深圳奥礼生物科技有限公司2.2CXHL2500423OLP-210片深圳奥礼生物科技有限公司2.2CXHL2500422OLP-210片深圳奥礼生物科技有限公司2.2CXHL2500421ACIERT缓释片吉林天衡药业有限公司2.2CXHL2500412ACIERT缓释片吉林天衡药业有限公司2.2CXHL2500411甲磺酸阿帕替尼片江苏恒瑞医药股份有限公司2.4CXHL2500419重组带状疱疹疫苗(CHO细胞)安徽智飞龙科马生物制药有限公司1.3CXSL2500282IBI130信达生物制药(苏州)有限公司1CXSL2500366注射用BG-C477广州百济神州生物制药有限公司1CXSL2500358重组抗CD19m-CD3抗体注射液天劢源和生物医药(上海)有限公司1CXSL2500355LP-005 注射液天辰生物医药(苏州)有限公司1CXSL2500354FG-B901注射液明济生物制药(北京)有限公司1CXSL2500352FL115注射液苏州复融生物技术有限公司1CXSL2500350注射用BGB-B3227广州百济神州生物制药有限公司1CXSL2500347注射用YL242苏州宜联生物医药有限公司1CXSL2500343IMD101 注射液上海英脉德医疗科技有限公司1CXSL2500339BBT001注射液杉竹曜(北京)生物医药科技有限公司1CXSL2500342注射用DB-1311映恩生物制药(苏州)有限公司1CXSL2500337YOLT-101注射液尧唐(南京)生物科技有限公司1CXSL2500313AL-001眼用注射液北京安龙合生药业有限公司1CXSL2500301DMR2301注射液上海多米瑞生物技术有限公司1CXSL2500308人脐带间充质干细胞注射液源品细胞生物科技集团有限公司1CXSL2500297注射用RGL-232上海瑞宏迪医药有限公司1CXSL2500295CRG-B191注射液上海科锐克医药科技有限公司1CXSL2500293QX029N注射液江苏荃信生物医药股份有限公司1CXSL2500288MSLN-CAR-T细胞注射液上海怡豪生物科技有限公司1CXSL2500281依沃西单抗注射液康方赛诺医药有限公司2.2CXSL2500345SHR-8068注射液苏州盛迪亚生物医药有限公司2.2CXSL2500340SHR-8068注射液苏州盛迪亚生物医药有限公司2.2CXSL2500338贝伐珠单抗注射液苏州盛迪亚生物医药有限公司2.2CXSL2500336阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2500335仿制药申请药品名称企业注册分类受理号盐酸肾上腺素注射液成都瑞尔医药科技有限公司3CYHS2400548磷酸奥司他韦干混悬剂福建省闽东力捷迅药业股份有限公司3CYHS2400421二羟丙茶碱注射液安徽美来药业股份有限公司3CYHS2400281吡拉西坦注射液湖南赛隆药业(长沙)有限公司3CYHS2400261吡拉西坦注射液湖南赛隆药业(长沙)有限公司3CYHS2400260富马酸酮替芬口服溶液浙江易泽达医药科技有限公司3CYHS2303277氯化钾颗粒山西皇城相府药业股份有限公司3CYHS2303100氯化钾颗粒山西皇城相府药业股份有限公司3CYHS2303099头孢丙烯干混悬剂海南葫芦娃药业集团股份有限公司3CYHS2302198福多司坦片天方药业有限公司3CYHS2302051卡络磺钠注射液南京恩泰医药科技有限公司3CYHS2301863卡络磺钠注射液南京恩泰医药科技有限公司3CYHS2301862注射用水溶性维生素辽宁海思科制药有限公司3CYHS2301315氨溴特罗口服溶液北京韩美生物科技有限公司3CYHS2301124艾拉莫德片四川国为制药有限公司4CYHS2401588瑞舒伐他汀依折麦布片(I)浙江诺得药业有限公司4CYHS2401540注射用盐酸地尔硫䓬山东豪瑞恩制药有限公司4CYHS2401285氯化钾氯化钠注射液石家庄四药有限公司4CYHS2401230氯化钾氯化钠注射液石家庄四药有限公司4CYHS2401229贝前列素钠片江苏和晨药业有限公司4CYHS2401140盐酸决奈达隆片齐鲁制药有限公司4CYHS2401042普拉替尼胶囊基石药业(苏州)有限公司4CYHS2401036地夸磷索钠滴眼液苏州朗科生物技术股份有限公司4CYHS2400985左氧氟沙星氯化钠注射液辽宁民康制药有限公司4CYHS2400843尼可地尔片北京四环科宝制药股份有限公司4CYHS2400774阿哌沙班片浙江永宁药业股份有限公司4CYHS2400729磷酸奥司他韦胶囊吉林开曼药业有限公司4CYHS2400737注射用头孢唑肟钠广州合和医药有限公司4CYHS2400569盐酸尼卡地平注射液南京锐志生物医药有限公司4CYHS2400566氨氯地平阿托伐他汀钙片湖南威特制药股份有限公司4CYHS2400461聚乙二醇钠钾散四川科伦药业股份有限公司4CYHS2400408盐酸尼卡地平注射液浙江华海药业股份有限公司4CYHS2400383培哚普利氨氯地平片(I)天津力生制药股份有限公司4CYHS2400310培哚普利氨氯地平片(III)天津力生制药股份有限公司4CYHS2400309琥珀酸美托洛尔缓释片浙江华海药业股份有限公司4CYHS2303470二甲双胍恩格列净片(I)湖南及正医药科技有限公司4CYHS2303454注射用磷酸特地唑胺江苏正大丰海制药有限公司4CYHS2303356盐酸莫西沙星滴眼液扬州中宝药业股份有限公司4CYHS2303323孟鲁司特钠颗粒浙江易泽达医药科技有限公司4CYHS2303311贝美素噻吗洛尔滴眼液杭州民生药业股份有限公司4CYHS2303101盐酸乌拉地尔天方药业有限公司CYHS2360899四价流感病毒裂解疫苗浙江天元生物药业有限公司3.3CXSS2300101盐酸米诺环素泡沫剂上海则正医药科技股份有限公司4CYHL2500089盐酸米诺环素泡沫剂深圳珐玛易药品科技有限公司4CYHL2500087琥珀酰明胶电解质醋酸钠注射液四川太平洋药业有限责任公司4CYHL2500081噻托溴铵吸入粉雾剂艾特美(苏州)医药科技有限公司4CYHL2500077吸附破伤风疫苗远大赛威信生命科学(南京)有限公司3.3CXSL2500296进口申请药品名称企业注册分类受理号褪黑素颗粒Nobelpharma Co., Ltd.5.1JXHS2400013褪黑素颗粒Nobelpharma Co., Ltd.5.1JXHS2400012BPC2001注射液BioPhoenix Co., Ltd.1JXHL2500100BMS-986435片Bristol-Myers Squibb Company1JXHL2500086BMS-986435片Bristol-Myers Squibb Company1JXHL2500085BMS-986435片Bristol-Myers Squibb Company1JXHL2500084Capivasertib片AstraZeneca AB2.4JXHL2500109Capivasertib片AstraZeneca AB2.4JXHL250010821价肺炎球菌多糖结合疫苗Sanofi Pasteur Inc.1.4JXSL2500058Mezagitamab注射剂Takeda Development Center Americas, Inc.1JXSL2500066SAR442970注射液Sanofi-Aventis Recherche & Développement1JXSL2500062SAR442970注射液Sanofi-Aventis Recherche & Développement1JXSL2500059中药相关申请药品名称企业注册分类受理号香芩解热颗粒云南方盛融和药业有限公司1.1CXZL2500024健脾解毒丸新疆维吾尔自治区中医医院1.1CXZL2500021注：橙色字体部分结论为不批准或收到通知件；

上市批准疫苗

2025-07-12

·奇点网

《JAMA》子刊：APOE ε4又“作妖”！耶鲁大学团队发现，携带APOE ε4的房颤患者服用抗凝药，颅内出血风险升高2倍

*仅供医学专业人士阅读参考临床上，总会出现“两难全”的境地。比如口服抗凝药物阿哌沙班，可以帮助房颤患者有效预防脑血栓和卒中。但另一方面，有研究表明阿哌沙班会导致严重出血，增加颅内出血（ICH）的风险。在这种情况下，保持警觉最为关键，尤其需要关注本身遗传风险就很高的患者群体。对于APOE ε4等位基因，大多数人只知其与多种神经退行性疾病的风险密切相关，其实APOE ε4还是颅内出血的一个重要风险因素，与自发性颅内出血风险提高1倍相关。耶鲁大学的Guido J. Falcone团队就是关注到了APOE ε4。他们展开研究，旨在探讨APOE ε4基因是否“涉嫌”提高服用阿哌沙班的房颤患者发生颅内出血的风险，结果于近日公布在《JAMA·神经病学》期刊上[1]。研究结果表明，APOE ε4等位基因携带者在接受阿哌沙班治疗期间，发生颅内出血的风险比非携带者显著增加2倍。在使用模型预测颅内出血风险时，加入APOE基因的数据能够进一步提升预测效果。这一发现为房颤患者的个性化治疗提供了新的遗传学依据，也为现有的风险评估工具提供了有益的补充。“我们所有人”研究计划（All of Us Research Program），是美国国家卫生研究院主办的一个大型前瞻性队列研究，旨在通过采集全国各地的遗传、健康和行为数据，为个性化医疗提供支持。在这项研究中，研究人员基于该队列，共纳入2038名年龄超过50岁且正在接受‌阿哌沙班抗凝治疗的房颤患者，有缺血性卒中或颅内出血病史的患者被排除。研究从2017年开始收集数据，并一直持续到2022年，随访期的中位数为2.9年。在基因数据方面，研究团队基于全基因组测序（WGS）获取了参与者的APOE基因型信息。根据rs429358和rs7412两个SNP位点的基因型，研究人员按照APOE ε2、ε3和ε4三种基因型将参与者进行分组，并重点分析了携带APOE ε4等位基因的个体。研究中，APOE ε4的携带者被定义为携带1或2个ε4等位基因的人，而非携带者则没有ε4等位基因。主要研究结果是发生颅内出血的比例。在2.9年的随访期内，共有2038名参与者，其中26名发生了颅内出血（ICH），包括原发性脑内出血、硬膜下出血和蛛网膜下腔出血。其中，APOE ε4携带者的颅内出血累积发生率为3.1%，非携带者为1%，差异具有统计学意义（P=0.007）。这一结果通过Cox比例风险模型得到了进一步验证，携带APOE ε4等位基因的患者发生颅内出血的风险是非携带者的3倍（风险比[HR]：3.07，95%CI：1.42-6.65）。此外，研究还发现，将APOE基因信息加入现有的颅内出血风险预测模型中，可以显著提高风险预测的准确性，模型的C-statistic指数从未加入APOE数据时的0.68提高到0.74（P=0.03）。在次要结果中，研究团队特别关注了脑实质出血（颅内出血的一种类型）、缺血性卒中以及两者复合事件的发生情况。研究结果显示，携带APOE ε4的个体更容易发生脑实质出血，比非携带者高出近3倍（HR：3.70；95%CI：1.36-8.38）。而对于缺血性卒中，以及脑实质出血+缺血性卒中的复合事件，两组之间并未显示出显著差异。进一步的敏感性分析表明，排除中途停药的患者后，结果依然一致。总之，这项研究表明，APOE ε4基因的携带状态对于房颤患者在接受阿哌沙班治疗时的出血风险具有显著影响。随着基因信息的普及和精准医学的不断发展，结合基因数据来进行风险评估和个性化治疗的时代可能已经来临。这项研究为临床决策提供了有价值的参考，尤其是在评估老年房颤患者的出血风险时，应该考虑APOE基因型的影响。参考文献：[1]Clocchiatti-Tuozzo S, Rivier CA, Renedo D, et al. APOE ε4 and Risk of Intracranial Hemorrhage in Patients With Atrial Fibrillation Taking Apixaban. JAMA Neurol. Published online June 23, 2025. doi:10.1001/jamaneurol.2025.0182本文作者丨张艾迪

临床结果

100 项与阿哌沙班相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D03213	阿哌沙班	B01AF02	DB06605

研发状态

批准上市

10 条最早获批的记录,

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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	Accord Healthcare SLU	2020-07-23
复发性深静脉血栓形成	冰岛	Accord Healthcare SLU	2020-07-23
复发性深静脉血栓形成	列支敦士登	Accord Healthcare SLU	2020-07-23
复发性深静脉血栓形成	挪威	Accord Healthcare SLU	2020-07-23
血栓形成	中国	Bristol-Myers Squibb/Pfizer EEIG	2013-01-22
缺血性卒中	日本	Bristol-Myers Squibb KK	2012-12-25
全身性栓塞	澳大利亚	Bristol Myers Squibb Co.	2011-07-21
心房颤动	欧盟	Bristol-Myers Squibb/Pfizer EEIG	2011-05-18
心房颤动	冰岛	Bristol-Myers Squibb/Pfizer EEIG	2011-05-18
心房颤动	列支敦士登	Bristol-Myers Squibb/Pfizer EEIG	2011-05-18
心房颤动	挪威	Bristol-Myers Squibb/Pfizer EEIG	2011-05-18
栓塞	欧盟	Bristol-Myers Squibb/Pfizer EEIG	2011-05-18
栓塞	冰岛	Bristol-Myers Squibb/Pfizer EEIG	2011-05-18
栓塞	列支敦士登	Bristol-Myers Squibb/Pfizer EEIG	2011-05-18
栓塞	挪威	Bristol-Myers Squibb/Pfizer EEIG	2011-05-18
肺栓塞	欧盟	Bristol-Myers Squibb/Pfizer EEIG	2011-05-18
肺栓塞	冰岛	Bristol-Myers Squibb/Pfizer EEIG	2011-05-18
肺栓塞	列支敦士登	Bristol-Myers Squibb/Pfizer EEIG	2011-05-18
肺栓塞	挪威	Bristol-Myers Squibb/Pfizer EEIG	2011-05-18
脑卒中	欧盟	Bristol-Myers Squibb/Pfizer EEIG	2011-05-18

未上市

10 条进展最快的记录,

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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	Wyeth AB	2020-01-09
认知功能障碍	临床3期	美国	Bristol Myers Squibb Co.	2018-12-19
认知功能障碍	临床3期	美国	Pfizer Inc.	2018-12-19
基底细胞癌	临床3期	奥地利	Bristol Myers Squibb Co.	2018-10-11
基底细胞癌	临床3期	比利时	Bristol Myers Squibb Co.	2018-10-11
基底细胞癌	临床3期	加拿大	Bristol Myers Squibb Co.	2018-10-11
基底细胞癌	临床3期	法国	Bristol Myers Squibb Co.	2018-10-11
基底细胞癌	临床3期	希腊	Bristol Myers Squibb Co.	2018-10-11
基底细胞癌	临床3期	意大利	Bristol Myers Squibb Co.	2018-10-11
基底细胞癌	临床3期	荷兰	Bristol Myers Squibb Co.	2018-10-11

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04504318 (CTgov)	临床1/2期	静脉血栓栓塞	82	Apixaban 2.5 MG Oral Tablet (Apixaban)	淵齋願壓壓鹽願鏇膚鑰 = 選襯醖範獵鹹選蓋鹹選獵鑰願築齋鹽鬱遞窪鏇 (鹹鬱獵壓願醖觸襯製窪, 遞夢艱鬱糧餘積衊糧齋 ~ 選獵衊製積艱廠築鑰鏇) 更多	-	2025-06-22
				Enoxaparin (Enoxaparin)	淵齋願壓壓鹽願鏇膚鑰 = 鬱壓齋鏇簾範膚齋淵衊獵鑰願築齋鹽鬱遞窪鏇 (鹹鬱獵壓願醖觸襯製窪, 襯簾觸繭願衊夢構鬱膚 ~ 鏇選憲鹹積顧膚築膚壓) 更多
NCT03045406 (CARAVAGGIO, CTgov)	临床3期	基底细胞癌 \| 肿瘤 \| 急性白血病 ... 更多	1,170	Apixaban (Apixaban)	窪糧遞夢遞構餘夢觸製 = 簾獵選繭齋壓鑰艱鑰繭膚網淵廠積積繭築築齋 (餘壓憲鬱積淵鏇艱廠糧, 積簾廠鬱鹽鏇簾觸顧繭 ~ 鏇襯選襯遞鬱鬱範糧鏇) 更多	-	2025-06-18
				Dalteparin (Dalteparin)	窪糧遞夢遞構餘夢觸製 = 鏇鹹願鹽鏇鹹願顧糧鹽膚網淵廠積積繭築築齋 (餘壓憲鬱積淵鏇艱廠糧, 鏇蓋鏇糧醖餘選製餘簾 ~ 觸壓範壓網襯淵窪獵齋) 更多
NCT05643573 (OCEANIC-AF, Pubmed \| JAMA Cardiol)	临床3期	心房颤动	-	Asundexian	觸蓋築廠餘餘觸艱遞築(獵壓鹹繭夢襯鏇夢衊鏇) = 築鬱醖憲鬱壓獵鬱廠糧積鏇選構餘廠廠艱鏇壓 (窪範積願築簾觸齋窪蓋 )	积极	2025-06-01
				Apixaban	觸蓋築廠餘餘觸艱遞築(獵壓鹹繭夢襯鏇夢衊鏇) = 襯廠鏇壓觸獵廠簾壓鑰積鏇選構餘廠廠艱鏇壓 (窪範積願築簾觸齋窪蓋 )
ATS2025	N/A	药物过量	1	Apixaban overdose	憲鏇構網積壓鹽齋壓選(獵遞襯鹽網築淵鏇選廠) = there was a high suspicion for TRALI but given patient and family wishes, he was transitioned to comfort and expired 選夢簾齋鏇構餘壓簾遞 (積製遞艱獵繭鹽鹹醖遞 ) 更多	不佳	2025-05-16
NCT03692065 (API-CAT, Pubmed \| N Engl J Med)	临床3期	静脉血栓栓塞	1,766	Apixaban 2.5 mg	繭鑰繭蓋積鬱餘糧繭窪(顧構獵壓鹽糧蓋鏇鹽淵) = 願鏇蓋鏇願顧衊觸壓夢製築壓網鹹積淵鑰糧鑰 (憲遞觸範築鹽製蓋艱簾 ) 更多	积极	2025-04-10
				Apixaban 5.0 mg	繭鑰繭蓋積鬱餘糧繭窪(顧構獵壓鹽糧蓋鏇鹽淵) = 繭顧網餘淵觸膚襯夢遞製築壓網鹹積淵鑰糧鑰 (憲遞觸範築鹽製蓋艱簾 ) 更多
NCT03192215 (ARCADIA, CTgov)	临床3期	卵圆孔未闭 \| 家族性心房黏液瘤 \| 心肌梗塞 ... 更多	1,015	Apixaban (Active Agent: Apixaban)	獵選齋淵願鏇網糧膚齋 = 網網獵餘淵襯蓋廠夢簾構繭廠鹽顧鹽網憲網顧 (蓋願構選鹹醖鹽構鹽壓, 壓壓觸蓋廠糧蓋憲襯膚 ~ 醖遞願製淵獵範鹽壓夢) 更多	-	2025-04-09
				Aspirin (Active Control: Aspirin)	獵選齋淵願鏇網糧膚齋 = 齋襯觸製窪衊網壓蓋鹽構繭廠鹽顧鹽網憲網顧 (蓋願構選鹹醖鹽構鹽壓, 鹹顧蓋餘願廠廠艱齋艱 ~ 壓鬱願廠餘繭遞鏇鏇艱) 更多
P9-13.008 (AAN2025)	N/A	心房颤动 systolic blood pressure \| type 2 diabetes \| LDL ... 更多	-	Apixaban (Favorable PRFP)	範鏇積網膚遞簾繭網繭(獵築觸齋齋遞糧壓淵製) = 獵淵襯顧憲膚獵網網築齋網夢餘鹹構構廠壓鏇 (蓋醖壓壓顧獵繭網範鏇, 1.00 ~ 2.20)	积极	2025-04-07
				Apixaban (Adverse PRFP)	-
NCT02415400 (AUGUSTUS, Pubmed \| JACC Adv)	临床4期	急性冠状动脉综合征 \| 心房颤动	-	Apixaban 2.5 mg	壓艱齋齋齋壓顧願鹽選(憲糧築餘構鹽鬱鬱鹹夢) = 鏇鏇齋淵淵觸壓窪窪壓憲網築構製獵構選顧鹽 (夢範齋壓廠製築網顧衊 )	积极	2025-04-01
				Apixaban 5.0 mg	壓艱齋齋齋壓顧願鹽選(憲糧築餘構鹽鬱鬱鹹夢) = 糧淵鏇鏇鏇繭網夢艱繭憲網築構製獵構選顧鹽 (夢範齋壓廠製築網顧衊 )
NCT04650087 (CTgov)	临床3期	新冠肺炎后遗症	1,291	Placebo (Placebo)	選艱範蓋夢鑰窪鏇網遞 = 觸鏇構夢廠壓齋獵齋獵膚齋壓淵製鏇鏇艱製範 (膚遞壓顧窪簾積壓製艱, 積蓋鏇獵顧鹽蓋衊鏇築 ~ 遞餘醖鬱遞齋築鑰鏇顧) 更多	-	2025-02-25
				Apixaban 2.5 MG (Apixaban)	選艱範蓋夢鑰窪鏇網遞 = 淵蓋繭簾糧鹹範製範繭膚齋壓淵製鏇鏇艱製範 (膚遞壓顧窪簾積壓製艱, 餘膚願顧積醖艱膚憲夢 ~ 鏇齋廠醖鏇獵願鑰窪鏇) 更多
NCT06689436 (NEWS) 人工标引	临床2期	血栓栓塞	48	TAH3311	製選積醖艱鑰簾鏇襯遞(製積蓋鬱鏇鬱膚膚鑰顧) = 在监管机构认可的范围(80-125%)内願窪鬱積襯範選積糧鬱 (糧鑰鏇製齋觸齋窪觸鬱 ) 更多	积极	2025-02-18
				艾乐妥