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1.
Angiology ; 71(1): 27-37, 2020 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-31533437

RESUMEN

We assessed the cardiovascular safety of long-term direct-acting oral anticoagulant (DOAC) treatment. A search of the medical literature was performed from inception until May 31, 2019. Inclusion criteria were (1) randomized trial that assessed the clinical efficacy and/or safety of 1 or more DOAC, (2) control group including oral anticoagulation and/or antiplatelet and/or placebo treatment, and (3) the incidence of acute coronary syndrome during follow-up was reported. Fixed-effect and random-effects models were applied. The analyzed outcomes were myocardial infarction (MI), major bleeding, and mortality. Twenty-eight randomized clinical trials (196 761 patients) were included. Rivaroxaban was associated with a 21% reduction in the relative risk of MI when compared to placebo (relative risk [RR]: 0.79 [95% credible interval, CrI: 0.65-0.94]) and a 31% reduction (RR: 0.70 [95% CrI: 0.53-0.89]) when compared to dabigatran. Apixaban resulted in 24% (RR: 0.76 [95% CrI: 0.58-0.99]) and vitamin K antagonists anticoagulation resulted in 19% (RR: 0.81 [95% CrI: 0.65-0.98]) risk reduction compared to dabigatran. The computed probability of being the first best choice of treatment was 61.8% for rivaroxaban. Cardiovascular safety shows considerable heterogeneity among oral anticoagulants. Treatment with rivaroxaban is associated with reduced rate of MI.


Asunto(s)
Anticoagulantes/administración & dosificación , Infarto del Miocardio/prevención & control , Administración Oral , Anticoagulantes/efectos adversos , Esquema de Medicación , Hemorragia/inducido químicamente , Humanos , Infarto del Miocardio/mortalidad , Metaanálisis en Red , Factores Protectores , Ensayos Clínicos Controlados Aleatorios como Asunto , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento
2.
Gan To Kagaku Ryoho ; 46(12): 1883-1885, 2019 Dec.
Artículo en Japonés | MEDLINE | ID: mdl-31879408

RESUMEN

A woman in her 70s developed deep vein thromboembolism(DVT)and pulmonary embolism(PE)during chemotherapy for advanced transverse colon cancer. After the first treatment with heparin and warfarin, the anticoagulant was changed to edoxaban to reduce the risk of bleeding. She continued receiving chemotherapy for 4 years. We recommend edoxaban as the first choice of anticoagulant for patients with DVT and PE requiring chemotherapy with fluoropyrimidine-based antineoplastic agents.


Asunto(s)
Anticoagulantes/efectos adversos , Neoplasias del Colon , Fluorouracilo/uso terapéutico , Embolia Pulmonar , Piridinas/efectos adversos , Tiazoles/efectos adversos , Tromboembolia , Tromboembolia Venosa , Anciano , Neoplasias del Colon/tratamiento farmacológico , Humanos , Embolia Pulmonar/inducido químicamente , Tromboembolia Venosa/inducido químicamente
4.
Pan Afr Med J ; 33: 160, 2019.
Artículo en Francés | MEDLINE | ID: mdl-31565122

RESUMEN

Intra-alveolar bleeding is a rare and severe medical emergency due to numerous causes. We report the clinical case of a patient who could contribute to extend the literature on this subject. The study included a 62-year old man, with a history of a trial fibrillation, under anti-vitamins K antagonist admitted with dyspnoea of sudden onset associated with haemoptysis and practising self-medication using non-steroidal anti-inflammatory drugs. X-rays and chest scan showed diffuse bilateral alveolar opacities. Haemostatic screening tests on admission showed non-coagulable INR. The diagnosis of intra-alveolar bleeding was clinically and radiologically suspected and then confirmed by bronchial endoscopy with broncho-alveolar lavage (BAL) which detected uniformly hemorrhagic liquid. Previous studies of similar complications occurring after anti-vitamins K antagonists assumption are rare. In conclusion, it seems very important to emphasize the interest of strict and optimal clinico-biological monitoring of patients treated in anti-vitamins K antagonists to avoid an overdose which could contribute to a life-threatening severe haemorrhagic event.


Asunto(s)
Acenocumarol/efectos adversos , Anticoagulantes/efectos adversos , Hemorragia/inducido químicamente , Alveolos Pulmonares/patología , Acenocumarol/administración & dosificación , Anticoagulantes/administración & dosificación , Disnea/inducido químicamente , Hemoptisis/inducido químicamente , Humanos , Masculino , Persona de Mediana Edad , Vitamina K/antagonistas & inhibidores
5.
Rev. Pesqui. (Univ. Fed. Estado Rio J., Online) ; 11(5): 1312-1318, out.-dez. 2019. ilus
Artículo en Inglés, Portugués | LILACS, BDENF - Enfermería | ID: biblio-1022225

RESUMEN

Objective: The study's purpose has been to relate the drug interactions of oral anticoagulants with other medications used by elderly people hospitalized in a cardiology hospital. Methods: It is a prospective exploratory study with 16 elderly people taking oral anticoagulant, who were hospitalized at a governmental cardiology institution in São Paulo State over the period from November to December 2017. Results: Among 73 medicines prescribed and analyzed in the Micromedex 2.0, 24 (33.3%) interacted with Warfarin, the only prescribed oral anticoagulant. There were found Omeprazole (70; 97.2%); Dipyrone (68; 94.4%); Simvastatin (43; 59.72%); Enoxaparin (42; 58.33%); Amiodarone (29; 40.27%); Sertraline (28; 38.88%); Spironolactone (21; 29.16%); and Atenolol (11; 15.27%), whose interactions could either potentialize or inhibit the anticoagulant action. Considering the interactions, 14 (58.33%) were of moderate severity, 10 (41.66%) of high severity and 14 (58.33%) of fast effect. Conclusion: Polypharmacy and the use of oral anticoagulants in elderly patients bearing heart diseases are common events. Moreover, a better understanding about drug interactions is also required, bearing in mind that they can either potentialize or decrease the anticoagulant effect, with high or moderate severity


Objetivo: Relacionar as interações medicamentosas dos anticoagulantes orais com os medicamentos utilizados por idosos internados em hospital cardiológico. Método: Estudo exploratório, prospectivo, com 16 idosos em uso de anticoagulantes orais, internados numa instituição cardiológica governamental de São Paulo entre novembro e dezembro de 2017. Resultados: Dentre 73 medicamentos prescritos e analisados no Micromedex 2.0, 24 (33,3%) interagiam com a Varfarina, único anticoagulante oral prescrito. Encontrou-se Omeprazol (70;97,2%); Dipirona (68;94,4%); Sinvastatina (43;59,72%); Enoxaparina (42;58,33%); Amiodarona (29;40,27%); Sertralina (28;38,88%); Espironolactona (21;29,16%); e Atenolol (11;15,27%), cujas interações poderiam potencializar ou inibir a ação anticoagulante. Das interações, 14 (58,33%) eram de gravidade moderada, 10 (41,66%) maior e 14 (58,33%) de efeito rápido. Conclusão: A polifarmácia e o uso de anticoagulante oral em idosos cardiopatas é comum e, conhecer as interações medicamentosas, é imperativa, considerando que potencializam ou diminuem a ação anticoagulante, com gravidade maior ou moderada


Objetivo: Relacionar las interacciones medicamentosas de los anticoagulantes orales con los medicamentos utilizados por ancianos internados em um hospital cardiológico. Método:Estudio exploratorio, prospectivo, con 16 ancianos en uso de anticoagulantes orales, internados en una institución cardiológica gubernamental de São Paulo entre noviembre y diciembre de 2017. Resultados:Entre 73 medicamentos prescritos y analizados en el Micromedex 2.0, 24 (33,3%) interactuaban con la Varfarina, único anticoagulante oral prescrito. Se encontró Omeprazol (70, 97,2%); Dipirona (68, 94,4%); Sinvastatina (43, 59,72%); Enoxaparina (42, 58,33%); Amiodarona (29, 40,27%); Sertralina (28, 38,88%); Espironolactona (21, 29,16%); y Atenolol (11, 15,27%), cuyas interacciones podrían potenciar o inhibir la acción anticoagulante. De las interacciones, 14 (58,33%) eran de gravedad moderada, 10 (41,66%) mayor y 14 (58,33%) de efecto rápido. Conclusión: La polifarmacia y el uso de anticoagulante oral en ancianos cardiopatas es común y, conocer las interacciones medicamentosas, es imperativa, considerando que potencian o disminuyen la acción anticoagulante, con gravedad mayor o moderada


Asunto(s)
Humanos , Masculino , Femenino , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , Warfarina/uso terapéutico , Interacciones de Drogas , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Anticoagulantes/uso terapéutico , Warfarina/efectos adversos , Salud del Anciano , Anticoagulantes/efectos adversos
6.
JAMA ; 322(9): 834-842, 2019 09 03.
Artículo en Inglés | MEDLINE | ID: mdl-31479138

RESUMEN

Importance: The optimal international normalized ratio (INR) to prevent venous thromboembolism (VTE) in warfarin-treated patients with recent arthroplasty is unknown. Objective: To determine the safety and efficacy of a target INR of 1.8 vs 2.5 for VTE prophylaxis after orthopedic surgery. Design, Setting, and Participants: The randomized Genetic Informatics Trial (GIFT) of Warfarin to Prevent Deep Vein Thrombosis enrolled 1650 patients aged 65 years or older initiating warfarin for elective hip or knee arthroplasty at 6 US medical centers. Enrollment began in April 2011 and follow-up concluded in October 2016. Interventions: In a 2 × 2 factorial design, participants were randomized to a target INR of 1.8 (n = 823) or 2.5 (n = 827) and to either genotype-guided or clinically guided warfarin dosing. For the first 11 days of therapy, open-label warfarin dosing was guided by a web application. Main Outcomes and Measures: The primary outcome was the composite of VTE (within 60 days) or death (within 30 days). Participants underwent screening duplex ultrasound postoperatively. The hypothesis was that an INR target of 1.8 would be noninferior to an INR target of 2.5, using a noninferiority margin of 3% for the absolute risk of VTE. Secondary end points were bleeding and INR values of 4 or more. Results: Among 1650 patients who were randomized (mean age, 72.1 years; 1049 women [63.6%]; 1502 white [91.0%]), 1597 (96.8%) received at least 1 dose of warfarin and were included in the primary analysis. The rate of the primary composite outcome of VTE or death was 5.1% (41 of 804) in the low-intensity-warfarin group (INR target, 1.8) vs 3.8% (30 of 793) in the standard-treatment-warfarin group (INR target, 2.5), for a difference of 1.3% (1-sided 95% CI, -∞ to 3.05%, P = .06 for noninferiority). Major bleeding occurred in 0.4% of patients in the low-intensity group and 0.9% of patients in the standard-intensity group, for a difference of -0.5% (95% CI, -1.6% to 0.4%). The INR values of 4 or more occurred in 4.5% of patients in the low-intensity group and 12.2% of the standard-intensity group, for a difference of -7.8% (95% CI, -10.5% to -5.1%). Conclusions and Relevance: Among older patients undergoing hip or knee arthroplasty and receiving warfarin prophylaxis, an international normalized ratio goal of 1.8 compared with 2.5 did not meet the criterion for noninferiority for risk of the composite outcome of VTE or death. However, the trial may have been underpowered to meet this criterion and further research may be warranted. Trial Registration: ClinicalTrials.gov Identifier: NCT01006733.


Asunto(s)
Anticoagulantes/administración & dosificación , Artroplastia de Reemplazo de Cadera , Artroplastia de Reemplazo de Rodilla , Relación Normalizada Internacional , Tromboembolia Venosa/prevención & control , Warfarina/administración & dosificación , Anciano , Anticoagulantes/efectos adversos , Femenino , Estudios de Seguimiento , Hemorragia/inducido químicamente , Humanos , Estimación de Kaplan-Meier , Masculino , Modelos de Riesgos Proporcionales , Tromboembolia Venosa/mortalidad , Warfarina/efectos adversos
9.
Lancet Haematol ; 6(10): e530-e539, 2019 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-31444124

RESUMEN

BACKGROUND: Hospital-associated venous thromboembolism is a major patient safety concern. Provision of prophylaxis to patients admitted for elective total knee replacement surgery has been proposed as an effective strategy to reduce the incidence of venous thromboembolism. We aimed to assess the relative efficacy and safety of all available prophylaxis strategies in this setting. METHODS: We did a systematic review and Bayesian network meta-analyses of randomised controlled trials to assess the relative efficacy and safety of venous thromboembolism prophylaxis strategies and to populate an economic model that assessed the cost-effectiveness of these strategies and informed the updated National Institute for Health and Care Excellence (NICE) guideline recommendations for patients undergoing elective total knee replacement surgery. The Cochrane Library (CENTRAL), Embase, and Medline were last searched on June 19, 2017, with key terms relating to the population (venous thromboembolism and total knee replacement) and the interventions compared, including available pharmacological and mechanical interventions. Outcomes of interest were deep vein thrombosis (symptomatic and asymptomatic), pulmonary embolism, and major bleeding. Risk of bias was assessed, and relevant data extracted from the included randomised controlled trials for the network meta-analyses. Relative risks (RR; with 95% credible intervals [95% CrI]) compared to no prophylaxis, median ranks (with 95% CrI), and the probability of being the best intervention were calculated. The study was done in accordance with PRISMA guidelines. FINDINGS: 25 randomised controlled trials were included in the network meta-analyses. 23 trials (19 interventions; n=15 028) were included in the deep vein thrombosis network, 12 in the pulmonary embolism network (13 interventions; n=15 555), and 19 in the major bleeding network (11 interventions; n=19 797). Risk of bias ranged from very low to high. Rivaroxaban ranked first for prevention of deep vein thrombosis (RR 0·12 [95% CrI 0·06-0·22]). Low molecular weight heparin (LMWH; standard prophylactic dose, 28-35 days) ranked first in the pulmonary embolism network (RR 0·02 [95% CrI 0·00-3·86]) and LMWH (low prophylactic dose, 10-14 days) ranked first in the major bleeding network (odds ratio 0·08 [95% CrI 0·00-1·76]), but the results for pulmonary embolism and major bleeding are highly uncertain. INTERPRETATION: Single prophylaxis strategies are more effective in prevention of deep vein thrombosis in the elective total knee replacement population than combination strategies, with rivaroxaban being the most effective. The results of the pulmonary embolism and major bleeding meta-analyses are uncertain and no clear conclusion can be made other than what is biologically plausible (eg, that no prophylaxis and mechanical prophylaxis strategies should have the lowest risk of major bleeding). FUNDING: National Institute for Health and Care Excellence.


Asunto(s)
Anticoagulantes/uso terapéutico , Tromboembolia Venosa/prevención & control , Anticoagulantes/efectos adversos , Artroplastia de Reemplazo de Rodilla , Hemorragia/etiología , Heparina de Bajo-Peso-Molecular/efectos adversos , Heparina de Bajo-Peso-Molecular/uso terapéutico , Humanos , Oportunidad Relativa , Riesgo , Tromboembolia Venosa/patología
10.
Med Clin North Am ; 103(5): 847-862, 2019 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-31378330

RESUMEN

Oral anticoagulation significantly reduces the risk of stroke in patients with atrial fibrillation (AF), and the decision to initiate therapy is based on assessing the patient's yearly risk of stroke. Although warfarin remains the drug of choice in patients with AF and artificial mechanical valves, the novel anticoagulation agents are becoming the drug of choice for all other patients with AF, because of their efficacy, safety, and ease of use. This article summarizes the current evidence for stroke prevention in AF, including valvular AF, subclinical AF, AF in patients with renal insufficiency, as well as stroke prevention around AF cardioversion.


Asunto(s)
Anticoagulantes/administración & dosificación , Fibrilación Atrial/tratamiento farmacológico , Accidente Cerebrovascular/prevención & control , Administración Oral , Anticoagulantes/efectos adversos , Fibrilación Atrial/complicaciones , Ensayos Clínicos como Asunto , Humanos , Guías de Práctica Clínica como Asunto , Accidente Cerebrovascular/etiología , Warfarina/administración & dosificación , Warfarina/efectos adversos
11.
Vasc Health Risk Manag ; 15: 175-186, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31417269

RESUMEN

Venous thromboembolism (VTE) is a common cause of morbidity and mortality in patients with cancer. Compared with the general population, cancer patients with VTE have higher rates of both VTE recurrence and bleeding. While low molecular weight heparin (LMWH) has been the mainstay of treatment for cancer-associated VTE for over a decade, direct oral anticoagulants (DOACs) have recently emerged as a new therapeutic option due to their ease of administration and because they do not require laboratory monitoring. Several large randomized clinical trials have been performed or are ongoing at the time of writing, comparing DOACs with LMWH in this population. Three of these trials have thus far been published and suggest that DOACs are a reasonable alternative to LMWH for management of cancer-associated VTE. Despite the advantages offered by DOACs, these agents may not be appropriate for certain patient groups owing to increased risk of bleeding, organ compromise, extremes of weight, and other issues. Finally, data are emerging suggesting that DOACs may be useful for primary thromboprophylaxis in cancer patients in conjunction with validated risk assessment scores. In this evidence-based review, data for the use of DOACs to treat cancer-associated VTE will be examined, focusing on efficacy, safety, and timing of treatment. Guidance on choosing the optimal anticoagulant for a given patient is also offered.


Asunto(s)
Anticoagulantes/administración & dosificación , Coagulación Sanguínea/efectos de los fármacos , Neoplasias/tratamiento farmacológico , Tromboembolia Venosa/prevención & control , Administración Oral , Anticoagulantes/efectos adversos , Hemorragia/inducido químicamente , Humanos , Neoplasias/sangre , Neoplasias/diagnóstico , Neoplasias/mortalidad , Recurrencia , Medición de Riesgo , Factores de Riesgo , Resultado del Tratamiento , Tromboembolia Venosa/sangre , Tromboembolia Venosa/diagnóstico , Tromboembolia Venosa/mortalidad
12.
Lancet Haematol ; 6(10): e500-e509, 2019 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-31420317

RESUMEN

BACKGROUND: Rivaroxaban has been shown to be efficacious for treatment of venous thromboembolism in adults, and has a reduced risk of bleeding compared with standard anticoagulants. We aimed to develop paediatric rivaroxaban regimens for the treatment of venous thromboembolism in children and adolescents. METHODS: In this phase 2 programme, we did three studies to evaluate rivaroxaban treatment in children younger than 6 months, aged 6 months to 5 years, and aged 6-17 years. Our studies used a multicentre, single-arm design at 54 sites in Australia, Europe, Israel, Japan, and north America. We included children with objectively confirmed venous thromboembolism previously treated with low-molecular weight heparin, fondaparinux, or a vitamin K antagonist for at least 2 months or, in children who had catheter-related venous thromboembolism for at least 6 weeks. We administered rivaroxaban orally in a bodyweight-adjusted 20 mg-equivalent dose, based on physiologically-based pharmacokinetic modelling predictions and EINSTEIN-Jr phase 1 data in young adults, in either a once-daily (tablets; for those aged 6-17 years), twice-daily (in suspension; for those aged 6 months to 11 years), or three times-daily (in suspension; for those younger than 6 months) dosing regimen for 30 days (or 7 days for those younger than 6 months). The primary aim was to define rivaroxaban treatment regimens that match the target adult exposure range. The principal safety outcome was major bleeding and clinically relevant non-major bleeding. Analyses were per-protocol. The predefined efficacy outcomes were symptomatic recurrent venous thromboembolism, asymptomatic deterioration on repeat imaging at the end of the study treatment period. These trials are registered at ClinicalTrials.gov, numbers NCT02564718, NCT02309411, and NCT02234843. FINDINGS: Between Feb 11, 2013, and Dec 20, 2017, we enrolled 93 children (ten children younger than 6 months; 15 children aged 6 months to 1 year; 25 children aged 2-5 years; 32 children aged 6-11 years; and 11 children aged 12-17 years) into our study. 89 (96%) children completed study treatment (30 days of treatment, or 7 days in those younger than 6 months), and 93 (100%) children received at least one dose of study treatment and were evaluable for the primary endpoints. None of the children had a major bleed, and four (4%, 95% CI 1·2-10·6) of these children had a clinically relevant non-major bleed (three children aged 12-17 years with menorrhagia and one child aged 6-11 years with gingival bleeding). We found no symptomatic recurrent venous thromboembolism in any patients (0%, 0·0-3·9). 24 (32%) of 75 patients with repeat imaging had their thrombotic burden resolved, 43 (57%) patients improved, and eight (11%) patients were unchanged. No patient deteriorated. We confirmed therapeutic rivaroxaban exposures with once-daily dosing in children with bodyweights of at least 30 kg and with twice-daily dosing in children with bodyweights of at least 20 kg and less than 30 kg. Children with low bodyweights (<20 kg, particularly <12 kg) showed low exposures so, for future studies, rivaroxaban dosages were revised for these weight categories, to match the target adult exposure range. 61 (66%) of 93 children had adverse events during the study. Pyrexia was the most common adverse event (ten [11%] events), and anaemia and neutropenia or febrile neutropenia were the most frequent grade 3 or worse events (four [4%] events each). No children died or were discontinued from rivaroxaban because of adverse events. INTERPRETATION: Treatment with bodyweight-adjusted rivaroxaban appears to be safe in children. The treatment regimens that we confirmed in children with bodyweights of at least 20 kg and the revised treatment regimens that we predicted in those with bodyweights less than 20 kg will be evaluated in the EINSTEIN-Jr phase 3 trial in children with acute venous thromboembolism. FUNDING: Bayer AG, Janssen Research and Development.


Asunto(s)
Anticoagulantes/uso terapéutico , Rivaroxabán/uso terapéutico , Tromboembolia Venosa/tratamiento farmacológico , Adolescente , Anemia/etiología , Anticoagulantes/efectos adversos , Anticoagulantes/farmacocinética , Peso Corporal , Niño , Preescolar , Esquema de Medicación , Cálculo de Dosificación de Drogas , Factor Xa/análisis , Femenino , Semivida , Hemorragia/etiología , Humanos , Lactante , Masculino , Neutropenia/etiología , Tiempo de Protrombina , Rivaroxabán/efectos adversos , Rivaroxabán/farmacocinética , Resultado del Tratamiento , Tromboembolia Venosa/patología
13.
West J Emerg Med ; 20(4): 619-625, 2019 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-31316701

RESUMEN

Introduction: Warfarin is a potent anticoagulant used for the prevention and treatment of venous and arterial thrombosis. Occasionally, patients require emergent warfarin reversal due to active bleeding, supratherapeutic international normalized ratio, or emergent diagnostic or therapeutic interventions. Various agents can be used for emergent warfarin reversal, including fresh frozen plasma (FFP) and 4-factor prothrombin complex concentrate (4F-PCC). Both FFP and 4F-PCC are generally considered safe; however, both agents contain coagulation factors and have the potential to provoke a thromboembolic event. Although clinical trials have compared the efficacy and safety of FFP and 4F-PCC, data are limited comparing the risk of thromboembolism between the two agents. Methods: A retrospective chart review was performed at a single, urban, academic medical center comparing the incidence of thromboembolism with FFP or 4F-PCC for warfarin reversal during a three-year period in the emergency department (ED) at Massachusetts General Hospital. Patients were included in the study if they were at least 18 years of age and were on warfarin per electronic health records. Patients were excluded if they had received both FFP and 4F-PCC during the same visit. The primary outcome was the frequency of thromboembolism within 30 days of 4F-PCC or FFP. Secondary outcomes included time to thromboembolic event and in-hospital mortality. Results: Three hundred and thirty-six patients met the inclusion criteria. Thromboembolic events within 30 days of therapy occurred in seven patients (2.7%) in the FFP group and 14 patients (17.7%) in the 4F-PCC group (p=<0.001). Death occurred in 39 patients (15.2%) who received FFP and 18 patients (22.8%) who received 4F-PCC (p=0.115). Since the 4F-PCC group was treated disproportionately for central nervous system (CNS) bleeding, a subgroup analysis was performed including patients requiring reversal due to CNS bleeds that received vitamin K. The primary outcome remained statistically significant, occurring in four patients (4.1%) in the FFP group and nine patients (14.1%) in the 4F-PCC group (p=0.02). Conclusion: Our study found a significantly higher risk of thromboembolic events in patients receiving 4F-PCC compared to FFP for urgent warfarin reversal. This difference remained statistically significant when controlled for CNS bleeds and administration of vitamin K.


Asunto(s)
Factores de Coagulación Sanguínea/efectos adversos , Plasma , Tromboembolia/inducido químicamente , Anciano , Anticoagulantes/efectos adversos , Factores de Coagulación Sanguínea/administración & dosificación , Servicio de Urgencia en Hospital , Femenino , Humanos , Masculino , Estudios Retrospectivos , Tromboembolia/epidemiología , Warfarina/efectos adversos
14.
Cancer Treat Res ; 179: 103-115, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31317483

RESUMEN

The management of cancer-associated thrombosis (CAT) is complex, and treatment strategies have been evolving over the past 15 years. It is well recognized that oral vitamin K antagonists are difficult to use in cancer patients, with higher rates of treatment failure and bleeding complications than in non-cancer patients. Low-molecular-weight-heparin (LMWH) became the widely accepted standard of care for treatment of cancer-associated thrombosis, following the CLOT study comparing dalteparin with warfarin in 2003. LMWH remains widely used for the treatment of CAT. However, in the past two years, several studies have served to validate direct oral anticoagulants as a safe and effective alternative to LMWH. Two randomized clinical trials comparing edoxaban and rivaroxaban with dalteparin, and several retrospective studies have shown the efficacy of edoxaban and rivaroxaban for the treatment of CAT. However, there is an evidence of increased bleeding with the DOACs, particularly gastrointestinal or urinary tract bleeding in patients with lesions within the gastrointestinal or urinary tracts. This chapter discusses the ongoing development of optimal treatment strategies for cancer-associated thrombosis.


Asunto(s)
Anticoagulantes/administración & dosificación , Inhibidores del Factor Xa/administración & dosificación , Heparina de Bajo-Peso-Molecular/administración & dosificación , Neoplasias/complicaciones , Tromboembolia Venosa/tratamiento farmacológico , Administración Oral , Anticoagulantes/efectos adversos , Anticoagulantes/uso terapéutico , Inhibidores del Factor Xa/efectos adversos , Inhibidores del Factor Xa/uso terapéutico , Hemorragia/inducido químicamente , Heparina de Bajo-Peso-Molecular/uso terapéutico , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Retrospectivos , Tromboembolia Venosa/etiología
15.
Cancer Treat Res ; 179: 179-189, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31317488

RESUMEN

Venous thromboembolism is commonly diagnosed in patients with primary and secondary brain tumors. Anticoagulation management in the setting of brain tumors is complicated by the high background rate of spontaneous intracranial hemorrhage. Until recently, there was limited evidence to support the decision to administer therapeutic anticoagulation in the setting of brain metastases or primary brain tumors. The current evidence suggests that the safety profile of therapeutic low molecular weight heparin for the treatment of venous thromboembolism is contingent on whether the origin of brain tumor is primary (i.e., glioma) versus secondary. In patients with brain metastases, the rate of intracranial hemorrhage often exceeds 20% but is not influenced by the administration of low molecular weight heparin. In contrast, in primary brain tumors such as glioma, therapeutic anticoagulation is associated with an increased risk of intracranial hemorrhage that can negatively impact survival. This chapter reviews the underlying mechanisms contributing to thrombosis and hemorrhage in brain tumors and summarizes the current evidence and approaches in anticoagulation to treat venous thromboembolism.


Asunto(s)
Anticoagulantes/uso terapéutico , Neoplasias Encefálicas/complicaciones , Hemorragias Intracraneales/etiología , Tromboembolia Venosa/tratamiento farmacológico , Anticoagulantes/efectos adversos , Neoplasias Encefálicas/patología , Neoplasias Encefálicas/secundario , Humanos , Hemorragias Intracraneales/inducido químicamente , Tromboembolia Venosa/etiología
16.
Khirurgiia (Mosk) ; (7): 52-57, 2019.
Artículo en Ruso | MEDLINE | ID: mdl-31355815

RESUMEN

OBJECTIVE: To compare incidence of thromboembolic and hemorrhagic complications in patients with atrial fibrillation (AF) undergoing elective surgery on different schemes of perioperative anticoagulant therapy (ACT). MATERIAL AND METHODS: There were 86 patients (56 (65.1%) men and 30 (34.9%) women, mean age was 69 (64; 78) years) with non-valvular AF who underwent elective interventions. Forty (46.5%) patients underwent abdominal surgery, 34 (39.5%) - cardiovascular procedures, 12 (14.0%) patients underwent surgery for malignant diseases. We have analyzed incidence of thromboembolic and hemorrhagic events and compliance of perioperative ACT modes with current international guidelines. RESULTS: Thromboembolic and hemorrhagic events developed in 14 (16.3%) patients. Thromboembolic complications were noted in 6 (7.0%) patients, hemorrhagic events - in 8 (9.3%) cases. Maximum complication rate was observed in case of bridge-therapy (n=12, 20.0%). Cancellation of ACT was followed by 2 (9.5%) complications, bridge-therapy - by 4 (6.7%) thromboembolic complications. Hemorrhagic events were 2 times more common in case of this therapy (n=8, 13.3%). It was found that ESC guidelines for perioperative ACT were applied in less than half of patients (41, 47.7% patients with AF undergoing elective surgery). Half of complications (8 out of 16) occurred if unapproved modes of ACT were used (including 7 cases of bridge-therapy was not necessary). The causes of these complications were inadequate assessment of perioperative risk of thromboembolic and hemorrhagic events; unreasonable administration of bridge therapy. CONCLUSION: An unambiguous clinical effect of bridge therapy has not been confirmed in patients with high risk of thromboembolic complications. Cancer patients have higher risk of complications compared with others. These events occur mainly due to non-compliance with clinical guidelines and insufficient prevention of thromboembolic events.


Asunto(s)
Anticoagulantes/efectos adversos , Fibrilación Atrial/tratamiento farmacológico , Procedimientos Quirúrgicos Electivos/efectos adversos , Hemorragia/prevención & control , Tromboembolia/prevención & control , Anciano , Anticoagulantes/uso terapéutico , Fibrilación Atrial/complicaciones , Femenino , Adhesión a Directriz , Hemorragia/etiología , Humanos , Masculino , Persona de Mediana Edad , Tromboembolia/etiología
17.
Expert Opin Drug Saf ; 18(9): 869-874, 2019 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-31311346

RESUMEN

Objectives: Non-vitamin K oral anticoagulants (NOACs) are a relatively new group of anticoagulants. Characteristics of adverse drug reactions (ADRs) as experienced by patients in everyday use have not yet been fully clarified. The aim was to gain insight into the safety profile of NOACs from a patient's perspective. Methods: This was a prospective, observational web-based cohort event monitoring study among first-time users of NOACs. Patients were recruited between July 2012 and April 2017. They were invited to complete four web-based questionnaires 2 weeks, 5 weeks, 3 months and 6 months after starting treatment. Information was collected about patient characteristics, drug use, and characteristics of ADRs. Results: 1748 NOAC users were included. 661 (38%) experienced at least one ADR. The reported ADRs were comparable with the information described in the Summary of Product Characteristics and generally occurred within 1 week after the start. In 59% of ADRs the patients recovered. These ADRs had no impact on the use and dosage of the NOAC in 68%. In total, 9% of the patients discontinued the NOAC because of ADRs. Conclusion: Overall NOACs were well tolerated by the participants. Most reported ADRs occurred within 1 week after the start. Patients recovered from most ADRs without changes to the use of the NOAC.


Asunto(s)
Anticoagulantes/efectos adversos , Antitrombinas/administración & dosificación , Farmacovigilancia , Administración Oral , Anciano , Anticoagulantes/administración & dosificación , Antitrombinas/efectos adversos , Estudios de Cohortes , Femenino , Humanos , Internet , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Encuestas y Cuestionarios , Factores de Tiempo
18.
Medicine (Baltimore) ; 98(26): e16194, 2019 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-31261559

RESUMEN

BACKGROUND: Atrial fibrillation (AF) is increasingly prevalent in chronic kidney disease (CKD) patients. The efficacy and safety of non-vitamin K antagonist oral anticoagulants (NOACs) in AF and CKD patients remains unknown. This systematic review and meta-analysis will mainly assess net clinical benefit (NCB) property of NOACs versus warfarin in patients with AF and CKD by a pooled-analysis. METHODS: We will search Medline, Embase, Cochrane Library, and Clinical Trials.gov Website comprehensively for eligible randomized controlled trials that report the efficacy and safety outcomes according to renal function of NOACs. Relative risks and their 95% confidence intervals will be calculated using fixed- and random-effects models. Subgroup, sensitivity, and regression analyses will be performed to evaluate intertrial heterogeneity and bias of the results. NCB that balance stroke/systemic embolism (SSE) and major bleeding will be calculated using Singer's method. RESULTS: This systemic review and meta-analysis will evaluate the NCB of NOACs versus warfarin via SSE, major bleeding and all-cause death in patients with CKD. CONCLUSIONS: This study will provide new evidence for clinical profile of NOACs on SSE, major bleeding, all-cause death, and NCB in CKD patients. PROSPERO REGISTRATION NUMBER: CRD42019116940.


Asunto(s)
Anticoagulantes/uso terapéutico , Fibrilación Atrial/tratamiento farmacológico , Metaanálisis como Asunto , Insuficiencia Renal Crónica/tratamiento farmacológico , Revisiones Sistemáticas como Asunto , Administración Oral , Anticoagulantes/efectos adversos , Anticoagulantes/farmacología , Fibrilación Atrial/complicaciones , Humanos , Insuficiencia Renal Crónica/complicaciones , Proyectos de Investigación , Warfarina/efectos adversos , Warfarina/uso terapéutico
20.
J Stroke Cerebrovasc Dis ; 28(9): 2363-2375, 2019 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-31281110

RESUMEN

The prevalence of atrial fibrillation (AF), the most common cardiac arrhythmia, increases with age, predisposing elderly patients to an increased risk of embolic stroke. With an increasingly aged population the number of people who experience a stroke every year, overall global burden of stroke, and numbers of stroke survivors and related deaths continue to increase. Anticoagulation with vitamin K antagonists (VKAs) reduces the risk of ischemic stroke in patients with AF; however, increased bleeding risk is well documented, particularly in the elderly. Consequently, VKAs have been underused in the elderly. Alternative anticoagulants may offer a safer choice, particularly in patients who have experienced previous stroke. The aim of this narrative review is to examine available evidence for the effective treatment of patients with AF and previous cerebral vascular events with non-VKA oral anticoagulants, including the most appropriate time to start or reinitiate treatment after a stroke, systemic embolism, or clinically relevant bleed. For patients with AF treated with oral anticoagulants it is important to balance increased protection against future stroke/systemic embolism and reduced risk of major bleeding events. For patients with AF who have previously experienced a cerebrovascular event, the use of oral anticoagulants alone also appears more effective than low-molecular weight heparin (LMWH) alone or LMWH followed by oral anticoagulants. Available data suggest that significant reduction in stroke, symptomatic cerebral bleeding, and major extracranial bleeding within 90 days from acute stroke can be achieved if oral anticoagulation is initiated at 4-14 days from stroke onset.


Asunto(s)
Anticoagulantes/administración & dosificación , Fibrilación Atrial/tratamiento farmacológico , Prevención Secundaria/métodos , Accidente Cerebrovascular/prevención & control , Administración Oral , Anticoagulantes/efectos adversos , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/epidemiología , Esquema de Medicación , Humanos , Hemorragias Intracraneales/inducido químicamente , Hemorragias Intracraneales/epidemiología , Recurrencia , Medición de Riesgo , Factores de Riesgo , Accidente Cerebrovascular/diagnóstico , Accidente Cerebrovascular/epidemiología , Factores de Tiempo , Resultado del Tratamiento
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