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Resumo Fundamento: Os ensaios clínicos demonstraram a segurança da Edoxabana, um anticoagulante oral não dependente de vitamina K (NOAC), e a sua eficácia na prevenção de acidente vascular cerebral e embolia sistémica em pacientes com fibrilação atrial não valvar (FANV) e também na prevenção e tratamento de tromboembolismo venoso. No entanto, pesquisas adicionais são necessárias para avaliar a segurança e a eficácia da Edoxabana em um cenário real na população brasileira. Objetivo: A fim de compreender os riscos e benefícios do uso da Edoxabana em cenários clínicos de rotina, o estudo EdoBRA está sendo conduzido para obter informações sobre a segurança e eficácia do uso da Edoxabana em pacientes não pré-selecionados com FANV no Brasil. Métodos: O estudo EdoBRA é um estudo multicêntrico, prospectivo e observacional, realizado em 36 centros no Brasil. São elegíveis para este estudo pacientes com FANV, ≥ 18 anos de idade, tratados com Edoxabana disponível comercialmente, que iniciaram o tratamento por pelo menos 14 dias e não mais do que 90 dias antes da data de inclusão no estudo, e que não estão participando de nenhum outro estudo de intervenção. Ao todo, 700 pacientes devem ser inscritos e acompanhados por um ano, com coletas de dados programadas para o período basal e 3, 6 e 12 meses após a inscrição no estudo. O objetivo primário de segurança é o sangramento clinicamente relevante (de acordo com critérios da Sociedade Internacional de Trombose e Hemostasia - ISTH), e o objetivo secundário de eficácia são desfechos cardiovasculares relevantes relacionados à FANV. Conclusão: O estudo observacional EdoBRA gerará informações adicionais relevantes sobre a Edoxabana enquanto NOAC em diversos aspectos do manejo de pacientes no atendimento clínico de rotina, como perfil de segurança e efetividade em pacientes com FANV no Brasil.
Abstract Background: Clinical trials showed the safety of Edoxaban, a non-vitamin K-dependent oral anticoagulant (NOAC), and its efficacy to prevent stroke and systemic embolism in non-valvular atrial fibrillation (NVAF) patients and also to prevent and treat venous thromboembolism. However, additional research is needed to evaluate the safety and effectiveness of Edoxaban in a real-world scenario in the Brazilian population. Objective: In order to understand the risks and benefits of Edoxaban use in routine clinical settings, the EdoBRA study is being conducted to gain insight into the safety and effectiveness of Edoxaban use in non-preselected patients with NVAF in Brazil. Methods: The EdoBRA study is a multicenter, prospective, observational study conducted in 36 sites in Brazil. NVAF patients ≥ 18 years treated with commercially available Edoxaban who initiated treatment for at least 14 days and no longer than 90 days prior to enrollment, and who are not simultaneously participating in any interventional study are eligible for this study. Seven hundred patients are planned to be enrolled and one-year of follow up, with data collections expected at baseline and 3, 6, and 12 months after the study enrollment. The primary safety objective is ISTH Clinically Relevant Bleeding, and the secondary effectiveness objective focuses on relevant cardiovascular outcomes related to NVAF. Conclusion: EdoBRA observational study will generate relevant additional information about NOAC Edoxaban on various aspects of patient management in routine care, such as its safety and effectiveness profile in patients with NVAF in Brazil.
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Rivaroxaban is a direct factor Xa inhibitor. Its interindividual variability is large and may be connected to the occurrence of adverse drug reactions or drug inefficacy. Pharmacogenetics studies concentrating on the reasons underlying rivaroxaban's inadequate response could help explain the differences in treatment results and medication safety profiles. Against this background, this study evaluated whether polymorphisms in the gene encoding the ABCG2 transporter modify the pharmacokinetic characteristics of rivaroxaban. A total of 117 healthy volunteers participated in two bioequivalence experiments with a single oral dose of 20 mg rivaroxaban, with one group fasting and the other being fed. Ultra-high-performance liquid chromatography coupled with mass spectrometry was employed to determine the plasma concentrations of rivaroxaban, and the WinNonlin program was used to calculate the pharmacokinetics parameters. In the fasting group, the rivaroxaban pharmacokinetic parameters of Vd (508.27 vs 334.45 vs 275.59 L) and t1/2 (41.04 vs 16.43 vs 15.47 h) were significantly higher in ABCG2 421 A/A genotype carriers than in ABCG2 421 C/C and 421 C/A genotype carriers (P<0.05). The mean values of Cmax (145.81 vs 176.27 vs 190.19 ng/mL), AUC0-t (1193.81 vs 1374.69 vs 1570.77 ng/mL·h), and Cl (11.82 vs 14.50 vs 13.01 mL/h) for these groups were lower, but this difference was not statistically significant (P>0.05). These findings suggested that the ABCG2 421 A/A genotype may impact rivaroxaban parameters after a single dose in healthy subjects. This finding must be validated before it is applied in clinical practice.
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Objective A comprehensive evaluation of oral anticoagulants(OACs)was conducted using the A Quick Guideline for Drug Evaluation and Selection in Chinese Medical Institutions(the Second Edition),to provide a reference for drug selection and clinical medication decisions in medical institutions.Methods Evaluation evidence was collected,and the drugs included in the evaluation were quantified on four dimensions of clinical properties(efficiency and safety),pharmaceutical properties,economy and others.Results All oral anticoagulants included in the evaluation had a score of 70 or higher in the comprehensive evaluation,while warfarin had the highest overall score.Clinical properties and pharmacologic properties were identified as the core attributes for drug selection evaluation.When considering only these factors,edoxaban received the highest score.Conclusion OACs are the preferred option for patients requiring long-term anticoagulation therapy.Various OACs offer distinct clinical advantages.Utilizing the Guidelines(Second Edition)for oral anticoagulant selection and evaluation can offer visual evidence for drug selection and promote the scientific,rational,and safe use of drugs in clinical management.
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Introducción: El tratamiento con anticoagulantes ha demostrado su eficacia en la prevención de complicaciones cardioembólicas; sin embargo, la adherencia probablemente tiene el mayor impacto en la calidad de la anticoagulación. Objetivo: Determinar los factores que influyen en la adherencia al tratamiento anticoagulante y en la estabilidad del índice de estandarización internacional (INR). Métodos: Se realizó un estudio analítico, observacional y prospectivo que se corresponde con un estudio farmacoepidemiológico de utilización de medicamentos (Esquema Terapéutico), en pacientes con diagnóstico de trastornos de la coagulación, en el área de salud del municipio Manzanillo, entre el 1ro de septiembre de 2018 al 1ro de diciembre de 2020. Los datos de la investigación se obtuvieron de una entrevista y su historia clínica. Fueron utilizados el test del Xi-cuadrado (X2), t de Student, ANOVA y Kruskall Wallis, con un valor de p=0,05 durante el procesamiento estadístico. Resultados: Se constató un grado bajo de adherencia farmacoterapéutica en la población estudiada. Las variables sociodemográficas relacionadas con la adherencia terapéutica fueron el sexo, la escolaridad y la ocupación. Existe relación entre los recursos económicos, el conocimiento que tiene el paciente sobre su enfermedad, el cumplimiento del tratamiento no farmacológico y el cumplimiento del tratamiento farmacológico con la adherencia. Las reacciones adversas y la disponibilidad de los medicamentos fueron los factores dependientes del tratamiento relacionados con la adherencia. Las orientaciones del médico al paciente, el seguimiento del paciente y la relación médico-paciente, fueron los factores dependientes del médico. Conclusiones: Las cinco dimensiones de la adherencia terapéutica que plantea la OMS (factores socioeconómicos, relacionados con el paciente, relacionados con la enfermedad, relacionados con el tratamiento y relacionados con el sistema de salud) se asociaron con la adherencia al tratamiento y la estabilidad del índice de estandarización internacional.
Introduction: Anticoagulant therapy has demonstrated efficacy in preventing cardioembolic complications. However, adherence is probably the most important determinant of the quality of anticoagulation. Objective: The aim of this research wasto determine the factors that influence adherence to anticoagulation therapy and the stability of the international normalized ratio (INR). Methods: Between September 1, 2018 and December 1, 2020was conducted an analytical, observational andprospective study, corresponding to a pharmacoepidemiological study of drug utilization (Therapeutic Scheme). The object of this study were patients with a diagnosis of coagulation disorders, in the health area of the municipality of Manzanillo. The research data were obtained through an interview and their clinical history. The Xi-squared test (X2), Student's t-test, ANOVA and Kruskall Wallis were used, with a value of p = 0.05 in statistical processing. Results: As a result, a low level of pharmacotherapeutic adherence was observed in the studied population. The sociodemographic variables associated with adherence were sex, education and occupation. There was an association between economic resources, patients' knowledge of their disease, compliance with nonpharmacological treatment, and compliance with pharmacological treatment and adherence. Also, adverse drug reactions and drug availability were the treatment-related factors associated with adherence. And, physician orientation to the patient, patient follow-up, and physician-patient relationship were the physician-dependent factors. Conclusions: To sump up, the five dimensions of adherence proposedbyWHO (socioeconomic, patient-related, disease-related, treatment-related and health system-related factors) were associated with adherence and stability of the international standardization index.
Introdução: A terapêutica anticoagulante tem-se revelado eficaz na prevenção de complicações cardioembólicas. Objetivo: O objetivo desta investigação foi determinar os factores que influenciam a adesão à terapêutica anticoagulante e a estabilidade do rácio normalizado internacional (INR). Métodos: Um estudo analítico, observacional e prospetivo, correspondente a um estudo farmacoepidemiológico de utilização de medicamentos (Esquema Terapêutico) foi realizado entre 1 de setembro de 2018 e 1 de dezembro de 2020.O objeto deste estudo foram pacientes com diagnóstico de distúrbios de coagulação, da área de saúde do município de Manzanillo. Os dados da pesquisa foram obtidos através de uma entrevista e sua história clínica. Utilizou-se o teste do Xi-quadrado (X2), teste t de Student, ANOVA e Kruskall Wallis, com um valor de p = 0,05 no processamento estatístico. Resultados: Como resultado, observou-se um baixo nível de adesão à farmacoterapia na população estudada. As variáveis sociodemográficas associadas à adesão foram sexo, escolaridade e ocupação. Observou-se associação entre recursos financeiros, conhecimento da doença pelo paciente, adesão ao tratamento não farmacológico e adesão ao tratamento farmacológico e adesão. Além disso, as reacções adversas a medicamentos e a disponibilidade de medicamentos foram os factores relacionados com o tratamento associados à adesão. E a orientação médico-paciente, o acompanhamento do paciente e a relação médico-paciente foram os factores dependentes do médico. Conclusões: Concluindo, as cinco dimensões da adesão propostas pela OMS (factores socioeconómicos, relacionados com o doente, relacionados com a doença, relacionados com o tratamento e relacionados com o sistema de saúde) estiveram associadas à adesão e à estabilidade do índice de normalização internacional.
Résumé
OBJECTIVE To systematically evaluate the efficacy and safety of new oral anticoagulants (NOACs) in patients with nonvalvular atrial fibrillation after left atrial appendage occlusion (LAAO). METHODS Retrieved from PubMed, Embase, Web of Science, the Cochrane Library, CNKI and Wanfang data, randomized controlled trials (RCTs) and cohort studies about NOACs (trial group) versus warfarin or dual antiplatelet agents (control group) were collected during the inception and November 2022. After literature screening, data extraction and quality evaluation, meta-analysis was performed by using RevMan 5.4 software. RESULTS A total of 10 studies were included, involving 2 RCTs and 8 cohort studies, with a total of 2 653 patients. RCT results showed that there was no statistically significant difference in the incidence of device-related thrombosis (DRT), stroke/ systemic embolism (SSE), major bleeding events, total bleeding events or all-cause mortality between 2 groups (P>0.05). Results of cohort studies showed that compared with dual antiplatelet agents, there was no statistically significant difference in the incidence of DRT, stroke/SSE, major bleeding events or all-cause mortality in the trial group (P>0.05). Compared with warfarin, the incidence of DRT [RR=0.40, 95%CI (0.19,0.82), P=0.01] and total bleeding events [RR=0.28, 95%CI (0.18, 0.44), P< 0.000 01] in the trial group were decreased significantly; there was no statistical significance in the incidence of stroke/SSE, major bleeding events or all-cause mortality (P>0.05). CONCLUSIONS For patients with nonvalvular atrial fibrillation after LAAO, NOACs have comparable antithrombotic efficacy and safety with dual antiplatelet agents, and the incidence of DRT and total bleeding events are lower than warfarin.
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Atrial fibrillation (AF) is the most common supraventricular arrhythmia in patients with hypertrophic cardiomyopathy. Patients with hypertrophic cardiomyopathy and atrial fibrillation have a significantly increased risk of thromboembolism. Currently, guidelines recommend lifelong anticoagulant therapy for all such patients. The data on the use of non-vitamin K antagonist oral anticoagulants in patients with hypertrophic cardiomyopathy and atrial fibrillation are limited, and their efficacy and safety are not well established. This article provides a review of the current evidence on this issue.
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Objective: To analyze the safety and efficacy of using novel oral anticoagulants (rivaroxaban and others) in patients with cirrhosis accompanied with portal vein thrombosis (PVT). Methods: Clinical research literature published from the establishment of the database to June 20, 2021, was retrieved from PubMed, Web of Science, CNKI, Wanfang, and Weipu databases by combining subject terms and free words. RevMan software was used for the random group meta-analysis model. Results: In terms of PVT recanalization, the novel oral anticoagulants (such as low molecular weight heparin and others) had a higher recanalization rate than traditional anticoagulants (OR = 13.75, 95%CI 3.58-52.9, P = 0.000 1). In terms of bleeding, the novel oral anticoagulants did not increase the risk of bleeding compared with traditional anticoagulants (OR = 2.42, 95%CI 0.62-9.41, P = 0.20). Conclusion: The novel oral anticoagulant drugs are superior to traditional anticoagulants in terms of the occurrence of PVT recanalization; however, there is no statistically significant difference in terms of the occurrence of bleeding between the two groups.
Sujets)
Humains , Veine porte/anatomopathologie , Résultat thérapeutique , Thrombose veineuse/complications , Cirrhose du foie/anatomopathologie , Anticoagulants/usage thérapeutique , HémorragieRésumé
In the past few decades, heparin and warfarin have been the main anticoagulants used to treat and prevent venous thromboembolism. Recent studies at home and abroad have shown that non-vitamin K antagonist oral anticoagulants (NOACs) have similar or better efficacy and safety in the prevention and treatment of venous thromboembolism and non-valvular atrial fibrillation. NOACs do not require routine coagulation monitoring when used at a fixed dose. However, in special populations or specific scenarios such as emergency surgery, etc., an overdose or underdose and abnormal metabolism of NOACs may reduce the drug efficacy and safety, so monitoring and evaluating the anticoagulant effect of NOACs is more conducive to the prognosis of patients.This paper briefly reviewed the common laboratory monitoring methods of NOACs and their use in special populations, aiming to explain different monitoring methods for different NOACs and the applicability of NOACs in special populations, and hoping to provide reference for clinical standard monitoring and use of NOACS.
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Rivaroxaban, a novel oral anticoagulant drug, is widely prescribed in clinical practice. Rivaroxaban offers predictable pharmacokinetic and pharmacodynamic properties, a lowprobability of drug-drug and food-drug interactions. Compared with warfarin, rivaroxaban does not require continuous therapeutic monitoring and can be administered in fixed doses.However,in certain emergency clinical situations, such as bleeding, acute stroke, acute kidney injury, prior to urgent surgery and in the suspected accumulation of durg, plasma concentration monitoring of rivaroxaban is necessary and important for patients. Existing studies proved that there were significant individual variability and wide range in the plasma rivaroxaban concentration, which increased the risk of clinical use. Therefore, Data in the degree of rivaroxaban concentration may provide recommendations for the clinical application to promote medication safety and individuality in the future. This article collected the latest literatures and case reports related to research progress of rivaroxaban plasma concentration monitoring, and Summarized influencing factors, monitoring methods, so as to provide a basis for further study on rational use of rivaroxaban in clinical.
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Abstract Direct oral anticoagulants (DOACs) have become the standard of care for acute and long-term therapy for venous thromboembolism (VTE) due to their efficacy and safety profiles. The 2021 International Society on Thrombosis and Haemostasis guidelines recommend using standard DOAC dosages in patients with BMI >40 kg/m2 or weight >120 kg. Use of DOACs remains uncertain in morbidly obese patients with VTE, including acute PE. A morbidly obese woman in her 30s who presented with acute worsening of dyspnea was diagnosed with acute intermediate-high risk acute pulmonary embolism and concomitant proximal deep vein thrombosis, constituting a clinically challenging scenario for treating her with rivaroxaban. Standard doses of rivaroxaban for acute and extended phase treatment of venous thromboembolism in individuals with morbid obesity at BMI>70 kg/m2 may be effective, and safe.
Resumo Devido à sua eficácia e aos seus perfis de segurança, os anticoagulantes orais diretos (DOACs) tornaram-se o padrão de cuidado para a terapia aguda e de longo prazo de tromboembolismo venoso (TEV). As diretrizes da Sociedade Internacional de Trombose e Hemostasia de 2021 recomendam o uso de dosagens padrão de DOACs em pacientes com índice de massa corporal (IMC) > 40 kg/m2 ou peso > 120 kg. O uso de DOACs em pacientes com obesidade mórbida e TEV, incluindo embolia pulmonar aguda, ainda não foi esclarecido. Uma mulher com obesidade mórbida na faixa dos 30 anos que apresentou piora aguda da dispneia foi diagnosticada com embolia pulmonar aguda de risco intermediário-alto e trombose venosa profunda proximal concomitante, com o cenário clínico desafiador de tratá-la com rivaroxabana. Doses padrão de rivaroxabana para tratamento e recorrência de tromboembolismo venoso em indivíduos com obesidade mórbida e IMC > 70 kg/m2 podem ser eficazes e seguras.
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Resumen Introducción: En la última década los anticoagulantes orales directos (ACOD) se incorporaron como herramienta para la anticoagulación en pacientes con tromboembolia pulmonar (TEP) aguda. Aunque tienen un mejor perfil farmacológico que los antagonistas de la vitamina K (AVK), el uso de estos fármacos no es masivo. El objetivo del presente trabajo fue evaluar el uso de ACOD en pacientes con TEP aguda y detectar determinantes de su indicación. Metodología: Análisis preespecificado del registro CONAREC XX que incorporó pacientes con TEP aguda en 64 centros de Argentina. Se realizó un análisis para detectar predictores de prescripción de ACOD al alta. Resultados: Se analizaron 579 pacientes que recibieron anticoagulación al alta hospitalaria: el 60% recibió AVK, el 21% heparinas y el 19% ACOD (de ellos, un 49% rivaroxabán, un 34% apixabán y un 17% dabigatrán). Los pacientes que recibieron ACOD tenían TEP de menor gravedad, menor riesgo de hemorragia y menos complicaciones intrahospitalarias. En el seguimiento a 30 días no hubo diferencias en mortalidad por todas las causas o sangrados. La cobertura de salud por un seguro social (odds ratio [OR] 7.45; intervalo de confianza del 95% [IC 95%]: 1.74-31.9; p < 0.01) o por cobertura privada (OR 10.5; IC 95%: 2.4-45.9; p < 0.01) fueron predictores independientes de la prescripción de ACOD al alta, y el antecedente de insuficiencia cardiaca (OR 0.19; IC 95%: 0.04-0.84; p = 0.028) y de enfermedad oncológica (OR 0.49; IC 95%: 0.27-0.89; p = 0.02) fueron predictores de no prescribirlos. Conclusiones: Uno de cada cinco supervivientes de TEP aguda recibió ACOD al egreso hospitalario en Argentina, y esto fue determinado por variables clínicas y económicas
Abstract Introduction: In the last decade, direct oral anticoagulants (DOACs) have been incorporated as an anticoagulation tool in patients with acute pulmonary thromboembolism (PTE). Although they have a better pharmacological profile than vitamin K antagonists (VKA), the use of these drugs is not massive. The objective of this study was to evaluate the use of DOACs in patients with acute PE and to detect determinants of its use. Methodology: Prespecified analysis of the CONAREC XX registry that included patients with acute PE in 64 centers in Argentina. An analysis was performed to detect predictors of DOAC prescription at discharge. Results: 579 patients who received anticoagulation at hospital discharge were analyzed: 60% received VKA, 21% heparin and 19% DOAC (of them, 49% Rivaroxaban, 34% Apixaban, and 17% Dabigatran). Patients receiving DOACs had less severe PE, lower risk of bleeding, and fewer in-hospital complications. At 30-day follow-up, there were no differences in all-cause mortality or bleeding. Health coverage by social insurance (OR 7.45, CI 95% 1.74-31.9, p < 0.01) or by private coverage (OR 10.5, CI 95% 2.4-45.9, p < 0.01) were independent predictors of DOAC prescription at discharge, and history of heart failure (OR 0.19, 95% CI 0.04-0.84, p = 0.028) and oncological disease (OR 0.49, 95% CI 0.27-0.89; p = 0.02) were predictors not prescribe them. Conclusions: One in five survivors of acute PE received DOACs at hospital discharge in Argentina, and this was determined by clinical and economic variables.
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Fundamentos: O sistema de saúde brasileiro é embasado nos princípios estabelecidos na Constituição Federal, que in-cluem igualdade, universalidade, equidade e participação popular, em um modelo de saúde totalmente gratuito. O Brasil vive um grande desafio para ofertar assistência de qualidade para toda população. Muitas vezes, é necessário solicitar à justiça um suporte para conseguir acesso à saúde pública. Entre os processos judiciais envolvendo questões de saúde, a maioria são referentes ao fornecimento de medicamentos. Dentre os medicamentos solicitados, destacam-se os anticoagulantes orais diretos (DOACs), cujos estudos apontam que apresentam melhor segurança e eficácia similar em relação à varfarina, medicamento padronizado no SUS para o tratamento do tromboembolismo venoso e fibrilação atrial. Objetivo: Avaliar o perfil dos pacientes e das solicitações dos DOACs atendidos por via judicial. Métodos: Estudo documental descritivo realizado em Divinópolis/MG a partir de todos os processos julgados com parecer favorável pela justiça referentes à solicitação dos DOACs. A coleta de dados foi realizada em três fontes secundárias: os pro-cessos judiciários, prontuários dos pacientes nas unidades básicas de saúde e no Sistema de Informações em Saúde. Resultados: Foram incluídos no estudo um total de 74 processos referentes à solicitação dos DOACs no município de Divinópolis-MG. Observou-se que 74,3% dos indivíduos eram do sexo feminino, com média de idade de 70 anos. O diagnóstico mais observado foi a fibrilação atrial (36,5%). Cerca de 52,7% dos médicos registraram que houve tenta-tiva terapêutica com varfarina antes da introdução dos DOACs e a comodidade (24,3%) foi a justificativa mais utilizada por optar pelos DOACs seguida por dificuldade em controlar a RNI (20,3%). Outro dado encontrado foi que 25,7% dos pacientes nunca obtiveram na farmácia do SUS o medicamento solicitado por via judicial. Conclusão: Concluímos que a demanda judicial que afoga tanto o sistema judiciário como o sistema de saúde, poderia ser evitada se fossem seguidas as recomendações da Comissão Nacional de Incorporação de Tecnologias no Sistema Único de Saúde para estabelecer a distribuição dos insumos de saúde. Além disso, nos processos judiciais faltam informações importantes para auxiliar o juiz a emitir um parecer, sendo baseadas, na maioria das vezes, em apenas uma opinião médica. (AU)
Fundamentals: The Brazilian health system is based on the principles established in the Federal Constitution, which include equality, universality, equity, and popular participation in a completely free health model. Brazil is under great challenge to offer quality care to the entire population. It is often necessary to ask the court for support to gain access to public health.Among the court proceedings involving health issues, the majority refer to the supply of medicines. Among the drugs requested, direct oral anticoagulants (DOACs) stand out, which indicate that they have better safety and similar efficacy concerning warfarin, a standardized medication in the SUS to treat venous thromboembolism (VTE) and atrial fibrillation (AF). Objective: Assess the profile of patients and requests for direct oral anticoagulants (DOACs) served by the court. Methods: Descriptive documental study carried out in Divinópolis/MG from all cases judged with a favorable opinion by the court regarding the request of DOACs. Data collection was carried out from three secondary sources: court proceedings, medical records of patients in basic health units, and the Health Information System (SIS). Results:A total of 74 lawsuits referring to the DOACs request in the city of Divinópolis-MG were included in the study. It was observed that 74.3% of the individuals were female, with a mean age of 70 years. The most common diagnosis was atrial fibrillation (36.5%). About 52.7% of physicians reported that there was a therapeutic attempt with warfarin before the introduction of DOACs, and convenience (24.3%) was the most used justification for choosing DOACs, followed by difficulty in controlling the INR (20.3%). Another finding was that 25.7% of the patients never obtained the medication requested through the courts at the SUS pharmacy. Conclusion: We concluded that the judicial demand that drowns both the judicial system and the health system could be avoided if the recommendations of the National Commission for the Incorporation of Technologies in the Unified Health System were followed to establish the distribution of health education. In addition, in court proceedings, important information is lacking to assist the judge in issuing an opinion and is most often based on only one medical opinion. (AU)
Sujets)
Humains , Mâle , Femelle , Fibrillation auriculaire/traitement médicamenteux , Warfarine/usage thérapeutique , Profil de Santé , Pharmacovigilance , Judicialisation de la Santé , Anticoagulants/usage thérapeutiqueRésumé
Resumen Los anticoagulantes orales directos han surgido como una de las herramientas que ha cambiado el manejo de la enfermedad trombótica en los últimos 15 años. Sus ventajas, desde el punto de vista de la facilidad de uso y menor riesgo de sangrado, especialmente de sangrado cerebral, han posicionado a estos nuevos anticoagulantes como la primera alternativa de tratamiento en las dos indicaciones más frecuentes en que necesitamos estas drogas, la fibrilación auricular y la enfermedad tromboembólica venosa. Sin embargo, no todos los pacientes pueden recibir estos agentes, no todos los anticoagulantes directos tienen las mismas pro piedades y fundamentalmente, no todas las enfermedades con indicación de un anticoagulante pueden tratarse con ellos;con lo cual es necesario que todos los profesionales que están involucrados en el manejo de estos medicamentos estén obligados a conocerlos en profundidad, para poder decidir el mejor tratamiento en cada caso particular. Este documento de posición de expertos de diferentes especialidades de Argentina, presenta lineamientos para el uso correcto de los anticoagulantes directos en base a nueva evidencia y a la experiencia de uso de un amplio grupo de profesionales. La forma de relacionarnos con el tratamiento anticoagulante ha cambiado. Los médicos que trabajamos con ellos también debemos hacerlo.
Abstract Direct oral anticoagulants have emerged as the drugs that have changed the man agement of the antithrombotic treatment in the last 15 years. Their advantages, like a more friendly way of anticoagulation and their lower risk of bleeding, especially in the brain, have positioned these new anticoagu lants as the first drug of choice in the two most frequent indications of anticoagulation, atrial fibrillation, and the venous thromboembolic disease. However, not all the patients can receive these agents, not all the direct oral anticoagulants have the same characteristics, and most importantly, not all the diseases with an indication of an anticoagulant drug can be treated with them. Therefore, it is mandatory that all the faculties involved in the management of these drugs must know them in depth, to decide the best treatment for the patient. This position paper, from a group of experts in anticoagulation in Argentina, can help the general practitioner in the daily use of direct oral anticoagulants based on the new evidence and the experience of a wide group of professionals. The way we relate to the anticoagulant treatment has changed in the last years. The doctors who work with them must also do so.
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Fundamentos: A judicialização da saúde no Brasil gera aumento anual significativo das demandas por recursos financei-ros. Em 2016, com intuito de promover uma comunicação entre o sistema jurídico e o sistema de saúde, implementaram o sistema e-NatJus (Núcleos de Apoio Técnico do Poder Judiciário). A função do e-NatJus é fornecer apoio técnico aos juízes nas questões relativas à saúde por meio da elaboração de Notas Técnicas (NT). Objetivo: Analisar o perfil e a qualidade das NT de solicitação de anticoagulantes orais diretos (DOACs) disponíveis no portal eletrônico do e-NatJus para consultas por juízes. Métodos: Trata-se de um estudo documental descritivo, em que foram avaliadas as características sociodemo-gráficas, do diagnóstico e tratamento dos pacientes, bem como informações sobre as evidências da eficácia e segurança da tecnologia e conclusão de todas as NT referentes à solicitação de DOACs obtidas na plataforma e-NatJus desde sua im-plantação em 2018 até junho de 2020. Resultados: Foram incluídas no estudo 181 NT: rivaroxabana (67,0%), apixabana (16,0%), dabigatrana (12,0%) e edoxabana (5,0%). A média de idade dos indivíduos foi de 65,7 (±15,1) anos, sendo, (50,3%) do sexo feminino. São Sebastião do Paraíso foi o município que mais solicitou apoio nas NT (5,0%), e o estado com mais solicitações foi Santa Catarina (34,8%). Em relação ao diagnóstico dos pacientes, os mais prevalentes foram fibrilação atrial (FA)(31,5%) e troembolismo venoso (TEV)(16,4%). Aproximadamente 86 NT estavam com conteúdo semelhante no item evidência científica. Observou-se que (57,5%) tiveram a conclusão não favorável para disponibilizar o medicamento solicitado. Dentre as 77 NT que tiveram a conclusão favorável, (57,1%) não avaliaram as recomendações da Comissão Na-cional de Incorporação de Tecnologias (CONITEC). Conclusão: De forma geral, nosso estudo permitiu conhecer o perfil das NT e os principais motivos de solicitações dos DOACs, com intuito de compreender melhor se são realizadas realmente de forma consciente e responsável. A população que solicitou os DOACs via judicial é uma população idosa e não houve grande diferença entre os sexos. Os diagnósticos mais prevalentes nas NT foram FA e TEV corroborando com a indicação desses medicamentos. Pode-se observar que a maioria das NT que concedeu parecer favorável não evidenciou consulta à CONITEC e não apresentou evidência científica que contemplava de forma concreta sua decisão (AU)
Background: The judicialization of health in Brazil generates an annual increase in demands for financial resources. In 2016, to promote communication between the legal system and the health system, the implementation of e-NatJus system (Technical Support Centers of the Judiciary). The role of e-NatJus is to provide technical support to judges on health-related issues through the preparation of Technical Notes (NT). Objective: Analyze the profile and quality of TNs requesting Direct Oral Anticoagulants (DOACs) available on the e-NatJus electronic portal for consultation by judges. Methods: This is a descriptive documentary study, which evaluated the sociodemographic characteristics, diagnosis, and treatment of patients, as well as information on the evidence of the efficacy and safety of technology and the conclusion of all NT related to the request for DOACs obtained in the e-NatJus platform since its implementation in 2018 to June 24, 2020. Results: The study included 181 NT: rivaroxaban (67,0%), apixaban (16,0%), dabigatran (12,0%), and edoxaban (5,0%). The mean age of the individuals was 65.7 (±15.1) years, being (50,3%) female. São Sebastião do Paraíso was the municipality that most requested support in the NT (5,0%), and the state with the most requests was Santa Catarina (34,8%). Regarding the diagnosis, the most prevalent patients were AF (31,5%) and VTE (16,4%). Approximately 86 NT had similar content in the scientific evidence item. It was observed that (57,5%) had an unfavorable conclusion about making the requested drug available. Among the 77 NT that had a favorable conclusion, (57,1%) did not evaluate the rec-ommendations of the National Commission for the Incorporation of Technologies (CONITEC). Conclusion: In general, our study is effective to know the profile of the NT and the main reasons for consulting DOACs, to better understand the form of knowledge and the DOACs. It can be observed that most NTs granted a favorable opinion, did not evidence CONITEC and did not present scientific evidence that contemplated the concrete form of their decision (AU)
Sujets)
Humains , Warfarine/usage thérapeutique , Ressources Financières en Santé , Inhibiteurs du facteur XaRésumé
Rivaroxaban has been widely used for prevention and treatment of pulmonary embolism in adults due to the convenience of oral taking, rapid effect, less drug interaction, less influence by diet, no need of monitoring and fixed dose.However, its clinical application in children has been controversial.The EINSTEIN-Jr clinical trial and case reports at home and abroad have demonstrated the safety and effectiveness of Rivaroxaban in children with venous thrombus embolism.Therefore, Rivaroxaban can be considered as an alternative to standard anticoagulant therapy for children with venous thrombus embolism.This study reviews the application progress of Rivaroxaban in children with thromboembolic diseases.
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Objective:To systematically review the efficacy and safety of new oral anticoagulants(NOACs)for the treatment of patients over 70 years with atrial fibrillation.Methods:Studies comparing NOACs(dabigatran, rivaroxaban, apixaban, ximelagatran and edoxaban)versus warfarin for the treatment of patients over 70 years with atrial fibrillation were searched through databases including PubMed, Embase and the Cochrane Library, from the earliest electronic records to those published in March 2021.Stata15.0 software was used for meta-analysis.Results:A total of 19 studies and 215 471 patients were included.Meta-analysis results showed that, compared with warfarin, either a low-dose(110 mg)or a standard-dose(150 mg)of dabigatran reduced the risk of stroke/systemic embolism(SSE)in patients over 70 years with atrial fibrillation.A standard-dose of dabigatran did not decrease the risk of major bleeding, but a low dose was able to achieve it.A standard-dose(20 mg)of rivaroxaban could considerably reduce the risk of SSE in geriatric patients over 70 years with atrial fibrillation without increasing the risk of major bleeding.A standard-dose(5 mg)of apixaban could considerably decrease the risk of SSE and major bleeding in patients over 70 years with atrial fibrillation; A standard-dose(36 mg)of ximelagatran was as effective as warfarin in decreasing the incidence of SSE in patients over 70 years with atrial fibrillation, but could also considerably decrease the risk of major bleeding; A low-dose(15-30 mg)or a standard-dose(30-60 mg)of edoxaban decreased the incidence of SSE in patients over 70 years with atrial fibrillation, as did warfarin, but edoxaban considerably decreased the risk of major bleeding.Conclusions:Compared with warfarin, most of new oral anticoagulants show good efficacy in patients over 70 years old with atrial fibrillation, NOACs given at standard doses increase the risk of major bleeding, but at low doses can realize both efficacy and safety.
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Bilateral adrenal hemorrhage is a rare cause of primary adrenal insufficiency, and bilateral adrenal hemorrhage due to anticoagulant use is even rarer. We describe the case of a 62-year-old woman receiving post total knee arthroplasty anticoagulant therapy who presented fever, vomitting, stomachache, and severe fatigue on the 8th day. It was until 4 months later that the patient was finally diagnosed with adrenal insufficiency resuting from bilateral adrenal hemorrhage, her symptoms were relieved by glucocorticoid replacement therapy. In order to promote the awareness, diagnosis, and mangement of post-surgery anticoagulants induced bilateral adrenal hemorrhage, the clinical characteristics of the reported cases were summarized and analyzed.
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Resumen Objetivo: Establecer las características demográficas, clínicas y terapéuticas de los pacientes anticoagulados atendidos en las clínicas de anticoagulación del Hospital Universitario Fundación Santa Fe de Bogotá (HUFSFB) y del Hospital Universitario San Vicente Fundación Medellín (HUSVF), en los años 2015 y 2016. Método: Se realizó un estudio descriptivo, retrospectivo y transversal. La población de referencia la conformaron los pacientes atendidos en las clínicas de anticoagulación del HUSVF y el HUFSFB en el periodo comprendido entre marzo de 2015 y marzo de 2016. La información se tomó de los registros clínicos de ambos hospitales y para el análisis se utilizó estadística descriptiva. Resultados: Se evaluaron 502 pacientes en las dos clínicas de anticoagulación, con una edad promedio de 64 años en el HUFSFB y de 61 años en el HUSVF. La principal indicación de anticoagulación fue fibrilación o flutter auricular en el HUSVF (46.5%) y enfermedad tromboembólica venosa en el HUFSFB (69.7%). El 100% de los pacientes del HUSVF fueron anticoagulados con warfarina, frente a solo el 23% de los del HUFSFB; el tiempo en rango terapéutico fue del 69% en el HUFSFB y del 55% en el HSVF. Se presentó retrombosis en tres pacientes en cada una de las instituciones, y los eventos de sangrado fueron 7 (3,8%) en el HUFSFB y 30 (9,3%) en el HUSVF. Conclusiones: Las diferencias administrativas entre las dos instituciones se ven reflejadas en los resultados obtenidos. Existe, ligada al sistema de salud de nuestro país, una gran diferencia en la población, las enfermedades y el acceso a los servicios y a los medicamentos.
Abstract Objective: To establish the demographic, clinical and therapeutic characteristics of the anticoagulated patients treated at the anticoagulation clinics of Fundación Santa Fe de Bogotá (HUSVF) and Hospital Universitario San Vicente Fundación Medellin (HUFSFB), between 2015 and 2016. Method: A transversal retrospective descriptive study was carried out. The reference population consist in patients treated in the anticoagulation clinics of the HUSVF in Medellin and the HUFSFB in Bogotá between March 2015 to 2016. The information was taken from the clinical records of both hospitals and descriptive statistics were used for the data analysis. Results: A total of 502 patients were evaluated in both anticoagulation clinics. Patients' average age in HUFSFB was 64 years while in HUSVF was 61; the main pathology that required anticoagulation was the fibrillation/auricular flutter in HUSVF (46,5%) and venous thromboembolic disease in HUFSFB (69.7%). 100% of HUSVF patients are anticoagulated using warfarin and only 23% of those in HUFSFB; the time in therapeutic range (TTR) was 69% in HUFSFB and 55% in HSVF. Re-thrombosis was presented in 3 patients in each of the institutions and the bleeding events were 7 (3.8%) in HUFSFB and 30 (9.3%) in HUSVF. Conclusions: The administrative differences between the two institutions are reflected in the results obtained; there is a great difference in the population, pathologies, access to services and medicines, linked to the health system of our country.
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Humains , Warfarine , AnticoagulantsRésumé
The new oral anticoagulants (NOAC) dabigatran, rivaroxaban, apixaban, and edoxaban are widely used in clinical anticoagulation because of their fixed doses and superior safety. Studies have pointed out that there are large inter-individual differences in the pharmacokinetic parameters and response of NOAC, which may be related to the genetic polymorphisms of transporters and metabolic enzymes involved in in-vivo processes. This article reviews the influence of gene polymorphism on the pharmacokinetics and adverse reactions of NOAC, and provides directions for future research.