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1.
Ther Adv Cardiovasc Dis ; 14: 1753944720924255, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32449469

RESUMO

BACKGROUND: Recombinant factor VIIa (rFVIIa) (Novoseven®) is utilized for the reversal of anticoagulation-associated bleeding and refractory bleeding in cardiac surgery. In August 2015, rFVIIa was transferred from the blood bank to the pharmacy at New York University (NYU) Langone Health. Concordantly, an off-label dosing guideline was developed. The objective of this study was to describe utilization and cost of rFVIIa and assess compliance to our dosing guideline. METHODS: We performed a retrospective, observational review of rFVIIa administrations post-implementation of an off-label dosing guideline. All patients who received rFVIIa between September 2015 and June 2017 were evaluated. For each rFVIIa administration, anticoagulation and laboratory values, indications for use, dosing, ordering and administration times, concomitant blood products, and adverse events were collected. Adverse events included venous thromboembolism, stroke, myocardial infarction, and death due to systemic embolism and mortality. The primary endpoint was the utilization of rFVIIa in accordance with the off-label dosing guideline. Secondary endpoints included hemostatic efficacy of rFVIIa, adverse events, blood products administered, and cost-effectiveness of rFVIIa transition to pharmacy. RESULTS: A total of 63 patients [pediatric (n = 6), adult (n = 57)] received rFVIIa, with the majority of use for refractory bleeding after cardiac surgery. The utilization of rVIIa decreased after development of the off-label dosing guideline and transition from blood bank to pharmacy. The total incidence of thromboembolic events within 30 days was 19.6%; 17.6% arterial and 2% venous; 70% of patients with an adverse event were over 70 years of age. Use of rFVIIa reduced the median number of units of blood products administered. CONCLUSION: Administration of rFVIIa for cardiac surgery appears to be effective for hemostasis. Transitioning rFVIIa from the blood bank to pharmacy and implementation of a dosing guideline appears to have reduced utilization. Patients receiving rFVIIa should be monitored for thromboembolic events. Elderly patients may be at higher risk for thromboembolic events.


Assuntos
Centros Médicos Acadêmicos , Anticoagulantes/efeitos adversos , Perda Sanguínea Cirúrgica/prevenção & controle , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Fator VIIa/administração & dosagem , Hemorragia/prevenção & controle , Hemostáticos/administração & dosagem , Padrões de Prática Médica , Centros Médicos Acadêmicos/economia , Idoso , Procedimentos Cirúrgicos Cardíacos/economia , Criança , Pré-Escolar , Custos de Medicamentos , Cálculos da Dosagem de Medicamento , Revisão de Uso de Medicamentos , Fator VIIa/efeitos adversos , Fator VIIa/economia , Feminino , Hemorragia/induzido quimicamente , Hemorragia/economia , Hemostáticos/efeitos adversos , Hemostáticos/economia , Humanos , Lactente , Recém-Nascido , Masculino , Pessoa de Meia-Idade , Cidade de Nova Iorque , Uso Off-Label , Padrões de Prática Médica/economia , Proteínas Recombinantes/administração & dosagem , Proteínas Recombinantes/efeitos adversos , Proteínas Recombinantes/economia , Estudos Retrospectivos , Fatores de Risco , Tromboembolia/induzido quimicamente , Resultado do Tratamento
2.
Ann Intern Med ; 172(3): 202-209, 2020 02 04.
Artigo em Inglês | MEDLINE | ID: mdl-32016334

RESUMO

The term transgender refers to persons whose gender identity is different from that recorded at birth. Similar to other marginalized populations, transgender patients commonly experience discrimination in the health care setting, and they may not have access to medical professionals who can provide competent care. In addition to primary medical and preventive health care, transgender patients need access to gender-affirming interventions, including hormone therapy and surgeries. In 2017, the Endocrine Society updated its clinical practice guideline for the care of transgender persons on the basis of the best available evidence from systematic reviews and individual studies. Among its general requirements for adolescents and recommendations for adults were the following: Involvement of a mental health professional who is knowledgeable about the diagnostic criteria for gender dysphoria and criteria for gender-affirming treatment, has training and experience in assessing psychopathology, and is willing to participate in ongoing care. Hormone therapy should be offered to transgender adult patients, with levels maintained within the normal range for gender identity and treatment appropriately monitored. Clinicians involved in the care of transgender adult patients should be knowledgeable about diagnostic criteria for gender dysphoria/gender incongruence, the use of medical and surgical gender-affirming interventions, and appropriate monitoring for reproductive organ cancer risk. Here, 2 clinicians with expertise in this area debate whether psychological evaluation is warranted in a transgender patient requesting gender-affirming hormones or surgery, the potential risks and benefits of estrogen therapy, and the role of the primary care practitioner in the care of transgender persons.


Assuntos
Serviços de Saúde Mental , Atenção Primária à Saúde , Pessoas Transgênero/psicologia , Adulto , Doenças Cardiovasculares/induzido quimicamente , Estrogênios/efeitos adversos , Estrogênios/uso terapêutico , Feminino , Humanos , Papel do Médico , Guias de Prática Clínica como Assunto , Encaminhamento e Consulta , Fatores de Risco , Procedimentos de Readequação Sexual , Tromboembolia/induzido quimicamente
3.
Eur J Ophthalmol ; 30(1): 66-71, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30618282

RESUMO

BACKGROUND: Systemic complications of intravitreal anti-vascular endothelial growth factor agents are relatively uncommon but highly significant. OBJECTIVES: Primary objective: To assess the risk for thromboembolic events following intravitreal bevacizumab injection in neovascular age-related macular degeneration patients by a large population-based study. Secondary objective: To analyze the association between injection frequency and the risk for thromboembolic events, the time interval between the injection and the thromboembolic events, and the influence of chronic diseases on complications rate. DESIGN: A retrospective cohort study. METHODS: Consecutive neovascular age-related macular degeneration patients receiving intravitreal bevacizumab at Soroka University Medical Center from December 2005 to December 2013 were included. Thromboembolic events analyzed included acute coronary syndrome, acute myocardial infarction, stroke, deep vein thrombosis, and pulmonary embolism. The thromboembolic event rate was compared 2 years prior and 2 years after the initial intravitreal bevacizumab injection. RESULTS: A total of 2102 patients were included. Acute coronary syndrome and stroke rate were higher 2 years after intravitreal bevacizumab (p = 0.03 and p = 0.01, respectively). No statistical significant difference was found for the rest of thromboembolic events. Patients older than 80 years and patients receiving less than six intravitreal bevacizumab injections were more likely to experience stroke. Patients with known cardiovascular risk factors before starting injections did not develop significant more thromboembolic events. CONCLUSION: In our study population, patients treated with intravitreal bevacizumab were significantly more likely to experience stroke during 2 years after first injection.


Assuntos
Inibidores da Angiogênese/efeitos adversos , Bevacizumab/efeitos adversos , Neovascularização de Coroide/tratamento farmacológico , Tromboembolia/induzido quimicamente , Degeneração Macular Exsudativa/tratamento farmacológico , Síndrome Coronariana Aguda/induzido quimicamente , Idoso , Idoso de 80 Anos ou mais , Inibidores da Angiogênese/uso terapêutico , Bevacizumab/uso terapêutico , Neovascularização de Coroide/fisiopatologia , Feminino , Humanos , Injeções Intravítreas , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/induzido quimicamente , Embolia Pulmonar/induzido quimicamente , Estudos Retrospectivos , Fatores de Risco , Acidente Vascular Cerebral/induzido quimicamente , Tromboembolia/diagnóstico , Tromboembolia/fisiopatologia , Fator A de Crescimento do Endotélio Vascular/antagonistas & inibidores , Trombose Venosa/induzido quimicamente , Degeneração Macular Exsudativa/fisiopatologia
4.
Ann Hematol ; 99(1): 121-126, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31773215

RESUMO

It is uncertain if different immunomodulatory drugs (IMID) pose distinct thrombotic risk in patients with newly diagnosed multiple myeloma (MM). Among 2397 MM patients from the SEER-Medicare database from 2007 to 2013, 78% received lenalidomide, and 22% received thalidomide. After inverse probability weighting to balance confounders, the 12-month incidences of venous thromboembolism (VTE 10%) and arterial thromboembolism (ATE 5%) were similarly high in both groups. Lenalidomide versus thalidomide had a subdistribution hazard ratio of 1.11 (0.59-2.02) for VTE and a subdistribution hazard ratio of 0.96 (0.45-1.98) for ATE. Overall survival was not significantly different with a hazard ratio of 0.88 (0.60-1.18) for lenalidomide versus thalidomide. Concurrent anticoagulant prophylaxis was infrequently prescribed in < 20% of both groups. Our study demonstrates that despite improvement in myeloma-directed therapy and supportive care, thrombosis remains an important consideration for all IMID-treated MM patients. Appropriate risk stratification and vigilant thromboprophylaxis remain essential to prevent this complication.


Assuntos
Lenalidomida , Mieloma Múltiplo , Sistema de Registros , Talidomida , Tromboembolia , Idoso , Feminino , Humanos , Lenalidomida/administração & dosagem , Lenalidomida/efeitos adversos , Masculino , Mieloma Múltiplo/tratamento farmacológico , Mieloma Múltiplo/epidemiologia , Estudos Retrospectivos , Talidomida/administração & dosagem , Talidomida/efeitos adversos , Tromboembolia/induzido quimicamente , Tromboembolia/epidemiologia
5.
Rev Bras Anestesiol ; 69(5): 484-492, 2019.
Artigo em Português | MEDLINE | ID: mdl-31640900

RESUMO

BACKGROUND AND OBJECTIVES: The administration of antifibrinolytics has been shown to be effective in reducing blood loss and the need for transfusions in surgeries. However, few studies have evaluated these drugs in cancer surgery. The objective was to review the efficacy and safety of the treatment with antifibrinolytics in patients who underwent oncologic surgeries. CONTENTS: An electronic bibliographic research was conducted in PubMed, OVID, MEDLINE, EMBASE, EBSCO and in the Cochrane Library data basis in order to identify randomized clinical trials performed in any type of oncologic surgery. The data evaluated were blood loss, need for transfusion and incidence of arteriovenous thromboembolism. Five randomized controlled trials evaluating 838 patients met the inclusion requirements. In the analysis of the incidence of thromboembolic events in the five RCTs, there was no statistically significant difference between the administration of tranexamic acid when compared with the placebo (OR=0.36, 95% IC: 0.11-1.19, p=0.09, I2=0%). However, when total estimated blood loss and need for blood transfusion are analyzed, the use of tranexamic acid was associated with a significant reduction over placebo (MD=-135.79, 95% CI: -179.50 to -92.08, p<0.00001, I2=68%) and (OR=0.45, 95% CI: 0.32-0.65, p<0.00001, I2=60%), respectively. CONCLUSIONS: This meta-analysis found no evidence that the administration of antifibrinolytics increases the risk of thromboembolic complications in patients submitted to oncologic surgery, and has shown evidence that it is effective in reducing total perioperative blood loss and the need for blood transfusion.


Assuntos
Antifibrinolíticos/uso terapêutico , Neoplasias/cirurgia , Antifibrinolíticos/efeitos adversos , Humanos , Complicações Pós-Operatórias/induzido quimicamente , Complicações Pós-Operatórias/epidemiologia , Tromboembolia/induzido quimicamente , Tromboembolia/epidemiologia , Resultado do Tratamento
6.
Drugs Aging ; 36(11): 1047-1055, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31486994

RESUMO

INTRODUCTION: Direct oral anticoagulants (DOACs) were developed to overcome some of the limitations associated with vitamin K antagonists (VKAs), such as interindividual variability or the need for therapeutic drug monitoring. However, the complexity of DOAC dose regimens can still lead to dosing errors and potential bleeding-related or thromboembolic adverse events, especially in the elderly. OBJECTIVE: Our objective was to evaluate the rate of inappropriate preadmission DOAC prescriptions at hospital and to evaluate the ability of hospitals to correct them. METHODS: An observational prospective study was conducted in elderly patients (aged ≥ 65 years) hospitalized in six acute units of three Parisian university hospitals between February and July 2018. DOAC prescriptions prior to admission and at discharge were analyzed according to the guidelines in the summaries of product characteristics. RESULTS: A total of 157 patients were included in the study, with a median age of 84 years (interquartile range [IQR] 77-89). The median glomerular filtration rate, determined with the Cockcroft-Gault equation, was 48 mL/min (IQR 35-61). Apixaban was the most frequently prescribed drug, mainly for atrial fibrillation. Overall, 48 (30.6%) and 34 (22.4%) prescriptions were inappropriate prior to admission and at discharge, respectively, showing a significant decrease (p < 0.001). Hospitals significantly corrected more inappropriate prescriptions (37.5%) than they generated (4.6%) (p < 0.05). The nature of the inappropriate prescribing was underdosing (68.8% and 76.5% prior to admission and at discharge, respectively), followed by overdosing (stable rate at almost 20%) and indication errors. No risk factors for inappropriate use were identified by our analysis. CONCLUSION: One-third of DOAC preadmission prescriptions for elderly patients were inappropriate, indicating that a need remains to strengthen DOAC prescribing guidelines in ambulatory clinical practice. However, the rate of inappropriate prescriptions decreased at patient discharge. Future studies are needed to test actions to promote the proper use of DOACs.


Assuntos
Anticoagulantes/administração & dosagem , Prescrição Inadequada/estatística & dados numéricos , Admissão do Paciente/estatística & dados numéricos , Alta do Paciente/estatística & dados numéricos , Administração Oral , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , Feminino , França , Hemorragia/induzido quimicamente , Hospitalização/estatística & dados numéricos , Humanos , Masculino , Estudos Prospectivos , Pirazóis/administração & dosagem , Pirazóis/uso terapêutico , Piridonas/administração & dosagem , Piridonas/uso terapêutico , Fatores de Risco , Rivaroxabana/administração & dosagem , Rivaroxabana/uso terapêutico , Tromboembolia/induzido quimicamente
7.
Chin Med J (Engl) ; 132(18): 2229-2236, 2019 Sep 20.
Artigo em Inglês | MEDLINE | ID: mdl-31478927

RESUMO

OBJECTIVE: Anabolic-androgenic steroids (AAS) represents a group of synthetic testosterone derivatives that play an important role in clinical treatment. These drugs are widely abused among the general public to increase lean weight and improve athletic performance. It has been reported that AAS use can produce many adverse effects, especially the occurrence of cardiovascular risk. Although there are many related studies, there has been no consensus on AAS use and cardiovascular risk. The present study was to review the effect of AAS on the cardiovascular system. DATA SOURCES: The data in this review were obtained from articles included in PubMed and the National Center for Biotechnology Information database. STUDY SELECTION: Original articles, case reports, and systematic reviews about AAS were selected for the article. RESULTS: The use/abuse of AAS is correlated with higher cardiovascular risks, and many AAS users/abusers had cardiovascular diseases. However, there are many confounding factors in the studies that explored the causality between AAS intake and disease development, and additional studies are required to determine AAS toxicity. CONCLUSION: AAS produces toxic effects on the cardiovascular system, and it is necessary to ensure that more people know this about AAS, including medical personnel.


Assuntos
Congêneres da Testosterona/efeitos adversos , Aterosclerose/induzido quimicamente , Doenças Cardiovasculares , Sistema Cardiovascular/efeitos dos fármacos , Feminino , Humanos , Hipertensão/induzido quimicamente , Masculino , Fatores de Risco , Tromboembolia/induzido quimicamente
8.
BMJ Case Rep ; 12(8)2019 Aug 22.
Artigo em Inglês | MEDLINE | ID: mdl-31444258

RESUMO

There is ongoing debate about the best neo-adjuvant strategy for localised resectable oesophageal cancer, however chemotherapy is often employed. Both oesophageal cancer and cisplatin carry an increased risk of thrombosis. Here, we look at an unusual finding in a previously fit woman who presented following neo-adjuvant chemotherapy for resectable oesophageal cancer with increasing difficulty in walking and lower limb paraesthesia. This case looks particularly at the diagnostic challenge and concerns raised in a patient undergoing radical treatment as well as the challenge of complications secondary to treatment with chemotherapy. Willingness to reassess and revisit is a vital part of the diagnostic process. Vascular complications of a disease can be notorious to diagnose and, as in this case can mimic arguably more logical diagnoses. Cancer care provides the unique challenge of investigating unusual presentations related both to disease and treatment.


Assuntos
Adenocarcinoma/terapia , Antineoplásicos/efeitos adversos , Cisplatino/efeitos adversos , Neoplasias Esofágicas/terapia , Parestesia/diagnóstico , Tromboembolia/diagnóstico , Aorta Torácica , Terapia Combinada , Diagnóstico Diferencial , Feminino , Humanos , Artéria Ilíaca , Pessoa de Meia-Idade , Terapia Neoadjuvante , Parestesia/induzido quimicamente , Parestesia/diagnóstico por imagem , Tromboembolia/induzido quimicamente , Tromboembolia/diagnóstico por imagem , Tomografia Computadorizada por Raios X
9.
West J Emerg Med ; 20(4): 619-625, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31316701

RESUMO

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.


Assuntos
Fatores de Coagulação Sanguínea/efeitos adversos , Plasma , Tromboembolia/induzido quimicamente , Idoso , Anticoagulantes/efeitos adversos , Fatores de Coagulação Sanguínea/administração & dosagem , Serviço Hospitalar de Emergência , Feminino , Humanos , Masculino , Estudos Retrospectivos , Tromboembolia/epidemiologia , Varfarina/efeitos adversos
11.
Eur J Orthop Surg Traumatol ; 29(8): 1729-1735, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31359178

RESUMO

BACKGROUND: Topical intra-articular tranexamic acid (IA-TXA) has been proven to be safe and effective in reducing postoperative blood loss after primary total knee arthroplasty (TKA). The objective of this study was to investigate the efficacy of high dose (3 g) compared with low dose (500 mg) of IA-TXA in postoperative blood loss after primary TKA. METHODS: A double-blind randomized controlled trial was conducted in 80 patients who had undergone primary TKA. The patients were divided into two groups according to intra-articular TXA doses: high-dose group (3 g IA-TXA) and low-dose group (500 mg IA-TXA). The drug was injected into the joint capsule after fascial closure without suction drainage. The primary outcomes were maximum hemoglobin drop (g/dL) and calculated total blood loss (mL). Postoperative blood transfusions, thromboembolic events and functional outcomes were also recorded. RESULTS: The mean maximum hemoglobin drop was 1.3 g/dL lower in 3 g IA-TXA group compared to the 500 mg IA-TXA group [1.7 vs 3.0 g/dL, 95% confidence interval (CI) 0.9-1.7 g/dL, P < 0.001]. The 3 g IA-TXA group had 370 mL less calculated total blood loss compared to the 500 mg IA-TXA group (551 vs 921 mL, 95% CI 252-489 mL, P < 0.001). One patient in the 500 mg IA-TXA group required transfusion, while no patient in the 3 g IA-TXA group received transfusion (P = 0.31). Any thromboembolic event was not found, and functional outcome was similar between the two groups. CONCLUSIONS: Application of high-dose, 3 g topical IA-TXA was 43% more effective in reducing postoperative blood loss compared with low dose of 500 mg in primary TKA. Optimal doses in between the above two doses may be a worthwhile further investigation.


Assuntos
Antifibrinolíticos/administração & dosagem , Artroplastia do Joelho/efeitos adversos , Hemorragia Pós-Operatória/prevenção & controle , Ácido Tranexâmico/administração & dosagem , Administração Tópica , Idoso , Antifibrinolíticos/efeitos adversos , Transfusão de Sangue , Volume Sanguíneo , Método Duplo-Cego , Feminino , Hemoglobinas/metabolismo , Humanos , Injeções Intra-Articulares , Masculino , Pessoa de Meia-Idade , Hemorragia Pós-Operatória/sangue , Estudos Prospectivos , Tromboembolia/induzido quimicamente , Ácido Tranexâmico/efeitos adversos
12.
Expert Opin Drug Saf ; 18(9): 803-815, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31309853

RESUMO

Introduction: Intravitreal anti-VEGF is the most effective therapy for wet AMD, although systemic effects on the endothelium cannot be excluded. Areas covered: The purpose of this review was to evaluate risk of thromboembolic events associated with intravitreal anti-VEGF. Expert opinion: Current data are insufficient to confirm the safety of these compounds, due to the paucity of specific studies. Thus, pharmacovigilance for all anti-VEGF should be improved to verify the true role of anti-VEGF in the occurrence of systemic adverse events.


Assuntos
Inibidores da Angiogênese/efeitos adversos , Tromboembolia/induzido quimicamente , Degeneração Macular Exsudativa/tratamento farmacológico , Inibidores da Angiogênese/administração & dosagem , Inibidores da Angiogênese/farmacologia , Humanos , Injeções Intravítreas , Farmacovigilância , Tromboembolia/epidemiologia , Fator A de Crescimento do Endotélio Vascular/antagonistas & inibidores
13.
Transfus Med ; 29(4): 268-274, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31347218

RESUMO

OBJECTIVE: To evaluate the effectiveness and safety of prothrombin complex concentrates (PCCs) in approved and off-label indications. BACKGROUND: PCCs are approved for the urgent reversal of vitamin K antagonists (VKAs). Data concerning the efficacy, safety and dosing for off-label indications are limited, but they are included in massive bleeding protocols. METHODS: This was a retrospective review of cases treated with four-factor PCCs (4F-PCCs) between January 2009 and 2016. Efficacy end-points include: (i) VKA reversal efficacy assessed by international normalised ratio (INR) normalisation (<1·5) and (ii) clinical efficacy as bleeding cessation and/or decreased number of transfused blood components and 24-h mortality in bleeding coagulopathy. The safety end-point is the incidence of thromboembolic events. RESULTS: A total of 328 patients were included (51·8% male, median age 78 years old). Indications were as follows: VKA reversal (66·6%), bleeding coagulopathy (30·5%) and direct anticoagulant (DOAC) reversal due to bleeding (2·5%). VKA reversal was effective in 97·1% of patients, and 76·5% demonstrated complete reversal (INR < 1·5); only 34·3% patients needed hemoderivatives. Prior to emergency procedures, PCCs achieved global responses in 83% of patients, with no bleeding complication during intervention. DOAC reversal was effective in 88·9% of patients. Bleeding cessation was associated with the dose administered (P = 0·002). In coagulopathy bleeding, haemorrhage cessation, established by the International Society of Thrombosis and Haemostais (ISTH) definition, occurred in 56·7% of massive bleeding events and in 42·5% of other coagulopathies; 24-h mortality was 30%, mainly related to active bleeding. Ten thrombotic episodes were observed (3·1%). CONCLUSION: 4F-PCC was effective as adjuvant treatment with an acceptable safety profile, not only for the emergent reversal of VKAs but also for refractory coagulopathy associated with major bleeding.


Assuntos
Anticoagulantes/efeitos adversos , Fatores de Coagulação Sanguínea/administração & dosagem , Coagulação Intravascular Disseminada , Hemorragia , Uso Off-Label , Segurança , Vitamina K/antagonistas & inibidores , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/administração & dosagem , Fatores de Coagulação Sanguínea/efeitos adversos , Coagulação Intravascular Disseminada/sangue , Coagulação Intravascular Disseminada/tratamento farmacológico , Coagulação Intravascular Disseminada/mortalidade , Feminino , Hemorragia/sangue , Hemorragia/induzido quimicamente , Hemorragia/tratamento farmacológico , Hemorragia/mortalidade , Humanos , Incidência , Coeficiente Internacional Normatizado , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Tromboembolia/sangue , Tromboembolia/induzido quimicamente , Tromboembolia/mortalidade
14.
Br J Cancer ; 120(3): 301-305, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30655614

RESUMO

PURPOSE: Thromboembolism is a common adverse event in women treated with tamoxifen (TAM) for breast cancer. The risk in male breast cancer patients is poorly investigated. We aimed to examine the risk of thrombotic events after TAM in male breast cancer patients. PATIENTS AND METHODS: In this prospective cohort study, 448 patients treated between May 2009 and July 2017 for male breast cancer (BC) were assessed for eligibility. Patients with follow-up shorter than 6 months were excluded. The cumulative risk of thromboembolism was evaluated. RESULTS: The median follow-up was 47 months (range 6-101 months) with a median age of 69.4 years (range 27-89 years). Oestrogen receptor and progesterone receptor expression levels were observed in 98.3 and 94.9% of cases, respectively. During the follow-up period, thrombotic events were documented in 21 (11.9%) of 177 patients receiving TAM and in 1 (2.5%) of 41 patients who did not receive tamoxifen. The estimated incidence was 51.9 per 1000 person-years and 21.5 per 1000 person-years, respectively. Notably, the highest risk was identified in the first 18 months, where 81% of the observed thrombotic events occurred. Patients aged older than 71 years had a significantly increased risk of thrombotic event under TAM treatment than their younger counterparts (p = 0.033). History of thrombotic event, cardiovascular and liver disease, as well as additional adjuvant treatment were not associated with increased thrombotic risk. CONCLUSION: The risk of thrombotic event in men treated with TAM for breast cancer is markedly increased in the first 18 months of treatment, and should be considered during treatment decisions.


Assuntos
Neoplasias da Mama Masculina/tratamento farmacológico , Tamoxifeno/efeitos adversos , Tromboembolia/patologia , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Neoplasias da Mama Masculina/complicações , Neoplasias da Mama Masculina/genética , Neoplasias da Mama Masculina/patologia , Quimioterapia Adjuvante/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Fatores de Risco , Tamoxifeno/administração & dosagem , Tromboembolia/induzido quimicamente , Resultado do Tratamento
15.
Congenit Heart Dis ; 14(3): 331-340, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-30681774

RESUMO

OBJECTIVE: Women with congenital heart disease (CHD) are at increased risk of pregnancy complications and need information on safe, effective contraceptive methods to avoid unintended pregnancy. This systematic review examines evidence regarding safety of contraceptive use among women with CHD. METHODS: The PubMed database was searched for any peer-reviewed articles published through April 2018 that included safety outcomes associated with reversible contraceptive methods among women with CHD. RESULTS: Five articles met inclusion criteria: three studies comparing contraceptive users to nonusers and two noncomparative studies. Sample sizes ranged from 65 to 505 women with CHD. Two studies found a higher percent of thromboembolic complications among women with Fontan palliation or transposition of the great arteries using oral contraceptives. One study, among women with Fontan palliation, found no increased risk of thromboembolic complications between contraceptive users (not separated by type) and nonusers. Two studies found no endocarditis among intrauterine device users. CONCLUSIONS: There is a paucity of data regarding the safety of contraceptive methods among women with CHD. Limited evidence suggests an increased incidence of thromboembolic complications with use of oral contraceptives. Further studies are needed to evaluate contraceptive safety and quantify risk in this growing population. There is also limited data regarding the safety of contraceptive methods among women with CHD. Further information is needed to assist practitioners counseling women with CHD on safety of contraceptive methods.


Assuntos
Anticoncepção/métodos , Cardiopatias Congênitas/cirurgia , Gravidez não Planejada , Adolescente , Adulto , Anticoncepção/efeitos adversos , Anticoncepcionais Orais/efeitos adversos , Feminino , Cardiopatias Congênitas/complicações , Cardiopatias Congênitas/diagnóstico , Cardiopatias Congênitas/fisiopatologia , Humanos , Incidência , Gravidez , Medição de Risco , Fatores de Risco , Tromboembolia/induzido quimicamente , Tromboembolia/epidemiologia , Resultado do Tratamento , Adulto Jovem
16.
Pediatr Blood Cancer ; 66(2): e27483, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30362248

RESUMO

BACKGROUND: The literature is void of an evidence-based anticoagulation therapy (ACT) management strategy in the context of thrombocytopenia. We examined the impact of thrombocytopenia on low-molecular-weight heparin (LMWH) dosing and incidence of bleeding in children with acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL) who developed thromboembolism (TE) during therapy according to DFCI ALL protocols. PROCEDURE: Patient records from our tertiary care center were reviewed for demographics, details of diagnoses and therapy of ALL/LL and TE diagnoses, platelet counts during ACT, LMWH dosing, and bleeding episodes. RESULTS: Thirty-nine TEs were diagnosed in 33 patients [mean age 9 years (range, 2.5-18); 16 males and 31 with ALL] during the study period. A majority (85%) of patients were diagnosed with TE in the consolidation phase with mean time to TE 5.75 months from ALL/LL diagnosis. All patients received LMWH, and the median duration of ACT was 5.9 months (range, 1-11 months). Platelets were measured weekly. On 29 occasions, platelet nadir was <50 × 109 /L, and twice it was < 20 × 109 /L. One (3%) patient had major bleeding episode while on ACT. Platelet count at the time of bleeding was 222 × 109 /L. Ninety-two procedures [83 lumbar punctures (LPs), 9 central venous line (CVL) insertion/revision] were completed without bleeding complications. Asparaginase was held temporarily with TE diagnosis in 48% of patients; most (88%) patients completed all scheduled doses as per protocol. CONCLUSIONS: Ability to administer full-dose LMWH, expected bleeding rate, and completion of asparaginase doses while on ACT suggest full-dose ACT is feasible and safe in children with ALL/LL who develop TE during DFCI ALL consortium therapy protocols.


Assuntos
Anticoagulantes/administração & dosagem , Heparina de Baixo Peso Molecular/administração & dosagem , Leucemia-Linfoma Linfoblástico de Células Precursoras , Trombocitopenia/complicações , Tromboembolia/tratamento farmacológico , Adolescente , Antineoplásicos/efeitos adversos , Criança , Pré-Escolar , Estudos de Coortes , Estudos de Viabilidade , Feminino , Hemorragia/epidemiologia , Humanos , Incidência , Masculino , Leucemia-Linfoma Linfoblástico de Células Precursoras/complicações , Leucemia-Linfoma Linfoblástico de Células Precursoras/tratamento farmacológico , Estudos Retrospectivos , Trombocitopenia/induzido quimicamente , Tromboembolia/induzido quimicamente
17.
J Intern Med ; 285(3): 333-340, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30460728

RESUMO

BACKGROUND: The lifetime prevalence of androgenic anabolic steroid abuse is estimated to be around 6% for men, but there is limited knowledge about the side effects of these drugs. OBJECTIVE: To investigate mortality and morbidity amongst users of androgenic anabolic steroids (AAS). METHODS: In this retrospective matched cohort study, 545 male subjects tested positive for AAS in Danish fitness centres during the period 3 January 2006 to 1 March 2018. Subjects were matched with 5450 male controls. In addition, 644 men who were sanctioned because they refused to submit to a doping test and 6440 controls were included as a replication cohort. RESULTS: Mortality was three times higher amongst users of AAS than amongst nonuser controls (hazard ratio 3.0, 95% CI 1.3-7.0). The median annual number of hospital contacts was 0.81 in the cohort of AAS users and 0.36 in the control cohort (P < 0.0001). Acne, gynaecomastia and erectile dysfunction affected more than 10% of the androgenic anabolic steroid users, and the prevalence of these disorders was significantly higher than in the control group (P < 0.0001). The results could be replicated in a similar cohort. CONCLUSION: Androgenic anabolic steroid users have an increased risk of dying and significantly more hospital admissions than their nonuser peers. Side effects of AAS and their metabolites were highly prevalent. Given the high rate of androgenic anabolic steroid abuse, these side effects are of public health concern.


Assuntos
Anabolizantes/efeitos adversos , Acne Vulgar/induzido quimicamente , Acne Vulgar/epidemiologia , Adulto , Fibrilação Atrial/induzido quimicamente , Fibrilação Atrial/epidemiologia , Cardiomiopatias/induzido quimicamente , Cardiomiopatias/epidemiologia , Estudos de Casos e Controles , Estudos de Coortes , Dinamarca/epidemiologia , Disfunção Erétil/induzido quimicamente , Disfunção Erétil/epidemiologia , Ginecomastia/induzido quimicamente , Ginecomastia/epidemiologia , Humanos , Infertilidade Masculina/induzido quimicamente , Infertilidade Masculina/epidemiologia , Masculino , Mortalidade , Estudos Retrospectivos , Tromboembolia/induzido quimicamente , Tromboembolia/epidemiologia
18.
Clin Breast Cancer ; 19(1): e186-e194, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30292625

RESUMO

BACKGROUND: The cyclin-dependent kinase 4/6 inhibitor palbociclib has emerged as a novel therapeutic agent in metastatic breast cancer. Neutropenia is commonly observed, and thus stringent treatment guidelines regarding complete blood count (CBC) monitoring have been developed. The aim of this study was to provide a real-world experience of the toxicities associated with palbociclib therapy and to evaluate compliance with CBC monitoring. PATIENTS AND METHODS: We performed a retrospective single-center audit of hormone receptor-positive metastatic breast cancer patients treated with palbociclib over a 6-month period in an Irish tertiary referral hospital. RESULTS: A total of 64 patients were included in the analysis. Palbociclib was most commonly used in combination with letrozole (n = 40). A total of 28 patients (44%; 95% confidence interval, 31.2-56.2) had treatment deferrals due to neutropenia, with a median time to first deferral of 4 weeks. Fifteen patients (23%; 95% confidence interval, 15.4-37.7) required dose adjustments; however, there was no association with an increased risk of progressive disease (P = .56). Only 3 patients discontinued treatment as a result of poor tolerance. Adverse events were as expected; however, 7 venous thromboembolic events were reported. CONCLUSION: Compliance was good with existing CBC monitoring guidelines. We observed an 11% incidence of venous thromboembolic events, a significant increase from 2% reported in the PALOMA-3 trial. Further studies are recommended to determine if prophylactic anticoagulation may benefit these patients.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Contagem de Células Sanguíneas/métodos , Neoplasias da Mama/tratamento farmacológico , Fidelidade a Diretrizes/estatística & dados numéricos , Neutropenia/epidemiologia , Guias de Prática Clínica como Assunto/normas , Tromboembolia/epidemiologia , Idoso , Neoplasias da Mama/metabolismo , Neoplasias da Mama/patologia , Relação Dose-Resposta a Droga , Feminino , Seguimentos , Humanos , Incidência , Irlanda/epidemiologia , Letrozol/administração & dosagem , Pessoa de Meia-Idade , Gradação de Tumores , Metástase Neoplásica , Estadiamento de Neoplasias , Neutropenia/induzido quimicamente , Piperazinas/administração & dosagem , Piridinas/administração & dosagem , Receptor ErbB-2/metabolismo , Receptores Estrogênicos/metabolismo , Receptores de Progesterona/metabolismo , Estudos Retrospectivos , Tromboembolia/induzido quimicamente
19.
Eur J Trauma Emerg Surg ; 45(4): 719-726, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-29922895

RESUMO

INTRODUCTION: Tranexamic acid (TXA) is one of the debated therapies in the management of traumatic brain injury (TBI). We conducted this study to evaluate the benefits of TXA in TBI on the mortality and its safety in these patients. METHODS: This was a prospective randomized open-label trial including all patients, aged at 18 years or older, hospitalized in the emergency room during a 13-month period, for TBI. After the realization of the body CT scan, the patients were included if they had intracranial bleeding, and were then randomized according to their medical file number to receive or not the TXA. The eligibility criteria were based on the uncertainty principle, patients with significant extracranial bleeding were excluded since there was evidence that TXA improve their outcome. RESULTS: We enrolled 180 patients aged at 42 ± 20 years, with an 88% men-proportion. Subarachnoid haemorrhage was the most frequent lesion in the brain CT-scan (67.5%). After randomization, 96 patients were in the TXA group (53%). Demographic data, clinical, biological and radiological features were statistically comparable in the two groups of patients ('TXA' and 'noTXA'). The needs of transfusion or neurosurgery, the mortality rate, the in-hospital length of stay and the dependency at 28-post-traumatic day were similar in the two groups of patients. However, pulmonary embolism was statistically more frequent in 'TXA' group (11.5 versus 2.4%, p = 0.02). CONCLUSION: TXA is an interesting treatment in haemorrhagic shock. Its efficiency in head trauma is still debated and controversial. Its impact on the mortality and the needs of transfusion or surgery were not demonstrated in this study. Nevertheless, its safety worth to be studied in larger samples as we found a higher rate of pulmonary embolism in the treated group.


Assuntos
Antifibrinolíticos/administração & dosagem , Lesões Encefálicas Traumáticas/tratamento farmacológico , Ácido Tranexâmico/administração & dosagem , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Antifibrinolíticos/efeitos adversos , Transfusão de Componentes Sanguíneos/estatística & dados numéricos , Lesões Encefálicas Traumáticas/mortalidade , Esquema de Medicação , Feminino , Seguimentos , Humanos , Tempo de Internação/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Embolia Pulmonar/induzido quimicamente , Tromboembolia/induzido quimicamente , Ácido Tranexâmico/efeitos adversos , Adulto Jovem
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