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1.
Biol Pharm Bull ; 47(4): 758-763, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38569843

RESUMO

Enoxaparin and daikenchuto are commonly administered to prevent venous thromboembolism and intestinal obstruction after gynecological malignancy surgery. However, the effects of their combined use on hepatic function are not well studied. This study aimed to clarify the effects of the coadministration of enoxaparin and daikenchuto on hepatic function. First, Japanese Adverse Drug Event Report (JADER) data were analyzed to identify signals of hepatic disorders. Second, a retrospective observational study of patients who underwent surgery for gynecological malignancies was conducted. This study defined hepatic disorders as an increase in aspartate aminotransferase (AST) or alanine aminotransaminase (ALT) levels above the reference values, using 1-h postoperative values as the baseline. The analysis of JADER data revealed an increased risk for hepatic disorders with the coadministration of enoxaparin and daikenchuto. An observational study also showed higher odds ratios (95% confidence intervals) for the occurrence of hepatic disorders in the coadministration group (4.27; 2.11-8.64) and enoxaparin alone group (2.48; 1.31-4.69) than in the daikenchuto alone group. The median increase in the ALT level was also higher in the coadministration group (34; 15-59) than in the enoxaparin alone (19; 6-38) and daikenchuto alone groups (8; 3-33). In conclusion, our study suggests that compared with the use of enoxaparin or daikenchuto alone, enoxaparin and daikenchuto coadministration increases the risk of hepatic disorders, with more significant increases in AST and ALT levels. Healthcare workers need to be aware of these potential side effects when combining these drugs after surgery for gynecological malignancies.


Assuntos
Neoplasias dos Genitais Femininos , Panax , Extratos Vegetais , Zanthoxylum , Zingiberaceae , Feminino , Humanos , Enoxaparina/efeitos adversos , Neoplasias dos Genitais Femininos/cirurgia , Neoplasias dos Genitais Femininos/tratamento farmacológico , Anticoagulantes/efeitos adversos , Complicações Pós-Operatórias/prevenção & controle , Complicações Pós-Operatórias/induzido quimicamente , Complicações Pós-Operatórias/tratamento farmacológico
2.
PLoS One ; 19(4): e0298152, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38626226

RESUMO

BACKGROUND: This study compares aspirin to enoxaparin for symptomatic VTE prophylaxis within 90 days of any type of hip or knee arthroplasty performed for any diagnosis, in patients enrolled in the CRISTAL trial. MATERIALS AND METHODS: CRISTAL was a cluster-randomised crossover, registry-nested non-inferiority trial across 31 hospitals in Australia. The primary publication was restricted to patients undergoing primary total hip or knee arthroplasty for a diagnosis of osteoarthritis. This report includes all enrolled patients undergoing hip or knee arthroplasty procedures (partial or total, primary or revision) performed for any indication. Hospitals were randomized to administer patients aspirin (100mg daily) or enoxaparin (40mg daily), for 35 days after hip arthroplasty and 14 days after knee arthroplasty. Crossover occurred after the patient enrolment target had been met for the first group. The primary outcome was symptomatic VTE within 90 days. Analyses were performed by randomization group. RESULTS: Between April 20, 2019 and December 18, 2020, 12384 patients were enrolled (7238 aspirin group and 5146 enoxaparin). Of these, 6901 (95.3%) given aspirin and 4827 (93.8%) given enoxaparin (total 11728, 94.7%) were included in the final analyses. Within 90 days, symptomatic VTE occurred in 226 (3.27%) aspirin patients and 85 (1.76%) enoxaparin patients, significant for the superiority of enoxaparin (estimated treatment difference 1.85%, 95% CI 0.59% to 3.10%, p = 0.004). Joint-related reoperation within 90 days was lower in the enoxaparin group (109/4827 (2.26%) vs 171/6896 (2.47%) with aspirin, estimated difference 0.77%; 95% CI 0.06% to 1.47%, p = 0.03). There were no significant differences in the other secondary outcomes. CONCLUSION: In patients undergoing hip or knee arthroplasty (of any type, performed for any indication) enrolled in the CRISTAL trial, aspirin compared to enoxaparin resulted in a significantly higher rate of symptomatic VTE and joint-related reoperation within 90 days. These findings extend the applicability of the CRISTAL trial results. TRIAL REGISTRATION: Anzctr.org.au, identifier: ACTRN12618001879257.


Assuntos
Artroplastia de Quadril , Artroplastia do Joelho , Artroplastia de Substituição , Tromboembolia Venosa , Humanos , Enoxaparina/uso terapêutico , Aspirina/uso terapêutico , Tromboembolia Venosa/etiologia , Tromboembolia Venosa/prevenção & controle , Tromboembolia Venosa/tratamento farmacológico , Artroplastia do Joelho/efeitos adversos , Artroplastia de Quadril/efeitos adversos , Anticoagulantes/uso terapêutico
3.
PLoS One ; 19(4): e0301906, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38626095

RESUMO

BACKGROUND: Low molecular weight heparin has proven to be safe and effective but is not without potential risks such as spontaneous bleeding in the abdominal cavity. There is limited evidence evaluating the true incidence of this potential risk and the available literature is primarily via case reports. CASE SUMMARY: The purpose of this study was to identify the incidence and risk factors associated with enoxaparin use (prophylaxis or treatment) abdominal hematomas in a 350-bed community hospital during an 8-month time period. A total of 44 patients were identified as clinically significant bleeds receiving enoxaparin treatment or prophylactic therapy. Ultimately, 25 patients were excluded from the analysis due to an external cause of the abdominal hematoma or a temporal mismatch in enoxaparin administration and hematoma formation. After exclusion, there were a total of 19 patients that were assessed for the risk factors such as age, gender, renal function, and weight. After evaluation of risks, over half of the patients developing a clinically significant bleed were considered elderly (>65 years of age) and impaired renal function with a creatinine clearance of 60ml/min or less. CONCLUSION: Patients at risk for an enoxaparin associated hematoma include female patients with a CrCl <60ml/min and/or BMI >30 kg/m2 receiving enoxaparin treatment dosing.


Assuntos
Enoxaparina , Heparina de Baixo Peso Molecular , Humanos , Feminino , Idoso , Enoxaparina/efeitos adversos , Heparina de Baixo Peso Molecular/uso terapêutico , Hematoma/induzido quimicamente , Hemorragia Gastrointestinal/induzido quimicamente , Fatores de Risco , Anticoagulantes/efeitos adversos
4.
J Vasc Nurs ; 42(1): 10-17, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38555173

RESUMO

Venous thromboembolism (VTE), including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been an increasingly common post-surgical complication for surgical patients. In the United States, VTE has become a leading cause of preventable hospital death with more than half occurring after discharge and are directly linked to a recent (within 30 days) hospitalization or surgery [1]. In large, hospital-associated/acquired VTE (HA-VTE) are preventable through measures such as the use of risk stratification tools and chemoprophylaxis. The project institution, a community, academic, medical center, for multiple years has consistently remained a high outlier for postoperative VTE. Also, the choice of VTE chemoprophylaxis in surgical patients at the time of discharge depended on, and varied between, the individual prescribing physician. The goal was to implement and determine the efficacy of a standardized intervention tool, the Caprini risk assessment model (RAM), for reducing postoperative VTE complications and its influence on the physician's prescription of enoxaparin at discharge. Results: Risk assessment scoring pre-operatively increased from 0% baseline to 26.3% at Plan-Do-Study-Act (PDSA) cycle 1 and demonstrated a statistically significant change (p-value = 0.006). Risk assessment scoring pre-operatively was 42.9% by PDSA cycle 2 but was not statistically significantly different from PDSA cycle 1. Risk assessment scoring post-operatively (for eligible patients) remained the same throughout all three cycles at 0%. Appropriate prescription of anticoagulation declined from baseline (12.5%) to PDSA cycle 1 (0%), and improved at PDSA cycle 2 (33.3%), however no differences were significant (p-value 0.302). The National Surgical Quality Improvement Project (NSQIP) database showed a decline in VTE occurrences at the projects institution from baseline (1.02%, 6 occurrences, 2021) to PDSA cycle 2 (0.92%, 4 occurrences, 2022) when compared to the national benchmark (1.0%) for the first time since 2018. Given the significant national problem HA-VTE pose to the public, and the rise in occurrences, this quality improvement (QI) project is clinically relevant.


Assuntos
Enoxaparina , Tromboembolia Venosa , Humanos , Enoxaparina/uso terapêutico , Tromboembolia Venosa/prevenção & controle , Tromboembolia Venosa/tratamento farmacológico , Tromboembolia Venosa/etiologia , Alta do Paciente , Medição de Risco , Complicações Pós-Operatórias/prevenção & controle , Complicações Pós-Operatórias/etiologia , Prescrições , Fatores de Risco , Estudos Retrospectivos , Anticoagulantes/uso terapêutico
5.
BMJ Case Rep ; 17(3)2024 Mar 15.
Artigo em Inglês | MEDLINE | ID: mdl-38490698

RESUMO

We describe a case of a term neonate with a swollen right arm and weakened pulses, diagnosed with arterial thromboembolism in the right axillary and brachial arteries. Treatment involved heparin, followed by enoxaparin, resulting in significant improvement. Maternal SARS-CoV-2 infection during pregnancy was considered as a potential factor, supported by the newborn's reactive COVID antibodies. The authors hypothesise a potential correlation between neonatal thrombosis and maternal SARS-CoV-2 infection during pregnancy. It is important to note that this association remains speculative and warrants further investigation for validation. The case underscores the importance of recognising and managing neonatal arterial thrombosis, especially in the context of maternal illness. We discuss the case in detail and review current knowledge on this condition.


Assuntos
COVID-19 , Complicações Infecciosas na Gravidez , Trombose , Gravidez , Recém-Nascido , Feminino , Humanos , COVID-19/complicações , SARS-CoV-2 , Heparina/uso terapêutico , Enoxaparina/uso terapêutico , Trombose/tratamento farmacológico , Trombose/etiologia
6.
Am J Cardiol ; 218: 63-67, 2024 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-38432342

RESUMO

Intravenous unfractionated heparin (UFH) is the most frequently used anticoagulant for percutaneous coronary intervention (PCI). Intravenous enoxaparin, a low-molecular-weight heparin, has superior pharmacokinetic and pharmacodynamic properties compared with UFH. Multiple trials have shown enoxaparin to be safe and effective in PCI. However, there has not been a contemporary study evaluating its safety and efficacy. To assess its efficacy and safety, intravenous enoxaparin during PCI through radial artery access was evaluated in PCI patients from January 2015 to December 2019. Outcomes included procedural success, all-cause mortality, ischemic complications, and bleeding complications from the time of the procedure until hospital discharge. A total of 1019 consecutive eligible patients were identified. Median age was 63 years, and 70% were men. The indication for PCI was stable and unstable angina in two-thirds of cases (77%). Few patients had myocardial infarction (MI) (2.2%) as the indication for intervention. The procedure was successful in 98.2% of cases. There were no deaths. Procedural MI occurred in 0.3% of patients. Acute stent thrombosis occurred in 0.4%. Urgent revascularization and stroke occurred in 0.1% each. Small wrist hematomas occurred in 0.3% and all were managed conservatively. There was one radial artery pseudoaneurysm. There were no cases of major bleeding. In conclusion, this single-center study showed that intravenous enoxaparin is a reasonable alternative anticoagulant for use in low-risk and elective non-MI PCI through radial artery access.


Assuntos
Infarto do Miocárdio , Intervenção Coronária Percutânea , Masculino , Humanos , Pessoa de Meia-Idade , Feminino , Enoxaparina , Heparina , Resultado do Tratamento , Anticoagulantes
7.
Clin Neurol Neurosurg ; 239: 108205, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38471196

RESUMO

INTRODUCTION: Degenerative spine surgeries often require postoperative immobilization or reduced mobility, predisposing patients to the formation of thrombosis and higher risk of thromboembolic complications. Despite the significance of this issue, there remains a lack of consensus on the optimal anticoagulant agent for postoperative thromboprophylaxis in spinal stenosis and degenerative spine surgeries. Low molecular weight heparins and direct Xa inhibitors represent two anticoagulant groups with high chemoprophylactic potential. METHODS: This study included a prospective cohort of patients undergoing posterior decompressive surgery with or without instrumentation for degenerative spine disease and/or spinal stenosis. Patients receiving postoperative prophylactic Enoxaparin and Apixaban were selected to evaluate the rate of complications, as assessed by Clavien-Dindo classification, thromboembolic events, and 30-day mortality, readmission, and reoperation rate between the two anticoagulants. RESULTS: 130 patients were included in the analysis. 65 patients received Apixaban and Enoxaparin in each group. Mean age of the participants was 57.6±11.0. 83.1% underwent laminectomy and posterior spinal fusion, while 22 patients underwent decompressive surgery only. The incidence of venous thromboembolism (P-value=0.403), deep vein thrombosis (p-value=0.999), hematoma formation (p-value=0.403), surgical site infection (p-value=0.901), readmission (p-value=0.545), reoperation (p=0.510), mortality (p=0.648), and complications rate (p-value=0.232) were not statistically different between Enoxaparin and Apixaban. DISCUSSION: Both Apixaban and Enoxaparin may be viable options for postoperative thromboprophylaxis in spine surgeries with comparable efficacy and safety profile. Future research endeavors should investigate the efficacy of these agents in comparison to placebo in a randomized setting.


Assuntos
Pirazóis , Piridonas , Estenose Espinal , Tromboembolia Venosa , Humanos , Enoxaparina/efeitos adversos , Anticoagulantes/efeitos adversos , Tromboembolia Venosa/epidemiologia , Estenose Espinal/cirurgia , Estenose Espinal/complicações , Estudos Prospectivos
9.
Zhonghua Nei Ke Za Zhi ; 63(2): 183-191, 2024 Feb 01.
Artigo em Chinês | MEDLINE | ID: mdl-38326045

RESUMO

Objective: To analyze the differences between trans-radial access (TRA) and trans-femoral access (TFA) in hepatic arterial perfusion chemotherapy (HAIC) in terms of patient experience, postoperative complications, and patient preferences; explore whether TRA in HAIC is associated with better patient experience and compliance; and determine whether it is safer than TFA. Methods: The study was a retrospective cohort study of patients with advanced hepatocellular carcinoma and liver metastases from colorectal cancer treated with HAIC. We enrolled a total of 91 patients with advanced liver malignancies treated with HAIC from November 2022 to May 2023 in the Department of Interventional Therapy and Hepatobiliary Medicine at Tianjin Medical University Cancer Hospital. The patients were divided into three groups: group TRA (n=20, receiving TRA HAIC only), group TFA (n=33, receiving TFA HAIC only), and crossover group [n=19, receiving TFA HAIC (Cross-TFA group) first, followed by TRA HAIC (Cross-TRA group)]. Meanwhile, to facilitate the expression of partial results, all patients receiving TRA HAIC were defined as the TRA-HAIC group (n=39, TRA+Cross-TRA group), and all patients receiving TFA HAIC were defined as the TFA-HAIC group (n=52, TFA+Cross-TFA group). The primary research index was the Quality of Life (QOL) visualization scale score. The secondary research index included approach-related and catheter-related adverse events, duration of surgery, and mean length of patient stay. We used various statistical methods such as Mann-Whitney U test, t-test, Chi-square test, Fisher's exact test, univariate logistic regression analysis, and multi-factor analysis. Results: TRA patients had significantly lower QOL scores than TFA patients (all P<0.001). The QOL scores of the Cross-TRA group were significantly lower than those of the Cross-TFA group (pain at the puncture site Z=-3.24, P=0.001, others P<0.001). The QOL scores of the Cross-TRA group were compared with those of the TRA group, which showed that the scores of the Cross-TRA group in overall discomfort (Z=-3.07,P=0.002), postoperative toilet difficulty (Z=-2.12, P=0.034), and walking difficulty (Z=-2.58, P=0.010) were significantly lower than those of the TRA group. Satisfaction scores were significantly higher in the Cross-TRA group than in the Cross-TFA group (Z=-3.78, P<0.001), and patients were more likely to receive TRA HAIC as the next procedure (χ2=30.42, P<0.001). In terms of mean length of stay, patients receiving TRA HAIC had a significantly lower mean length of stay than those receiving TFA HAIC (50.1±3.2 h vs. 58.4±6.4 h, t=7.98, P<0.001). The incidence of radial artery occlusion (RAO) as an approach-related adverse event was 15.4% (6/39) in the TRA-HAIC group, which was significantly higher than that in the TFA-HAIC group (15.4% vs. 0, χ2=8.56, P=0.005). Notably, multifactorial analysis of RAO-related factors showed that intraoperative enoxaparin use and patency of radial artery flow during pressure were significantly associated with a reduced risk of postoperative RAO (P=0.037 for enoxaparin use and P=0.049 for pressure). Conclusions: With respect to procedure approach, TRA was significantly better than TFA in terms of patient satisfaction and mean length of stay. Through further process optimization and prevention of adverse reactions, the incidence of adverse reactions can be maintained at a relatively low level, so that patients can benefit from TRA in future operations in terms of cost-effectiveness and medical efficiency.


Assuntos
Neoplasias Hepáticas , Qualidade de Vida , Humanos , Estudos Retrospectivos , Enoxaparina , Resultado do Tratamento , Artéria Radial/cirurgia , Perfusão
10.
Circulation ; 149(16): 1258-1267, 2024 Apr 16.
Artigo em Inglês | MEDLINE | ID: mdl-38406848

RESUMO

BACKGROUND: Postprocedural anticoagulation (PPA) is frequently administered after primary percutaneous coronary intervention in ST-segment-elevation myocardial infarction, although no conclusive data support this practice. METHODS: The RIGHT trial (Comparison of Anticoagulation Prolongation vs no Anticoagulation in STEMI Patients After Primary PCI) was an investigator-initiated, multicenter, randomized, double-blind, placebo-controlled, superiority trial conducted at 53 centers in China. Patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention were randomly assigned by center to receive low-dose PPA or matching placebo for at least 48 hours. Before trial initiation, each center selected 1 of 3 PPA regimens (40 mg of enoxaparin once daily subcutaneously; 10 U·kg·h of unfractionated heparin intravenously, adjusted to maintain activated clotting time between 150 and 220 seconds; or 0.2 mg·kg·h of bivalirudin intravenously). The primary efficacy objective was to demonstrate superiority of PPA to reduce the primary efficacy end point of all-cause death, nonfatal myocardial infarction, nonfatal stroke, stent thrombosis (definite), or urgent revascularization (any vessel) within 30 days. The key secondary objective was to evaluate the effect of each specific anticoagulation regimen (enoxaparin, unfractionated heparin, or bivalirudin) on the primary efficacy end point. The primary safety end point was Bleeding Academic Research Consortium 3 to 5 bleeding at 30 days. RESULTS: Between January 10, 2019, and September 18, 2021, a total of 2989 patients were randomized. The primary efficacy end point occurred in 37 patients (2.5%) in both the PPA and placebo groups (hazard ratio, 1.00 [95% CI, 0.63 to 1.57]). The incidence of Bleeding Academic Research Consortium 3 to 5 bleeding did not differ between the PPA and placebo groups (8 [0.5%] vs 11 [0.7%] patients; hazard ratio, 0.74 [95% CI, 0.30 to 1.83]). CONCLUSIONS: Routine PPA after primary percutaneous coronary intervention was safe but did not reduce 30-day ischemic events. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03664180.


Assuntos
Infarto do Miocárdio , Intervenção Coronária Percutânea , Infarto do Miocárdio com Supradesnível do Segmento ST , Humanos , Heparina/efeitos adversos , Enoxaparina/efeitos adversos , Intervenção Coronária Percutânea/efeitos adversos , Infarto do Miocárdio com Supradesnível do Segmento ST/tratamento farmacológico , Recidiva Local de Neoplasia/tratamento farmacológico , Infarto do Miocárdio/tratamento farmacológico , Hemorragia/induzido quimicamente , Hemorragia/tratamento farmacológico , Fragmentos de Peptídeos/uso terapêutico , Anticoagulantes/efeitos adversos , Resultado do Tratamento , Proteínas Recombinantes
11.
Ann Afr Med ; 23(1): 46-52, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38358171

RESUMO

Introduction: Portomesenteric venous thrombosis (PMVT) may complicate sleeve gastrectomy. We believe that single dose of enoxaparin postoperatively can reduce the risk of PMVT. Objective: The objective was to study the outcomes of enoxaparin single dose compared to other perioperative prophylactic doses in preventing PMVT. Methods: Participants included 590 patients who underwent laparoscopic sleeve gastrectomy (LSG). These retrospective cohort data were collected from patient medical charts after bariatric surgery. Patients were followed up in the close postoperative period and at 1, 3, 6, 12, and 18 months. Descriptive statistical analysis was carried out. The objective was to estimate the incidence of PMVT with postoperative single 40 mg subcutaneous enoxaparin prophylactic regimen. Results: From January 2017 to December 2021, 590 patients with obesity underwent LSG. Five patients developed PMVT with an estimate incidence of 0.85%. Three patients had unexplained tachycardia and three patients had postoperative bleeding. Conclusions: Single-dose enoxaparin 40 mg is an effective thrombosis prophylaxis without increasing risk of bleeding.


Résumé Introduction: La thrombose veineuse portomésentérique (TVPM) peut compliquer la gastrectomie en manchon. Nous pensons qu'une dose unique d'énoxaparine en postopératoire peut réduire le risque de PMVT. Objectif: L'objectif était d'étudier les résultats de la dose unique d'énoxaparine par rapport à d'autres doses prophylactiques périopératoires dans la prévention de la PMVT. Méthodes: Les participants comprenaient 590 patients ayant subi une gastrectomie laparoscopique en manchon (LSG). Ces données de cohorte rétrospectives ont été collectées à partir des dossiers médicaux des patients après une chirurgie bariatrique. Les patients ont été suivis dans la période postopératoire étroite et à 1, 3, 6, 12 et 18 mois. Une analyse statistique descriptive a été réalisée. L'objectif était d'estimer l'incidence de la PMVT avec un régime prophylactique postopératoire unique d'énoxaparine sous-cutanée de 40 mg. Résultats: De janvier 2017 à décembre 2021, 590 patients obèses ont subi une LSG. Cinq patients ont développé une PMVT avec une incidence estimée à 0,85 %. Trois patients présentaient une tachycardie inexpliquée et trois patients présentaient des hémorragies postopératoires. Conclusions: Une dose unique d'énoxaparine de 40 mg est une prophylaxie efficace contre la thrombose sans augmenter le risque de saignement. Mots-clés: Énoxaparine, gastrectomie laparoscopique en manchon, thrombose veineuse portomésentérique prophylaxie, thromboembolie veineuse.


Assuntos
Laparoscopia , Obesidade Mórbida , Trombose Venosa , Humanos , Enoxaparina/uso terapêutico , Estudos Retrospectivos , Obesidade Mórbida/cirurgia , Laparoscopia/efeitos adversos , Veia Porta , Veias Mesentéricas , Anticoagulantes/uso terapêutico , Trombose Venosa/etiologia , Trombose Venosa/prevenção & controle , Gastrectomia/efeitos adversos , Complicações Pós-Operatórias/prevenção & controle , Complicações Pós-Operatórias/tratamento farmacológico
13.
J Thromb Thrombolysis ; 57(4): 658-667, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38393675

RESUMO

DOACs have emerged as first-line treatment in most cancer-associated thrombosis (CAT), representing a paradigm shift in its management. However, CAT management remains challenging and requires careful risk-benefit considerations. A retrospective analysis of CAT presentations to a tertiary referral centre from January 2011 to December 2020. Outcomes in CAT patients were compared to VTE patients without malignancy. Subgroup analysis was also conducted for CAT according to anticoagulation type. 514 CAT cases from 491 patients were identified from 3230 total VTE cases. CAT patients had higher rates of major VTE (PE and/or proximal DVT) compared to patients without malignancy (78.4% vs. 66.8%, p < 0.001). CAT patients also had higher rates of VTE recurrence (HR 1.66, 95%CI 1.23-2.26), major bleeding (HR 3.41, 95%CI 2.36-4.93), VTE-related mortality (HR 2.59, 95%CI 1.46-4.62) and bleeding-related mortality (HR 2.66, 95%CI 1.05-6.73). There were no significant differences in rates of VTE recurrence, major bleeding, VTE-related mortality or fatal bleeding between CAT patients treated with DOACs, enoxaparin or warfarin. In the subgroup of CAT treated with DOACs, there was no significant difference in rates of GI bleeding compared to the enoxaparin subgroup (HR 0.17, 95%CI 0.02-1.26). CAT was associated with a larger clot burden and higher rates of VTE recurrence, major bleeding and mortality compared to VTE patients without malignancy in this large real-world study. This study demonstrated no significant differences in complication rates for CAT patients treated with DOACs over enoxaparin, suggesting that DOACs can be safely used in most cases of CAT.


Assuntos
Neoplasias , Trombose , Tromboembolia Venosa , Humanos , Anticoagulantes/uso terapêutico , Tromboembolia Venosa/tratamento farmacológico , Enoxaparina/uso terapêutico , Estudos Retrospectivos , Hemorragia/induzido quimicamente , Trombose/tratamento farmacológico , Resultado do Tratamento , Neoplasias/complicações , Administração Oral
14.
J Thromb Thrombolysis ; 57(4): 587-597, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38402505

RESUMO

Enoxaparin is a hydrophilic drug with obesity having little effect on its apparent volume of distribution, therefore patients with obesity receiving standard 1 mg/kg dosing may be at a higher risk of supratherapeutic dosing. Conversely, dose reducing patients with obesity could place already at risk patients at higher risk of a thrombotic event. Data and recommendations are variable for the most appropriate weight-based dose of therapeutic enoxaparin in obese patients, particularly those a weight > 100 kg or a body mass index (BMI) ≥ 40 kg/m2. The purpose of this systematic review was to globally evaluate these data to surmise optimal dosing recommendations for patients with obesity. A systematic review of English language studies was conducted and identified articles via Pubmed, EMBASE, and the Cochrane Central Register of Controlled Trials (CENTRAL) searches. Studies were included if they reported therapeutic enoxaparin use in adult patients with a BMI ≥ 40 kg/m2 or body weight > 100 kg and the percentage of patients achieving a therapeutic anti-Xa based on a weight-based dose or the weight-based dose required to produce a therapeutic anti-Xa level. Therapeutic attainment of anti-Xa levels were assessed across enoxaparin weight-based dosing categories including a very low dose group: < 0.75 mg/kg, low dose group: 0.75-0.85 mg/kg, and standard dose group: ≥ 0.95 mg/kg. Rates of bleeding and thrombosis were also evaluated. A total of eight studies were included. For anti-Xa level assessment, 682 patients were included. A total of 62% of anti-Xa levels were therapeutic in the very low dose group, 66% in the low dose group, and 42% in the standard dose group. Overall rates of total bleeding and thrombosis were assessed in 798 patients. A total of 29 bleedings (3.6%) occurred, and 27 reported a relationship to dose. Most bleedings, 85.2% (n = 23/27), occurred with doses in the standard dose group (≥ 0.95 mg/kg). Thrombosis occurred in 5 patients (0.6%). Utilization of a reduced weight-based dosing strategy for therapeutic enoxaparin in obese patients may increase the percentage of patients with a therapeutic anti-Xa level.


Assuntos
Trombose , Tromboembolia Venosa , Adulto , Humanos , Enoxaparina , Anticoagulantes/uso terapêutico , Heparina de Baixo Peso Molecular/uso terapêutico , Obesidade/tratamento farmacológico , Hemorragia/induzido quimicamente , Trombose/tratamento farmacológico , Tromboembolia Venosa/tratamento farmacológico , Estudos Retrospectivos
15.
Blood Coagul Fibrinolysis ; 35(3): 101-107, 2024 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-38358899

RESUMO

Venous thromboembolism (VTE) is a preventable cause of significant morbidity and mortality in hospitalized patients world-wide. In Australia, the low-molecular weight heparins (LMWHs) enoxaparin or dalteparin are usually used as first-line prophylaxis for VTE, though there is uncertainty whether dalteparin has the same effectiveness as enoxaparin in real-world settings. This is relevant because dalteparin is less renally cleared and may be more cost effective than enoxaparin. The aim of this study was to explore VTE event incidence in a general cohort of hospitalized adult inpatients who were prescribed enoxaparin or dalteparin for VTE prophylaxis. A retrospective observational study was conducted at a quaternary hospital in Brisbane, Australia, of patients who had experienced a hospital-acquired VTE from 1 September 2021 to 1 March 2023. Patients were identified from routinely collected data following an in-hospital VTE event, and further data was retrieved retrospectively from the integrated electronic Medical Record (ieMR). Incidence and type of VTE events, LMWH-prescribing patterns, and risk factors were assessed. The incidence of VTE events were similar across the dalteparin and enoxaparin cohorts (42.1 events/10 000 patients vs. 34.4 events/10 000 patients, respectively), although patients prescribed enoxaparin had a higher number of risk factors, particularly obesity and active cancer. Our research indicates comparable incidence of VTE in patients prescribed dalteparin compared with enoxaparin in an Australian hospital general cohort of adult inpatients. Dalteparin may be as effective as enoxaparin for VTE prophylaxis in a real-world cohort of patients, and as such dalteparin may be considered a suitable alternative to enoxaparin for VTE prophylaxis. Further research including large randomized controlled trials are required to confirm these results.


Assuntos
Dalteparina , Tromboembolia Venosa , Adulto , Humanos , Dalteparina/uso terapêutico , Enoxaparina/uso terapêutico , Tromboembolia Venosa/etiologia , Tromboembolia Venosa/prevenção & controle , Tromboembolia Venosa/tratamento farmacológico , Heparina de Baixo Peso Molecular/uso terapêutico , Estudos Retrospectivos , Austrália , Anticoagulantes/uso terapêutico
17.
J Thromb Thrombolysis ; 57(3): 418-427, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38281232

RESUMO

To evaluate the safety of direct oral anticoagulants (DOACs) versus low-molecular weight heparin (LMWH) in patients with central nervous system (CNS) malignancies and secondary metastases. All adult patients with CNS malignancies and secondary metastases who were treated with a DOAC or LMWH for any indication from 2018 to 2022 were included. The primary outcome was the incidence of any intracranial hemorrhage (ICH) after anticoagulation initiation. Secondary outcomes included non-ICH bleeding events and thromboembolic events. Tolerability was assessed by any changes in anticoagulant therapy during study period. 153 patients were included; 48 patients received enoxaparin and 105 received DOACs, of which apixaban was used most commonly. The population was predominantly White (74%) and male (59%) with a median age of 65. Data was censored for immortal time bias for outcomes evaluated beyond 3 months. ICH occurred in 7.7% of the population, more frequently in the enoxaparin group (DOACs 4, 4% vs. enoxaparin 7, 16%, p = 0.037). Non-ICH bleeds were predominantly minor and more common in the DOAC group (DOACs 13, 13% vs. enoxaparin 1, 2%, p = 0.037). Thromboembolic events were not different between groups (DOACs 9. 9% vs, enoxaparin 2, 4%, p = 0.503). Anticoagulant switches occurred more in the enoxaparin group (DOACs 12, 12.4% vs. enoxaparin, 37.8%, p < 0.001), primarily due to patient or provider preference. Our data supports DOACs to be preferred over LMWH for the treatment of VTE or for stroke prevention with AF to prevent ICH in patients with brain tumors or metastases.


Assuntos
Neoplasias Encefálicas , Tromboembolia , Tromboembolia Venosa , Adulto , Humanos , Masculino , Anticoagulantes/efeitos adversos , Heparina de Baixo Peso Molecular/uso terapêutico , Enoxaparina/uso terapêutico , Tromboembolia/prevenção & controle , Hemorragia/induzido quimicamente , Hemorragia/tratamento farmacológico , Hemorragias Intracranianas/induzido quimicamente , Hemorragias Intracranianas/complicações , Neoplasias Encefálicas/complicações , Tromboembolia Venosa/prevenção & controle , Administração Oral
18.
J Orthop Traumatol ; 25(1): 1, 2024 Jan 09.
Artigo em Inglês | MEDLINE | ID: mdl-38194191

RESUMO

BACKGROUND: Several clinical investigations have compared different pharmacologic agents for the prophylaxis of venous thromboembolism (VTE). However, no consensus has been reached. The present investigation compared enoxaparin, fondaparinux, aspirin and non-vitamin K antagonist oral anticoagulants (NOACs) commonly used as prophylaxis following total hip arthroplasty (THA). A Bayesian network meta-analysis was performed, setting as outcomes of interest the rate of deep venous thrombosis (DVT), pulmonary embolism (PE) and major and minor haemorrhages. METHODS: This study was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) extension statement for reporting systematic reviews incorporating network meta-analyses of healthcare interventions. All randomised controlled trials (RCTs) comparing two or more drugs used for the prophylaxis of VTE following THA were accessed. PubMed, Web of Science and Google Scholar databases were accessed in March 2023 with no time constraint. RESULTS: Data from 31,705 patients were extracted. Of these, 62% (19,824) were women, with age, sex ratio, and body mass index (BMI) being comparable at baseline. Apixaban 5 mg, fondaparinux, and rivaroxaban 60 mg were the most effective in reducing the rate of DVT. Dabigatran 220 mg, apixaban 5 mg, and aspirin 100 mg were the most effective in reducing the rate of PE. Apixaban 5 mg, ximelagatran 2 mg and aspirin 100 mg were associated with the lowest rate of major haemorrhages, while rivaroxaban 2.5 mg, apixaban 5 mg and enoxaparin 40 mg were associated with the lowest rate of minor haemorrhages. CONCLUSION: Administration of apixaban 5 mg demonstrated the best balance between VTE prevention and haemorrhage control following THA. Level of evidence Level I, network meta-analysis of RCTs.


Assuntos
Artroplastia de Quadril , Tromboembolia Venosa , Feminino , Humanos , Masculino , Artroplastia de Quadril/efeitos adversos , Aspirina/uso terapêutico , Enoxaparina/uso terapêutico , Fibrinolíticos/uso terapêutico , Fondaparinux/uso terapêutico , Hemorragia/induzido quimicamente , Metanálise em Rede , Rivaroxabana/uso terapêutico , Tromboembolia Venosa/etiologia , Tromboembolia Venosa/prevenção & controle
19.
Medicina (Kaunas) ; 60(1)2024 Jan 15.
Artigo em Inglês | MEDLINE | ID: mdl-38256416

RESUMO

Low-molecular-weight heparins are a class of drugs derived from the enzymatic depolymerization of unfractionated heparin that includes enoxaparin. Several studies have been performed on enoxaparin in recent years, in particular for the prevention and treatment of venous thromboembolism and for the treatment of acute coronary syndrome. Furthermore, the use of enoxaparin has been extended to other clinical situations that require antithrombotic pharmacological prevention, such as hemodialysis and recurrent abortion. In this review, we report the main clinical experiences of using enoxaparin in the prevention of VTE in nonsurgical patients.


Assuntos
Síndrome Coronariana Aguda , Enoxaparina , Feminino , Gravidez , Humanos , Enoxaparina/farmacologia , Enoxaparina/uso terapêutico , Heparina , Heparina de Baixo Peso Molecular , Pacientes
20.
BMC Pharmacol Toxicol ; 25(1): 8, 2024 01 10.
Artigo em Inglês | MEDLINE | ID: mdl-38200581

RESUMO

BACKGROUND: We aimed to examine the efficiency of fixed daily dose enoxaparin (40 mg) thromboprophylaxis strategy for patients undergoing inpatient rehabilitation. METHODS: This was an observational, prospective, cohort study that included 63 hospitalized patients undergoing rehabilitative treatment following sub-acute ischemic stroke (SAIS) or spinal cord injury (SCI), with an indication for thromboprophylaxis. Anti-Xa level measured three hours post-drug administration (following three consecutive days of enoxaparin treatment or more) was utilised to assess in vivo enoxaparin activity. An anti-Xa level between 0.2-0.5 U/ml was considered evidence of effective antithrombotic activity. RESULTS: We found sub-prophylactic levels of anti-Xa (<0.2 U/ml) in 19% (12/63). Results were within the recommended prophylactic range (0.2-0.5 U/ml) in 73% (46/63) and were supra-prophylactic (>0.5 U/ml) in 7.9% (5/63) of patients. Anti-Xa levels were found to inversely correlate with patients' weight and renal function as defined by creatinine clearance (CrCl) (p<0.05). CONCLUSIONS: Our study confirmed that a one-size-fits-all approach for venous thromboembolism (VTE) prophylaxis may be inadequate for rehabilitation patient populations. The efficacy of fixed-dose enoxaparin prophylaxis is limited and may be influenced by renal function and weight. This study suggests that anti-Xa studies and prophylactic enoxaparin dose adjustments should be considered in certain patients, such as those who are underweight, overweight and or have suboptimal renal function. TRIAL REGISTRATION: No. NCT103593291, registered August 2018.


Assuntos
AVC Isquêmico , Tromboembolia Venosa , Humanos , Pacientes Internados , Enoxaparina/uso terapêutico , Anticoagulantes/uso terapêutico , Tromboembolia Venosa/tratamento farmacológico , Tromboembolia Venosa/prevenção & controle , Estudos de Coortes , Estudos Prospectivos
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