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1.
Lancet Haematol ; 7(1): e18-e27, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31699660

RESUMO

BACKGROUND: Treatment of venous thromboembolism in children is based on data obtained in adults with little direct documentation of its efficacy and safety in children. The aim of our study was to compare the efficacy and safety of rivaroxaban versus standard anticoagulants in children with venous thromboembolism. METHODS: In a multicentre, parallel-group, open-label, randomised study, children (aged 0-17 years) attending 107 paediatric hospitals in 28 countries with documented acute venous thromboembolism who had started heparinisation were assigned (2:1) to bodyweight-adjusted rivaroxaban (tablets or suspension) in a 20-mg equivalent dose or standard anticoagulants (heparin or switched to vitamin K antagonist). Randomisation was stratified by age and venous thromboembolism site. The main treatment period was 3 months (1 month in children <2 years of age with catheter-related venous thromboembolism). The primary efficacy outcome, symptomatic recurrent venous thromboembolism (assessed by intention-to-treat), and the principal safety outcome, major or clinically relevant non-major bleeding (assessed in participants who received ≥1 dose), were centrally assessed by investigators who were unaware of treatment assignment. Repeat imaging was obtained at the end of the main treatment period and compared with baseline imaging tests. This trial is registered with ClinicalTrials.gov, number NCT02234843 and has been completed. FINDINGS: From Nov 14, 2014, to Sept 28, 2018, 500 (96%) of the 520 children screened for eligibility were enrolled. After a median follow-up of 91 days (IQR 87-95) in children who had a study treatment period of 3 months (n=463) and 31 days (IQR 29-35) in children who had a study treatment period of 1 month (n=37), symptomatic recurrent venous thromboembolism occurred in four (1%) of 335 children receiving rivaroxaban and five (3%) of 165 receiving standard anticoagulants (hazard ratio [HR] 0·40, 95% CI 0·11-1·41). Repeat imaging showed an improved effect of rivaroxaban on thrombotic burden as compared with standard anticoagulants (p=0·012). Major or clinically relevant non-major bleeding in participants who received ≥1 dose occurred in ten (3%) of 329 children (all non-major) receiving rivaroxaban and in three (2%) of 162 children (two major and one non-major) receiving standard anticoagulants (HR 1·58, 95% CI 0·51-6·27). Absolute and relative efficacy and safety estimates of rivaroxaban versus standard anticoagulation estimates were similar to those in rivaroxaban studies in adults. There were no treatment-related deaths. INTERPRETATION: In children with acute venous thromboembolism, treatment with rivaroxaban resulted in a similarly low recurrence risk and reduced thrombotic burden without increased bleeding, as compared with standard anticoagulants. FUNDING: Bayer AG and Janssen Research & Development.


Assuntos
Anticoagulantes/uso terapêutico , Rivaroxabana/uso terapêutico , Tromboembolia Venosa/tratamento farmacológico , Adolescente , Criança , Pré-Escolar , Feminino , Humanos , Lactente , Masculino , Fatores de Risco
2.
Lancet Haematol ; 6(10): e500-e509, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31420317

RESUMO

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.


Assuntos
Anticoagulantes/uso terapêutico , Rivaroxabana/uso terapêutico , Tromboembolia Venosa/tratamento farmacológico , Adolescente , Anemia/etiologia , Anticoagulantes/efeitos adversos , Anticoagulantes/farmacocinética , Peso Corporal , Criança , Pré-Escolar , Esquema de Medicação , Cálculos da Dosagem de Medicamento , Fator Xa/análise , Feminino , Meia-Vida , Hemorragia/etiologia , Humanos , Lactente , Masculino , Neutropenia/etiologia , Tempo de Protrombina , Rivaroxabana/efeitos adversos , Rivaroxabana/farmacocinética , Resultado do Tratamento , Tromboembolia Venosa/patologia
3.
Blood Coagul Fibrinolysis ; 30(5): 239-242, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31157683

RESUMO

: Acquired von Willebrand syndrome (AVWS) is a rare hemorrhagic condition that poses both a diagnostic and a therapeutic challenge. Here we report a singular case of AVWS with two associated conditions, small lymphocytic lymphoma (SLL) and Sjögren's syndrome. The patient presented with recurrent and severe digestive bleeding that forced us to raise a curative attempt of AVWS. A first immunosuppressive therapy with immunoglobulins was unsuccessful and it was later decided to treat lymphoproliferative entity with bendamustine and rituximab effectively achieving SLL and AVWS remission. On the basis of our case and through literature review, we discuss potential strategies to achieve AVWS remission when it appears in the setting of several causative associated conditions.


Assuntos
Leucemia Linfocítica Crônica de Células B/complicações , Síndrome de Sjogren/complicações , Doenças de von Willebrand/complicações , Idoso , Antineoplásicos Alquilantes/uso terapêutico , Antineoplásicos Imunológicos/uso terapêutico , Cloridrato de Bendamustina/uso terapêutico , Feminino , Hemorragia/etiologia , Hemorragia/terapia , Humanos , Imunoglobulinas/uso terapêutico , Leucemia Linfocítica Crônica de Células B/terapia , Rituximab/uso terapêutico , Síndrome de Sjogren/terapia , Doenças de von Willebrand/terapia
4.
J Comp Eff Res ; 8(3): 165-178, 2019 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-30654626

RESUMO

AIM: To analyze the effectiveness and safety of direct oral anticoagulants (DOACs) in atrial fibrillation (AF) patients attended in clinical practice. METHODS: Observational and prospective study of AF patients that started treatment with DOACs. RESULTS: 1443 patients (age 77.2 ± 9.7 years, CHA2DS2-VASc = 4.1 ± 1.5) were included. 46.0% were taking rivaroxaban, 24.4% dabigatran, 22.5% apixaban and 7.1% edoxaban. Patients taking dabigatran were younger, had lower CHA2DS2-VASc and lesser renal insufficiency. Patients taking apixaban had higher CHA2DS2-VASc and more renal insufficiency. Rates of stroke/major bleeding/intracranial bleeding were 0.7/1.3/0.2 events/100 patient-years, respectively. CONCLUSION: This was the first prospective study that analyzed the use of all DOACs in AF patients in Spain, showing a good profile in terms of safety and effectiveness in accordance with pivotal studies.

5.
Thromb J ; 16: 29, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30410424

RESUMO

Background: Venous thromboembolism (VTE) in young children is not well documented. Methods: Clinicians from 12 institutions retrospectively evaluated the presentation, therapeutic management, and outcome of VTE in children younger than 2 years seen in 2011-2016. Feasibility of recruiting these children in EINSTEIN-Jr. phase III, a randomized trial evaluating rivaroxaban versus standard anticoagulation for VTE, was assessed. Results: We identified 346 children with VTE, of whom 227 (65.6%) had central venous catheter-related thrombosis (CVC-VTE), 119 (34.4%) had non-CVC-VTE, and 156 (45.1%) were younger than 1 month. Of the 309 children who received anticoagulant therapy, 86 (27.8%) had a short duration of therapy (i.e. < 6 weeks for CVC-VTE and < 3 months for non-CVC-VTE) and 17 (5.5%) had recurrent VTE during anticoagulation (n = 8, 2.6%) or shortly after its discontinuation (n = 9, 2.9%). A total of 37 (10.7%) children did not receive anticoagulant therapy and 4 (10.5%) had recurrent VTE.The average number of children aged < 0.5 years and 0.5-2 years who would have been considered for enrolment in EINSTEIN-Jr is approximately 1.0 and 0.9 per year per site, respectively. Conclusions: Young children with VTE most commonly have CVC-VTE and approximately one-tenth and one-fourth received no or only short durations of anticoagulant therapy, respectively. Recurrent VTE rates without anticoagulation, during anticoagulation or shortly after its discontinuation seem comparable to those observed in adults. Short and flexible treatment durations could potentially increase recruitment in EINSTEIN-Jr. phase III.

6.
Med. clín (Ed. impr.) ; 151(5): 210.e1-210.e13, sept. 2018. tab, graf
Artigo em Espanhol | IBECS | ID: ibc-173886

RESUMO

Antecedentes y objetivos: En los últimos años los anticoagulantes orales directos (ACOD) se han convertido en una alternativa a los antagonistas de la vitamina K (AVK) para la prevención del ictus y embolia sistémica en pacientes con fibrilación auricular no valvular (FANV), así como para la prevención y tratamiento de la trombosis venosa profunda. Los ensayos clínicos han demostrado la no inferioridad y la potencial superioridad en comparación con la warfarina, lo cual permite ampliar las opciones de anticoagulación. En nuestro medio, las Unidades de Tratamiento Anticoagulante (UTA) y los Centros de Atención Primaria (CAP) son los encargados de la educación, seguimiento, control de adherencia y del manejo en situaciones especiales de los pacientes anticoagulados. Estas consideraciones han motivado la preparación del presente documento de consenso, que tiene como objetivo establecer recomendaciones que incorporen los hallazgos de la investigación científica a la práctica clínica para mejorar la calidad asistencial en el ámbito de la anticoagulación. Material y métodos: Un grupo de expertos del Grupo Catalán de Trombosis (TROMBOC@T) ha revisado la bibliografía publicada entre 2007 y 2016 para poder establecer recomendaciones basadas en la evidencia clínica. Resultados: Como resultado del proyecto se han establecido un conjunto de recomendaciones de carácter práctico que facilitarán el tratamiento, educación, seguimiento y manejo en situaciones especiales de los pacientes anticoagulados con ACOD. Conclusiones: El aumento progresivo del uso de los ACOD requiere establecer y homogeneizar las directrices de actuación clínica en el paciente anticoagulado con estos antitrombóticos tanto en las UTA como en los CAP


Background and objectives: In recent years, direct oral anticoagulants (DOACs) have become an alternative to vitamin K antagonists (VKA) for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF) as well as for prevention and treatment of deep venous thrombosis. Pivotal trials have demonstrated non-inferiority and potential superiority compared to warfarin, which increases the options of anticoagulant treatment. In our setting, the Anticoagulant Treatment Units (ATUs) and Primary Care Centres (PCCs) play an important role in the education, follow-up, adherence control and management in special situations of anticoagulated patients. These considerations have motivated us to elaborate the present consensus document that aims to establish clear recommendations that incorporate the findings of scientific research into clinical practice to improve the quality of care in the field of anticoagulation. Material and methods: A group of experts from the Catalan Thrombosis Group (TROMBOC@T) reviewed all published literature from 2009 to 2016, in order to provide recommendations based on clinical evidence. Results: As a result of the project, a set of practical recommendations have been established that will facilitate treatment, education, follow-up and management in special situations of anticoagulated patients with ACODs. Conclusions: Progressive increase in the use of DOACs calls for measures to establish and homogenise clinical management guidelines for patients anticoagulated with DOACs in ATUs and PCCs


Assuntos
Humanos , Masculino , Feminino , Idoso de 80 Anos ou mais , Antifibrinolíticos/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , Tromboembolia Venosa/prevenção & controle , Anticoagulantes/uso terapêutico , Administração Oral , Vitamina K/antagonistas & inibidores , Doenças Cardiovasculares , Fibrilação Atrial/complicações , Tromboembolia Venosa/tratamento farmacológico
7.
Clin Cardiol ; 41(9): 1123-1129, 2018 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-30069910

RESUMO

Non-vitamin K dependent oral anticoagulants (NOAC) are now widely used in patients with nonvalvular atrial fibrillation (NVAF) for stroke prevention and in patients with venous thromboembolism (VTE) for the treatment and secondary prevention of the disease. Among NOAC, edoxaban demonstrated noninferiority to warfarin for stroke prevention in NVAF and for VTE treatment, with superior safety. EMIT-AF/VTE (Edoxaban Management in Diagnostic and Therapeutic Procedures) (NCT02950168) is a multicenter, prospective, and noninterventional registry study designed to collect detailed information on the periprocedural management of patients with NVAF and VTE receiving edoxaban. The primary objective of EMIT-AF/VTE is to document the periprocedural management of patients receiving edoxaban and to collect data on safety and other outcomes in these patients. The primary safety outcome is the rate of major bleeding. Other assessments include the evaluation of efficacy outcomes, periprocedural dosing, and timing of edoxaban. The observation period will start 5 days prior to the procedure and end 30 days post-procedure. EMIT-AF/VTE will aim to prospectively enroll up to approximately 1400 procedures from Europe. Enrollment commenced in December 2016 and will be completed in July 2018. As of July 2018, before database lock and with several procedure forms still temporarily inserted, a preliminary number of 1204 patients have been enrolled, who underwent a total of 1453 procedures. The prospective EMIT-AF/VTE registry program will expand the knowledge of periprocedural management of patients with NVAF and VTE receiving edoxaban in clinical practice.


Assuntos
Fibrilação Atrial/complicações , Piridinas/administração & dosagem , Prevenção Secundária/métodos , Acidente Vascular Cerebral/prevenção & controle , Tiazóis/administração & dosagem , Administração Oral , Idoso , Fibrilação Atrial/tratamento farmacológico , Relação Dose-Resposta a Droga , Europa (Continente)/epidemiologia , Inibidores do Fator Xa/administração & dosagem , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia
8.
Thromb Haemost ; 118(8): 1439-1449, 2018 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30060256

RESUMO

In the Hokusai VTE Cancer study, edoxaban was non-inferior to dalteparin for the composite outcome of recurrent venous thromboembolism (VTE) and major bleeding in 1,050 patients with cancer-associated VTE. The absolute rate of recurrent VTE was 3.4% lower with edoxaban, whereas the absolute rate of major bleeding was 2.9% higher. The present analysis focuses on the sites, clinical presentation, course and outcome of bleeding events, and the associated tumour types. Major bleeds and their severity (categories 1-4) were blindly adjudicated by a committee using a priori defined criteria, and data were analysed in the safety population. Major bleeding occurred in 32 of 522 patients given edoxaban (median treatment duration, 211 days) and in 16 of 524 patients treated with dalteparin (median treatment duration, 184 days); no patients had more than one major bleed. There were no fatal bleeds with edoxaban, and two with dalteparin. Severe bleeding at presentation (category 3 or 4) occurred in 10 (1.9%) and 11 (2.1%) patients in the edoxaban and dalteparin groups, respectively. The excess of major bleeding with edoxaban was confined to patients with gastrointestinal cancer. However, severe major bleeding at presentation (category 3 or 4) in this sub-group occurred in 5 of 165 (3.0%) and in 3 of 140 (2.1%) patients given edoxaban or dalteparin, respectively.In conclusion, this analysis suggests that while oral edoxaban is an appropriate alternative to subcutaneous dalteparin for treatment of cancer-associated VTE, the use of edoxaban in patients with gastrointestinal cancer requires careful benefit-risk weighting.


Assuntos
Anticoagulantes/efeitos adversos , Dalteparina/efeitos adversos , Inibidores do Fator Xa/efeitos adversos , Hemorragia/induzido quimicamente , Neoplasias/complicações , Piridinas/efeitos adversos , Tiazóis/efeitos adversos , Tromboembolia Venosa/tratamento farmacológico , Idoso , Anticoagulantes/administração & dosagem , Tomada de Decisão Clínica , Dalteparina/administração & dosagem , Inibidores do Fator Xa/administração & dosagem , Feminino , Hemorragia/diagnóstico , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasias/diagnóstico , Seleção de Pacientes , Piridinas/administração & dosagem , Recidiva , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença , Tiazóis/administração & dosagem , Fatores de Tempo , Resultado do Tratamento , Tromboembolia Venosa/diagnóstico , Tromboembolia Venosa/etiologia
9.
Med Clin (Barc) ; 151(5): 210.e1-210.e13, 2018 09 14.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-29602444

RESUMO

BACKGROUND AND OBJECTIVES: In recent years, direct oral anticoagulants (DOACs) have become an alternative to vitamin K antagonists (VKA) for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF) as well as for prevention and treatment of deep venous thrombosis. Pivotal trials have demonstrated non-inferiority and potential superiority compared to warfarin, which increases the options of anticoagulant treatment. In our setting, the Anticoagulant Treatment Units (ATUs) and Primary Care Centres (PCCs) play an important role in the education, follow-up, adherence control and management in special situations of anticoagulated patients. These considerations have motivated us to elaborate the present consensus document that aims to establish clear recommendations that incorporate the findings of scientific research into clinical practice to improve the quality of care in the field of anticoagulation. MATERIAL AND METHODS: A group of experts from the Catalan Thrombosis Group (TROMBOC@T) reviewed all published literature from 2009 to 2016, in order to provide recommendations based on clinical evidence. RESULTS: As a result of the project, a set of practical recommendations have been established that will facilitate treatment, education, follow-up and management in special situations of anticoagulated patients with ACODs. CONCLUSIONS: Progressive increase in the use of DOACs calls for measures to establish and homogenise clinical management guidelines for patients anticoagulated with DOACs in ATUs and PCCs.


Assuntos
Antitrombinas/uso terapêutico , Fibrilação Atrial/complicações , Embolia/prevenção & controle , Acidente Vascular Cerebral/prevenção & controle , Administração Oral , Fatores Etários , Anticoagulantes/administração & dosagem , Anticoagulantes/uso terapêutico , Antitrombinas/administração & dosagem , Dabigatrana/administração & dosagem , Dabigatrana/uso terapêutico , Embolia/etiologia , Humanos , Pirazóis/administração & dosagem , Pirazóis/uso terapêutico , Piridinas/administração & dosagem , Piridinas/uso terapêutico , Piridonas/administração & dosagem , Piridonas/uso terapêutico , Rivaroxabana/administração & dosagem , Rivaroxabana/uso terapêutico , Acidente Vascular Cerebral/etiologia , Tiazóis/administração & dosagem , Tiazóis/uso terapêutico , Varfarina/uso terapêutico
11.
Transpl Int ; 30(12): 1266-1274, 2017 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-28801922

RESUMO

Venous thromboembolism (VTE) is a frequent complication after solid organ transplantation (SOT) and, specifically, after lung transplantation (LT). The objectives of this study were to evaluate prophylaxis with enoxaparin and to describe risk factors for VTE after LT. We retrospectively reviewed the clinical records of 333 patients who underwent LT in our institution between 2009 and 2014. We compared two consecutive cohorts: one that received enoxaparin only during post-transplant hospital admissions and a second cohort that received 90-day extended prophylaxis with enoxaparin. Cumulative incidence function for competing risk analysis was used to determine incidence of VTE during the first year after transplantation. Risk factors were analyzed using a Cox proportional hazards regression model. The cumulative incidence of VTE was 15.3% (95% CI: 11.6-19.4). Median time from transplant to the event was 40 (p25-p75, 14-112) days. Ninety-day extended prophylaxis did not reduce the incidence of VTE. In this study, the risk factors associated with VTE were male gender and interstitial lung disease. VTE is a major complication after LT, and 90-day extended prophylaxis was not able to prevent it. Large, multicenter, randomized clinical trials should be performed to define the best strategy for preventing VTE.


Assuntos
Anticoagulantes/administração & dosagem , Enoxaparina/administração & dosagem , Transplante de Pulmão/efeitos adversos , Tromboembolia Venosa/prevenção & controle , Adulto , Idoso , Análise de Variância , Estudos de Coortes , Bases de Dados Factuais , Rejeição de Enxerto , Sobrevivência de Enxerto , Humanos , Transplante de Pulmão/métodos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Complicações Pós-Operatórias/prevenção & controle , Valor Preditivo dos Testes , Prevenção Primária/métodos , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Medição de Risco , Análise de Sobrevida , Resultado do Tratamento , Tromboembolia Venosa/tratamento farmacológico
13.
J Clin Exp Dent ; 9(2): e223-e230, 2017 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-28210440

RESUMO

BACKGROUND: Dental consultation may provoke stress to the patient, especially when a dental surgery is going to be performed, stressful situations can cause a reaction in the sympathetic nervous system that could lead to cardiovascular alterations. Blood pressure and cardiac frequency are used often as an indirect measurement and this parameters combined can serve as good indicators of stress. Objective: Analyze the changes in vital signs and analytical parameters induced by a dental extraction. MATERIAL AND METHODS: 24 healthy patients who required a simple dental extraction underwent to a blood test and motorization of their pre- and post-extraction vital signs before, at 2 and 48 hours after the procedure. Data analysis was performed by means of repeated measures one way ANOVA followed by multiple comparisons Bonferroni's Post-hoc test. RESULTS: The evaluated patients were 13 women and 11 men with an average age of 35.1. Thirteen patients (54.17% of the sample) were smokers and five were regular drinkers (20.8%). No significant differences were observed in the vital signs with the exception of diastolic blood pressure and cardiac rate that were slightly lower after extraction. Only two analytical parameters showed statistical significant changes. Total bilirubin was significantly higher at 48 hours after extraction and leukocyte count was significantly lower at this time. In any case, the magnitude of the changes observed was very low. The analytical parameters and the vital signs did not show any relevant change. CONCLUSIONS: Eventual alterations found after simple tooth extraction should not be attributed to the procedure. Key words:Blood pressure, heart rate, monitoring physiologic, oxygen saturation, tooth extraction.

14.
Thromb Res ; 140: 22-9, 2016 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-27500301

RESUMO

BACKGROUND: Pregnant women with prior venous thromboembolism (VTE) are at risk of recurrence. Prophylaxis with low molecular weight heparin (LWMH) reduces that risk but is inconvenient, costly, and may be associated with increased risks of obstetrical bleeding. The views of pregnant women, crucial when making prophylaxis recommendations, are currently unknown. METHODS: Cross-sectional international multicenter study. We included women with a history of VTE who were either pregnant or planning pregnancy. We provided information regarding risk of VTE recurrence with and without LMWH and determined participant's willingness to receive LMWH prophylaxis through direct choice exercises, preference-elicitation (utilities) for health states (e.g. burden of LMWH prophylaxis), and a probability trade-off exercise. RESULTS: Of 123 women, more women at high risk than those at low risk of recurrence (86.4% vs. 60.0%; p = 0.003) chose to use LMWH. The median threshold reduction in VTE at which women were willing to accept use of LMWH, given a 16% risk of VTE without prophylaxis, was 3% (interquartile range: 1 to 6). Participants' evaluation of the relevant health states varied widely and was unrelated to their direct choices to use or not use LMWH. CONCLUSIONS: Although the majority of women with a previous VTE, pregnant or planning pregnancy choose to take LMWH during pregnancy, a minority ­and in low risk women, a large minority­ do not. Our results highlight the need for individualized shared decision-making (SDM) in the clinical encounter, and for guideline panels to make weak recommendations in favor of LMWH that make clear the need for SDM.


Assuntos
Anticoagulantes/uso terapêutico , Heparina de Baixo Peso Molecular/uso terapêutico , Complicações Cardiovasculares na Gravidez/prevenção & controle , Tromboembolia Venosa/prevenção & controle , Adulto , Estudos Transversais , Feminino , Humanos , Cooperação do Paciente , Gravidez , Complicações Cardiovasculares na Gravidez/etiologia , Recidiva , Fatores de Risco , Tromboembolia Venosa/complicações
15.
J Thromb Thrombolysis ; 41(3): 544-7, 2016 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-26036227

RESUMO

Congenital plasminogen deficiency is a rare autosomal recessive disorder, characterized by chronic mucosal membranous lesions. Although the most common clinical manifestation is eye involvement as ligneous conjunctivitis, extra-ocular lesions affecting other mucosal surfaces indicates a systemic disease. In this report we describe two cases with atypical extra-ocular involvement that includes pericarditis and recurrent hematocolpos, and one with paradoxical correlation between ocular lesions and plasminogen levels. In ligneous conjunctivitis, although different treatment strategies have been tried with mild success, the only effective therapy is topical or systemic plasminogen concentrates that are not commercially available. Unfortunately there is not either effective management for cases with multisystemic disease. Hence, treatment for plasminogen deficiency is still a challenge and the variability of the clinical spectrum in this pathology makes necessary a multidisciplinary approach.


Assuntos
Transtornos Herdados da Coagulação Sanguínea , Plasminogênio/administração & dosagem , Plasminogênio/deficiência , Transtornos Herdados da Coagulação Sanguínea/sangue , Transtornos Herdados da Coagulação Sanguínea/tratamento farmacológico , Transtornos Herdados da Coagulação Sanguínea/genética , Transtornos Herdados da Coagulação Sanguínea/patologia , Pré-Escolar , Conjuntivite/sangue , Conjuntivite/tratamento farmacológico , Conjuntivite/genética , Conjuntivite/patologia , Feminino , Hematocolpia/sangue , Hematocolpia/tratamento farmacológico , Hematocolpia/genética , Hematocolpia/patologia , Humanos , Masculino , Pessoa de Meia-Idade , Pericardite/sangue , Pericardite/tratamento farmacológico , Pericardite/genética , Pericardite/patologia
16.
Clin Oral Investig ; 20(5): 1055-63, 2016 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-26374745

RESUMO

OBJECTIVES: TT-173 is a new hemostatic agent consisting of yeast-derived microvesicles containing a modified version of recombinant human tissue factor. In the present work, the procoagulant activity of TT-173 has been evaluated for the first time in humans. METHODS: This is a phase I, randomized, placebo-controlled study to evaluate the efficacy, safety, systemic absorption, and immunogenicity of TT-173 in healthy volunteers undergoing tooth extraction. Subjects received TT-173 or placebo into the alveolar cavity, just after tooth extraction. Time to clot formation, bleeding time, and adverse events were recorded. RESULTS: Treatment with TT-173 reduced the bleeding time and the time to clot formation. No adverse events related with product administration were reported. In the same way, neither systemic absorption nor immunogenic reaction against the product was detected. Our findings pave the way to evaluate the usefulness of this new topical hemostatic agent in more complex oral surgeries and in those patients affected with coagulation disorders that may compromise the realization of dental procedures. CONCLUSION: The new hemostatic agent TT-173 has proven efficacious and safe in healthy subjects undergoing tooth extraction supporting its further evaluation in more complex surgeries. CLINICAL RELEVANCE: The development of this new topical hemostatic agent could contribute to bleeding control in oral and maxillofacial surgery.


Assuntos
Hemostáticos/farmacologia , Hemorragia Bucal/prevenção & controle , Tromboplastina/farmacologia , Extração Dentária , Administração Tópica , Adulto , Feminino , Hemostáticos/administração & dosagem , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Método Simples-Cego , Tromboplastina/administração & dosagem , Resultado do Tratamento
17.
Prog. obstet. ginecol. (Ed. impr.) ; 58(6): 257-263, jun.-jul. 2015. tab, graf
Artigo em Espanhol | IBECS | ID: ibc-139291

RESUMO

Estudio observacional que valoró la seguridad de heparina de bajo peso molecular (HBPM) administrada para la profilaxis o el tratamiento de complicaciones tromboembólicas durante el embarazo. Diseño: Se revisaron retrospectivamente historias clínicas y se recogió el resultado del embarazo y los acontecimientos adversos. El riesgo tromboembólico (ETEV) se analizó mediante la clasificación del Royal College of Obstetrics and Gynaecologist. Resultados: Se incluyeron 127 pacientes (131 fetos) con edad media de 32,3 ± 4,3 años. La HBPM se indicó por ETEV aguda en 11 (8,6%) pacientes y por profilaxis en 116 (91,4%). En el grupo de profilaxis hubo 38 (30,0%), 49 (38,6%) y 29 (22,8%) pacientes con riesgo de ETEV alto, moderado y bajo respectivamente. Los nacidos vivos fueron 127 (97%) —19 (15,1%) pretérmino—. Una paciente con déficit de antitrombina desarrolló ETEV. Hubo 25 casos de sangrado (18 [72%] hematomas subcutáneos). Conclusión: La HBPM es bien tolerada y segura para la profilaxis y el tratamiento de las complicaciones tromboembólicas del embarazo (AU)


This observational study evaluated the safety of low molecular weight heparin (LMWH) for the prophylaxis and treatment of thromboembolic complications in pregnancy. Study Design: The medical records of pregnant women were identified and reviewed retrospectively. Information was extracted on LMWH use, pregnancy outcome, and adverse events. The Guidelines of the Royal College of Obstetrics and Gynaecologists were used to evaluate the thromboembolic risk. Results: Data were collected on 127 pregnancies (131 fetuses); the mean age was 32.3 ± 4.3. LMWH was prescribed for acute venous thromboembolism in 11 patients (8.6%) and for prophylaxis in 116 (91.4%). For the prophylaxis group, there were 38 (30.0%), 49 (38.6%) and 29 (22.8%) patients with high, moderate and low venous thromboembolism risk, respectively. There were 127 (97%) live births (19 preterm [15.1%]). In the prophylaxis group, one venous thromboembolism occurred in a patient with antithrombin deficiency. Safety outcomes included 25 cases of bleeding (18 [72%] were injection site hematomas). Conclusion: We found that LMWH was well tolerated and safe for the prophylaxis and treatment of thromboembolic complications during pregnancy (AU)


Assuntos
Adulto , Feminino , Humanos , Gravidez , Heparina de Baixo Peso Molecular/uso terapêutico , Complicações Hematológicas na Gravidez/tratamento farmacológico , Tromboembolia/tratamento farmacológico , Tromboembolia/prevenção & controle , Pré-Medicação/métodos , Estudo Observacional
18.
Thromb Res ; 136(2): 341-7, 2015 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-26033397

RESUMO

BACKGROUND: Women with a history of venous thromboembolism (VTE) have an increased recurrence risk during pregnancy. Low molecular weight heparin (LMWH) reduces this risk, but is costly, burdensome, and may increase risk of bleeding. The decision to start thromboprophylaxis during pregnancy is sensitive to women's values and preferences. Our objective was to compare women's choices using a holistic approach in which they were presented all of the relevant information (direct-choice) versus a personalized decision analysis in which a mathematical model incorporated their preferences and VTE risk to make a treatment recommendation. METHODS: Multicenter, international study. Structured interviews were on women with a history of VTE who were pregnant, planning, or considering pregnancy. Women indicated their willingness to receive thromboprophylaxis based on scenarios using personalized estimates of VTE recurrence and bleeding risks. We also obtained women's values for health outcomes using a visual analog scale. We performed individualized decision analyses for each participant and compared model recommendations to decisions made when presented with the direct-choice exercise. RESULTS: Of the 123 women in the study, the decision model recommended LMWH for 51 women and recommended against LMWH for 72 women. 12% (6/51) of women for whom the decision model recommended thromboprophylaxis chose not to take LMWH; 72% (52/72) of women for whom the decision model recommended against thromboprophylaxis chose LMWH. CONCLUSIONS: We observed a high degree of discordance between decisions in the direct-choice exercise and decision model recommendations. Although which approach best captures individuals' true values remains uncertain, personalized decision support tools presenting results based on personalized risks and values may improve decision making.


Assuntos
Sistemas de Apoio a Decisões Clínicas/estatística & dados numéricos , Fibrinolíticos/uso terapêutico , Participação do Paciente/estatística & dados numéricos , Preferência do Paciente/estatística & dados numéricos , Complicações Cardiovasculares na Gravidez/prevenção & controle , Tromboembolia Venosa/prevenção & controle , Adolescente , Adulto , Feminino , Humanos , Internacionalidade , Pessoa de Meia-Idade , Participação do Paciente/psicologia , Preferência do Paciente/psicologia , Gravidez , Complicações Cardiovasculares na Gravidez/epidemiologia , Complicações Cardiovasculares na Gravidez/psicologia , Prevalência , Qualidade de Vida/psicologia , Valores Sociais , Revisão da Utilização de Recursos de Saúde , Tromboembolia Venosa/epidemiologia , Tromboembolia Venosa/psicologia , Adulto Jovem
19.
Transplant Rev (Orlando) ; 29(2): 85-92, 2015 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-25573688

RESUMO

Venous thromboembolism (VTE) is a major complication after solid organ transplantation (SOT), with an incidence that ranges from 2 to 34%. Besides genetic risk factors such as inherited thrombophilia, other specific risk factors for VTE in SOT recipients include impairment of fibrinolysis produced by corticosteroids, in vitro procoagulant effects of calcineurin inhibitors, endothelial damage due to cytomegalovirus infection, and specific surgical factors. Prevention strategies have not been systematically studied. Therefore, it is mandatory for the international scientific community to conduct large, multicenter, randomized clinical trials to define strategies for the prevention of VTE in SOT recipients.


Assuntos
Transplante de Órgãos/efeitos adversos , Embolia Pulmonar/epidemiologia , Embolia Pulmonar/prevenção & controle , Trombose Venosa/epidemiologia , Trombose Venosa/prevenção & controle , Anticoagulantes/uso terapêutico , Fibrinolíticos/uso terapêutico , Humanos , Embolia Pulmonar/diagnóstico , Trombose Venosa/diagnóstico
20.
Clin Drug Investig ; 33(12): 921-8, 2013 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-24127170

RESUMO

BACKGROUND AND OBJECTIVE: The management of patients on vitamin K antagonist therapy who require an invasive procedure is problematic. A randomised, controlled, double-blind clinical trial was designed to compare the efficacy and safety of bemiparin, a low molecular weight heparin (LMWH), with unfractionated heparin (UFH) as bridging therapy: the BERTA (BEmiparin Randomised Trial on bridging Anticoagulants) study. METHODS: Two hundred and six patients on long-term oral anticoagulation therapy (OAT) requiring an invasive procedure were randomized to receive bridging therapy with bemiparin + matching placebo or UFH. OAT was resumed on day 1. The study medication was continued for 5-6 days after the procedure. The primary efficacy endpoint was the combined incidence of arterial and venous thromboembolic events. The primary safety endpoint was the incidence of major bleeding within 10 days after the invasive procedure. RESULTS: There were no thromboembolic events in the bemiparin group, but two events (2.2 %) occurred in the UFH group. No major bleeding occurred in either group, but minor bleeding occurred in four patients (4.3 %) and six patients (6.1 %) in the bemiparin and UHF groups, respectively. No deaths and no cases of severe thrombocytopenia occurred during the whole study period. CONCLUSION: Despite its small size, the BERTA study is the first randomised, double-blind clinical trial comparing UFH with a fixed high-risk thromboprophylactic dose of an LMWH as bridging therapy. There were no thromboembolic events and fewer bleeding episodes in the bemiparin group than in the UFH group, hence we suggest that bemiparin is at least as safe as UFH as bridging therapy.


Assuntos
Anticoagulantes/uso terapêutico , Heparina de Baixo Peso Molecular/uso terapêutico , Heparina/uso terapêutico , Vitamina K/antagonistas & inibidores , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Assistência Perioperatória , Resultado do Tratamento
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