• 【apixaban与华法林在不同水平的预测国际标准化比率控制下预防房颤中风的疗效和安全性比较。】 复制标题 收藏 收藏
    DOI:10.1161/CIRCULATIONAHA.112.142158 复制DOI
    作者列表:
    BACKGROUND & AIMS: BACKGROUND:In the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial, apixaban compared with warfarin reduced stroke and systemic embolism, major bleeding, and mortality. We evaluated treatment effects in relation to 2 predictions of time in therapeutic range (TTR). METHODS AND RESULTS:The trial randomized 18 201 patients with atrial fibrillation to apixaban 5 mg twice daily or warfarin for at least 12 months. For each patient, a center average TTR was estimated with the use of a linear mixed model on the basis of the real TTRs in its warfarin-treated patients, with a fixed effect for country and random effect for center. For each patient, an individual TTR was also predicted with the use of a linear mixed effects model including patient characteristics as well. Median center average TTR was 66% (interquartile limits, 61% and 71%). Rates of stroke or systemic embolism, major bleeding, and mortality were consistently lower with apixaban than with warfarin across center average TTR and individual TTR quartiles. In the lowest and highest center average TTR quartiles, hazard ratios for stroke or systemic embolism were 0.73 (95% confidence interval [CI], 0.53-1.00) and 0.88 (95% CI, 0.57-1.35) (Pinteraction=0.078), for mortality were 0.91 (95% CI, 0.74-1.13) and 0.91 (95% CI, 0.71-1.16) (Pinteraction=0.34), and for major bleeding were 0.50 (95% CI, 0.36-0.70) and 0.75 (95% CI, 0.58-0.97) (Pinteraction=0.095), respectively. Similar results were seen for quartiles of individual TTR. CONCLUSIONS:The benefits of apixaban compared with warfarin for stroke or systemic embolism, bleeding, and mortality appear similar across the range of centers' and patients' predicted quality of international normalized ratio control.
    背景与目标:
  • 【阿哌沙班和利伐沙班治疗上肢深静脉血栓。】 复制标题 收藏 收藏
    DOI:10.1002/ajh.25820 复制DOI
    作者列表:Houghton DE,Casanegra AI,Peterson LG,Cochuyt J,Hodge DO,Vlazny D,McBane RD,Froehling D,Wysokinski WE
    BACKGROUND & AIMS: :Randomized controlled trials leading to the approval of apixaban and rivaroxaban for venous thromboembolism (VTE) did not include patients with upper extremity deep vein thrombosis (UE-DVT). We sought to evaluate the safety and effectiveness of rivaroxaban and apixaban for the treatment of acute UE-DVT. Consecutive patients with VTE enrolled into the Mayo Clinic VTE Registry, between March 1, 2013 and December 31, 2019, were followed prospectively. Clinical, demographic and imaging data were collected at the time of study recruitment. Patients with a diagnosis of acute UE-DVT who received rivaroxaban, apixaban, LMWH or warfarin were included. Recurrent VTE, major bleeding, clinical-relevant non-major bleeding (CRNMB), and death were assessed at 3-month intervals. During the study period, 210 patients with acute UE-DVT were included; 63 were treated with apixaban, 39 with rivaroxaban, and 108 with LWMH and/or warfarin. Overall 51% had catheter-associated UE-DVT, 60% had a diagnosis of malignancy, and 14% had concurrent pulmonary embolism. Malignancy was more common in patients treated with LMWH/warfarin (67% vs 52%, P = .03). At 3 months of follow up, one (0.9%) recurrent VTE occurred in a patient treated with LMWH/warfarin and one (1.0%) patient treated with apixaban or rivaroxaban (P = .97). Major bleeding occurred in three patients treated with LMWH/warfarin, and in none of those treated with apixaban or rivaroxaban (P = .09). Clinical-relevant non-major bleeding occurred in one patient (0.9%) treated with LWMH/warfarin and two patients (2.0%) treated with apixaban or rivaroxaban (P = .53). Treatment of UE-DVT with apixaban or rivaroxaban appears to be as safe and effective as LMWH/warfarin.
    背景与目标: : 导致批准阿哌沙班和利伐沙班用于静脉血栓栓塞 (VTE) 的随机对照试验不包括上肢深静脉血栓形成 (UE-DVT) 的患者。我们试图评估利伐沙班和阿哌沙班治疗急性u-dvt的安全性和有效性。在2013年3月1日和2019年12月31日之间,纳入Mayo Clinic VTE注册表的连续VTE患者进行了前瞻性随访。在研究招募时收集了临床,人口统计学和影像学数据。包括诊断为急性u-dvt的患者,这些患者接受了利伐沙班,阿哌沙班,LMWH或华法林治疗。每隔3个月评估复发性VTE,大出血,临床相关非大出血 (CRNMB) 和死亡。在研究期间,包括210例急性u-dvt患者; 63例接受阿哌沙班治疗,39例接受利伐沙班治疗,108例接受LWMH和/或华法林治疗。总体51% 有导管相关的ue-dvt,60% 诊断为恶性肿瘤,14% 并发肺栓塞。LMWH/华法林治疗的患者中恶性肿瘤更为常见 (67% vs 52%,P =  .03)。在3个月的随访中,用LMWH/华法林治疗的患者发生1例 (0.9%) 复发性VTE,用阿哌沙班或利伐沙班治疗的患者发生1例 (1.0% 例) (P =  .97)。3例LMWH/华法林治疗的患者发生大出血,而阿哌沙班或利伐沙班治疗的患者均未发生大出血 (P =  .09)。1例LWMH/华法林治疗的患者 (0.9%) 和2例阿哌沙班或利伐沙班治疗的患者 (2.0%) 发生了临床相关的非大出血 (P =  .53)。使用阿哌沙班或利伐沙班治疗UE-DVT似乎与LMWH/华法林一样安全有效。
  • 【阿哌沙班在静脉血栓栓塞治疗中的综合评价。】 复制标题 收藏 收藏
    DOI:10.1080/17474086.2020.1711731 复制DOI
    作者列表:Koehl JL,Hayes BD,Al-Samkari H,Rosovsky R
    BACKGROUND & AIMS: :Introduction: The emergence of the direct oral anticoagulants (DOACs) offers patients more convenient and accessible alternatives to warfarin or parenteral agents for the treatment of venous thromboembolism (VTE). Apixaban (Eliquis®) is an oral, direct factor Xa inhibitor that is approved for the acute treatment of deep-vein thrombosis (DVT) and pulmonary embolism (PE) as well as for the reduction in the risk of recurrent DVT and PE following initial therapy.Areas covered: This article reviews results from preclinical and healthy volunteer studies, large phase III trials evaluating the safety and efficacy of apixaban, as well as key studies that led to apixaban's current licensing. This review also will provide an overview of special populations where future areas of research are needed.Expert commentary: Apixaban offers several advantages over historical therapy for the treatment and secondary prevention of VTE. However, there are some populations in which the use of apixaban has not been extensively studied such as patients >75 years old, or those with cancer, low or high body weight, or poor renal function. Likewise, there is a dearth of data on pediatric patients and patients with a history of heparin-induced thrombocytopenia or identified forms of thrombophilia. Additional comparator studies on anticoagulation reversal involving andexanet alfa are also necessary to further assess its hemostatic efficacy and prothrombotic risk.
    背景与目标: 简介: 直接口服抗凝剂 (DOACs) 的出现为患者提供了更方便,更容易获得的华法林或肠胃外药物的替代品,用于治疗静脉血栓栓塞 (VTE)。阿哌沙班 (Eliquis®) 是一种口服直接因子Xa抑制剂,被批准用于深静脉血栓形成 (DVT) 和肺栓塞 (PE) 的急性治疗,以及在初始治疗后降低复发性DVT和PE的风险。本文回顾了临床前研究和健康志愿者研究,评估阿哌沙班安全性和有效性的大型III期试验以及导致阿哌沙班目前许可的关键研究的结果。这篇综述还将概述需要未来研究领域的特殊人群。专家评论: 阿哌沙班在治疗和二级预防VTE方面提供了优于历史疗法的几个优势。然而,在某些人群中,尚未对阿哌沙班的使用进行广泛研究,例如75岁以上的患者,或患有癌症,体重低或体重高或肾功能差的患者。同样,缺乏有关儿科患者和具有肝素诱导的血小板减少症或确定的血栓形成形式的患者的数据。还需要进行涉及andexanet alfa的抗凝逆转的其他比较研究,以进一步评估其止血功效和血栓形成风险。
  • 【阿哌沙班对不同类型房颤患者住院治疗的影响: 来自AVERROES试验的见解。】 复制标题 收藏 收藏
    DOI:10.1093/eurheartj/eht292 复制DOI
    作者列表:Hohnloser SH,Shestakovska O,Eikelboom J,Franzosi MG,Tan RS,Zhu J,Yusuf S,Connolly SJ
    BACKGROUND & AIMS: AIMS:The aim of this study was to evaluate the effects of apixaban, a novel oral factor Xa inhibitor, on the need for cardiovascular hospitalization. METHODS AND RESULTS:Our analysis is based on data from AVERROES, a randomized double-blind trial testing the efficacy and safety of apixaban against aspirin for the prevention of thrombo-embolism in 5599 atrial fibrillation (AF) patients unsuitable for vitamin K antagonist therapy. Hospitalizations were captured by dedicated case report forms and the outcome variable was time from randomization to the first hospitalization. Effects of treatment with apixaban on the rates of cardiovascular and non-cardiovascular hospitalizations were assessed using Cox proportional hazards regression models. During a mean follow-up of 1.1 years, 800 patients were hospitalized at least once for cardiovascular reasons, 442 (15.4%/year) in the aspirin group, 358 (12.3%) in the apixaban group [hazard ratio (HR) 0.80, 95% confidence interval (CI) 0.69-0.92; P = 0.002]. The reduction in cardiovascular hospitalization in the apixaban arm was predominantly due to a reduction in hospitalization for strokes, but there were also fewer hospitalizations for other cardiovascular causes. Patients with paroxysmal AF were significantly more likely to be hospitalized for AF treatment, whereas more heart failure admissions occurred in patients with permanent AF. Assignment to apixaban was the only independent predictor for a reduction in hospitalization. Cardiovascular hospitalization was the strongest independent predictor of subsequent mortality (HR: 3.95, 95% CI: 3.06-5.09; P < 0.001). CONCLUSION:In AVERROES, patients on apixaban therapy were less likely to be hospitalized. This may have important consequences for patients' well-being and for healthcare resources. This trial is registered underClinicalTrials.gov number, NCT00496769.
    背景与目标:
  • 【接受阿哌沙班或华法林治疗的非瓣膜性房颤患者的停药和初级保健就诊。】 复制标题 收藏 收藏
    DOI:10.2217/cer-2019-0005 复制DOI
    作者列表:Ramagopalan SV,Graham S,Carroll R,Raluy-Callado M,Nordstrom BL,Donaldson R,Colby C,Mehmud F,Alikhan R
    BACKGROUND & AIMS: AIM:Nonvalvular atrial fibrillation (NVAF) requires long-term anticoagulation treatment, which may necessitate frequent primary care visits. MATERIALS & METHODS:NVAF patients initiating warfarin or apixaban in 2012-2017 were identified from linked primary (Clinical Practice Research Datalink) and secondary care (Hospital Episode Statistics) data. A propensity score matched Cox regression model compared discontinuation risk. Primary care visits were compared via negative binomial regression. RESULTS:A total of 2695 apixaban users were matched to warfarin patients. Discontinuation risk was lower with apixaban than warfarin (hazard ratio: 0.40; 95% CI: 0.35-0.46). Apixaban patients averaged 12.2 annual primary care visits, versus 17.1 for warfarin users (p < 0.001). CONCLUSION:Apixaban was associated with reduced rates of discontinuation and primary care visits compared with warfarin.
    背景与目标:
  • 【先前用华法林治疗后,阿哌沙班对心房内血栓的溶栓作用: 一例病例报告。】 复制标题 收藏 收藏
    DOI:10.1159/000447539 复制DOI
    作者列表:Valero E,Santas E,Núñez J
    BACKGROUND & AIMS: OBJECTIVE:To highlight the usefulness of apixaban on intra-atrial thrombus that develops after previous treatment with warfarin. CLINICAL PRESENTATION AND INTERVENTION:A 69-year-old woman with a history of atrial fibrillation treated with warfarin presented with acute decompensated heart failure due to an episode of atrial fibrillation. Transesophageal echocardiogram revealed the presence of an intra-atrial thrombus. She was treated with apixaban, and transesophageal echocardiogram showed complete resolution of the thrombus after 3 weeks of treatment. CONCLUSION:This case highlights the usefulness of apixaban in the management of atrial fibrillation and proven intra-atrial thrombus.
    背景与目标:
  • 【使用阿哌沙班或维生素k拮抗剂治疗的非瓣膜性房颤患者的患者特征和出血事件: 来自意大利行政数据库的真实证据.】 复制标题 收藏 收藏
    DOI:10.2217/cer-2018-0054 复制DOI
    作者列表:Ramagopalan S,Allan V,Saragoni S,Esposti LD,Alessandrini D,Perrone V,Buda S,Stynes G,Toma C,DeSolda F,a LHUs group.
    BACKGROUND & AIMS: AIM:This study aimed to evaluate the risk of major bleeding among two cohorts of nonvalvular atrial fibrillation patients newly initiating a vitamin K antagonist (VKA) or apixaban in a real-world setting in Italy. PATIENTS & METHODS:A retrospective study using a large administrative database of Italian local health units was performed, using data from ten local health units and patients were included from the date of new initiation of apixaban or VKAs from January 2012 to June 2015. RESULTS:Risk of major bleeding was calculated using an adjusted Cox regression model. Compared with VKA, apixaban had a significantly lower risk of major bleeding (hazard ratio = 0.44 [95% CI: 0.12-0.97]). CONCLUSION:In this analysis, apixaban was associated with a lower risk of major bleeding compared with VKA.
    背景与目标:
  • 【新型冠状病毒肺炎的抗凝: 依诺肝素、肝素和阿哌沙班对死亡率的影响。】 复制标题 收藏 收藏
    DOI:10.1055/s-0040-1720978 复制DOI
    作者列表:Billett HH,Reyes-Gil M,Szymanski J,Ikemura K,Stahl LR,Lo Y,Rahman S,Gonzalez-Lugo JD,Kushnir M,Barouqa M,Golestaneh L,Bellin E
    BACKGROUND & AIMS: BACKGROUND: Mortality in coronavirus disease of 2019 (COVID-19) is associated with increases in prothrombotic parameters, particularly D-dimer levels. Anticoagulation has been proposed as therapy to decrease mortality, often adjusted for illness severity. OBJECTIVE: We wanted to investigate whether anticoagulation improves survival in COVID-19 and if this improvement in survival is associated with disease severity. METHODS: This is a cohort study simulating an intention-to-treat clinical trial, by analyzing the effect on mortality of anticoagulation therapy chosen in the first 48 hours of hospitalization. We analyzed 3,625 COVID-19+ inpatients, controlling for age, gender, glomerular filtration rate, oxygen saturation, ventilation requirement, intensive care unit admission, and time period, all determined during the first 48 hours. RESULTS: Adjusted logistic regression analyses demonstrated a significant decrease in mortality with prophylactic use of apixaban (odds ratio [OR] 0.46, p = 0.001) and enoxaparin (OR = 0.49, p = 0.001). Therapeutic apixaban was also associated with decreased mortality (OR 0.57, p = 0.006) but was not more beneficial than prophylactic use when analyzed over the entire cohort or within D-dimer stratified categories. Higher D-dimer levels were associated with increased mortality (p < 0.0001). When adjusted for these same comorbidities within D-dimer strata, patients with D-dimer levels < 1 µg/mL did not appear to benefit from anticoagulation while patients with D-dimer levels > 10 µg/mL derived the most benefit. There was no increase in transfusion requirement with any of the anticoagulants used. CONCLUSION: We conclude that COVID-19+ patients with moderate or severe illness benefit from anticoagulation and that apixaban has similar efficacy to enoxaparin in decreasing mortality in this disease.
    背景与目标:
  • 【阿哌沙班与目前房颤患者卒中预防标准的成本-效果.】 复制标题 收藏 收藏
    DOI:10.1093/eurheartj/ehu006 复制DOI
    作者列表:Dorian P,Kongnakorn T,Phatak H,Rublee DA,Kuznik A,Lanitis T,Liu LZ,Iloeje U,Hernandez L,Lip GY
    BACKGROUND & AIMS: AIMS:Warfarin, a vitamin K antagonist (VKA), has been the standard of care for stroke prevention in patients with atrial fibrillation (AF). Aspirin is recommended for low-risk patients and those unsuitable for warfarin. Apixaban is an oral anticoagulant that has demonstrated better efficacy than warfarin and aspirin in the ARISTOTLE and AVERROES studies, respectively, and causes less bleeding than warfarin. We evaluated the potential cost-effectiveness of apixaban against warfarin and aspirin from the perspective of the UK payer perspective. RESULTS AND METHODS:A lifetime Markov model was developed to evaluate the pharmacoeconomic impact of apixaban compared with warfarin and aspirin in VKA suitable and VKA unsuitable patients, respectively. Clinical events considered in the model include ischaemic stroke, haemorrhagic stroke, intracranial haemorrhage, other major bleed, clinically relevant non-major bleed, myocardial infarction, cardiovascular hospitalization and treatment discontinuations; data from the ARISTOTLE and AVERROES trials and published mortality rates and event-related utility rates were used in the model. Apixaban was projected to increase life expectancy and quality-adjusted life years (QALYs) compared with warfarin and aspirin. These gains were expected to be achieved at a drug acquisition-related cost increase over lifetime. The estimated incremental cost-effectiveness ratio was £11 909 and £7196 per QALY gained with apixaban compared with warfarin and aspirin, respectively. Sensitivity analyses indicated that results were robust to a wide range of inputs. CONCLUSIONS:Based on randomized trial data, apixaban is a cost-effective alternative to warfarin and aspirin, in VKA suitable and VKA unsuitable patients with AF, respectively.
    背景与目标:
  • 10 Apixaban: first global approval. 复制标题 收藏 收藏

    【Apixaban: 首次全球批准。】 复制标题 收藏 收藏
    DOI:10.2165/11596820-000000000-00000 复制DOI
    作者列表:Watson J,Whiteside G,Perry C
    BACKGROUND & AIMS: :Apixaban (Eliquis™), an oral direct factor Xa inhibitor, is being developed by Bristol-Myers Squibb and Pfizer as a therapy for the prevention and/or treatment of thrombotic disorders. Apixaban has been approved in the EU for the prevention of venous thromboembolism (VTE) after hip or knee replacement. A rolling submission for approval of apixaban for the prevention of stroke in patients with atrial fibrillation has also been initiated in the US. Worldwide phase III development of apixaban is underway for the prevention and treatment of VTE, and prevention of stroke in patients with atrial fibrillation. Development for acute coronary syndromes has been stopped following the discontinuation of the phase III APPRAISE-II trial. This article summarizes the milestones in the development of apixaban leading to this first approval for the prevention of VTE after hip or knee replacement.
    背景与目标: : 阿哌沙班 (Eliquis™百时美施贵宝 (Bristol-Myers Squibb) 和辉瑞 (Pfizer) 正在开发一种口服直接因子Xa抑制剂,作为预防和/或治疗血栓性疾病的疗法。阿哌沙班已在欧盟被批准用于预防髋关节或膝关节置换术后静脉血栓栓塞 (VTE)。在美国,还开始了批准阿哌沙班用于预防房颤患者中风的滚动提交。阿哌沙班的全球III期开发正在进行中,用于预防和治疗VTE以及预防房颤患者的中风。终止III期评估-II试验后,急性冠状动脉综合征的发展已停止。本文总结了阿哌沙班发展的里程碑,从而首次批准用于预防髋关节或膝关节置换术后的VTE。
  • 【阿哌沙班成功治疗WATCHMAN装置相关血栓: 一例报告。】 复制标题 收藏 收藏
    DOI:10.1097/MD.0000000000008693 复制DOI
    作者列表:Wong CK,Chan PH,Lam CC,Kwok OH,Lam YY,Siu CW
    BACKGROUND & AIMS: RATIONALE:Among atrial fibrillation patients with high risk of bleeding, left atrial appendage occlusion has emerged as an alternative to long-term oral anticoagulation therapy for stroke prevention. Device-related thrombus remains a major concern because it may result in recurrent embolic events. To date, there is no consensus on the optimal method of treating device-related-thrombus. PATIENT CONCERNS:A 78-year-old man with atrial fibrillation had an episode of intracranial hemorrhage while taking warfarin. He subsequently underwent percutaneous placement of a 30-mm Watchman device to the left atrial appendage. He was prescribed dual anti-platelet therapy with aspirin and clopidogrel. DIAGNOSIS:Reassessment echocardiography 3 months later found device-related thrombus. INTERVENTIONS:The antithrombotic regimen was switched from dual antiplatelet therapy to apixaban. OUTCOMES:Reassessment echocardiography 3 months later revealed complete resolution of the device-related thrombus. Apixaban was stopped. He had dual antiplatelet therapy for 6 more months followed by life-long aspirin. There was no bleeding complication since implantation of Watchman device. LESSONS:We demonstrated successful treatment of device-related thrombus with a short course of apixaban with complete resolution of thrombus. Further randomized controlled trials are required to determine the choice and duration of drug therapy for device-related thrombus.
    背景与目标:
  • 【阿哌沙班在预防非瓣膜性心房颤动中中风和全身性栓塞的作用.】 复制标题 收藏 收藏
    DOI:10.1358/dot.2013.49.7.1980498 复制DOI
    作者列表:Pujadas-Mestres L,Escolar G,Arellano-Rodrigo E,Galán AM
    BACKGROUND & AIMS: :Conventional anticoagulant therapies can significantly reduce the risk of stroke and related complications in patients with atrial fibrillation (AF). Classic oral anticoagulants based on vitamin K antagonism have shown effectiveness in the prevention of thromboembolic complications in this clinical setting. Unfortunately, vitamin K antagonists that have shown effectiveness in the prevention of thromboembolic complications in patients with nonvalvular AF hold inherent limitations including delayed onset of action, narrow therapeutic index, variability of their response, need for repeated control and numerous interactions with food and other drugs. Since the frequency of stroke related to AF increases with age, guidelines from different scientific societies advise that the risk of bleeding for a patient should be quantified before exposure to anticoagulation and balanced against the risk of stroke with and without anticoagulation. A consequence of assessing this risk/benefit balance is that not all patients with AF at thromboembolic risk receive adequate anticoagulant treatment. Apixaban is a new oral anticoagulant with a direct, specific and reversible inhibitory action on coagulation factor Xa and with demonstrated safety and efficacy in the prophylaxis and treatment of venous thromboembolism in several clinical studies involving thousands of patients subjected to major orthopedic surgery. Results of two large phase III trials have demonstrated the efficacy and safety of apixaban compared with aspirin or warfarin, in the prevention of stroke in patients with AF. Apixaban demonstrated superiority over classic vitamin K antagonists on the previously specified outcomes of stroke, systemic embolism, major bleeding and death. For those patients unsuitable for treatment with vitamin K antagonists because of an excessive bleeding risk, apixaban showed more efficacy than aspirin in stroke prevention with a not statistically significant modest increase of major bleeding.
    背景与目标: : 常规的抗凝治疗可以显着降低房颤 (AF) 患者的中风和相关并发症的风险。基于维生素k拮抗作用的经典口服抗凝剂已显示出在该临床环境中预防血栓栓塞并发症的有效性。不幸的是,已显示出对非瓣膜性AF患者的血栓栓塞并发症预防有效的维生素k拮抗剂具有固有的局限性,包括作用延迟,治疗指数狭窄,反应变异性,需要重复控制以及与食物和其他药物的多种相互作用。由于与AF相关的卒中频率随着年龄的增长而增加,因此来自不同科学社会的指南建议,在接受抗凝治疗之前,应量化患者的出血风险,并平衡有无抗凝治疗的中风风险。评估这种风险/收益平衡的结果是,并非所有具有血栓栓塞风险的AF患者都接受了足够的抗凝治疗。阿哌沙班是一种新型口服抗凝剂,对凝血因子Xa具有直接,特异性和可逆的抑制作用,并在预防和治疗静脉血栓栓塞症方面具有安全性和有效性,涉及数千例接受骨科手术的患者。两项大型III期试验的结果表明,与阿司匹林或华法林相比,阿哌沙班在预防房颤患者中风方面的有效性和安全性。阿哌沙班在先前指定的中风,全身性栓塞,大出血和死亡的结局方面表现出优于经典的维生素k拮抗剂的优势。对于那些由于出血风险过大而不适合使用维生素k拮抗剂治疗的患者,阿哌沙班在预防中风方面显示出比阿司匹林更高的功效,但主要出血的增加在统计学上没有显着增加。
  • 13 Apixaban: an emerging oral factor Xa inhibitor. 复制标题 收藏 收藏

    【阿哌沙班: 一种新兴的口服因子Xa抑制剂。】 复制标题 收藏 收藏
    DOI:10.1007/s11239-009-0421-4 复制DOI
    作者列表:Roser-Jones C,Becker RC
    BACKGROUND & AIMS: :Apixaban, an oral direct factor Xa inhibitor, is currently in late stage clinical development for the prevention and treatment of thromboembolic diseases. In comparison with current treatment standards for venous thromboembolism (VTE) prophylaxis, apixaban has shown decreased rates of clinically significant bleeding with mixed results in terms of non-inferiority for VTE events. Secondary treatment of VTE with apixaban is currently in phase III clinical study after earlier trials showed comparable safety and efficacy outcomes. The APPRAISE-1 trial, a phase II investigation of apixaban versus placebo following acute coronary syndrome showed a higher risk of clinically significant bleeding in addition to a trend toward decreased ischemic events. A large, international phase III clinical study (APPRAISE-2) of apixaban following acute coronary syndrome is currently underway. Large, phase III studies testing apixaban for the prevention of vascular events in subjects with non-valvular atrial fibrillation are also ongoing.
    背景与目标: : 阿哌沙班是一种口服直接因子Xa抑制剂,目前在预防和治疗血栓栓塞性疾病方面处于晚期临床开发阶段。与目前预防静脉血栓栓塞 (VTE) 的治疗标准相比,阿哌沙班的临床显着出血率降低,VTE事件的非劣效性结果参差不齐。在早期试验显示出相当的安全性和有效性结果后,阿哌沙班的VTE二次治疗目前处于III期临床研究中。评估-1试验是急性冠状动脉综合征后阿哌沙班与安慰剂的II期研究,除了缺血性事件减少的趋势外,临床上显着出血的风险更高。目前正在进行急性冠状动脉综合征后阿哌沙班的大型国际III期临床研究 (评估-2)。大型III期研究也在进行中,测试阿哌沙班预防非瓣膜性房颤患者的血管事件。
  • 【阿哌沙班与华法林预防心房颤动消融围手术期脑血栓栓塞的比较: 多中心前瞻性随机研究.】 复制标题 收藏 收藏
    DOI:10.1111/jce.12928 复制DOI
    作者列表:Kuwahara T,Abe M,Yamaki M,Fujieda H,Abe Y,Hashimoto K,Ishiba M,Sakai H,Hishikari K,Takigawa M,Okubo K,Takagi K,Tanaka Y,Nakajima J,Takahashi A
    BACKGROUND & AIMS: INTRODUCTION:Stroke can be a life-threatening complication of atrial fibrillation (AF) catheter ablation. Uninterrupted warfarin treatment contributes to minimizing the risk of stroke complications. METHODS AND RESULTS:This was a prospective, open-label, randomized, multicenter study assessing the safety and efficacy of apixaban for the prevention of cerebral thromboembolism complicating AF catheter ablation. Two hundred patients with drug-resistant AF were equally assigned to take either apixaban (5 mg or 2.5 mg twice daily) or warfarin (target international normalized ratio, 2-3) for at least 1 month before AF ablation. Neither drug regimen was interrupted throughout the operative period. Diffusion-weighted magnetic resonance imaging was performed for all patients to detect silent cerebral infarction (SCI) after the ablation. Primary outcomes were defined as the occurrence of stroke, transient ischemic attack, SCI, or major bleeding that required intervention. The secondary outcome was minor bleeding. The groups did not statistically differ in patients' backgrounds or procedural parameters. During AF ablation, the apixaban group required administration of more heparin to maintain an activated clotting time > 300 seconds than the warfarin group (apixaban, 14,000 ± 4,000 units; warfarin, 9,000 ± 3,000 units). Three primary outcome events occurred in each group (apixaban, 2 SCI and 1 major bleed; warfarin, 3 SCI, P = 1.00), and 3 and 4 secondary outcome events occurred in the apixaban and warfarin groups (P = 0.70), respectively. CONCLUSION:Apixaban has similar safety and effectiveness to warfarin for the prevention of cerebral thromboembolism during the periprocedural period of AF ablation.
    背景与目标:
  • 【在日本非瓣膜性房颤患者中,阿哌沙班,达比加群和小剂量利伐沙班与华法林的出血风险比较: 对行政索赔数据的倾向匹配分析。】 复制标题 收藏 收藏
    DOI:10.1080/03007995.2017.1374935 复制DOI
    作者列表:Kohsaka S,Murata T,Izumi N,Katada J,Wang F,Terayama Y
    BACKGROUND & AIMS: OBJECTIVES:There is scarce evidence comparing novel oral anticoagulants (NOACs) with warfarin in real-world settings in Japan. This study compared the risk of bleeding events among patients with non-valvular atrial fibrillation (NVAF) initiating treatment with NOACs versus warfarin. METHODS:A retrospective cohort study was conducted using a de-identified electronic health record based database of health claims and Diagnosis Procedure Combination data from 275 consenting hospitals in Japan. NVAF patients newly initiated on oral anticoagulants were eligible. Based on the first prescription, patients were assigned to 5/2.5 mg BID apixaban, 150/110 mg BID dabigatran, 15/10 mg QD rivaroxaban (approved dose lower in Japan compared to Western countries [20/15 mg QD]) or warfarin groups. One-to-one propensity score matching (PSM) was used to balance patient characteristics between warfarin and each NOAC. Patients were followed up to 1 year post-first prescription. RESULTS:Among 38,662 eligible patients, a total of 5977, 5090, and 6726 matched pairs were identified for warfarin versus apixaban, warfarin versus dabigatran, and warfarin versus rivaroxaban, respectively after PSM. Compared to warfarin, apixaban (hazard ratio [HR] 0.586; 95% CI 0.421-0.815), dabigatran (HR 0.617; 0.425-0.895) and rivaroxaban (HR 0.693; 0.514-0.933) were associated with a significantly lower risk of major bleeding. The risk of any bleeding was significantly lower for apixaban (HR 0.782; 0.682-0.896), but not for dabigatran (HR 0.988; 0.860-1.135) or rivaroxaban (HR 0.938; 0.832-1.057) when comparing to warfarin. CONCLUSIONS:Among Japanese patients with NVAF, treatment with apixaban 5/2.5 mg BID was associated with a significantly lower risk of major bleeding and any bleeding when compared to warfarin. Treatment with dabigatran 150/110 mg BID or rivaroxaban 15/10 mg QD was associated with a significantly lower risk of major bleeding, but not any bleeding, than warfarin. The potential benefit of individual NOACs in real-world practice needs to be assessed further.
    背景与目标:

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