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2.
J Thromb Haemost ; 21(1): 76-82, 2023 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-36695399

RESUMO

BACKGROUND: Central venous catheters are prone to clotting, particularly in patients with cancer. Although low-molecular-weight heparin and direct oral anticoagulants, such as apixaban and rivaroxaban, have been evaluated for the prevention of catheter thrombosis, their efficacy remains uncertain. OBJECTIVES: Compare apixaban and rivaroxaban with enoxaparin for the prevention of catheter-induced clotting in vitro. METHODS: To address this uncertainty, we used a well-established microplate-based assay to compare the effects of enoxaparin, apixaban, and rivaroxaban on catheter-induced thrombosis and thrombin generation in human plasma. RESULTS: Consistent with our previous findings, catheter segments shortened the clotting time and promoted thrombin generation. When compared at concentrations with similar anti-factor Xa activity as enoxaparin, apixaban and rivaroxaban were >20-fold less potent than enoxaparin for the prevention of catheter-induced clotting and thrombin generation. CONCLUSION: The prevention of catheter thrombosis in patients with cancer is challenging. Clinical trials are needed to compare the efficacy of low-molecular-weight heparin with that of direct oral anticoagulants both for the prevention and treatment of catheter thrombosis.


Assuntos
Neoplasias , Trombose , Humanos , Enoxaparina/farmacologia , Enoxaparina/uso terapêutico , Rivaroxabana/uso terapêutico , Anticoagulantes/uso terapêutico , Trombina , Piridonas/farmacologia , Piridonas/uso terapêutico , Heparina de Baixo Peso Molecular/uso terapêutico , Trombose/etiologia , Trombose/prevenção & controle , Cateteres , Neoplasias/tratamento farmacológico , Inibidores do Fator Xa/uso terapêutico
4.
Bioorg Med Chem Lett ; 80: 129127, 2023 Jan 15.
Artigo em Inglês | MEDLINE | ID: mdl-36634753

RESUMO

A series of pyrrolo[3,2-d]pyrimidineone compounds have been designed and synthesized as novel FXa inhibitors. Bioassay of the tested compounds showed moderate to excellent anticoagulant potency in vitro. Further FXa inhibitory and bioactivity evaluation in rats, the FeCl3-induced venous thrombosis model, showed that the compound 17a has good FXa inhibitory activity (IC50 = 1.57 nM) and in vivo antithrombotic potency. The anticoagulant effects of compound 17a were dose dependent whether in vitro or in vivo. The results further confirmed our hypothesis that the large conjugated structure is an ideal skeleton binding FXa.


Assuntos
Inibidores do Fator Xa , Trombose Venosa , Ratos , Animais , Fator Xa/metabolismo , Anticoagulantes
5.
Tidsskr Nor Laegeforen ; 142(1)2023 Jan 17.
Artigo em Norueguês | MEDLINE | ID: mdl-36655971

RESUMO

Venous thromboembolism is a common complication of cancer. The prevalence varies according to cancer type and increases proportionally with the stage of cancer. In the past 15-20 years, low molecular weight heparin has been recommended as the first-line treatment. New international guidelines now allow for use of direct factor Xa inhibitors both as prophylaxis and treatment for venous thromboembolism. Prophylaxis should as a general rule only be initiated in patients with moderate to high risk. Bleeding risk assessment is important before starting anticoagulation. Both thrombosis and bleeding risk can change and should therefore be assessed on an ongoing basis. In this clinical review, use of anticoagulation therapy in cancer patients is discussed with particular emphasis on the use of direct factor Xa inhibitors.


Assuntos
Neoplasias , Tromboembolia Venosa , Humanos , Tromboembolia Venosa/tratamento farmacológico , Tromboembolia Venosa/etiologia , Tromboembolia Venosa/prevenção & controle , Inibidores do Fator Xa/efeitos adversos , Anticoagulantes/efeitos adversos , Heparina de Baixo Peso Molecular/uso terapêutico , Heparina de Baixo Peso Molecular/efeitos adversos , Neoplasias/complicações , Neoplasias/tratamento farmacológico
6.
Nihon Yakurigaku Zasshi ; 158(1): 89-100, 2023.
Artigo em Japonês | MEDLINE | ID: mdl-36596498

RESUMO

Andexanet alfa is a modified recombinant human factor Xa (FXa) that was designed to serve as a binding target for FXa inhibitors as decoy protein. It sequesters FXa inhibitors from binding to endogenous FXa, thereby reversing anticoagulant effect of FXa inhibitors. Andexanet alfa has been approved in March 2022 in Japan for patients with life-threatening or uncontrolled bleeding while on treatment with a FXa inhibitor, apixaban, rivaroxaban, or edoxaban tosilate hydrate. It is administered via two dosing regimens, based on the type of FXa inhibitor, dose, and time since the last dose. In nonclinical studies, andexanet alfa significantly inhibited bleeding induced by FXa inhibitors in animal bleeding models. In the development for Japanese patients, the following two clinical studies have been conducted to confirm the efficacy and safety. First, safety and the reversal effect of andexanet alfa on the FXa inhibitor-mediated anticoagulant activity in healthy adults were confirmed in the overseas phase 2 study including Japanese subjects. Next, the reversal effect of andexanet alfa on the anticoagulation activity and the hemostasis were demonstrated in patients with acute major bleeding while on FXa inhibitor treatment in the global phase 3b/4 study (ANNEXA-4 study). The subgroup analysis of Japanese population showed that the efficacy and safety results were consistent with those of overall population. Andexanet alfa is the first approved reversal agent for FXa inhibitors in Japan and is expected to contribute to the improvement of prognosis in patients with fatal and/or uncontrolled bleeding by timely reversing anticoagulant effect of FXa inhibitors.


Assuntos
Inibidores do Fator Xa , Fator Xa , Hemorragia , Proteínas Recombinantes , Adulto , Animais , Humanos , Fator Xa/administração & dosagem , Inibidores do Fator Xa/efeitos adversos , Hemorragia/induzido quimicamente , Hemorragia/prevenção & controle , Injeções Intravenosas , Proteínas Recombinantes/administração & dosagem , Ensaios Clínicos Fase III como Assunto , Ensaios Clínicos Fase IV como Assunto
8.
Thromb Res ; 221: 92-96, 2023 01.
Artigo em Inglês | MEDLINE | ID: mdl-36495716

RESUMO

INTRODUCTION: Paediatric clinical practice for treatment of venous thromboembolism (VTE) is based on extrapolation from adult trials with minimal data on anticoagulation efficacy and safety in children. Based on EINSTEIN-Jr clinical trial data, rivaroxaban was approved to treat VTE and prevent its recurrence in children of all ages. AIM: To report the safety and efficacy of rivaroxaban use in paediatric VTE and to present real-world data, specifically about very young children. METHODS: We conducted a retrospective observational study at Birmingham Children's Hospital. Data were collected from patients <16 years old who received rivaroxaban after its licensure in the period between March 2021 and June 2022. RESULTS: Rivaroxaban was used for treatment of acute VTE in 64 patients. Thrombosis was CVC-related in 26 patients, unprovoked in 3, while the rest had one or more risk factors for VTE. Safety and efficacy of rivaroxaban were assessed in 52 patients after excluding patients who were on current rivaroxaban treatment and those who were lost to follow up or stopped rivaroxaban due to intolerance. No bleeding events were reported, and recurrence of thrombosis occurred in only 3.6 %. About 35 % had normalised re-imaging, 40.3 % improved, 9.6 % were unchanged and 11.5 % stopped rivaroxaban without re-imaging. Rivaroxaban was used for secondary VTE prophylaxis in 6 patients in our cohort with no recurrence of thrombosis or bleeding reports. CONCLUSIONS: Our real-world experience confirmed that rivaroxaban was well tolerated, effective and safe. Further real-world data and observational studies are essential to investigate the use of rivaroxaban among different risk groups.


Assuntos
Tromboembolia Venosa , Trombose Venosa , Adulto , Humanos , Criança , Pré-Escolar , Adolescente , Rivaroxabana/efeitos adversos , Tromboembolia Venosa/prevenção & controle , Hemorragia/induzido quimicamente , Trombose Venosa/tratamento farmacológico , Coagulação Sanguínea , Anticoagulantes/efeitos adversos , Inibidores do Fator Xa/efeitos adversos
9.
Am J Cardiovasc Drugs ; 23(1): 9-17, 2023 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-36515822

RESUMO

This article aims to highlight the dosing issues of direct oral anticoagulants (DOACs) in patients with renal impairment and/or obesity in an attempt to develop solutions employing advanced data-driven techniques. DOACs have become widely accepted by clinicians worldwide because of their superior clinical profiles, more predictable pharmacokinetics, and hence more convenient dosing relative to other anticoagulants. However, the optimal dosing of DOACs in extreme bodyweight  patients and patients with renal impairment is difficult to achieve using the conventional dosing approach. The standard dosing approach (fixed-dose) is based on limited data from clinical studies. The existing formulae (models) for determining the appropriate doses for these patient groups leads to suboptimal dosing. This problem of mis-dosing is worsened by the lack of standardized laboratory parameters for monitoring the exposure to DOACs in renal failure and extreme bodyweight patients. Model-informed precision dosing (MIPD) encompasses a range of techniques like machine learning and pharmacometrics modelling, which could uncover key variables and relationships as well as shed more light on the pharmacokinetics and pharmacodynamics of DOACs in patients with extreme bodyweight or renal impairment. Ultimately, this individualized approach-if implemented in clinical practice-could optimise dosing for the DOACs for better safety and efficacy.


Assuntos
Inibidores do Fator Xa , Insuficiência Renal , Humanos , Inibidores do Fator Xa/uso terapêutico , Anticoagulantes/efeitos adversos , Insuficiência Renal/complicações , Peso Corporal , Obesidade/tratamento farmacológico , Administração Oral
10.
Clin Chim Acta ; 538: 216-220, 2023 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-36574540

RESUMO

BACKGROUND: Direct oral anticoagulants (DOACs) may cause falsely increased levels of antithrombin (AT) activity depending on the AT activity method and the specific target of the DOAC. Activated carbon (AC) has proven to remove DOAC interference on PT, aPTT and LA assays. We evaluate whether AC could be useful to resolve DOAC interference on AT assays. METHODS: Normal pooled plasma (NPP) was diluted to obtain AT activity of 25 %, 50 % and 75 % respectively. The diluted NPPs were spiked with DOACs (apixaban, edoxaban, dabigatran and rivaroxaban) in concentrations of respectively 100, 250 and 500 ng/ml. DOAC concentrations and AT activity were tested at baseline and after treatment with 20 mg/ml AC. AT activity was measured with a FXa-based method (HemosIL Liquid Antithrombin®, Werfen). RESULTS: All DOAC concentrations were below the limit of quantification (LoQ) after addition of AC. DOAC interference on AT activity testing was removed by adding AC, resulting in correctly diagnosing low levels of AT for all dilutions. The influence of DOACs on AT activity was directly correlated to the concentration of the DOAC. As expected, only the anti-FXa DOACs influenced the used assay. CONCLUSIONS: AC effectively removes anti-FXa DOAC interference on FXa-based AT assays.


Assuntos
Antitrombinas , Carvão Vegetal , Humanos , Antitrombinas/farmacologia , Inibidores do Fator Xa/farmacologia , Inibidores do Fator Xa/uso terapêutico , Anticoagulantes/uso terapêutico , Testes de Coagulação Sanguínea , Rivaroxabana , Administração Oral
11.
Thromb Res ; 222: 20-23, 2023 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-36563521

RESUMO

INTRODUCTION: There is a scarcity of data on anticoagulation-related nephropathy (ARN) caused by direct-acting oral anticoagulants (DOACs) in recent years. MATERIALS AND METHODS: We collected literatures on DOACs-induced ARN to October 1, 2022, without language restrictions for retrospective analysis. RESULTS: Twenty events were included with a median onset time of 28 days among which fourteen were caused by dabigatran. Patients accompanied by chronic kidney disease (85 %) seemed more easily to have an ARN. Clinical symptoms associated with ARN were mostly presented as hematuria and acute decline of renal function (100 %), then abnormal coagulation function (75 %) but only one with an INR over 3. Renal biopsies were performed in 14 patients, with thirteen showing occlusive intratubular red blood cell casts and ten showing acute tubular injury of varying intensity or even tubular necrosis. Extensive changes in interstitial compartment like hemorrhage, fibrosis or inflammation were also presented in eight biopsies. IgA nephropathy as a latent or undiagnosed disease was demonstrated in eight biopsies. Treatments of ARN were mainly supportive with all patients discontinuing DOACs and 35 % initiating dialysis for acute deterioration of renal function. Steroids were used in 9 patients with a severe ARN verified by biopsy. 60 % of patients did not recover baseline renal function and some even deteriorated. CONCLUSIONS: In conclusion, DOACs-induced ARN is a rare but serious adverse reaction. A prompt diagnosis of ARN and supportive treatments are necessary for patients receiving DOACs concurrent with an acute renal injury.


Assuntos
Anticoagulantes , Glomerulonefrite por IGA , Humanos , Anticoagulantes/efeitos adversos , Inibidores do Fator Xa , Estudos Retrospectivos , Dabigatrana/efeitos adversos , Glomerulonefrite por IGA/complicações , Glomerulonefrite por IGA/diagnóstico , Glomerulonefrite por IGA/patologia , Administração Oral
12.
J Cardiovasc Pharmacol Ther ; 27: 10742484221142220, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36472155

RESUMO

BACKGROUND: The association of patient and prescriber characteristics with use of warfarin versus direct-acting oral anticoagulants (DOACs) in patients with atrial fibrillation (AF) and chronic kidney disease (CKD) is not well studied. METHODS: The 20% Centers for Medicare & Medicaid Services Parts A, B, and D claims data from 2010 to 2017 were used to identify patients with stage 3, 4, or 5 CKD and AF who received a DOAC (apixaban, dabigatran, rivaroxaban) or warfarin. Prescribers were categorized as cardiologists, primary care providers (PCPs), and others. Using logistic regression, we estimated odds ratios (ORs) for the association of baseline characteristics and prescriber specialty with first use of a DOAC, relative to warfarin. RESULTS: We identified 22,739 individuals with CKD who were newly initiated on oral anticoagulation for AF. New DOAC prescriptions increased from 490 in 2011 to 3261 in 2017, and displaced warfarin over time (1849, 2011; 945, 2017). By Q4 of 2014, cardiologists prescribed DOACs as initial treatment more frequently than warfarin, but non-cardiologists did not do so until 2015. As of 2017, apixaban was the most widely prescribed anticoagulant, comprising 56% and 50% of prescriptions by cardiologists and non-cardiologists, respectively. PCPs (OR 0.54, 0.51-0.58) and other providers (OR 0.55, 0.51-0.59) were less likely than cardiologists to prescribe DOACs. CONCLUSIONS: DOAC prescriptions, particularly apixaban, increased over time and gradually displaced warfarin. The total number of patients with AF and CKD receiving anticoagulation increased over time. Cardiologists increased DOAC prescriptions more rapidly than non-cardiologists.


Assuntos
Fibrilação Atrial , Insuficiência Renal Crônica , Acidente Vascular Cerebral , Humanos , Idoso , Estados Unidos , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/complicações , Varfarina/efeitos adversos , Inibidores do Fator Xa/efeitos adversos , Estudos Retrospectivos , Acidente Vascular Cerebral/tratamento farmacológico , Administração Oral , Medicare , Anticoagulantes/efeitos adversos , Dabigatrana/efeitos adversos , Rivaroxabana/efeitos adversos , Insuficiência Renal Crônica/diagnóstico , Insuficiência Renal Crônica/tratamento farmacológico , Estudos de Coortes
13.
Sci Rep ; 12(1): 21569, 2022 12 13.
Artigo em Inglês | MEDLINE | ID: mdl-36513734

RESUMO

Rivaroxaban, a direct oral anticoagulant, is effective against venous thromboembolism (VTE) recurrence without increasing the risk of major bleeding in patients with cancer-associated venous thromboembolism (CAT). However, its clot regression effects are poorly understood. This single-arm, prospective interventional study aimed to investigate the clot regression effects of rivaroxaban in 40 CAT patients, through a contrast-enhanced computed tomography at baseline, 3 weeks, and 3 months of rivaroxaban treatment. The primary endpoint was the clot-regression ratio calculated from the thrombus volumes at 3 weeks and 3 months. Compared with baseline, the total clot volume was significantly reduced at both 3 weeks and 3 months after initiation (p < 0.01). The clot-regression rates were statistically significant with 83.1% (95% confidence interval [CI], 73.8-92.3%) at 3 weeks and 98.7% (95% CI, 97.1-100.2%) at 3 months, with complete resolution in 36.1% and 80.8% of patients at 3 weeks and 3 months, respectively. One patient had recurrent VTE after dose reduction, and seven had non-fatal major bleeding. Therefore, rivaroxaban had a sufficient clot-regression effect against CAT with caution of bleeding complication.


Assuntos
Neoplasias , Trombose , Tromboembolia Venosa , Humanos , Rivaroxabana/farmacologia , Rivaroxabana/uso terapêutico , Tromboembolia Venosa/etiologia , Inibidores do Fator Xa/farmacologia , Inibidores do Fator Xa/uso terapêutico , Estudos Prospectivos , Hemorragia/induzido quimicamente , Trombose/tratamento farmacológico , Neoplasias/tratamento farmacológico , Anticoagulantes/efeitos adversos
14.
BMJ Open ; 12(12): e066846, 2022 12 29.
Artigo em Inglês | MEDLINE | ID: mdl-36581417

RESUMO

OBJECTIVE: The goal of this work is to evaluate if there is an increase in the risk of thromboembolic events (TEEs) due to concomitant exposure to dexamethasone and apixaban or rivaroxaban. Direct oral anticoagulants (DOACs), as well as corticosteroid dexamethasone, are commonly used to treat individuals hospitalised with COVID-19. Dexamethasone induces cytochrome P450-3A4 enzyme that also metabolises DOACs apixaban and rivaroxaban. This raises a concern about possible interaction between dexamethasone and DOACs that may reduce the efficacy of the DOACs and result in an increased risk of TEE. DESIGN: We used nested case-control study design. SETTING: This study was conducted in the National COVID Cohort Collaborative (N3C), the largest electronic health records repository for COVID-19 in the USA. PARTICIPANTS: Study participants were adults over 18 years who were exposed to a DOAC for 10 or more consecutive days. Exposure to dexamethasone was at least 5 or more consecutive days. PRIMARY AND SECONDARY OUTCOME MEASURES: Our primary exposure variable was concomitant exposure to dexamethasone for 5 or more days after exposure to either rivaroxaban or apixaban for 5 or more consecutive days. We used McNemar's Χ2 test and adjusted logistic regression to evaluate association between concomitant use of dexamethasone with either apixaban or rivaroxaban. RESULTS: McNemar's Χ2 test did not find a discernible association of TEE in patients concomitantly exposed to dexamethasone and a DOAC (χ2=0.5, df=1, p=0.48). In addition, a conditional logistic regression model did not find an increase in the risk of TEE (adjusted OR 1.15, 95% CI 0.32 to 4.18). CONCLUSION: This nested case-control study did not find evidence of an association between concomitant exposure to dexamethasone and a DOAC with an increase in risk of TEE. Due to small sample size, an association cannot be completely ruled out.


Assuntos
Fibrilação Atrial , COVID-19 , Adulto , Humanos , Rivaroxabana/efeitos adversos , Inibidores do Fator Xa/uso terapêutico , Anticoagulantes/efeitos adversos , Estudos de Casos e Controles , Dabigatrana/uso terapêutico , Piridonas/efeitos adversos , Interações Medicamentosas , Dexametasona/efeitos adversos , Administração Oral , Fibrilação Atrial/tratamento farmacológico , Estudos Retrospectivos
16.
J Korean Med Sci ; 37(48): e335, 2022 Dec 12.
Artigo em Inglês | MEDLINE | ID: mdl-36513051

RESUMO

BACKGROUND: Non-vitamin K antagonist oral anticoagulants (NOACs) are effective in preventing thromboembolisms and reduce the risk of bleeding compared with warfarin. There are few reports on the outcomes of on-label reduced-dose NOACs. The aim of this study was to assess the safety and efficacy of on-label reduced-dose edoxaban in patients with atrial fibrillation (AF). METHODS: This study is a multi-center, prospective, non-interventional study to evaluate the safety and efficacy of on-label reduced-dose edoxaban in patients with AF. We evaluated outcomes of major bleeding, stroke or systemic embolism, all-cause death, and composite clinical outcomes. RESULTS: A total of 2,448 patients (mean age 75.0 ± 8.3 years, 801 [32.7%] males) was included in the present study. The mean CHA2DS2-VASc score was 3.7 ± 1.5. Major bleeding events occurred at a rate of 1.34%/yr. The event rate of strokes and systemic embolisms was 1.13%/yr. The overall net clinical outcomes occurred at a rate of 3.19%/yr. There were no significant differences according to the number of dose reduction criteria, renal dysfunction, or body weight. Higher HAS-BLED score and higher combination of CHA2DS2-VASc and HAS-BLED score was associated with an increased risk of composite clinical outcomes compared to the lower score groups. CONCLUSIONS: This study was the largest prospective real-world study to investigate the safety and efficacy of on-label low-dose edoxaban in an Asian population. Reduced-dose edoxaban can be used safely in patients with severe renal dysfunction or extremely low body weight. Our observation suggests that physicians should consider bleeding risk even in a low-dose regimen. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03554837.


Assuntos
Fibrilação Atrial , Embolia , Nefropatias , Acidente Vascular Cerebral , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Administração Oral , Anticoagulantes/uso terapêutico , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/epidemiologia , Peso Corporal , Embolia/prevenção & controle , Embolia/complicações , Inibidores do Fator Xa/efeitos adversos , Hemorragia/induzido quimicamente , Nefropatias/induzido quimicamente , Estudos Prospectivos , Sistema de Registros , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Acidente Vascular Cerebral/epidemiologia
17.
BMC Cancer ; 22(1): 1322, 2022 Dec 16.
Artigo em Inglês | MEDLINE | ID: mdl-36526992

RESUMO

BACKGROUND: Although initial therapy with a parenteral anticoagulant is required before edoxaban, this strategy is frequently avoided in actual clinical practice because of its complexity. This study assessed the feasibility of edoxaban without initial heparin usage for asymptomatic cancer-associated thrombosis (CAT) in Japanese patients with gastrointestinal cancer (GIC) at high risk of bleeding. METHODS: In this multicenter prospective feasibility study conducted at 10 Japanese institutions, patients with active GIC who developed accidental asymptomatic CAT during chemotherapy were recruited. Edoxaban was orally administered once daily without initial parenteral anticoagulant therapy within 3 days after detecting asymptomatic CAT. The primary outcome was the incidence of major bleeding (MB) or clinically relevant non-major bleeding (CRNMB) during the first 3 months of edoxaban administration. RESULTS: Of the 54 patients enrolled from October 2017 to September 2020, one was excluded because of a misdiagnosis of CAT. In the remaining 53 patients, the primary outcome occurred in six patients (11.3%). MB occurred in four patients (7.5%), including gastrointestinal bleeding in three patients and intracranial hemorrhage in one patient. CRNMB occurred in two patients (3.8%), including bleeding from the stoma site and genital bleeding in one patient each. There were no deaths attributable to bleeding, and all patients who experienced MB or CRNMB recovered. CONCLUSIONS: The risk of bleeding after edoxaban without heparin pretreatment was acceptable, demonstrating new treatment options for asymptomatic CAT in patients with GIC.


Assuntos
Neoplasias Gastrointestinais , Trombose , Humanos , Inibidores do Fator Xa/efeitos adversos , Estudos Prospectivos , Estudos de Viabilidade , Anticoagulantes/efeitos adversos , Hemorragia/tratamento farmacológico , Heparina , Trombose/prevenção & controle , Trombose/induzido quimicamente , Neoplasias Gastrointestinais/complicações , Neoplasias Gastrointestinais/tratamento farmacológico
18.
Clin Appl Thromb Hemost ; 28: 10760296221144038, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36503260

RESUMO

We aimed to investigate the efficacy and safety of rivaroxaban for acute and long-term management of cerebral venous sinus thrombosis (CVST). This study reviewed CVST-diagnosed patients admitted to the First Affiliated Hospital of Guangxi Medical University from January 2015 to December 2020. The primary outcome was a composite of recurrent thrombosis or major bleeding events. The secondary efficacy outcomes included a disease recovery time (DRT) presenting the time from admission to the endpoint as recovery (the modified Rankin scale [mRS] score [0-1]) within 30 and 90 days, and length of hospital stay (LHS). Patients treated with rivaroxaban (38) and warfarin (45) were enrolled in the final analysis. The primary outcome had no significant difference (5.3% vs 11.1%, P = .576) between the 2 groups. The secondary efficacy outcome regarding the median 30-d DRT was 17 days (95% confidence interval [CI], 14.6-19.4) in the rivaroxaban group, compared with 26.0 days (95% CI, 16.8-35.2) in the warfarin group (hazard ratio, 1.806; 95% CI, 1.051-3.103; log-rank P = .026). Two groups have a significant difference in LHS (P = .041). Patients with cerebral edema, intracerebral hemorrhage, and mild/moderate disability (admission mRS score [2-3]) treated with rivaroxaban recovered faster than those with warfarin (log-rank P < .05). Patients with cerebral edema, intracerebral hemorrhage, and mild/moderate disability treated with rivaroxaban had a shorter recovery time than those treated with warfarin within 1 month from admission, indicating that rivaroxaban a promising convenient therapy for CVST, helping them speedily restore social functions.


Assuntos
Edema Encefálico , Trombose dos Seios Intracranianos , Humanos , Rivaroxabana/efeitos adversos , Inibidores do Fator Xa/efeitos adversos , Anticoagulantes/efeitos adversos , Edema Encefálico/induzido quimicamente , Edema Encefálico/tratamento farmacológico , China , Varfarina/efeitos adversos , Hemorragia Cerebral/tratamento farmacológico , Trombose dos Seios Intracranianos/tratamento farmacológico , Resultado do Tratamento
19.
PLoS One ; 17(12): e0278693, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36490245

RESUMO

BACKGROUND AND PURPOSE: Renal excretion of direct oral anticoagulants (DOACs) varies depending on the drug. Hypothetically, an increased glomerular filtration rate (GFR) may lead to suboptimal dosing and a higher thromboembolic events incidence. However, real-world patient data do not support the theoretical risk. The aim is to analyse DOAC outcomes in patients with normal and high (≥90 mL/min) GFR, focusing on biological parameters and thrombotic/haemorrhagic events. METHODS: Observational prospective single-centre study and registry of patients on DOACs. Follow-up was 1,343 patient-years. A bivariate analysis was performed of baseline variables according to GFR (<90 mL/min vs ≥90 mL/min). Anti-Xa activity before and after drug intake (HemosIL, Liquid Anti-Xa, Werfen) was measured for edoxaban, apixaban, and rivaroxaban; diluted thrombin time for dabigatran (HEMOCLOT); and additionally, plasma concentrations in edoxaban (HemosIl, Liquid Anti-Xa suitably calibrated). RESULTS: 1,135 patients anticoagulated with DOACs were included and 152 patients with GFR ≥90 mL/min. Of 18 serious thrombotic complications during follow-up, 17 occurred in patients with GFR <90 mL/min, and 1 in a patient with GFR ≥90 mL/min. A higher incidence of complications was observed in patients with normal GFR, but the difference was not statistically significant (p>0.05). No statistically significant differences with clinical relevance were observed between the normal or supranormal groups in anti-Xa activity or in edoxaban plasma concentrations. CONCLUSIONS: There was no increased incidence of thrombotic/haemorrhagic complications in our patients treated with DOACs, including 66% treated with edoxaban, and patients with GFR ≥90 mL/min. Likewise, drug anti-Xa activity and edoxaban plasma concentration did not seem to be influenced by GFR.


Assuntos
Fibrilação Atrial , Inibidores do Fator Xa , Humanos , Inibidores do Fator Xa/uso terapêutico , Anticoagulantes/efeitos adversos , Estudos Prospectivos , Rivaroxabana/efeitos adversos , Piridonas/efeitos adversos , Dabigatrana/efeitos adversos , Heparina de Baixo Peso Molecular/uso terapêutico , Rim , Administração Oral , Fibrilação Atrial/tratamento farmacológico
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