Post-polypectomy bleeding and thromboembolism risks associated with warfarin vs direct oral anticoagulants

AIM To verify the validity of the endoscopy guidelines for patients taking warfarin or direct oral anticoagulants(DOAC).METHODS We collected data from 218 patients receiving oral anticoagulants(73 DOAC users, 145 warfarin users) and 218 patients not receiving any antithrombotics(age-and sexmatched controls) who underwent polypectomy.(1) We evaluated post-polypectomy bleeding(PPB) risk in patients receiving warfarin or DOAC compared with controls;(2) we assessed the risks of PPB and thromboembolism between three AC management methods: Discontinuing AC with heparin bridge(HPB)(endoscopy guideline recommendation), continuing AC, and discontinuing AC without HPB.RESULTS PPB rate was significantly higher in warfarin users and DOAC users compared with controls(13.7% and 13.7% vs 0.9%, P < 0.001), but was not significantly different between rivaroxaban(13.2%), dabigatran(11.1%), and apixaban(13.3%) users. Two thromboembolic events occurred in warfarin users, but none in DOAC users. Compared with the continuing anticoagulant group, the discontinuing anticoagulant with HPB group(guideline recommendation) had a higher PPB rate(10.8% vs 19.6%, P = 0.087). These findings were significantly evident in warfarin but not DOAC users. One thrombotic event occurred in the discontinuing anticoagulant with HPB group and the discontinuing anticoagulant without HPB group; none occurred in the continuing anticoagulant group.CONCLUSION PPB risk was similar between patients taking warfarin and DOAC. Thromboembolism was observed in warfarin users only. The guideline recommendations for HPB should be re-considered.

Evaluation of the safety and effectiveness of direct oral anticoagulants and low molecular weight heparin in gastrointestinal cancer-associated venous thromboembolism

BACKGROUND Gastrointestinal cancer(GICA)is associated with a higher incidence of venous thromboembolism(VTE)compared to other solid tumors,moreover,recurrent VTE and major bleeding(MB)complications during anticoagulation treatment have an associated increase rate.GICA-VTE remains a challenging clinical scenario with MB concerns for utilization of direct oral anticoagulants(DOAC),especially with active cancer therapies.AIM To evaluate patient risk factors,effectiveness(VTE)and safety(MB)of DOACs and low molecular weight heparin(LMWH)in patients with active GICA-VTE.METHODS A retrospective chart review of patients receiving DOACs and LMWH with GICA and symptomatic or incidental VTE treated at comprehensive cancer center from November 2013 to February 2017 was performed.Inclusion criteria included active GI cancer diagnosed at any stage or treatment+/-6 mo of VTE diagnosis,whom were prescribed 6 mo or more of DOACs or LMWH.The Chi-squared test was used for overall and the Fisher exact test for pairwise comparisons of the proportions of patients experiencing recurrent VTE and MB events.Odds ratios were used to compare the relative odds of the occurrence of the outcome given exposure to the risk factor.RESULTS A total of 144 patients were prescribed anticoagulation,in which 106 fulfilled inclusion criteria apixaban(27.3%),rivaroxaban(34.9%)and enoxaparin(37.7%),and 38 were excluded.Patients median age was 66.5 years at GICA diagnosis and 67 years at CAVTE event,with 62%males,80%Caucasian,70%stage IV,pancreatic cancer(40.5%),30%Khorana Score(≥3 points),and 43.5%on active chemotherapy.Sixty-four percent of patients completed anticoagulation therapy(range 1 to 43 mo).Recurrent VTE at 6 mo was noted in 7.5%(n=3),6.8%(n=2)and 2.7%(n=1)of patients on enoxaparin,apixaban and rivaroxaban,respectively(all P=NS).MB at 6 mo were 5%(n=2)for enoxaparin,6.8%(n=2)for apixaban and 21.6%(n=8)for rivaroxaban(overall P=0.048;vs LMWH P=0.0423;all other P=NS).Significant predictors of a primary or secondary outcome for all anticoagulation therapies included:Active systemic treatment(OR=5.1,95%CI:1.3-19.3),high Khorana Score[≥3 points](OR=5.5,95%CI:1.7-17.1),active smoker(OR=6.7,95%CI:2.1-21.0),pancreatic cancer(OR=6.8,95%CI:1.9-23.2),and stage IV disease(OR=9.9,95%CI:1.2-79.1).CONCLUSION Rivaroxaban compared to apixaban and enoxaparin had a significantly higher risk of MB on GICA-VTE patients with equivocal efficacy.

Superior safety of direct oral anticoagulants compared to Warfarin in patients with atrial fibrillation and underlying cancer: a national veterans affairs database study

Background Studies evaluating safety of warfarin and direct oral anticoagulants(DOACs) for prevention of stroke in patients with atrial fibrillation(AF) are lacking. Methods & Results All patients(n = 196,521) receiving care at veteran’s affairs with active cancer and AF from 2010–2015 were included. One-year mortality was significantly higher in unadjusted analysis with warfarin(44.9%) compared to dabigatran(25%, P < 0.001), rivaroxaban(24.4%, P < 0.001) and apixaban(30%, P < 0.001) and after adjusting for age, sex and type of cancer mortality(OR = 2.66, 95% CI: 2.52–2.82, P < 0.001). Risk of ischemic stroke(13.5% vs. 11.1%, 12.0%, 14.0%) was similar, however risk of hemorrhagic stroke was significantly higher among patients receiving warfarin(1.2%) compared to patients receiving dabigatran(0.5%), rivaroxaban(0.7%) and apixaban(0.8%) respectively, P = 0.04. Conclusions We demonstrated the superior safety profile of DOACs compared to warfarin among patients with underlying cancer and AF. Warfarin was associated with higher mortality, similar ischemic stroke risk but higher risk of hemorrhagic stroke.

Compliance and adherence to oral anticoagulation therapy in elderly patients with atrial fibrillation in the era of direct oral anticoagulants

Thromboembolic complications represent a substantial problem in patients with atrial fibrillation （AF）. The prevalence of AF burden and associated arterial and venous thrombosis progressively increases with age. At the same time, representative national data regarding stroke incidence in AF patients aged 80 and older are limited.

Assessment of delayed bleeding after endoscopic submucosal dissection of early-stage gastrointestinal tumors in patients receiving direct oral anticoagulants

Delayed bleeding is a major and serious adverse event of endoscopic submucosal dissection(ESD)for early-stage gastrointestinal tumors.The rate of post-ESD bleeding for gastric cancer is higher(around 5%-8%)than that for esophagus,duodenum and colon cancer(around 2%-4%).Although investigations into the risk factors for post-ESD bleeding have identified several procedure-,lesion-,physician-and patient-related factors,use of antithrombotic drugs,especially anticoagulants[direct oral anticoagulants(DOACs)and warfarin],is thought to be the biggest risk factor for post-ESD bleeding.In fact,the post-ESD bleeding rate in patients receiving DOACs is 8.7%-20.8%,which is higher than that in patients not receiving anticoagulants.However,because clinical guidelines for management of ESD in patients receiving DOACs differ among countries,it is necessary for endoscopists to identify ways to prevent post-ESD delayed bleeding in clinical practice.Given that the pharmacokinetics(e.g.,plasma DOAC level at both trough and T_(max))and pharmacodynamics(e.g.,anti-factor Xa activity)of DOACs are related to risk of major bleeding,plasma DOAC level and anti-FXa activity may be useful parameters for monitoring the anti-coagulate effect and identifying DOAC patients at higher risk of post-ESD bleeding.

Multicenter experience with photoselective vaporization of the prostate on men taking novel oral anticoagulants

Objective:Photoselective vaporization of the prostate(PVP)is a widely performed surgical procedure for benign prostatic obstruction.This approach has become particular favoured for men on anti-platelet and anticoagulation agents such as clopidogrel and warfarin but there is minimal published experience in the setting of novel oral anticoagulants(NOACs).This study was to examine the perioperative outcomes in men on NOACs undergoing PVP,with particular reference to perioperative morbidity.Methods:A retrospective analysis of PVP datasets was undertaken from three centres in Sydney(Australia),Toulouse(France)and Boston(USA).Subjects who had been treated whilst on NOACs without discontinuation or bridging were identified.Perioperative outcomes and treatment parameters were examined and morbidity recorded according to Clavien-Dindo(CD)classification.Results:There were a total of 20 subjects who had undergone PVP whilst NOACs had been continued during the perioperative period.The mean age was 776.5 years.The mean prostate volume,energy utilization and vaporisation time was 9456 mL,301211 kJ,and 3521 min respectively.The mean postoperative duration of catheterization and duration of hospitalization was 2.22.4 days and 2.42.4 days respectively.There was a single episode of urinary tract infection and four subjects required re-catheterisation for non-hematuric retentions.Conclusions:This study supports the safety of men on NOACs undergoing PVP.Whilst this study represents the largest experience of PVP in these men,larger studies are necessary to confirm the safety of PVP in this group of men undergoing BPH-related surgery.

Efficacy and safety of non-vitamin K antagonist oral anticoagulants post-kidney transplantation

BACKGROUND Novel oral anticoagulants(NOACs)were developed as alternatives to vitamin K antagonists,primarily warfarin,as they do not require routine monitoring and have limited drug-drug and drug-food interactions.However,the efficacy and safety of these agents in kidney transplantation are not well studied.AIM To assess the profile and safety of NOACs for patients who had kidney transplantation,and to provide recommendations and guidelines on therapeutic strategies in these patients.METHODS This was a retrospective study carried out among adult patients who were actively on the following NOACs(apixaban,rivaroxaban or dabigatran)in our renal transplantation program from December 2015 to December 2016.The patients were identified primarily through electronic medical record system(patient data linkage).Data on the clinical and laboratory profile of the patients were retrieved and analyzed with SPSS 22.0.RESULTS Complete data on 42 renal transplant patients were retrieved:59.5%males,90.5%were whites and 66.7%were older than 60 years old.The mean duration since renal transplantation of the patients was 8.8±7.4 years.The most common risk factors for the development of end-stage renal disease in the subjects were hypertension(19.0%),polycystic kidney disease(19.0%),followed by diabetic nephropathy(16.7%)and chronic glomerulonephritis(16.7%).The main indications for NOACs use in the cohort were atrial fibrillation in 25 patients(59.5%)and venous thromboembolism in 10 patients(23.8%).Overall,29 patients(69%)were treated with apixaban,10 patients(23.8%)with rivaroxaban and 3 patients(7.14%)with dabigatran.No(0%)thromboembolic events were observed during the one-year period,but 3(7.1%)bleeding events occurred in the cohort consisting of 1 patient treated with rivaroxaban 15 mg daily and 2 patients who received apixaban 2.5 mg twice daily.There were no significant changes in serum tacrolimus level three days after the initiation of NOACs among patients treated with tacrolimus(pre-and post-NOACs tacrolimus levels were 7.2516 and 7.8867 ng/m L,P=0.55,respectively).Also,after one-year of treatment with NOACs there were no significant changes in the pre-and post-NOACs serum creatinine level(P=0.772)and estimated glomerular filtration rates(P=0.232).CONCLUSION No thromboembolic events or significant changes in renal profile were observed in our cohort of kidney transplant recipients who were treated with NOACs for at least a year.However,a few bleeding events were observed.This calls for further well-planned randomized controlled trials to assess the efficacy and safety of NOACs among renal transplant recipients.

Peribulbar anesthesia in 750 patients treated with oral anticoagulants

AIM: To check the safety of continuation of oral anticoagulants in ophthalmic procedures requiring a peribulbar anesthesia. ·METHODS: A prospective case control study included 750 patients with oral anticoagulants in group A and 750 patients who had never been treated with oral anticoagulant in group B. Hemorrhages were graded as follows: 1) spot ecchymosis of eyelid and or subconjunctival hemorrhage; 2) eyelid ecchymosis involving half of the lid surface area; 3) eyelid ecchymosis all around the eye,no increase in intraocular pressure; 4) retrobulbar hemorrhage with increased intraocular pressure. ·RESULTS: In group A,grade 1 was observed in 13 patients(1.74%) and grade 2 in 2 patients(0.26%). In group B,grade 1 was observed in 12 patients(1.6%) and grade 2 was absent. No 3 or 4 hemorrhage grade was encountered in both groups. There was not significant difference in grade 1 hemorrhage between both groups(P =0.21). ·CONCLUSION: Oral anticoagulants were not associated with a significant increase in potentially sight-threatening local anesthetic complications.

The Use of Direct Oral Anticoagulants for Prevention of Stroke and Systemic Embolic Events in East Asian Patients with Nonvalvular Atrial Fibrillation

As patients in East Asia age,the prevalence of age-related and chronic disease,including nonvalvular atrial fibrillation,may increase.Although warfarin has been the primary choice of anticoagulant for the prevention of stroke and systemic embolic events,the use of direct oral anticoagulants(DOACs)is increasing.DOACs do not require monitoring of the international normalized ratio to determine the optimal dose,and have a lower potential for food and drug interactions,improved benefi t-risk profiles,and a quicker onset and offset of action relative to warfarin.The pivotal phase 3 trials for each of the DOACs– dabigatran,rivaroxaban,apixaban,and edoxaban– included at least some East Asian patients.Additionally,several clinical trials were conducted specifically for East Asian patients.This review discusses patterns and predictors of anticoagulant use in East Asian patients with nonvalvular atrial fibrillation,summarizes current guideline recommendations for East Asian patients,details the primary results demonstrating the safety and efficacy of DOACs in East Asian patients relative to non– East Asian patients,provides real-world data supporting the phase 3 testing results,and addresses the clinical profile of DOACs in East Asian populations,including patients at high risk of stroke.

Liver injury from direct oral anticoagulants

BACKGROUND Drug-induced liver injury(DILI)can be caused by any prescribed drug and is a significant reason for the withdrawal of newly launched drugs.Direct-acting oral anticoagulants(DOACs)are non-vitamin K-based antagonists recently introduced and increasingly used for various clinical conditions.A meta-analysis of 29 randomised controlled trials and 152116 patients reported no increased risk of DILI with DOACs.However,it is challenging to predict the risk factors for DILI in individual patients with exclusion of patients with pre-existing liver disease from these studies.AIM To determine the risk factors and outcomes of patients who developed DILI secondary to DOACs by systematic review and meta-summary of recent case reports and series.METHODS A systematic search was conducted on multiple databases including PubMed,Science Direct,Reference Citation Analysis,and Google Scholar.The search terms included“Acute Liver Failure”OR“Acute-On-Chronic Liver Failure”OR“Acute Chemical and Drug Induced Liver Injury”OR“Chronic Chemical and Drug Induced Liver Injury”AND“Factor Xa Inhibitors”OR“Dabigatran”OR“Rivaroxaban”OR“apixaban”OR“betrixaban”OR“edoxaban”OR“Otamixaban”.The results were filtered for literature published in English and on adult patients.Only case reports and case studies reporting cases of DILI secondary to DOACs were included.Data on demographics,comorbidities,medication history,laboratory investigations,imaging,histology,management,and outcomes were extracted.RESULTS A total of 15 studies(13 case reports and 2 case series)were included in the analysis,comprising 27 patients who developed DILI secondary to DOACs.Rivaroxaban was the most commonly implicated DOAC(n=20,74.1%).The mean time to onset of DILI was 40.6 d.The most common symptoms were jaundice(n=15,55.6%),malaise(n=9,33.3%),and vomiting(n=9,33.3%).Laboratory investigations showed elevated liver enzymes and bilirubin levels.Imaging studies and liver biopsies revealed features of acute hepatitis and cholestatic injury.Most patients had a favourable outcome,and only 1 patient(3.7%)died due to liver failure.CONCLUSION DOACs are increasingly used for various clinical conditions,and DILI secondary to DOACs is a rare but potentially serious complication.Prompt identification and cessation of the offending drug are crucial for the management of DILI.Most patients with DILI secondary to DOACs have a favourable outcome,but a small proportion may progress to liver failure and death.Further research,including post-marketing population-based studies,is needed to better understand the incidence and risk factors for DILI secondary to DOACs.

Laboratory Tests in Assessing the Bleeding Risk in Patients Receiving Direct Oral Anticoagulants (DOACs)

Direct oral anticoagulants (DOACs)—apixaban, rivaroxaban and dabigatran have become the first line medications for patients with thromboembolism. However, DOAC therapy-associated bleeding complications remain the major clinical concern for these patients.?This study compared laboratory test results from 82 patients with and 361 patients without DOAC-associated bleeding with the goal of determining the value of laboratory tests in assessing bleeding risk in these patients.?There was no age or gender difference between patients with and without DOAC therapy-associated bleeding complications. Both prothrombin time?(PT) and partial thromboplastin time (PTT) prolonged at the same time showed good correlation with bleeding complications for patients receiving dabigatran (91.7%) and rivaroxaban (41.2%). When comparing patients with bleeding and those without bleeding complications, impaired renal function showed high correlation (p??0.01),?impaired liver function?showed moderate correlation (p?=?0.03), and thrombocytopenia showed no correlation (p?>?0.05)?among patients with bleeding complications.?A small population of patients had never experienced bleeding complications, despite thelaboratory test results being similar to patients?who suffered?from bleeding complications. Laboratory tests may be useful in the assessment and prediction of bleeding complications in patients receiving DOAC therapy. However, it is important to incorporate both laboratory findings with the clinical information, such as concomitant antithrombotic agents and other underlying diseases in the decision making of DOAC therapy in order to reduce therapy-related bleeding risk.

Direct oral anticoagulants for the treatment of splanchnic vein thrombosis:A state of art

Splanchnic vein thrombosis(SVT)is a manifestation of venous thromboembolism in an unusual site.Portal,mesenteric,and splenic veins are the most common vessels involved in SVT which occurs mainly in patients with liver cirrhosis,although non-cirrhotic patients could be affected as well.Thrombosis of hepatic veins,also known as Budd-Chiari syndrome,is another manifestation of SVT.Prompt diagnosis and intervention are mandatory in order to increase the recalization rate and reduce the risk of thrombus progression and hypertensive complications.Traditional anticoagulation with heparin and vitamin-K antagonists is the treatment of choice in these cases.However,recent studies have shown promising results on the efficacy and safety of direct oral anticoagulants(DOACs)in this setting.Available results are mainly based on retrospective studies with small sample size,but first clinical trials have been published in the last years.This manuscript aims to provide an updated overview of the current evidence regarding the role of DOACs for SVT in both cirrhotic and non-cirrhotic patients.

Role of novel oral anticoagulants in the management and prevention of venous thromboembolism

Venous thromboembolism(VTE) encompasses deep vein thrombosis and pulmonary embolism and is a major health burden, both medically and economically. Anticoagulation is the primary treatment and can be divided into three stages: initial, long term and extended treatment. Initial anticoagulation is given to reduce the risk of complications including fatal pulmonary embolism, while long term and extended treatment are aimed at prevention of recurrent VTE. Until recently, initial anticoagulation has only been achievable with administration of parental agents such as unfractionated or low molecular weight heparin, while vitamin K antagonists such as warfarin, have been the mainstay of long term and extended treatment. Factor-Xa inhibitors and direct thrombin inhibitors are oral anticoagulants that are being increasingly utilized as an alternative form of anticoagulation. This article aims to review the current guidelines in the management of VTE, the recent literature regarding novel anticoagulants in VTE, suggested treatment regimes and limitations.

New Type of Oral Anticoagulants

Since 1960,so far,has half a century,long-term oral vitamin K antagonists(VKA)for anticoagulation main plan,but the shortcomings of the VKA but not allow to ignore:(1)the VKA effect to be slow,VKA after diagnosis should be immediate treatment,this plan have to

Incidence, clinical impact and risk of bleeding during oral anticoagulation therapy

Bleeding is the most important complication of oral anticoagulation (OAC) with vitamin K-antagonists. Whilst bleeding is unavoidably related to OAC, it may have a great impact on the prognosis of treated subjects by leading to discontinuation of treatment, permanent disability or death. The yearly incidence of bleeding during OAC is 2%-5% for major bleeding, 0.5%-1% for fatal bleeding, and 0.2%-0.4% for intracranial bleeding. While OAC interruption and/or antagonism, as well as administration of coagulation factors, represent the necessary measures for the management of bleeding, proper stratification of the individual risk of bleeding prior to start OAC is of paramount importance. Several factors, including advanced age, female gender, poor control and higher intensity of OAC, associated diseases and medications, as well as genetic factors, have been proven to be associated with an increased risk of bleeding. Most of these factors have been included in the development of bleeding prediction scores, which should now be used by clinicians when prescribing and monitoring OAC. Owing to the many limitations of OAC, including a narrow therapeutic window, cumber-some management, and wide interand intra-individual variability, novel oral anticoagulants, such as factor Xa inhibitors and direct thrombin inhibitors, have been recently developed. These agents can be given in f ixed doses, have little interaction with foods and drugs, and do not require regular monitoring of anticoagulation. While the novel oral anticoagulants show promise for effective thromboprophylaxis in atrial f ibrillation and venous thromboembolism, def initive data on their safety and eff icacy are awaited.

Efficacy and safety of novel anticoagulants in the elderly

Atrial fibrillation and venous thromboembolism （VTE） are common disorders associated with maleficent thrombotic events, particularly in the elderly patients. Polypharmacy, co-morbidities, and altered pharmacokinetics, often present in these patients, render the use of antico-agulants quite challenging. Novel oral anticoagulants （NOACs） have recently emerged as alternatives to Vitamin K Antagonists （VKAs） and are gradually increasing their popularity mainly because of their fewer drug and food interactions and ease of use. Their effectiveness and safety has been weU-established in the general population but the balance between benefit and harm in the elderly is still unclear. Routine use in these patients is uncommon. Accumulating data have shown that the benefit of NOACs is consistent among all age groups, featuring equal or greater efficacy in preventing thrombotic events. Excess bleedings were lower with NOACs in comparison to VKAs, but bleeding patterns were disparate among them and head to head comparison is not available. The present review highlights on the efficacy and safety of novel anticoagulants in the elderly population.

Dual versus single antiplatelet therapy for patients with long-term oral anticoagulation undergoing coronary intervention： a systematic review and meta-analysis

Objective The main aim of this meta-analysis is to compare the efficacy and safety of dual versus single antiplatelet therapy for pa- tients taking oral anticoagulation （OAC） after coronary intervention. Background The optimal regimen remains controversial for patients taking OAC after coronary intervention. Methods PubMed, Embase and Cochrane Central Register of Controlled Trials were searched for eligible studies including data of triple therapy （TT） versus OAC plus single antiplatelet therapy for patients requiring OAC after coronary intervention. The primary outcome was major adverse cardiac and cerebrovascular event （MACCE）. The safety outcome was major bleeding. Results Fourteen studies with 32,825 patients were included. Among prospective studies, patients with TT had a trend toward a higher risk of major bleeding [odds ratios （OR）： 1.56, 95% confidence interval （CI）： 0.98-2.49, P = 0.06] and a markedly higher risk of all-cause death （OR; 2.11, 95% CI： 1.10-4.06 P = 0.02） compared with OAC plus clopidogrel. Meanwhile, TT was associated with decreased risks of MACCE （OR： 0.63, 95% CI： 051-0.77 P 〈 0.0001）, all-cause death （OR： 0.45, 95% CI： 0.20-0.97, P = 0.04）, and stroke/transient ischemic attack （TIA）/peripheral embolism （PE） （OR= 0.29, 95% CI： 0.09~3.96, P = 0.04） compared with OAC plus aspirin. Conclusions For pa- tients requiring OAC after coronary intervention, OAC plus clopidogrel may bring more clinical net benefit than TT, whereas OAC plus aspirin should be the last choice. More large-size randomized control trials are needed to confirm these findings.

Deciding the Gold Standard for Oral Anticoagulation Therapy

Healthcare practitioners have many anticoagulant options for treating various disease states pertaining to blood clots and blood clot formation. Each anticoagulant has pros and cons and the decision of which pharmacological agent to use can be confusing and difficult. In years past, Vitamin K antagonists have been the standard of care when treating specific disease states such as atrial fibrillation and venous thromboembolism based on habit and cost of care. The emergence of newer anticoagulants should be considered the new standard of care based on the evidence presented over the last several years.

利伐沙班在犬和猫临床应用的研究进展

血栓栓塞是犬、猫临床上多种疾病的并发症,可累及动脉或静脉,预后较差。目前兽医临床防治血栓栓塞可用的抗血栓药物种类有限,影响临床诊疗水平,引入新药具有实际意义。利伐沙班是一种新型非维生素K拮抗剂类口服抗凝药物,研究证明其能够特异性抑制活性凝血因子X从而抑制血栓形成。近年来人医领域对利伐沙班的相关临床研究逐渐丰富,涉及单用利伐沙班或使用双通路抑制疗法防治不同类型的动、静脉血栓栓塞,可为其应用于兽医临床提供据。犬、猫临床使用利伐沙班的研究正相继开展,论文就犬、猫血栓栓塞疾病发病情况、防治现状,利伐沙班的药理学特性及其在人医、兽医领域的临床试验研究进展进行综述,以期为兽医临床上利伐沙班的进一步研究提供参考。

基于真实世界对华法林、达比加群酯、利伐沙班上市后不良事件信号的挖掘和分析

目的挖掘华法林、达比加群酯、利伐沙班的药品不良事件(ADE)信号,为口服抗凝药物临床安全合理应用提供参考。方法基于美国FDA不良事件报告系统(FAERS),采用报告比值比法、比例报告比法对FAERS项目中目标药物在FDA获批上市起至2023年第1季度上报的ADE报告进行数据挖掘,分析报告病例基本情况;映射得到对应的系统器官分类(SOC)以及首选术语(PT)并进行分析。结果共收集到以目标药物为首要怀疑药物的ADE报告223649例,74.29%的报告集中在65岁以上人群。从中挖掘得到有效信号1678个,涉及27个SOC,发生频次最高的为胃肠道系统疾病。PT分析发现:根据频次排序,华法林、达比加群酯和利伐沙班居于首位的PT均为胃肠出血;根据信号强度排序,华法林中居于首位的PT为胃出血(1030例),达比加群酯为下消化道出血(1162例),利伐沙班为肠憩室出血(784例)。结论本研究的结果对真实世界中华法林、达比加群酯、利伐沙班的应用提出了重要警示,在临床实践应用中,高龄老年患者应用新型口服抗凝药物(NOACs)时,消化道出血风险应引起重视,应充分评估出血风险,重视个体化给药,严密动态监测出血迹象。