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Pesquisa : D09.698.373.400.300.150 [Categoria DeCS]
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[PMID]:29231094
[Au] Autor:Raskob GE; van Es N; Verhamme P; Carrier M; Di Nisio M; Garcia D; Grosso MA; Kakkar AK; Kovacs MJ; Mercuri MF; Meyer G; Segers A; Shi M; Wang TF; Yeo E; Zhang G; Zwicker JI; Weitz JI; Büller HR; Hokusai VTE Cancer Investigators
[Ad] Endereço:From the University of Oklahoma Health Sciences Center, College of Public Health, Oklahoma City (G.E.R.); the Department of Vascular Medicine, Academic Medical Center, University of Amsterdam (N.E., H.R.B.), and ITREAS, Academic Research Organization (A.S.) - both in Amsterdam; the Department of Vas
[Ti] Título:Edoxaban for the Treatment of Cancer-Associated Venous Thromboembolism.
[So] Source:N Engl J Med;378(7):615-624, 2018 02 15.
[Is] ISSN:1533-4406
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Low-molecular-weight heparin is the standard treatment for cancer-associated venous thromboembolism. The role of treatment with direct oral anticoagulant agents is unclear. METHODS: In this open-label, noninferiority trial, we randomly assigned patients with cancer who had acute symptomatic or incidental venous thromboembolism to receive either low-molecular-weight heparin for at least 5 days followed by oral edoxaban at a dose of 60 mg once daily (edoxaban group) or subcutaneous dalteparin at a dose of 200 IU per kilogram of body weight once daily for 1 month followed by dalteparin at a dose of 150 IU per kilogram once daily (dalteparin group). Treatment was given for at least 6 months and up to 12 months. The primary outcome was a composite of recurrent venous thromboembolism or major bleeding during the 12 months after randomization, regardless of treatment duration. RESULTS: Of the 1050 patients who underwent randomization, 1046 were included in the modified intention-to-treat analysis. A primary-outcome event occurred in 67 of the 522 patients (12.8%) in the edoxaban group as compared with 71 of the 524 patients (13.5%) in the dalteparin group (hazard ratio, 0.97; 95% confidence interval [CI], 0.70 to 1.36; P=0.006 for noninferiority; P=0.87 for superiority). Recurrent venous thromboembolism occurred in 41 patients (7.9%) in the edoxaban group and in 59 patients (11.3%) in the dalteparin group (difference in risk, -3.4 percentage points; 95% CI, -7.0 to 0.2). Major bleeding occurred in 36 patients (6.9%) in the edoxaban group and in 21 patients (4.0%) in the dalteparin group (difference in risk, 2.9 percentage points; 95% CI, 0.1 to 5.6). CONCLUSIONS: Oral edoxaban was noninferior to subcutaneous dalteparin with respect to the composite outcome of recurrent venous thromboembolism or major bleeding. The rate of recurrent venous thromboembolism was lower but the rate of major bleeding was higher with edoxaban than with dalteparin. (Funded by Daiichi Sankyo; Hokusai VTE Cancer ClinicalTrials.gov number, NCT02073682 .).
[Mh] Termos MeSH primário: Anticoagulantes/uso terapêutico
Dalteparina/uso terapêutico
Neoplasias/complicações
Piridinas/uso terapêutico
Tiazóis/uso terapêutico
Tromboembolia Venosa/tratamento farmacológico
[Mh] Termos MeSH secundário: Adulto
Idoso
Anticoagulantes/efeitos adversos
Dalteparina/efeitos adversos
Seguimentos
Hemorragia/induzido quimicamente
Heparina de Baixo Peso Molecular/efeitos adversos
Heparina de Baixo Peso Molecular/uso terapêutico
Seres Humanos
Análise de Intenção de Tratamento
Estimativa de Kaplan-Meier
Masculino
Meia-Idade
Piridinas/efeitos adversos
Recidiva
Tiazóis/efeitos adversos
Tromboembolia Venosa/etiologia
[Pt] Tipo de publicação:EQUIVALENCE TRIAL; JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL; RESEARCH SUPPORT, NON-U.S. GOV'T
[Nm] Nome de substância:
0 (Anticoagulants); 0 (Heparin, Low-Molecular-Weight); 0 (Pyridines); 0 (Thiazoles); NDU3J18APO (edoxaban); S79O08V79F (Dalteparin)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180228
[Lr] Data última revisão:
180228
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:171213
[Cl] Clinical Trial:ClinicalTrial
[St] Status:MEDLINE
[do] DOI:10.1056/NEJMoa1711948


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[PMID]:29363105
[Au] Autor:Hakoum MB; Kahale LA; Tsolakian IG; Matar CF; Yosuico VE; Terrenato I; Sperati F; Barba M; Schünemann H; Akl EA
[Ad] Endereço:Family Medicine, American University of Beirut, Beirut, Lebanon, 1107 2020.
[Ti] Título:Anticoagulation for the initial treatment of venous thromboembolism in people with cancer.
[So] Source:Cochrane Database Syst Rev;1:CD006649, 2018 01 24.
[Is] ISSN:1469-493X
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Compared with people without cancer, people with cancer who receive anticoagulant treatment for venous thromboembolism (VTE) are more likely to develop recurrent VTE. OBJECTIVES: To compare the efficacy and safety of three types of parenteral anticoagulants (i.e. fixed-dose low molecular weight heparin (LMWH), adjusted-dose unfractionated heparin (UFH), and fondaparinux) for the initial treatment of VTE in people with cancer. SEARCH METHODS: A comprehensive search included a major electronic search of the following databases: Cochrane Central Register of Controlled Trials (CENTRAL) (2018, Issue 1), MEDLINE (via Ovid) and Embase (via Ovid); handsearching of conference proceedings; checking of references of included studies; use of the 'related citation' feature in PubMed; and a search for ongoing studies. This update of the systematic review was based on the findings of a literature search conducted on 14 January 2018. SELECTION CRITERIA: Randomized controlled trials (RCTs) assessing the benefits and harms of LMWH, UFH, and fondaparinux in people with cancer and objectively confirmed VTE. DATA COLLECTION AND ANALYSIS: Using a standardized form, we extracted data in duplicate on study design, participants, interventions outcomes of interest, and risk of bias. Outcomes of interested included all-cause mortality, symptomatic VTE, major bleeding, minor bleeding, postphlebitic syndrome, quality of life, and thrombocytopenia. We assessed the certainty of evidence for each outcome using the GRADE approach. MAIN RESULTS: Of 15440 identified citations, 7387 unique citations, 15 RCTs fulfilled the eligibility criteria. These trials enrolled 1615 participants with cancer and VTE: 13 compared LMWH with UFH enrolling 1025 participants, one compared fondaparinux with UFH and LMWH enrolling 477 participants, and one compared dalteparin with tinzaparin enrolling 113 participants. The meta-analysis of mortality at three months included 418 participants from five studies and that of recurrent VTE included 422 participants from 3 studies. The findings showed that LMWH likely decreases mortality at three months compared to UFH (risk ratio (RR) 0.66, 95% confidence interval (CI) 0.40 to 1.10; risk difference (RD) 57 fewer per 1000, 95% CI 101 fewer to 17 more; moderate certainty evidence), but did not rule out a clinically significant increase or decrease in VTE recurrence (RR 0.69, 95% CI 0.27 to 1.76; RD 30 fewer per 1000, 95% CI 70 fewer to 73 more; moderate certainty evidence).The study comparing fondaparinux with heparin (UFH or LMWH) did not exclude a beneficial or detrimental effect of fondaparinux on mortality at three months (RR 1.25, 95% CI 0.86 to 1.81; RD 43 more per 1000, 95% CI 24 fewer to 139 more; moderate certainty evidence), recurrent VTE (RR 0.93, 95% CI 0.56 to 1.54; RD 8 fewer per 1000, 95% CI 52 fewer to 63 more; moderate certainty evidence), major bleeding (RR 0.82, 95% CI 0.40 to 1.66; RD 12 fewer per 1000, 95% CI 40 fewer to 44 more; moderate certainty evidence), or minor bleeding (RR 1.53, 95% CI 0.88 to 2.66; RD 42 more per 1000, 95% CI 10 fewer to 132 more; moderate certainty evidence)The study comparing dalteparin with tinzaparin did not exclude a beneficial or detrimental effect of dalteparin on mortality (RR 0.86, 95% CI 0.43 to 1.73; RD 33 fewer per 1000, 95% CI 135 fewer to 173 more; low certainty evidence), recurrent VTE (RR 0.44, 95% CI 0.09 to 2.16; RD 47 fewer per 1000, 95% CI 77 fewer to 98 more; low certainty evidence), major bleeding (RR 2.19, 95% CI 0.20 to 23.42; RD 20 more per 1000, 95% CI 14 fewer to 380 more; low certainty evidence), or minor bleeding (RR 0.82, 95% CI 0.30 to 2.21; RD 24 fewer per 1000, 95% CI 95 fewer to 164 more; low certainty evidence). AUTHORS' CONCLUSIONS: LMWH is possibly superior to UFH in the initial treatment of VTE in people with cancer. Additional trials focusing on patient-important outcomes will further inform the questions addressed in this review. The decision for a person with cancer to start LMWH therapy should balance the benefits and harms and consider the person's values and preferences.
[Mh] Termos MeSH primário: Anticoagulantes/uso terapêutico
Neoplasias/complicações
Tromboembolia Venosa/tratamento farmacológico
[Mh] Termos MeSH secundário: Dalteparina/uso terapêutico
Fibrinolíticos/uso terapêutico
Hemorragia/induzido quimicamente
Heparina/uso terapêutico
Heparina de Baixo Peso Molecular/uso terapêutico
Seres Humanos
Polissacarídeos/uso terapêutico
Ensaios Clínicos Controlados Aleatórios como Assunto
Recidiva
Prevenção Secundária
Tromboembolia Venosa/mortalidade
[Pt] Tipo de publicação:JOURNAL ARTICLE; META-ANALYSIS; RESEARCH SUPPORT, NON-U.S. GOV'T; REVIEW
[Nm] Nome de substância:
0 (Anticoagulants); 0 (Fibrinolytic Agents); 0 (Heparin, Low-Molecular-Weight); 0 (Polysaccharides); 7UQ7X4Y489 (tinzaparin); 9005-49-6 (Heparin); J177FOW5JL (fondaparinux); S79O08V79F (Dalteparin)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180226
[Lr] Data última revisão:
180226
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180125
[St] Status:MEDLINE
[do] DOI:10.1002/14651858.CD006649.pub7


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[PMID]:29216619
[Au] Autor:Kirkham K; Munson JM; McCluskey SV; Graner KK
[Ad] Endereço:Mayo Clinic Rochester, Rochester, Minnesota. kirkham.kylian@mayo.edu.
[Ti] Título:Stability of Dalteparin 1,000 Unit/mL in 0.9% Sodium Chloride for Injection in Polypropylene Syringes.
[So] Source:Int J Pharm Compd;21(5):426-429, 2017 Sep-Oct.
[Is] ISSN:1092-4221
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:The stability of dalteparin 1,000 units/mL in 0.9% sodium chloride for injection stored in polypropylene syringes under refrigeration was examined. Dalteparin 1,000-units/mL syringes were prepared by adding 9 mL of 0.9% sodium chloride for injection to 1 mL of dalteparin sodium 10,000 unit/mL from commercial single-use syringes. Compounded solutions in 0.5-mL aliquots were transferred to 1-mL polypropylene syringes and sealed with a Luer lock tip cap and stored at refrigerated temperatures (2°C to 8°C) with ambient fluorescent light exposure. Syringes from three batches of dalteparin 1,000 units/mL were potency tested in duplicate by a stability-indicating high-performance liquid chromatography assay using a 0.5-mL sample at specified intervals. Visual and pH testing were performed on each batch. Samples were visually inspected for container integrity, color, and clarity. Samples for pH testing were prepared using a 1:1 dilution of dalteparin 1,000 units/mL in sterile water for injection and underwent duplicate analysis at each time point. High-performance liquid chromatography analyses showed a remaining percent of the initial dalteparin content at day 30 of 94.88% ± 2.11%. Samples remained colorless and clear with no signs of container compromise and no visual particulate matter at each time point. Throughout the 30-day study period, pH values remained within 0.3-pH units from the initial value of 5.84. Dalteparin 1,000 unit/mL in 0.9% sodium chloride for injection, packaged in 1-mL polypropylene syringes was stable for at least 30 days while stored at refrigerated conditions with ambient fluorescent light exposure.
[Mh] Termos MeSH primário: Dalteparina/química
[Mh] Termos MeSH secundário: Cromatografia Líquida de Alta Pressão
Dalteparina/análise
Dalteparina/farmacologia
Estabilidade de Medicamentos
Inibidores do Fator Xa/farmacologia
Concentração de Íons de Hidrogênio
Injeções
Polipropilenos
Cloreto de Sódio
Seringas
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Factor Xa Inhibitors); 0 (Polypropylenes); 451W47IQ8X (Sodium Chloride); S79O08V79F (Dalteparin)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180220
[Lr] Data última revisão:
180220
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171208
[St] Status:MEDLINE


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[PMID]:29224638
[Au] Autor:Clark NP; Douketis JD; Hasselblad V; Schulman S; Kindzelski AL; Ortel TL; BRIDGE Investigators
[Ad] Endereço:Kaiser Permanente Colorado, Aurora, CO. Electronic address: nathan.clark@Kp.org.
[Ti] Título:Predictors of perioperative major bleeding in patients who interrupt warfarin for an elective surgery or procedure: Analysis of the BRIDGE trial.
[So] Source:Am Heart J;195:108-114, 2018 Jan.
[Is] ISSN:1097-6744
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: The use of low-molecular weight heparin bridge therapy during warfarin interruption for elective surgery/procedures increases bleeding. Other predictors of bleeding in this setting are not well described. METHODS: BRIDGE was a randomized, double-blind, placebo-controlled trial of bridge therapy with dalteparin 100 IU/kg twice daily in patients with atrial fibrillation requiring warfarin interruption. Bleeding outcomes were documented from the time of warfarin interruption until up to 37 days postprocedure. Multiple logistic regression and time-dependent hazard models were used to identify major bleeding predictors. RESULTS: We analyzed 1,813 patients of whom 895 received bridging and 918 received placebo. Median patient age was 72.6 years, and 73.3% were male. Forty-one major bleeding events occurred at a median time of 7.0 days (interquartile range, 4.0-18.0 days) postprocedure. Bridge therapy was a baseline predictor of major bleeding (odds ratio [OR]=2.4, 95% CI: 1.2-4.8), as were a history of renal disease (OR=2.9, 95% CI: 1.4-6.0), and high-bleeding risk procedures (vs low-bleeding risk procedures) (OR=2.9, 95% CI: 1.4-5.9). Perioperative aspirin use (OR=3.6, 95% CI: 1.1-11.9) and postprocedure international normalized ratio >3.0 (OR=2.1, 95% CI: 1.5-3.1) were time-dependent predictors of major bleeding. Major bleeding was most common in the first 10 days compared with 11-37 days postprocedure (OR=3.5, 95% CI: 1.8-6.9). CONCLUSIONS: In addition to bridge therapy, perioperative aspirin use, postprocedure international normalized ratio >3.0, a history of renal failure, and having a high-bleeding risk procedure increase the risk of major bleeding around the time of an elective surgery/procedure requiring warfarin interruption.
[Mh] Termos MeSH primário: Fibrilação Atrial/tratamento farmacológico
Dalteparina/efeitos adversos
Procedimentos Cirúrgicos Eletivos/efeitos adversos
Hemorragia Pós-Operatória/etiologia
Acidente Vascular Cerebral/prevenção & controle
Varfarina/farmacologia
Suspensão de Tratamento
[Mh] Termos MeSH secundário: Idoso
Anticoagulantes/efeitos adversos
Anticoagulantes/uso terapêutico
Fibrilação Atrial/complicações
Dalteparina/uso terapêutico
Método Duplo-Cego
Feminino
Seres Humanos
Incidência
Injeções Subcutâneas
Masculino
North Carolina/epidemiologia
Hemorragia Pós-Operatória/epidemiologia
Acidente Vascular Cerebral/etiologia
[Pt] Tipo de publicação:JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Anticoagulants); 5Q7ZVV76EI (Warfarin); S79O08V79F (Dalteparin)
[Em] Mês de entrada:1712
[Cu] Atualização por classe:171220
[Lr] Data última revisão:
171220
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:171212
[St] Status:MEDLINE


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[PMID]:28234587
[Au] Autor:Plante S; Belzile EL; Fréchette D; Lefebvre J
[Ad] Endereço:From the Department of Pharmacy, CHU de Québec-Université Laval, Hôpital St-François d'Assise, Québec, Que. (Plante, Fréchette); the Division of Orthopaedic Surgery, Department of Surgery, Université Laval, Québec, Que. (Belzile); and the Faculty of Pharmacy, Université Laval, Québec, Que. (Lefebvre
[Ti] Título:Analysis of contributing factors influencing thromboembolic events after total knee arthroplasty.
[So] Source:Can J Surg;60(1):30-36, 2017 Feb.
[Is] ISSN:1488-2310
[Cp] País de publicação:Canada
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Venous thromboembolic events (VTE) are a known and well-described complication following total knee arthroplasty (TKA). We sought to validate the American College of Chest Physicians thromboprophylaxis recommendations after elective TKA, paying special attention to our dose adjustments for weight, and their impact on VTE in our population. METHODS: We retrospectively investigated risk factors in patients undergoing TKA, focusing mainly on symptomatic VTE occurrence rates from deep vein thrombosis (DVT) or pulmonary embolism (PE). The anticoagulation protocol consisted of starting low molecular-weight heparin (LMWH) therapy, with dalteparin administered 12 h after surgery in patients who received general anesthesia or 24 h later in patients who received single-dose regional anesthesia. RESULTS: Data from 346 patients (mean age 66.8 [range 24-91] yr) who underwent primary or revision TKA depicted an overall symptomatic VTE rate of 15%. The proximal DVT rate was 1.7%, and the nonfatal PE rate was 0.9%. The mean time to VTE diagnosis was 5.6 days. The first dalteparin dose was administered 19.5 (range 10-48) h after surgery in patients without VTE and 22.6 (range 11.5-52) h after surgery in patients with VTE ( = 0.003). With a first dose of dalteparin administered 12 h postoperatively, patients presented significantly lower DVT and PE rates than if it was administered 24 h postoperatively (8.5% v. 16.3%, = 0.048). CONCLUSION: Delayed administration of LMWH has deleteriously impacted the VTE rate after TKA at our institution. Prompt initiation of LMWH (≤ 12 h after surgery) is appropriate, without increasing the risk of major bleeding.
[Mh] Termos MeSH primário: Anticoagulantes/farmacologia
Artroplastia do Joelho/efeitos adversos
Dalteparina/farmacologia
Avaliação de Processos e Resultados (Cuidados de Saúde)
Complicações Pós-Operatórias/prevenção & controle
Guias de Prática Clínica como Assunto/normas
Embolia Pulmonar/prevenção & controle
Tromboembolia Venosa/prevenção & controle
Trombose Venosa/prevenção & controle
[Mh] Termos MeSH secundário: Adulto
Idoso
Idoso de 80 Anos ou mais
Anticoagulantes/administração & dosagem
Artroplastia do Joelho/estatística & dados numéricos
Dalteparina/administração & dosagem
Procedimentos Cirúrgicos Eletivos
Feminino
Seres Humanos
Masculino
Meia-Idade
Complicações Pós-Operatórias/epidemiologia
Complicações Pós-Operatórias/etiologia
Embolia Pulmonar/epidemiologia
Embolia Pulmonar/etiologia
Estudos Retrospectivos
Fatores de Risco
Tromboembolia Venosa/epidemiologia
Tromboembolia Venosa/etiologia
Trombose Venosa/epidemiologia
Trombose Venosa/etiologia
Adulto Jovem
[Pt] Tipo de publicação:JOURNAL ARTICLE; VALIDATION STUDIES
[Nm] Nome de substância:
0 (Anticoagulants); S79O08V79F (Dalteparin)
[Em] Mês de entrada:1704
[Cu] Atualização por classe:170406
[Lr] Data última revisão:
170406
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170225
[St] Status:MEDLINE


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[PMID]:28204995
[Au] Autor:Dranitsaris G; Shane LG; Galanaud JP; Stemer G; Debourdeau P; Woodruff S
[Ad] Endereço:Augmentium Pharma Consulting Inc, 283 Danforth Ave, Suite 448 M4K 1N2, Toronto, Canada. george@augmentium.com.
[Ti] Título:Dalteparin or vitamin K antagonists to prevent recurrent venous thromboembolism in cancer patients: a patient-level economic analysis for France and Austria.
[So] Source:Support Care Cancer;25(7):2093-2102, 2017 Jul.
[Is] ISSN:1433-7339
[Cp] País de publicação:Germany
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: International guidelines recommend extended duration secondary prophylaxis in cancer patients who develop primary venous thromboembolism (VTE). Agent selection is guided in part by one large randomized trial (i.e., CLOT; Lee et al., N Engl J Med 349:146-53, 2003) which demonstrated that dalteparin reduced the relative risk of recurrence by 52% compared with oral vitamin K antagonists (VKA; HR = 0.48, 95% CI, 0.30 to 0.77). In a subgroup analysis from that same trial, patients with renal impairment also derived benefit with dalteparin (VTE rates = 3% vs. 17%; p = 0.011). To measure the economic value of secondary VTE prophylaxis with dalteparin, a patient-level pharmacoeconomic analysis was conducted from the Austrian and French healthcare system perspectives. METHODS: Chapter 1 Healthcare resource use collected during the CLOT trial was extracted and converted into direct cost estimates. Incremental cost differences between the dalteparin and VKA groups were then combined with health state utilities to measure the cost per quality-adjusted life year (QALY) gained. RESULTS: The dalteparin group had significantly higher costs than the VKA group in both countries (Austria: dalteparin = €2687 vs. VKA = €2012; France: dalteparin = €2053 vs. VKA = €1352: p < 0.001). However, when the incremental costs were combined with the utility gain, dalteparin had a cost of €6600 and €4900 per QALY gained in Austria and France, respectively. The analyses in patients with renal impairment suggested an even better economic profile, with the cost per QALY gained being less than €4000 in both countries. CONCLUSIONS: Secondary prophylaxis with dalteparin is a cost-effective alternative to VKA for the prevention of recurrent VTE in patients with cancer.
[Mh] Termos MeSH primário: Anticoagulantes/uso terapêutico
Dalteparina/uso terapêutico
Neoplasias/complicações
Qualidade de Vida/psicologia
Tromboembolia Venosa/economia
Tromboembolia Venosa/prevenção & controle
Vitamina K/antagonistas & inibidores
[Mh] Termos MeSH secundário: Áustria
Análise Custo-Benefício
Dalteparina/administração & dosagem
Dalteparina/farmacologia
Feminino
França
Seres Humanos
Masculino
Meia-Idade
Neoplasias/tratamento farmacológico
Recidiva
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Anticoagulants); 12001-79-5 (Vitamin K); S79O08V79F (Dalteparin)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171030
[Lr] Data última revisão:
171030
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170217
[St] Status:MEDLINE
[do] DOI:10.1007/s00520-017-3610-2


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[PMID]:28139259
[Au] Autor:Khorana AA; Francis CW; Kuderer NM; Carrier M; Ortel TL; Wun T; Rubens D; Hobbs S; Iyer R; Peterson D; Baran A; Kaproth-Joslin K; Lyman GH
[Ad] Endereço:Cleveland Clinic, Cleveland, OH, USA. Electronic address: Khorana@ccf.org.
[Ti] Título:Dalteparin thromboprophylaxis in cancer patients at high risk for venous thromboembolism: A randomized trial.
[So] Source:Thromb Res;151:89-95, 2017 Mar.
[Is] ISSN:1879-2472
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Ambulatory cancer patients at high-risk for venous thromboembolism (VTE) can be identified using a validated risk score (Khorana score). We evaluated the benefit of outpatient thromboprophylaxis with dalteparin in high-risk patients in a multicenter randomized study. METHODS: Cancer patients with Khorana score≥3 starting a new systemic regimen were screened for VTE and if negative randomized to dalteparin 5000units daily or observation for 12weeks. Subjects were screened with lower extremity ultrasounds every 4weeks on study and with chest CT at 12weeks. The primary efficacy endpoint was all VTE over 12weeks and primary safety endpoint was clinically relevant bleeding events over 13weeks. The study was terminated early due to low accrual. RESULTS: Of 117 enrolled patients, 10 (8.5%) had VTE on baseline screening and were not randomized. Of 98 randomized patients, VTE occurred in 12% (N=6/50) of patients on dalteparin and 21% (N=10/48) on observation (hazard ratio, HR 0.69, 95% CI 0.23-1.89). Major bleeding was similar (N=1) in each arm but clinically relevant bleeding was higher in dalteparin arm (N=7 versus 1 on observation) (HR=7.0, 95% CI 1.2-131.6). There was no difference in overall survival. CONCLUSIONS: Thromboprophylaxis is associated with a non-significantly reduced risk of VTE and significantly increased risk of clinically relevant bleeding in this underpowered study. The Khorana score successfully identifies patients with high incidence of VTE both at baseline and during treatment. Future studies should continue to focus on risk-adapted approaches to reduce the burden of VTE in cancer. TRIAL REGISTRATION: clinicaltrials.gov identifier: NCT00876915.
[Mh] Termos MeSH primário: Anticoagulantes/uso terapêutico
Dalteparina/uso terapêutico
Neoplasias/complicações
Tromboembolia Venosa/etiologia
Tromboembolia Venosa/prevenção & controle
[Mh] Termos MeSH secundário: Idoso
Anticoagulantes/efeitos adversos
Dalteparina/efeitos adversos
Feminino
Hemorragia/induzido quimicamente
Seres Humanos
Masculino
Meia-Idade
Resultado do Tratamento
[Pt] Tipo de publicação:JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Anticoagulants); S79O08V79F (Dalteparin)
[Em] Mês de entrada:1704
[Cu] Atualização por classe:170428
[Lr] Data última revisão:
170428
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170201
[St] Status:MEDLINE


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[PMID]:27712038
[Au] Autor:Rodríguez-Pozo ML; Armengou L; Monreal L; Viu J; Cesarini C; Jose-Cunilleras E
[Ad] Endereço:Servei de Medicina Interna Equina i Unitat Equina, Fundació Hospital Clínic Veterinari, Departament de Medicina i Cirurgia Animals, Universitat Autònoma de Barcelona, Barcelona, 08310, Spain.
[Ti] Título:Evaluation of an oral direct factor Xa inhibitor anticoagulant in healthy adult horses.
[So] Source:J Vet Emerg Crit Care (San Antonio);27(1):82-88, 2017 Jan.
[Is] ISSN:1476-4431
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:OBJECTIVE: To assess whether an oral direct factor Xa inhibitor (DiXaI) anticoagulant drug used at the low end of the recommended dose in people achieves presumed prophylactic plasma concentrations and does not induce bleeding in horses. DESIGN: Experimental study. SETTING: Field study. ANIMALS: Ten healthy adult horses. INTERVENTIONS: A DiXaI was administered at a dose of 0.125 mg/kg every 24 h orally for 4 days. Following a wash-out period of 2 weeks, 8 of 10 horses received daily subcutaneous doses of a low molecular weight heparin (dalteparin) for 4 consecutive days at 50 IU/kg. In both trials, antifactor Xa activity was measured at baseline time and 3 hours after each dose administration. Activated partial thromboplastin time, prothrombin time, hematocrit, erythrocyte agglutination, and platelet aggregation were monitored throughout the study. In addition, an in vitro spiking experiment was performed to demonstrate anticoagulant activity of this DiXaI in horse plasma. MAIN RESULTS: When treated with the DiXaI, this group of horses did not achieve the suggested thromboprophylactic plasma range of antifactor Xa activity (0.1-0.2 IU/mL), except for 1 horse after the first administration of the drug. In contrast, median values of plasma antifactor Xa activity 3 hours after receiving dalteparin were within the prophylactic range (0.16 IU/mL). No hemorrhagic events or erythrocyte agglutination were observed. In vitro addition of this DiXaI caused a concentration-dependent effect in antifactor Xa activity. CONCLUSIONS: At the low end of the recommended dose in people this oral formulation of DiXaI did not reach prophylactic plasma antifactor Xa activity in this group of healthy adult horses. Further studies are warranted in order to establish the prophylactic dose for horses.
[Mh] Termos MeSH primário: Anticoagulantes/farmacologia
Coagulação Sanguínea/efeitos dos fármacos
Dalteparina/farmacologia
Inibidores do Fator Xa/farmacologia
[Mh] Termos MeSH secundário: Administração Oral
Animais
Anticoagulantes/administração & dosagem
Testes de Coagulação Sanguínea/veterinária
Dalteparina/administração & dosagem
Inibidores do Fator Xa/administração & dosagem
Feminino
Cavalos
Injeções Subcutâneas/veterinária
Masculino
Tempo de Tromboplastina Parcial/veterinária
[Pt] Tipo de publicação:CLINICAL TRIAL; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Anticoagulants); 0 (Factor Xa Inhibitors); S79O08V79F (Dalteparin)
[Em] Mês de entrada:1704
[Cu] Atualização por classe:170817
[Lr] Data última revisão:
170817
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161007
[St] Status:MEDLINE
[do] DOI:10.1111/vec.12540


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[PMID]:28045359
[Au] Autor:Brand B; Aegerter C
[Ad] Endereço:1 Küsnacht.
[Ti] Título:Thrombose in der Schwangerschaft..
[So] Source:Ther Umsch;73(10):605-612, 2016.
[Is] ISSN:0040-5930
[Cp] País de publicação:Switzerland
[La] Idioma:ger
[Mh] Termos MeSH primário: Complicações Hematológicas na Gravidez/sangue
Complicações Hematológicas na Gravidez/tratamento farmacológico
Tromboembolia Venosa/sangue
Tromboembolia Venosa/tratamento farmacológico
[Mh] Termos MeSH secundário: Adulto
Cesárea
Dalteparina/efeitos adversos
Dalteparina/uso terapêutico
Feminino
Fidelidade a Diretrizes
Heparina de Baixo Peso Molecular/efeitos adversos
Heparina de Baixo Peso Molecular/uso terapêutico
Seres Humanos
Gravidez
Transtornos Puerperais/sangue
Transtornos Puerperais/tratamento farmacológico
Embolia Pulmonar/sangue
Embolia Pulmonar/tratamento farmacológico
Medição de Risco
[Pt] Tipo de publicação:CASE REPORTS; JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Heparin, Low-Molecular-Weight); S79O08V79F (Dalteparin)
[Em] Mês de entrada:1703
[Cu] Atualização por classe:170324
[Lr] Data última revisão:
170324
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170104
[St] Status:MEDLINE
[do] DOI:10.1024/0040-5930/a000838


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[PMID]:27852568
[Au] Autor:Bobinskas A; Dunbar E; Koppel D
[Ad] Endereço:Oral and Maxillofacial Surgery Unit, Southern General Hospital, Glasgow, UK.
[Ti] Título:Spontaneous lingual haematoma secondary to thrombolysis.
[So] Source:BMJ;355:i5569, 2016 Nov 16.
[Is] ISSN:1756-1833
[Cp] País de publicação:England
[La] Idioma:eng
[Mh] Termos MeSH primário: Dalteparina/efeitos adversos
Fibrinolíticos/efeitos adversos
Hematoma/induzido quimicamente
Ativador de Plasminogênio Tecidual/efeitos adversos
Doenças da Língua/induzido quimicamente
[Mh] Termos MeSH secundário: Idoso
Diagnóstico Diferencial
Seres Humanos
Masculino
Embolia Pulmonar/tratamento farmacológico
[Pt] Tipo de publicação:CASE REPORTS; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Fibrinolytic Agents); EC 3.4.21.68 (Tissue Plasminogen Activator); S79O08V79F (Dalteparin)
[Em] Mês de entrada:1704
[Cu] Atualização por classe:170817
[Lr] Data última revisão:
170817
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:161118
[St] Status:MEDLINE
[do] DOI:10.1136/bmj.i5569



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