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1.
Hautarzt ; 70(11): 850-853, 2019 Nov.
Artigo em Alemão | MEDLINE | ID: mdl-31560079

RESUMO

Current guidelines generally recommend continuation of blood thinning drugs in dermatologic surgery and the previously used "bridging" with subcutaneous or intravenous heparin is obsolete. While the guidelines are increasingly implemented in daily practice, there is still uncertainty concerning the use of the novel direct oral anticoagulants (NOAC = DOAC). In this review, we analyze current developments and formulate concise recommendations for continuation during skin surgery under consideration of individual risk.


Assuntos
Anticoagulantes/administração & dosagem , Dabigatrana/administração & dosagem , Procedimentos Cirúrgicos Dermatológicos/métodos , Hemorragia Pós-Operatória/induzido quimicamente , Guias de Prática Clínica como Assunto , Pirazóis/administração & dosagem , Piridonas/administração & dosagem , Rivaroxabana/administração & dosagem , Administração Oral , Anticoagulantes/uso terapêutico , Humanos , Hemorragia Pós-Operatória/terapia , Medição de Risco
3.
Medicine (Baltimore) ; 98(31): e16585, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31374026

RESUMO

RATIONALE: Hypercoagulability can lead to thromboembolic events that are a life-threatening complication of nephrotic syndrome (NS). Conventional anticoagulants are first-line treatment in the presence of demonstrated thrombosis in NS. Direct-acting oral anticoagulants (DOACs) have provided useful alternatives for the prevention and treatment of thromboembolic events. PATIENT CONCERNS: A 59-year-old male developed lower limbs deep vein thrombosis (DVT) during the early course of NS but presented poor response to oral therapeutic doses of rivaroxaban. The decision was made to switch from rivaroxaban to heparin and subsequently bridged to warfarin. The patient presented significant clinical symptom improvement. DIAGNOSIS: NS with Lower limbs DVT. INTERVENTIONS: Rivaroxaban was discontinued and switch to heparin and subsequently bridged to warfarin. OUTCOMES: Venography result of both lower limb vein showed the venous wall was smooth without obvious stenosis or obstruction. Edema of the patient's lower limbs gradually improved and disappeared. LESSONS: The existing published data on the application of DOACs in NS are limited. DOACs have an immediate anticoagulant effect and have demonstrated safety and efficacy and required no routine monitoring, however, application of these agents in NS likely requires further investigation before widespread adoption.


Assuntos
Anticoagulantes/uso terapêutico , Síndrome Nefrótica/complicações , Rivaroxabana/uso terapêutico , Trombose Venosa/tratamento farmacológico , Trombose Venosa/etiologia , Varfarina/uso terapêutico , Anticoagulantes/administração & dosagem , Humanos , Masculino , Pessoa de Meia-Idade , Síndrome Nefrótica/tratamento farmacológico , Rivaroxabana/administração & dosagem , Trombofilia/tratamento farmacológico , Trombofilia/etiologia , Varfarina/administração & dosagem
4.
Ther Adv Cardiovasc Dis ; 13: 1753944719863641, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31364490

RESUMO

BACKGROUND: This analysis aimed to evaluate the impact of rivaroxaban exposure and patient characteristics on efficacy and safety outcomes in patients with acute coronary syndrome (ACS) and to determine whether therapeutic drug monitoring might provide additional information regarding rivaroxaban dose, beyond what patient characteristics provide. METHODS: A post hoc exposure-response analysis was conducted using data from the phase III ATLAS ACS 2 Thrombolysis in Myocardial Infarction (TIMI) 51 study, in which 15,526 randomized ACS patients received rivaroxaban (2.5 mg or 5 mg twice daily) or placebo for a mean of 13 months (maximum follow up: 31 months). A multivariate Cox model was used to correlate individual predicted rivaroxaban exposures and patient characteristics with time-to-event clinical outcomes. RESULTS: For the incidence of myocardial infarction (MI), ischemic stroke, or nonhemorrhagic cardiovascular death, hazard ratios (HRs) for steady-state maximum plasma concentration (Cmax) in the 5th and 95th percentiles versus the median were statistically significant but close to 1 for both rivaroxaban doses. For TIMI major bleeding events, a statistically significant association was observed with Cmax [HR, 1.08; 95% CI, 1.06-1.11 (95th percentile versus median, 2.5 mg twice daily)], sex [HR, 0.56; 95% CI, 0.38-0.84 (female versus male)], and previous revascularization [HR, 0.62; 95% CI, 0.44-0.87 (no versus yes)]. CONCLUSIONS: The shallow slopes of the exposure-response relationships and the lack of a clear therapeutic window render it unlikely that therapeutic drug monitoring in patients with ACS would provide additional information regarding rivaroxaban dose beyond that provided by patient characteristics.


Assuntos
Síndrome Coronariana Aguda/tratamento farmacológico , Inibidores do Fator Xa/administração & dosagem , Modelos Biológicos , Rivaroxabana/administração & dosagem , Síndrome Coronariana Aguda/sangue , Síndrome Coronariana Aguda/diagnóstico , Síndrome Coronariana Aguda/mortalidade , Idoso , Isquemia Encefálica/mortalidade , Tomada de Decisão Clínica , Ensaios Clínicos Fase III como Assunto , Relação Dose-Resposta a Droga , Cálculos da Dosagem de Medicamento , Monitoramento de Medicamentos , Inibidores do Fator Xa/efeitos adversos , Inibidores do Fator Xa/farmacocinética , Feminino , Hemorragia/induzido quimicamente , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/mortalidade , Ensaios Clínicos Controlados Aleatórios como Assunto , Medição de Risco , Fatores de Risco , Rivaroxabana/efeitos adversos , Rivaroxabana/farmacocinética , Acidente Vascular Cerebral/mortalidade , Resultado do Tratamento
5.
Medicine (Baltimore) ; 98(30): e16514, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31348262

RESUMO

ABSTRCT: The purpose of this study was to evaluate the efficacy and safety of rivaroxaban for the treatment of cancer-associated venous thromboembolism (VTE).We performed a retrospective chart review of cancer patients with a pulmonary embolism, deep vein thrombosis, or both. Our analysis included all patients who received rivaroxaban from March 2013 to June 2016 at the Hemato-Oncology Division at the Pusan National University Hospital in Korea.Preliminary results identified 123 patients with a history of cancer that were treated with rivaroxaban. The average duration of rivaroxaban therapy was 95.25 days. While 35 patients had resolved VTE after the initiation of rivaroxaban, only one patient had it recur on rivaroxaban treatment. Major bleeding was observed in 6 (4.9%) patients and minor bleeding in 12 (9.8%) patients. The majority of bleeding events occurred spontaneously and most incidences of bleeding could be treated conservatively. Recurrence and major bleeding events on rivaroxaban were relatively low despite the fact that many patients had metastatic disease. Among 52 patient deaths (42.3%), none were due to VTE or bleeding complications; the cause of death in the majority of cases was cancer progression.Rivaroxaban is effective and safe for the treatment of cancer-associated VTE.


Assuntos
Neoplasias/epidemiologia , Rivaroxabana/administração & dosagem , Tromboembolia Venosa/epidemiologia , Tromboembolia Venosa/prevenção & controle , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Embolia Pulmonar/epidemiologia , Embolia Pulmonar/prevenção & controle , República da Coreia/epidemiologia , Estudos Retrospectivos , Trombose Venosa/epidemiologia , Trombose Venosa/prevenção & controle , Adulto Jovem
6.
Expert Rev Clin Pharmacol ; 12(8): 771-780, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31269825

RESUMO

Introduction: The current approach of using only antiplatelet therapy for secondary prevention leaves a substantial risk of recurrent cardiovascular complications and mortality. Areas covered: In this manuscript, the role of coagulation in atherothrombosis is reviewed, as well as the impact of vascular doses of rivaroxaban on major cardiovascular outcomes and major adverse limb events. Expert opinion: In COMPASS, among patients with coronary heart disease and/or peripheral artery disease, compared to aspirin, the addition of rivaroxaban 2.5 mg twice daily to aspirin, significantly reduced the risk of major atherosclerotic outcomes, cardiovascular death and death for any cause, with a significant increase in the risk of major bleeding, but not fatal or intracranial bleedings. Preclinical data strongly suggest that rivaroxaban exerts vascular protection through different mechanisms, including improvement of endothelial functionality and fibrinolytic activity at endothelium, anti-inflammatory properties, and platelet-dependent thrombin generation. All these data indicate that among patients with atherosclerotic vascular disease, the addition of rivaroxaban 2.5 mg may provide further vascular protection.


Assuntos
Aterosclerose/prevenção & controle , Inibidores do Fator Xa/administração & dosagem , Rivaroxabana/administração & dosagem , Animais , Aspirina/administração & dosagem , Aterosclerose/patologia , Doenças Cardiovasculares/mortalidade , Doenças Cardiovasculares/prevenção & controle , Quimioterapia Combinada , Inibidores do Fator Xa/efeitos adversos , Inibidores do Fator Xa/farmacologia , Hemorragia/induzido quimicamente , Humanos , Rivaroxabana/efeitos adversos , Rivaroxabana/farmacologia , Prevenção Secundária/métodos
7.
Khirurgiia (Mosk) ; (5): 94-103, 2019.
Artigo em Russo | MEDLINE | ID: mdl-31169827

RESUMO

The review is devoted to the issue of optimal duration of anticoagulant therapy for venous thromboembolic complications (VTEC) using oral anticoagulants (OAC). These drugs are characterized by higher safety in comparison with vitamin K antagonists and make it possible to increase the duration of treatment for not only spontaneous thrombosis (with high risk of recurrence), but also thrombosis provoked by minor persistent and transient risk factors of VTEC. Efficacy and safety of prolonged treatment of VTEC using OAC was analyzed. Different classifications of primary thrombotic episode depending on risk of subsequent recurrence are presented. Moreover, scales for individual assessment of risk of recurrent thrombosis after anticoagulant therapy cancellation and risk of bleeding in case of continued treatment are given. Outcomes of long-term administration of rivaroxaban for VTEC are analyzed. It was concluded that OAC are safe for prolonged management of primary thrombotic episode. However, overall duration of treatment should be determined considering individual balance of benefits and risks.


Assuntos
Anticoagulantes/administração & dosagem , Inibidores do Fator Xa/administração & dosagem , Rivaroxabana/administração & dosagem , Tromboembolia Venosa/tratamento farmacológico , Anticoagulantes/efeitos adversos , Anticoagulantes/uso terapêutico , Esquema de Medicação , Inibidores do Fator Xa/efeitos adversos , Inibidores do Fator Xa/uso terapêutico , Hemorragia/induzido quimicamente , Humanos , Recidiva , Fatores de Risco , Rivaroxabana/efeitos adversos , Rivaroxabana/uso terapêutico , Trombose/etiologia , Fatores de Tempo , Suspensão de Tratamento
8.
Gastroenterology ; 157(3): 682-691.e2, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-31152740

RESUMO

BACKGROUND & AIMS: Proton pump inhibitors (PPIs) are effective at treating acid-related disorders. These drugs are well tolerated in the short term, but long-term treatment was associated with adverse events in observational studies. We aimed to confirm these findings in an adequately powered randomized trial. METHODS: We performed a 3 × 2 partial factorial double-blind trial of 17,598 participants with stable cardiovascular disease and peripheral artery disease randomly assigned to groups given pantoprazole (40 mg daily, n = 8791) or placebo (n = 8807). Participants were also randomly assigned to groups that received rivaroxaban (2.5 mg twice daily) with aspirin (100 mg once daily), rivaroxaban (5 mg twice daily), or aspirin (100 mg) alone. We collected data on development of pneumonia, Clostridium difficile infection, other enteric infections, fractures, gastric atrophy, chronic kidney disease, diabetes, chronic obstructive lung disease, dementia, cardiovascular disease, cancer, hospitalizations, and all-cause mortality every 6 months. Patients were followed up for a median of 3.01 years, with 53,152 patient-years of follow-up. RESULTS: There was no statistically significant difference between the pantoprazole and placebo groups in safety events except for enteric infections (1.4% vs 1.0% in the placebo group; odds ratio, 1.33; 95% confidence interval, 1.01-1.75). For all other safety outcomes, proportions were similar between groups except for C difficile infection, which was approximately twice as common in the pantoprazole vs the placebo group, although there were only 13 events, so this difference was not statistically significant. CONCLUSIONS: In a large placebo-controlled randomized trial, we found that pantoprazole is not associated with any adverse event when used for 3 years, with the possible exception of an increased risk of enteric infections. ClinicalTrials.gov Number: NCT01776424.


Assuntos
Aspirina/administração & dosagem , Doenças Cardiovasculares/tratamento farmacológico , Inibidores do Fator Xa/administração & dosagem , Hemorragia Gastrointestinal/prevenção & controle , Pantoprazol/administração & dosagem , Doença Arterial Periférica/tratamento farmacológico , Inibidores da Agregação de Plaquetas/administração & dosagem , Inibidores da Bomba de Prótons/administração & dosagem , Rivaroxabana/administração & dosagem , Idoso , Aspirina/efeitos adversos , Doenças Cardiovasculares/diagnóstico , Método Duplo-Cego , Esquema de Medicação , Enterocolite Pseudomembranosa/induzido quimicamente , Enterocolite Pseudomembranosa/microbiologia , Inibidores do Fator Xa/efeitos adversos , Feminino , Hemorragia Gastrointestinal/induzido quimicamente , Humanos , Masculino , Pessoa de Meia-Idade , Pantoprazol/efeitos adversos , Doença Arterial Periférica/diagnóstico , Inibidores da Agregação de Plaquetas/efeitos adversos , Estudos Prospectivos , Inibidores da Bomba de Prótons/efeitos adversos , Medição de Risco , Fatores de Risco , Rivaroxabana/efeitos adversos , Fatores de Tempo , Resultado do Tratamento
9.
Med. clín (Ed. impr.) ; 152(12): 482-487, jun. 2019. mapas, tab
Artigo em Espanhol | IBECS | ID: ibc-183318

RESUMO

Objetivo: Comparar la incidencia de hemorragias entre los anticoagulantes orales (ACO) y analizar los factores que influyen en la aparición de hemorragias. Material y métodos: Estudio observacional, retrospectivo unicéntrico. Tras estudiar la población total en tratamiento con ACO, se analizó a los pacientes en tratamiento con un ACO del sector II de Zaragoza que acudieron al Servicio de Urgencias de Hospital Universitario Miguel Servet de julio a diciembre de 2015 por presentar algún evento. Se registraron datos demográficos, variables clínicas y características del evento hemorrágico. Como factores independientes en la aparición de hemorragias se valoró la dosis, fármacos, el sexo y la edad. Resultados: Había 9.452 pacientes en tratamiento con ACO, de los cuales 371 presentaron un evento hemorrágico (3,9%). La frecuencia por ACO fue 4,1% (311) en pacientes tratados con antagonistas de la vitamina K (AVK), 3,8% (33) con rivaroxaban, 3,3% (19) con dabigatran y, por último, con apixaban 2,1% (8) (p<0,05). En el análisis multivariante solo obtuvieron una influencia estadísticamente significativa la selección del anticoagulante y el sexo, en concreto, la dosis de apixaban 2,5mg y ser mujer presentaban menor riesgo de hemorragia (OR=0,1; IC=0,014-0,71 y OR=0,688; IC=0,55-0,85, respectivamente). Conclusión: Según los datos obtenidos, las mujeres y los pacientes en tratamiento con apixaban presentaban menor riesgo hemorrágico, si bien existen dudas de si este mejor perfil de seguridad está relacionado con una infradosificación, que podría influir en su efectividad. Por lo tanto, estos resultados deben ser analizados con prudencia y se deben realizar más estudios para confirmar estos datos


Objective: To compare the occurrence of haemorrhages among the different oral anticoagulants (OAC) and to analyse factors that influence it. Material and methods: Single-centre, observational, retrospective study. After studying the total population treated with OAC, patients who were treated with an OAC from July 2015 to December 2015 in the II Sector of the Zaragoza Hospital, who consulted the Emergency Department of the Miguel Servet University Hospital and presented a haemorrhagic event, were analysed. Patients' demographic data, clinical variables and data on the haemorrhagic event characteristics were gathered. Results: There were 9,452 patients treated with an OAC, 371 (3.9%) of which presented a haemorrhagic event. The frequency per OAC was; 4.1% (311) in patients treated with vitamin K antagonists, 3.8% (33) with rivaroxaban, 3.3% (19) with dabigatran and 2.1% (8) with apixaban. In the multivariate analysis, only the choice of anticoagulant and sex had a statistically significant influence of a lower risk of haemorrhage, in particular the dose of apixaban at 2.5mg and being female. (OR=0.1, CI=0.014-0.71 and OR=0.688, CI=0.55-0.85, respectively). Conclusion: According to the results obtained, females and patients undergoing treatment with apixaban presented lower haemorrhagic risk, although there are doubts about whether this better safety profile is related to underdosing, which could influence its effectiveness. Therefore, these results should be analysed with caution and further studies are needed to confirm this data


Assuntos
Humanos , Feminino , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Masculino , Anticoagulantes/administração & dosagem , Hemorragia/epidemiologia , Resultado do Tratamento , Anticoagulantes/uso terapêutico , Hemorragia/tratamento farmacológico , Estudos Retrospectivos , Análise Multivariada , Rivaroxabana/administração & dosagem , Dabigatrana/administração & dosagem , Análise Estatística , Eficácia
10.
Gastroenterology ; 157(2): 403-412.e5, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-31054846

RESUMO

BACKGROUND & AIMS: Antiplatelets and anticoagulants are associated with increased upper gastrointestinal bleeding. We evaluated whether proton pump inhibitor therapy could reduce this risk. METHODS: We performed a 3 × 2 partial factorial double-blind trial of 17,598 participants with stable cardiovascular disease and peripheral artery disease. Participants were randomly assigned to groups given pantoprazole 40 mg daily or placebo, as well as rivaroxaban 2.5 mg twice daily with aspirin 100 mg once daily, rivaroxaban 5 mg twice daily, or aspirin 100 mg alone. The primary outcome was time to first upper gastrointestinal event, defined as a composite of overt bleeding, upper gastrointestinal bleeding from a gastroduodenal lesion or of unknown origin, occult bleeding, symptomatic gastroduodenal ulcer or ≥5 erosions, upper gastrointestinal obstruction, or perforation. RESULTS: There was no significant difference in upper gastrointestinal events between the pantoprazole group (102 of 8791 events) and the placebo group (116 of 8807 events) (hazard ratio, 0.88; 95% confidence interval [CI], 0.67-1.15). Pantoprazole significantly reduced bleeding of gastroduodenal lesions (hazard ratio, 0.52; 95% confidence interval, 0.28-0.94; P = .03); this reduction was greater when we used a post-hoc definition of bleeding gastroduodenal lesion (hazard ratio, 0.45; 95% confidence interval, 0.27-0.74), although the number needed to treat still was high (n = 982; 95% confidence interval, 609-2528). CONCLUSIONS: In a randomized placebo-controlled trial, we found that routine use of proton pump inhibitors in patients receiving low-dose anticoagulation and/or aspirin for stable cardiovascular disease does not reduce upper gastrointestinal events, but may reduce bleeding from gastroduodenal lesions. ClinicalTrials.gov ID: NCT01776424.


Assuntos
Anticoagulantes/efeitos adversos , Doenças Cardiovasculares/prevenção & controle , Hemorragia Gastrointestinal/prevenção & controle , Pantoprazol/administração & dosagem , Úlcera Péptica/prevenção & controle , Inibidores da Bomba de Prótons/administração & dosagem , Administração Oral , Idoso , Anticoagulantes/administração & dosagem , Aspirina/administração & dosagem , Aspirina/efeitos adversos , Relação Dose-Resposta a Droga , Método Duplo-Cego , Esquema de Medicação , Quimioterapia Combinada/efeitos adversos , Quimioterapia Combinada/métodos , Feminino , Hemorragia Gastrointestinal/induzido quimicamente , Hemorragia Gastrointestinal/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Úlcera Péptica/induzido quimicamente , Úlcera Péptica/epidemiologia , Rivaroxabana/administração & dosagem , Rivaroxabana/efeitos adversos , Resultado do Tratamento
11.
Clin Appl Thromb Hemost ; 25: 1076029619850897, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31088302

RESUMO

Extended thromboprophylaxis with oral anticoagulation can reduce the risk of symptomatic venous thromboembolism (VTE) in high-risk patients. We sought to estimate the proportion of medically ill patients in the United States who might qualify for extended thromboprophylaxis according to the criteria used in the Medically-Ill Patient Assessment of Rivaroxaban versus Placebo in Reducing Post-Discharge Venous ThromboEmbolism Risk (MARINER) trial. We analyzed 2014 National Inpatient Sample (NIS) data that provide a 20% weighted annual sample of all discharges from US acute-care hospitals. Hospitalizations for acute medically ill patients were identified as those with a primary discharge diagnosis code for heart or respiratory failure, ischemic stroke, infection, or inflammatory diseases. Patients were excluded if they were <40 years old, admitted for surgery or trauma, had a length of stay <3- or >35-days, or were contraindicated to nonvitamin K antagonist oral anticoagulants. The modified International Medical Prevention Registry on Venous Thromboembolism (IMPROVE)-VTE score was used to stratify patients' risk for postdischarge VTE, with a score of 2 to 3 suggesting patients were at moderate- and ≥4 as high-risk. Of the 35 358 810 hospitalizations in the 2014 NIS, 1 849 535 were medically ill patients admitted for heart failure (10.1%), respiratory failure (12.2%), ischemic stroke (8.8%), infection (58.5%), or inflammatory diseases (10.4%). The modified IMPROVE-VTE score classified 1 186 475 (64.1%) of these hospitalizations as occurring in moderate-risk and 407 095 (22.0%) in high-risk patients. This real-world study suggests a substantial proportion of acute medically ill patients might benefit from extended thromboprophylaxis using the modified IMPROVE-VTE score and clinical elements of the MARINER trial.


Assuntos
Anticoagulantes/administração & dosagem , Isquemia Encefálica/prevenção & controle , Tempo de Internação , Sistema de Registros , Rivaroxabana/administração & dosagem , Acidente Vascular Cerebral/prevenção & controle , Tromboembolia Venosa/prevenção & controle , Administração Oral , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade
12.
Medicine (Baltimore) ; 98(20): e15705, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-31096518

RESUMO

RATIONALE: Rivaroxaban has numerous advantages over traditional anticoagulation therapy. Fixed doses can be administered without requiring routine monitoring of coagulation, and anticoagulation efficacy is more predictable. Safety, including fewer drug interactions, and reduced bleeding, is also improved with rivaroxaban based on current recommendations. The goal of this report was to explore if low-dose rivaroxaban 10 mg once daily was effective in an elderly patient who developed minor bleeding when treated with rivaroxaban (10 mg twice daily) for a pulmonary embolism. PATIENT CONCERNS: We present an 88-year-old female with dyspnea and fatigue, which became increasingly worse over a month in the absence of medication. Her weight was 64 kg. Routine coagulation assays and renal function were normal at time of admission. DIAGNOSIS: Deep vein thrombosis and pulmonary embolism were confirmed by venous compression ultrasonography and computed tomography pulmonary angiography. INTERVENTIONS: Oral rivaroxaban 10 mg twice daily was administered, but the patient developed hemoptysis and gum bleeding 5 days later. The dose of rivaroxaban was reduced to 10 mg once daily, and bleeding gradually disappeared after 3 days. OUTCOME: At follow-up 90 days after treatment, the patient reported no discomfort. Venous compression ultrasonography and computed tomography pulmonary angiography showed normal results; therefore, treatment was terminated. LESSONS: Elderly patients exhibit variable tolerance of anticoagulants, warranting careful consideration of the risk of bleeding. Low-dose rivaroxaban was an effective treatment for pulmonary embolism in the elderly patient presented here.


Assuntos
Embolia Pulmonar/tratamento farmacológico , Rivaroxabana/uso terapêutico , Trombose Venosa/tratamento farmacológico , Administração Oral , Assistência ao Convalescente , Idoso de 80 Anos ou mais , Angiografia por Tomografia Computadorizada/métodos , Inibidores do Fator Xa/administração & dosagem , Inibidores do Fator Xa/efeitos adversos , Inibidores do Fator Xa/uso terapêutico , Feminino , Hemorragia/etiologia , Hemorragia/prevenção & controle , Humanos , Embolia Pulmonar/diagnóstico por imagem , Rivaroxabana/administração & dosagem , Rivaroxabana/efeitos adversos , Resultado do Tratamento , Ultrassonografia/métodos , Trombose Venosa/diagnóstico por imagem
13.
BMJ Case Rep ; 12(4)2019 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-30940667

RESUMO

A 63-year-old woman with known antiphospholipid syndrome (APLS) presented with catastrophic APLS and multiorgan dysfunction after a change in her anticoagulation from warfarin to rivaroxaban. Evidence suggests direct-acting oral anticoagulants (DOACs) like rivaroxaban may be less effective than warfarin in secondary prevention of thrombotic events in high-risk APLS patients.


Assuntos
Síndrome Antifosfolipídica/tratamento farmacológico , Rivaroxabana/administração & dosagem , Prevenção Secundária , Trombose/prevenção & controle , Administração Oral , Anticoagulantes/uso terapêutico , Síndrome Antifosfolipídica/complicações , Inibidores do Fator Xa/administração & dosagem , Inibidores do Fator Xa/efeitos adversos , Feminino , Humanos , Pessoa de Meia-Idade , Rivaroxabana/efeitos adversos , Trombose/etiologia , Varfarina/uso terapêutico
14.
Eur J Haematol ; 103(1): 43-46, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31009121

RESUMO

INTRODUCTION: Direct oral anticoagulants (DOACs) are being increasingly used. However, unlike warfarin, less is known regarding their long-term side effects. To better evaluate the rates of DOAC-related adverse events (AEs) on a population level, we examined AEs reported to the FDA for three commonly used DOACs and warfarin. METHODS: We evaluated the FDA Adverse Event Reporting System (FAERS) database, which compiles reported drug-related AEs from 1969 onwards. The safety profiles of the included drugs were assessed by comparing AEs per outpatient prescription and with proportional reporting ratios (PRR). RESULTS: Rivaroxaban had the highest proportion of reported AEs. Most notably the rate for breakthrough venous thromboembolism (VTE) was higher than other DOACs. Dabigatran had the highest reported rates of ischemic stroke. When the DOAC data were analyzed using PRR, reported rates of VTE were again higher with rivaroxaban while dabigatran again showed slightly higher than expected rates of ischemic stroke. Apixaban did not show higher than expected rates in any category. CONCLUSION: Our analysis found rates of reported breakthrough VTE were significantly higher with rivaroxaban, while apixaban had no higher than expected rates of any studied AEs.


Assuntos
Anticoagulantes/efeitos adversos , Notificação de Abuso , United States Food and Drug Administration , Administração Oral , Assistência Ambulatorial , Anticoagulantes/administração & dosagem , Anticoagulantes/classificação , Bases de Dados Factuais , Prescrições de Medicamentos , Humanos , Rivaroxabana/administração & dosagem , Rivaroxabana/efeitos adversos , Estados Unidos , Tromboembolia Venosa/complicações , Tromboembolia Venosa/tratamento farmacológico , Tromboembolia Venosa/epidemiologia
15.
Chin Med Sci J ; 34(1): 60-64, 2019 Mar 30.
Artigo em Inglês | MEDLINE | ID: mdl-30961783

RESUMO

Heparin-induced thrombocytopenia (HIT) is a relatively infrequent complication of heparin administration. HIT can cause devastating thrombosis, making it one of the most serious adverse drug reactions encountered in clinical practice. We successfully treated a case of severe HIT presenting with thrombosis and life-threatening bleeding complications with intravenous immunoglobulin (IVIG), platelet transfusion and oral anticoagulant Rivaroxaban. In this case, we considered that IVIG played the most important role by preventing further thrombosis, increasing the platelet count, and ensuring the efficacy of Rivaroxaban. We therefore suggest that IVIG might be the optimal treatment for patients with this urgent condition.


Assuntos
Heparina/efeitos adversos , Imunoglobulinas Intravenosas/administração & dosagem , Transfusão de Plaquetas , Rivaroxabana/administração & dosagem , Trombocitopenia/induzido quimicamente , Trombocitopenia/terapia , Idoso de 80 Anos ou mais , Feminino , Heparina/administração & dosagem , Humanos
16.
Braz J Med Biol Res ; 52(4): e8006, 2019 Apr 08.
Artigo em Inglês | MEDLINE | ID: mdl-30970082

RESUMO

The aim of the study was to evaluate the diagnostic accuracy of thromboelastometry for assessing rivaroxaban concentrations. The accuracy of thromboelastometry was compared with the high-performance liquid chromatography tandem mass spectrometry (HPLC-MS/MS) method, which is the gold standard for drug plasma monitoring (the reference standard). Forty-six clinically stable patients were treated with 10, 15, or 20 mg of rivaroxaban once daily (OD group) or 15 mg twice a day (BID group) (no particular indication for treatment). Patient samples were collected 2 h after the use of the medication (peak) and 2 h before the next dose (trough). The rivaroxaban plasma concentrations were determined via HPLC-MS/MS, and thromboelastometry was performed using a ROTEM® delta analyzer. There were significant prolongations in clotting time (CT) for the 10, 15, and 20 mg of rivaroxaban treatments in the OD groups. In the 15 mg BID group, the responses at the peak and trough times were similar. At the peak times, there was a positive correlation between the plasma concentration of rivaroxaban and CT (Spearman correlation rho=0.788, P<0.001) and clot formation time (rho=0.784, P<0.001), and a negative correlation for alpha angle (rho=-0.771, P<0.001), amplitude after 5 min (rho=-0.763, P<0.001), and amplitude after 10 min (rho=-0.680, P<0.001). The CT presented higher specificity and sensitivity using the cut-off determined by the receiver characteristics curve. ROTEM has potential as screening tool to measure possible bleeding risk associated with rivaroxaban plasma levels.


Assuntos
Monitoramento de Medicamentos/métodos , Inibidores do Fator Xa/sangue , Hemorragia/prevenção & controle , Rivaroxabana/sangue , Adulto , Idoso , Idoso de 80 Anos ou mais , Testes de Coagulação Sanguínea , Cromatografia Líquida de Alta Pressão , Confiabilidade dos Dados , Inibidores do Fator Xa/administração & dosagem , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Rivaroxabana/administração & dosagem , Espectrometria de Massas em Tandem , Tromboelastografia
17.
J Vet Intern Med ; 33(3): 1322-1330, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-30859645

RESUMO

BACKGROUND: The chromogenic anti-Xa assay, the gold standard for monitoring the anti-Xa effect of rivaroxaban, is not available as a cage-side diagnostic test for use in a clinical setting. HYPOTHESIS/OBJECTIVES: To evaluate clinical modalities for measuring the anticoagulant effects of rivaroxaban using a point-of-care prothrombin time (PT) and thromboelastography (TEG). ANIMALS: Six healthy Beagle dogs. METHODS: Prospective, experimental study. Four different doses of rivaroxaban (0.5, 1, 2, and 4 mg/kg) were administered PO to dogs. Single PO and 3 consecutive dosing regimens also were assessed. Plasma rivaroxaban concentration was determined using a chromogenic anti-Xa assay, point-of-care PT, and TEG analysis with 4 activators (RapidTEG, 1 : 100 tissue factor [TF100], 1 : 3700 tissue factor [TF3700], and kaolin), and results were compared. Spearman correlation coefficients were calculated between ratios (peak to baseline PT; peak reaction time [R] of TEG to baseline [R] of TEG) and anti-Xa concentration. RESULTS: Anti-Xa concentration had a significant correlation with point-of-care PT (R = 0.82, P < .001) and RapidTEG-TEG, TF100-TEG, and TF3700-TEG (R = 0.76, P < .001; R = 0.82, P < .001; and R = 0.83, P < .001, respectively). CONCLUSIONS AND CLINICAL IMPORTANCE: Overall, a 1.5-1.9 × delay in PT and R values of TEG 3 hours after rivaroxaban administration is required to achieve therapeutic anti-Xa concentrations of rivaroxaban in canine plasma. The R values of TEG, specifically using tissue factors (RapidTEG, TF100, TF3700) and point-of-care PT for rivaroxaban can be used practically for therapeutic monitoring of rivaroxaban in dogs.


Assuntos
Inibidores do Fator Xa/farmacologia , Tempo de Protrombina/veterinária , Rivaroxabana/farmacologia , Tromboelastografia/veterinária , Animais , Cães/sangue , Inibidores do Fator Xa/administração & dosagem , Inibidores do Fator Xa/farmacocinética , Masculino , Estudos Prospectivos , Rivaroxabana/administração & dosagem , Rivaroxabana/farmacocinética
18.
Orv Hetil ; 160(13): 509-515, 2019 Mar.
Artigo em Húngaro | MEDLINE | ID: mdl-30907102

RESUMO

INTRODUCTION: In the treatment of non-valvular atrial fibrillation (AF) with oral anticoagulants (OAC), medical adherence is a relevant factor for stroke prevention. AIM: To evaluate the one-year persistence of vitamin K antagonists (VKA) and direct oral anticoagulants (DOAC) in patients suffering from AF and already treated with OACs. METHOD: Information from the National Health Insurance Fund of Hungary prescriptions database on pharmacy claims between June 1, 2015 and December 31, 2015 was analysed. Authors identified patients who filled prescriptions for OACs (VKAs or DOACs) prescribed for AF who have already received OACs therapy during one year before. Apparatus of survival analysis was used, where 'survival' was the time to abandon the medication. RESULTS: 196 016 patients met the inclusion criteria. 181 810 patients received VKA and 14 206 patients were treated with DOACs. The one-year persistence rate in patients taking VKA was 52.9% whereas it was 66.8% in those on the DOACs. The persistence rates after 360 days were 67.5% for rivaroxaban, 63.6% for apixaban and 63.4% for dabigatran. The mean duration of persistence was 311 days for rivaroxaban, 308 days for apixaban and 284 days for dabigatran. The actual rate of discontinuation was 14% (HR = 1.14 [95% CI 1.05-1.24]), p = 0.0015) for apixaban, 15% (HR = 1.15 [95% CI 1.08-1.23], p = 0.003) for dabigatran and 62% (HR = 1.62 [95% CI 1.56-1.69], p<0.0001) for VKA compared to rivaroxaban (reference). CONCLUSIONS: The authors have confirmed that the one-year persistence of DOAKs was significantly higher compared to KVA therapy in AF. The one-year persistence of rivaroxaban was more favoured than apixaban and dabigatran. Orv Hetil. 2019; 160(13): 509-515.


Assuntos
Anticoagulantes/administração & dosagem , Fibrilação Atrial/tratamento farmacológico , Administração Oral , Dabigatrana/administração & dosagem , Bases de Dados Factuais , Humanos , Hungria , Pirazóis/administração & dosagem , Piridonas/administração & dosagem , Rivaroxabana/administração & dosagem , Resultado do Tratamento , Vitamina K/antagonistas & inibidores
19.
Clin Appl Thromb Hemost ; 25: 1076029619835053, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30907118

RESUMO

Dabigatran and rivaroxaban, direct oral anticoagulants (DOACs), affect coagulation tests, and knowledge of their effects is important for therapeutic monitoring. Our aim was to examine the association between DOAC levels and routine coagulation tests in patients with nonvalvular atrial fibrillation. Samples from patients receiving dabigatran (150 mg) and patients receiving rivaroxaban (20 mg) were collected 2 hours after drug intake. Direct oral anticoagulant concentrations were determined using direct Hemoclot thrombin inhibitor (HTI) assay (HTI test) and a direct Xa inhibitor (Anti Xa-Riva). The routine coagulation measured included activated partial thromboplastin time (aPTT) and prothrombin time (PT). The median plasmatic dabigatran was 128.3 ng/mL (95% confidence interval [CI]: 93.7-222.6 ng/mL). The HTI exhibited a good correlation with aPTT ( R2 = 0.74; P < .0001). The median plasmatic rivaroxaban was 223.9 ng/mL (95% CI: 212.3-238.9 ng/mL). Anti-Xa-Riva correlated with PT ( R2 = 0.69, P< .0001) and aPTT (R2 = 0.36, P < .001), but prolonged PT results were obtained, even below the rivaroxaban therapeutic range (20%). The routine coagulation tests were able to identify out of therapeutic range concentrations for dabigatran and rivaroxaban. We suggest the use of these screening tests to better understand and monitor the subtherapeutic concentrations of these DOACs.


Assuntos
Fibrilação Atrial/sangue , Fibrilação Atrial/tratamento farmacológico , Dabigatrana/administração & dosagem , Monitoramento de Medicamentos/métodos , Rivaroxabana/administração & dosagem , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Tempo de Tromboplastina Parcial , Tempo de Protrombina
20.
J Thromb Thrombolysis ; 47(4): 505-511, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-30903459

RESUMO

Autologous adoptive T cell immunotherapy has been recognized as an effective treatment for cancer patients. The initial qualified lymphocytes is the core element determining the immunotherapeutic outcomes clinically. Cell separator based apheresis procedure is an optimal procedure to collect adequate mono-nucleated lymphocytes to generate efficient ex vivo T cell expansions; however, potential catheter-associated femoral vein thrombosis at post-apheresis might rise an additional deteriorated morbidity for cancer patients. The emerging prophylactic medications are required at such circumstances. Therefore this study was designed to compare the prophylactic effects of rivaroxaban versus low molecular weight heparin (LMWH) in patients who had exposed during the femoral vein catheterization for apheresis. 74 Patients were randomized 1:1:1 into three groups: subcutaneous injection of LMWH, Fraxiparine (n = 23) (0.4 ml, 3800 IU/day) for 2 days, oral rivaroxaban 10 mg/d (n = 26), and oral rivaroxaban 20 mg/d (n = 25) for consecutive 2 days. The primary endpoint was to compare the venous thromboembolism (VTE) occurrence cases in one month post catheterization. There were 4 cases confirmed VTE occurrence in LMWH group with contrast to 1 case in rivaroxaban 10 mg administration group. None was seen in rivaroxaban 20 mg group (P = 0.02 as the comparison with LMWH). Meantime there was no bleeding events occurrence afterwards. Oral rivaroxaban 20 mg/day was recommendable to be considered which superior to LMWH. Although these limited data and patient volume reached the statistical difference which was able to provide the evidence proofed to compare the potency of those two anticoagulants, it could be regarded as the preliminary data provide the clinical results for cancer patients who were placed in the condition of apheresis and subsequently undergone adoptive T cell immunotherapy.Trial registration ClinicalTrials.gov identifier, NCT03282643. Registered 16 February 2016, http://www.ClinicalTrials.gov/ NCT03282643.


Assuntos
Transferência Adotiva , Remoção de Componentes Sanguíneos , Heparina de Baixo Peso Molecular/administração & dosagem , Neoplasias/terapia , Rivaroxabana/administração & dosagem , Trombose/prevenção & controle , Adulto , Idoso , Feminino , Seguimentos , Heparina de Baixo Peso Molecular/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasias/sangue , Estudos Prospectivos , Rivaroxabana/efeitos adversos , Linfócitos T/metabolismo , Linfócitos T/patologia , Trombose/sangue
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