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2.
N Engl J Med ; 382(17): 1599-1607, 2020 04 23.
Artigo em Inglês | MEDLINE | ID: mdl-32223112

RESUMO

BACKGROUND: Recent guidelines recommend consideration of the use of oral edoxaban or rivaroxaban for the treatment of venous thromboembolism in patients with cancer. However, the benefit of these oral agents is limited by the increased risk of bleeding associated with their use. METHODS: This was a multinational, randomized, investigator-initiated, open-label, noninferiority trial with blinded central outcome adjudication. We randomly assigned consecutive patients with cancer who had symptomatic or incidental acute proximal deep-vein thrombosis or pulmonary embolism to receive oral apixaban (at a dose of 10 mg twice daily for the first 7 days, followed by 5 mg twice daily) or subcutaneous dalteparin (at a dose of 200 IU per kilogram of body weight once daily for the first month, followed by 150 IU per kilogram once daily). The treatments were administered for 6 months. The primary outcome was objectively confirmed recurrent venous thromboembolism during the trial period. The principal safety outcome was major bleeding. RESULTS: Recurrent venous thromboembolism occurred in 32 of 576 patients (5.6%) in the apixaban group and in 46 of 579 patients (7.9%) in the dalteparin group (hazard ratio, 0.63; 95% confidence interval [CI], 0.37 to 1.07; P<0.001 for noninferiority). Major bleeding occurred in 22 patients (3.8%) in the apixaban group and in 23 patients (4.0%) in the dalteparin group (hazard ratio, 0.82; 95% CI, 0.40 to 1.69; P = 0.60). CONCLUSIONS: Oral apixaban was noninferior to subcutaneous dalteparin for the treatment of cancer-associated venous thromboembolism without an increased risk of major bleeding. (Funded by the Bristol-Myers Squibb-Pfizer Alliance; Caravaggio ClinicalTrials.gov number, NCT03045406.).


Assuntos
Anticoagulantes/administração & dosagem , Dalteparina/administração & dosagem , Hemorragia/induzido quimicamente , Neoplasias/complicações , Pirazóis/administração & dosagem , Piridonas/administração & dosagem , Prevenção Secundária/métodos , Tromboembolia Venosa/prevenção & controle , Administração Oral , Idoso , Anticoagulantes/efeitos adversos , Dalteparina/efeitos adversos , Feminino , Hemorragia/epidemiologia , Humanos , Incidência , Injeções Subcutâneas , Análise de Intenção de Tratamento , Masculino , Pessoa de Meia-Idade , Neoplasias/mortalidade , Modelos de Riscos Proporcionais , Embolia Pulmonar/prevenção & controle , Pirazóis/efeitos adversos , Piridonas/efeitos adversos , Método Simples-Cego , Tromboembolia Venosa/tratamento farmacológico , Tromboembolia Venosa/etiologia , Trombose Venosa/prevenção & controle
5.
Rev Med Suisse ; 15(674): 2232-2235, 2019 Dec 04.
Artigo em Francês | MEDLINE | ID: mdl-31804034

RESUMO

The use of direct oral anticoagulants (DOACs) has been largely -implemented in the management of venous thromboembolic disease in non-cancer patients. In cancer-associated thrombosis, low molecular weight heparins (LMWHs) and especially dalteparin have long been the reference standard therapy. Following the publication of two randomised trials comparing edoxaban and rivaroxaban to -dalteparin, DOACs now represent an alternative with an interesting efficacy and safety profile. Moreover, they offer the comfort of an oral administration and a lower cost. In patients with gastrointestinal or genitourinary cancers however, a higher bleeding risk has been shown with DOACs. LMWHs thus remain the treatment of choice in this group of patients.


Assuntos
Anticoagulantes/administração & dosagem , Anticoagulantes/uso terapêutico , Neoplasias/complicações , Tromboembolia Venosa/complicações , Tromboembolia Venosa/tratamento farmacológico , Administração Oral , Dalteparina/administração & dosagem , Dalteparina/uso terapêutico , Heparina de Baixo Peso Molecular/administração & dosagem , Heparina de Baixo Peso Molecular/uso terapêutico , Humanos , Piridinas/administração & dosagem , Piridinas/uso terapêutico , Rivaroxabana/administração & dosagem , Rivaroxabana/uso terapêutico , Tiazóis/administração & dosagem , Tiazóis/uso terapêutico
8.
Implement Sci ; 14(1): 75, 2019 07 24.
Artigo em Inglês | MEDLINE | ID: mdl-31340835

RESUMO

BACKGROUND: The study covered in- and out-of-hospital care in a region in north-western Spain. The intervention evaluated took the form of a change in the hospital drugs formulary. Before the intervention, the formulary contained four of the five low molecular weight heparins (LMWHs) marketed in Spain. The intervention consisted of withdrawing two LMWHs (bemiparin and dalteparin) from the formulary and restricting the use of another (tinzaparin), leaving only enoxaparin as an unrestricted prescription LMWH. Accordingly, the aim of this study was to evaluate the effect on in- and outpatient drug prescriptions of removing and restricting the use of several LMWHs in a hospital drugs formulary. METHODS: We used a natural, before-after, quasi-experimental design with a control group and monthly data from January 2011 to December 2016. Based on data drawn from official Public Health Service sources, the following dependent variables were extracted: defined daily doses (DDD) per 1000 inhabitants per day (DDD/TID), DDD per 100 stays per day, and expenditure per DDD. RESULTS: The two compounds that were removed from the formulary registered an immediate decrease at both an intra- and out-of-hospital level (66.6% and 55.6% for bemiparin and 73.0% and 92.2% for dalteparin, respectively); similarly, the compound that was restricted also registered an immediate decrease (36.1% and 9.0% at the in- and outpatient levels, respectively); in contrast, the remaining LMWH (enoxaparin) registered an immediate, significant increase at both levels (44.9% and 32.6%, respectively). The intervention led to an immediate reduction of 6.8% and a change in trend in out-of-hospital cost/DDD; it also avoided an expenditure of €477,317.1 in the 21 months following the intervention. CONCLUSIONS: The results indicate that changes made in a hospital drugs formulary towards more efficient medications may lead to better use of pharmacotherapeutic resources in its health catchment area.


Assuntos
Prescrições de Medicamentos/estatística & dados numéricos , Uso de Medicamentos/estatística & dados numéricos , Enoxaparina/uso terapêutico , Formulários de Hospitais como Assunto , Heparina de Baixo Peso Molecular/uso terapêutico , Análise de Séries Temporais Interrompida , Dalteparina/provisão & distribução , Enoxaparina/economia , Enoxaparina/provisão & distribução , Heparina de Baixo Peso Molecular/economia , Heparina de Baixo Peso Molecular/provisão & distribução , Humanos , Espanha , Tinzaparina/provisão & distribução
9.
Thromb Res ; 180: 37-42, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31200341

RESUMO

INTRODUCTION: While trials have demonstrated non-inferiority of direct oral anticoagulant drugs (DOAC) to low-molecular-weight heparins (LMWH) for the treatment of cancer associated thrombosis (CAT), it is unclear if the newer intervention is cost-effective. METHODS: We performed a cost-utility analysis using a Markov state-transition model over a time horizon of 60 months in a hypothetical cohort of 65-year-old patients with active malignancy and first acute symptomatic CAT who were eligible to receive either rivaroxaban/edoxaban or dalteparin. We obtained transition probability, relative risk, cost, and utility inputs from the literature. We estimated the differential impact on costs and quality-adjusted life years (QALYs) per patient and performed one-way and probabilistic sensitivity analyses to test the robustness of results. RESULTS: Using the base-case analysis over 60 months, DOAC versus dalteparin was associated with an incremental cost reduction of $24,129 with an incremental QALY reduction of 0.04. In the one-way sensitivity analysis, the cost of dalteparin contributed the most to the incremental cost difference; relative risk of death related to underlying cancer contributed the most of the incremental QALY difference. The probabilistic sensitivity analysis confirmed the base-case analysis, with a large reduction in cost but small reduction in QALYs. CONCLUSION: Rivaroxaban or edoxaban as compared to dalteparin is cost saving from a payer's perspective for the treatment of CAT. Professional organizations and healthcare systems may want to consider this analysis in future practice recommendations.


Assuntos
Anticoagulantes/uso terapêutico , Dalteparina/uso terapêutico , Inibidores do Fator Xa/uso terapêutico , Piridinas/uso terapêutico , Rivaroxabana/uso terapêutico , Tiazóis/uso terapêutico , Trombose/tratamento farmacológico , Anticoagulantes/economia , Análise Custo-Benefício , Dalteparina/economia , Inibidores do Fator Xa/economia , Humanos , Neoplasias/complicações , Piridinas/economia , Anos de Vida Ajustados por Qualidade de Vida , Rivaroxabana/economia , Tiazóis/economia , Trombose/complicações , Trombose/economia
10.
J Thromb Thrombolysis ; 48(3): 382-386, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31228036

RESUMO

Malignancy is a well-established risk factor for venous thromboembolism and while low-molecular-weight heparin therapy has been standard of care for cancer-associated thrombosis for many years, many patients find injection therapy burdensome. The direct oral anticoagulant edoxaban has been shown to be noninferior to dalteparin for the treatment of cancer-associated thrombosis. In a Markov simulation model, edoxaban with 6-month time horizon and a United States societal perspective with 2017 US dollars, edoxaban was the preferred strategy in the general cancer population (6-month cost $6061 with 0.34 quality adjusted life years) and in a subgroup of patients with gastrointestinal malignancy (6-month cost $7227 with 0.34 quality adjusted life years). The incremental cost effectiveness ratio of dalteparin compared to edoxaban was $1,873,535 in the general oncology population and $694,058 in the gastrointestinal malignancy population.


Assuntos
Análise Custo-Benefício , Dalteparina/uso terapêutico , Piridinas/uso terapêutico , Tiazóis/uso terapêutico , Trombose/tratamento farmacológico , Trombose/economia , Anticoagulantes/economia , Anticoagulantes/uso terapêutico , Dalteparina/economia , Neoplasias Gastrointestinais/tratamento farmacológico , Neoplasias Gastrointestinais/economia , Humanos , Cadeias de Markov , Modelos Teóricos , Neoplasias/complicações , Piridinas/economia , Anos de Vida Ajustados por Qualidade de Vida , Tiazóis/economia , Trombose/etiologia , Estados Unidos
11.
J Thromb Thrombolysis ; 47(4): 495-504, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-30859370

RESUMO

In patients with active cancer and acute venous thromboembolism (VTE), the low-molecular-weight-heparin (LMWH) dalteparin is more effective than vitamin K antagonist (VKA) in reducing the risk of recurrent venous thromboembolism (rVTE) without increasing the risk of bleeding. However, the relative benefit of LMWH versus VKA in patients with active cancer at high or low risk of rVTE and bleeding is unclear. This post hoc analysis used data from the CLOT study to explore the efficacy and safety of LMWH versus VKA in preventing recurrent thrombosis in high- and low-risk patients with active cancer. High-risk patients were defined by metastatic disease and/or antineoplastic treatment at baseline; low-risk patients presented with neither. Among high-risk patients, rVTE occurred in 25/318 (8%) (LMWH) versus 53/314 (17%) (VKA) (hazard ratio, 0.44; p = 0.001). No significant difference was detected in the rate of major or any bleeding. The 6-month mortality rate was 40% (LMWH) versus 41% (VKA). In low-risk patients, 2/20 (10%) (LMWH) had rVTE versus 0/24 (0%) (VKA) (hazard ratio, not estimable; p = 0.998). No significant difference was detected in the rate of major or any bleeding. The 6-month mortality rate was 20% (LMWH) versus 29% (VKA). In patients with cancer-associated thrombosis at high risk of rVTE and bleeding, the LMWH dalteparin was more effective than VKA in reducing the risk of rVTE without increasing the risk of bleeding. No difference in rate of rVTE or bleeding was observed between LMWH and VKA among low-risk patients.


Assuntos
Cumarínicos/administração & dosagem , Dalteparina/administração & dosagem , Neoplasias/tratamento farmacológico , Trombose/tratamento farmacológico , Tromboembolia Venosa/tratamento farmacológico , Idoso , Cumarínicos/efeitos adversos , Dalteparina/efeitos adversos , Intervalo Livre de Doença , Feminino , Hemorragia/induzido quimicamente , Hemorragia/mortalidade , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasias/mortalidade , Neoplasias/patologia , Taxa de Sobrevida , Trombose/mortalidade , Trombose/patologia , Tromboembolia Venosa/mortalidade , Tromboembolia Venosa/patologia
12.
J Med Chem ; 62(2): 1067-1073, 2019 01 24.
Artigo em Inglês | MEDLINE | ID: mdl-30608147

RESUMO

Heparin is a polypharmacological agent with anticoagulant activity. Periodate oxidation of the nonsulfated glucuronic acid residue results in non-anticoagulant heparin derivative (NACH) of reduced molecular weight. Similar treatment of a low molecular weight heparin, dalteparin, also removes its anticoagulant activity, affording a second heparin derivative (D-NACH). A full structural characterization of these two derivatives reveals their structural differences. SPR studies display their ability to bind to several important heparin-binding proteins, suggesting potential new therapeutic applications.


Assuntos
Heparina de Baixo Peso Molecular/química , Preparações Farmacêuticas/química , Animais , Anticoagulantes/química , Ligação Competitiva , Cromatografia Líquida de Alta Pressão , Dalteparina/química , Heparina de Baixo Peso Molecular/análise , Espectrometria de Massas , Oxirredução , Ácido Periódico/química , Ressonância de Plasmônio de Superfície , Suínos
13.
Palliat Med ; 33(5): 510-517, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30488789

RESUMO

BACKGROUND: Cancer patients have a four- to fivefold greater risk of thrombosis than the general population. Recommended treatment for cancer-associated thrombosis is 3-6 months of low-molecular-weight heparin. The 'select-d' trial is an open-label, randomised, multi-centre pilot trial in patients with cancer-associated thrombosis, utilising dalteparin (low-molecular-weight heparin) versus rivaroxaban (a direct oral anticoagulant), to assess effectiveness and safety. AIM: To explore patient and informal carers' experiences of cancer-associated thrombosis and their experience and understanding of the risk-benefit of thrombosis treatment. DESIGN: Qualitative substudy of the select-d trial, using semi-structured interviews. Interviews were audio-recorded and transcribed. Data were analysed using Framework Analysis. PARTICIPANTS: Participants were purposively sampled ( n = 37 patients; 46% male; age 40-89; 9 with carer present). RESULTS: Three themes were found: experience of cancer-associated thrombosis, experience of anticoagulation and risk-benefit balance of the two modes of administration. Some were shocked by their thrombosis diagnosis (most were unaware of their risk), but others found it insignificant compared with cancer. Most patients found tablets more convenient, but injections were acceptable in the context of having cancer. While most were happy to follow medical advice, others weighed preference on the basis of effectiveness. CONCLUSION: Lack of awareness of thrombosis risk is concerning; cancer patients must be informed to enable prompt help-seeking. Tablets could provide a welcome choice for patients if there is equivalent risk-benefit to injected anticoagulants. Patients trust their clinicians to tailor their treatment. Future research could explore the effect of routine information giving about the risk of thrombosis.


Assuntos
Anticoagulantes/administração & dosagem , Dalteparina/administração & dosagem , Inibidores do Fator Xa/administração & dosagem , Neoplasias/complicações , Satisfação do Paciente , Rivaroxabana/administração & dosagem , Trombose Venosa/prevenção & controle , Administração Oral , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Injeções , Masculino , Pessoa de Meia-Idade
14.
J Obstet Gynaecol ; 39(4): 439-450, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-30426808

RESUMO

A systematic review of studies published between 1 January 1985 and 31 August 2017 was performed to analyse the efficacy of the low-molecular-weight heparin, dalteparin, in venous thromboembolism (VTE) treatment and prophylaxis during pregnancy, and to evaluate dosing practices, anticoagulant monitoring and adverse events. A therapeutic dosing throughout pregnancy or followed by reduced doses effectively prevented VTE recurrence. Anti-factor Xa activity was the most commonly used method of dose monitoring. The risk of bleeding with dalteparin was generally minor. Major bleeding was observed when a high dose of dalteparin was employed during (or close to) delivery, or postpartum. Other adverse events were minor. Disparity exists in VTE treatment and thromboprophylaxis, with wide variety in the dosing regimens, treatment strategies and monitoring practices employed. Large randomised controlled trials are warranted but due to ethical reasons, and the rarity of VTE-associated obstetric complications, case-control, registry and large observational studies present more likely options.


Assuntos
Anticoagulantes/efeitos adversos , Dalteparina/efeitos adversos , Hemorragia Pós-Parto/induzido quimicamente , Complicações Cardiovasculares na Gravidez/tratamento farmacológico , Tromboembolia Venosa/tratamento farmacológico , Adulto , Feminino , Humanos , Gravidez , Resultado do Tratamento
15.
J Cancer Res Ther ; 14(Supplement): S985-S992, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30539834

RESUMO

Purpose: To investigate the effects of dalteparin sodium on the expression of vascular endothelial growth factor (VEGF), VEGF receptor (VEGFR), and hypoxia-inducible factor 1α (HIF-1α) in A549 human lung cancer (LC) cell line and a human A549-grafted nude mouse model. Materials and Methods: A549 human lung adenocarcinoma cell line was divided into control group, treated using normal saline (NS); and dalteparin sodium groups, receiving 5, 15, 50, and 150 IU/ml of dalteparin sodium, respectively. Human A549-grafted nude mouse was induced through subcutaneous (SC) injection of A549 (5 × 106/0.2 ml) into the right armpit, and randomly assigned into control group (n = 6) receiving intraperitoneal (i.p.) injection of NS, cisplatin (DDP) group (n = 6, 3 mg/kg DDP alone, i.p., for 3 days), low molecular weight heparin (LMWH) group (n = 6) receiving SC injection of 1500 IU/kg dalteparin sodium for 35 days, and DDP plus LMWH group (n = 6, 3 mg/kg DDP, i.p., for 3 days, followed by SC injection of 1500 IU/kg dalteparin sodium for 35 days). Results: Significant difference was noted in the messenger RNA expression of VEGF, VEGFR, and HIF-1α after treating with heparin with a concentration of 15, 50, or 150 IU/ml in the A549 cell line at 24 and 48 h, respectively. In the human A549-grafted nude mouse model, a significant reduction was noted in the expression of VEGF, VEGFR, and HIF-1α in the tumor mass harvested from the mice receiving administration of dalteparin sodium plus DDP. Conclusion: Dalteparin sodium had the inhibitory effects on the growth of human LC A549 cells in vitro and A549 LC xenograft model, which could be enhanced when administrated together with DDP.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/farmacologia , Proliferação de Células/efeitos dos fármacos , Dalteparina/farmacologia , Neoplasias Pulmonares/tratamento farmacológico , Neovascularização Patológica/tratamento farmacológico , Células A549 , Animais , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Cisplatino/farmacologia , Cisplatino/uso terapêutico , Dalteparina/uso terapêutico , Sinergismo Farmacológico , Feminino , Humanos , Neoplasias Pulmonares/irrigação sanguínea , Neoplasias Pulmonares/patologia , Camundongos , Camundongos Endogâmicos BALB C , Camundongos Nus , Neovascularização Patológica/patologia , Receptores de Fatores de Crescimento do Endotélio Vascular/metabolismo , Resultado do Tratamento , Fator A de Crescimento do Endotélio Vascular/metabolismo , Ensaios Antitumorais Modelo de Xenoenxerto
16.
J Plast Surg Hand Surg ; 52(6): 375-381, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30442053

RESUMO

UVB exposure penetrates deeply into the dermis to alter skin barrier function, which is a primary factor in skin photoaging. We previously reported that dalteparin and protamine nanoparticles (D/P NPs) are effective carriers of FGF-2. This study aimed to examine the ability of FGF-2-containing D/P NPs (FGF-2&D/P NPs) to ameliorate UVB-induced skin photoaging in hairless mice. Dorsal skin of HR-1 hairless mice were exposed to UVB irradiation 5 days/week for 8 weeks (UV (+): final total, 2700 mJ/cm2). Mice were divided into four groups: Non-UVB (UV (-)) + saline, UV (+) + saline, UV (+) + FGF-2&D/P NPs, UV (+) + FGF-2, and UV (+) + D/P NPs, and following UVB irradiation, FGF-2&D/P NPs, FGF-2, and D/P NPs were applied to the groups of mice just after each UVB irradiation. Each group was subjected to evaluation of skin changes (elasticity), and histological examination using hematoxylin & eosin and terminal deoxynucleotidyl transferase-mediated dUTP nick-end labeling (TUNEL) staining. UVB irradiation of mice significantly induced a decline in elasticity and acanthosis, which was alleviated by application of FGF-2&D/P NPs. Furthermore, TUNEL-staining showed the proportions of apoptotic dermal fibroblast cells (DFCs) and epidermal keratinocyte cells (EKCs) in the UV (+) + FGF-2&D/P NPs group were significantly lower than those in the UV (+) + saline, UV (+) + FGF-2, and UV (+) + D/P NPs groups. Thus, FGF-2&D/P NPs may be effective in preventing skin photoaging accelerated by UVB irradiation such as declining elasticity, acanthosis, and apoptosis of DFCs and EKCs.


Assuntos
Dalteparina/farmacologia , Fator 2 de Crescimento de Fibroblastos/farmacologia , Nanopartículas , Protaminas/farmacologia , Envelhecimento da Pele/efeitos dos fármacos , Raios Ultravioleta/efeitos adversos , Animais , Apoptose/efeitos dos fármacos , Elasticidade/efeitos dos fármacos , Fibroblastos/metabolismo , Fibroblastos/patologia , Queratinócitos/metabolismo , Queratinócitos/patologia , Camundongos Pelados , Envelhecimento da Pele/efeitos da radiação
17.
Thromb Haemost ; 118(12): 2152-2161, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30453352

RESUMO

Most international guidelines recommend pharmacological thromboprophylaxis after total hip and knee arthroplasty (THA/TKA) for 10 to 35 days. However, a recent cohort study on fast-track THA and TKA questioned the need for prolonged thromboprophylaxis when length of stay (LOS) is ≤ 5 days. We aimed at re-investigating the incidence of venous thromboembolism (VTE) in fast-track THA and TKA with in-hospital only thromboprophylaxis when LOS was ≤ 5 days. Prospective cohort study from 1 December 2011 to 30 October 2015 on elective unilateral THA/TKA with in-hospital only thromboprophylaxis if LOS was ≤ 5 days. Prospective information on co-morbidity and complete 90-day follow-up through the Danish National Patient Registry and medical records. Patients with pre-operative use of anticoagulants were excluded. In per protocol analysis, 17,582 (95.5%) had LOS of ≤ 5 days (median, 2 [interquartile range, 2-3]) and in-hospital thromboprophylaxis only. Incidence of symptomatic VTE was 0.40%, consisting of 28 (0.16%) pulmonary embolisms (PEs), 38 (0.22%) deep vein thrombosis (DVT) and 4 (0.02%) combined DVT and PE. Two PEs (0.01%) were fatal. VTE-associated risk factors with in-hospital only thromboprophylaxis were age > 85 years, odds ratio (OR) of 3.74 (95% confidence interval: 1.15-12.14, p = 0.028), body mass index (BMI) of 35 to 40, OR of 2.55 (1.02-6.35, p = 0.045) and BMI > 40, OR of 3.28 (1.02-10.56, p = 0.046). In conclusion, 90-day incidence of VTE after fast-track THA and TKA with in-hospital thromboprophylaxis only was 0.40%. Prolonged thromboprophylaxis may be reserved for LOS > 5 days or specific high-risk patients, but requires further studies regarding optimal type and duration of thromboprophylaxis.


Assuntos
Anticoagulantes/uso terapêutico , Artroplastia de Quadril , Artroplastia do Joelho , Complicações Pós-Operatórias/epidemiologia , Tromboembolia Venosa/epidemiologia , Idoso , Dalteparina/uso terapêutico , Dinamarca/epidemiologia , Enoxaparina/uso terapêutico , Seguimentos , Hospitais , Humanos , Incidência , Pessoa de Meia-Idade , Complicações Pós-Operatórias/mortalidade , Complicações Pós-Operatórias/prevenção & controle , Estudos Prospectivos , Risco , Rivaroxabana/uso terapêutico , Análise de Sobrevida , Tromboembolia Venosa/etiologia , Tromboembolia Venosa/mortalidade , Tromboembolia Venosa/prevenção & controle
18.
G Ital Cardiol (Rome) ; 19(9 Suppl 1): 7S-12S, 2018 09.
Artigo em Italiano | MEDLINE | ID: mdl-30284557

RESUMO

Most clinical practice guidelines recommend low molecular weight heparin for the treatment of venous thromboembolism (VTE) in cancer patients. In the Hokusai VTE Cancer study, 1050 patients with cancer and acute VTE were randomized to oral edoxaban or subcutaneous dalteparin for at least 6 months and up to 12 months. Edoxaban was non-inferior to dalteparin with respect to the composite outcome of recurrent VTE and major bleeding. The rate of recurrent VTE was numerically lower, but the rate of major bleeding was significantly higher with edoxaban. The frequency of severe major bleeding was similar with edoxaban and dalteparin. The difference in major bleeding was mainly driven by a higher rate of upper gastrointestinal bleeding with edoxaban, especially in patients with gastrointestinal cancer. The pilot Select-D study randomized 406 patients with cancer and VTE to rivaroxaban or dalteparin for 6 months. Recurrent VTE was reduced, while both major and clinically relevant non major bleeding were significantly increased with rivaroxaban. Bleeding mostly involved the gastrointestinal tract and occurred in patients with gastroesophageal cancer. While waiting for ongoing studies on direct oral anticoagulants, the results of the Hokusai VTE Cancer suggest that edoxaban may represent a valuable alternative to low molecular weight heparin for the treatment of cancer-associated VTE. In patients with gastrointestinal cancer, the use of edoxaban requires careful benefit-risk weighting, taking into consideration patient's preferences.


Assuntos
Anticoagulantes/administração & dosagem , Hemorragia/induzido quimicamente , Neoplasias/complicações , Tromboembolia Venosa/tratamento farmacológico , Anticoagulantes/efeitos adversos , Dalteparina/administração & dosagem , Dalteparina/efeitos adversos , Hemorragia/epidemiologia , Heparina de Baixo Peso Molecular/administração & dosagem , Heparina de Baixo Peso Molecular/efeitos adversos , Humanos , Guias de Prática Clínica como Assunto , Piridinas/administração & dosagem , Piridinas/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Rivaroxabana/administração & dosagem , Rivaroxabana/efeitos adversos , Tiazóis/administração & dosagem , Tiazóis/efeitos adversos , Tromboembolia Venosa/etiologia
19.
Pediatr Nephrol ; 33(12): 2337-2341, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30173320

RESUMO

BACKGROUND: The aim of this study was to investigate whether dalteparin is a safe and effective anticoagulant for paediatric home haemodialysis (HD) and to assess the determinants of dosing. METHODS: Data were collected for all children (< 18 years) undergoing home HD from 2011 to 2017 at one large paediatric nephrology centre in the UK. All children had anticoagulation with dalteparin sodium according to a standardised protocol. Dalteparin safety was assessed by monitoring for accumulation, adequate clearance of dalteparin and adverse events. Dalteparin efficacy was assessed through monitoring for clot formation in dialysis circuits. Potential determinants of dalteparin dosing were assessed. RESULTS: Eighteen children were included, their median age at start was 12 years, and 50% were male. Eighty-three percent of children had four home HD sessions each week, with a median total dialysis hours of 20 h/week. Thirty-three percent of children had nocturnal home HD. Median dalteparin dose at 12-month follow-up was 40 IU/kg (range 8-142 IU/kg). Factors associated with higher dalteparin dosing requirements included a younger age of the child (p < 0.01), a lower blood flow rate (p < 0.01) and the use of a central venous line for dialysis access (p = 0.038). No children had evidence of bioaccumulation of dalteparin or inadequate clearance. No significant bleeding or adverse events were reported. CONCLUSIONS: Dalteparin is a safe and effective anticoagulant when used for paediatric home HD. In this study, there was no evidence of bioaccumulation or significant adverse events. Further research is required to directly compare dalteparin with unfractionated heparin (UFH) and evaluate anticoagulant choice for paediatric home HD.


Assuntos
Anticoagulantes/administração & dosagem , Dalteparina/administração & dosagem , Hemodiálise no Domicílio/efeitos adversos , Falência Renal Crônica/terapia , Trombose/prevenção & controle , Adolescente , Fatores Etários , Coagulação Sanguínea/efeitos dos fármacos , Criança , Pré-Escolar , Dalteparina/efeitos adversos , Relação Dose-Resposta a Droga , Feminino , Seguimentos , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Humanos , Masculino , Estudos Retrospectivos , Reino Unido
20.
Medicine (Baltimore) ; 97(32): e11810, 2018 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30095650

RESUMO

RATIONALE: Treprostinil, a potent vasodilator, is the treatment of choice for severe pulmonary arterial hypertension (PAH) during pregnancy. Its inhibition of platelet aggregation increases the risk of hemorrhage. In addition, anticoagulation therapy is widely used in pregnancy with PAH due to the hypercoagulable state. However, very little is known about the complications of anticoagulants' use in pregnancy with PAH. PATIENT CONCERNS: A 27-year-old pregnant woman was admitted to the hospital at 32weeks with progressive dyspnea. DIAGNOSES: The pregnant was diagnosed with ventricular septal defect 12 years prior to presentation. Combining clinical manifestation with results of right heart catheterization (RHC) and echocardiography, it was consistent with severe World Health Organization (WHO) group I PAH. INTERVENTIONS: Supportive treatment included supplemental oxygen, intravenous treprostinil, sildenafil and prophylactic anticoagulation. OUTCOMES: Gastrointestinal bleeding is occurred in our patient when dalteparin were used in conjunction with treprostinil. Her care was further complicated refractory to usual conservative measures before delivery. LESSONS: This case report illustrates the complexities that arise when prostacyclin therapies are combined with necessary anticoagulation in patients with PAH during pregnancy. More intention should play to the complications of anticoagulant in pregnancy with PAH during treprostinil therapy.


Assuntos
Anticoagulantes/uso terapêutico , Fármacos Cardiovasculares/uso terapêutico , Dalteparina/uso terapêutico , Hipertensão Pulmonar/tratamento farmacológico , Complicações Cardiovasculares na Gravidez/tratamento farmacológico , Adulto , Anticoagulantes/administração & dosagem , Anticoagulantes/efeitos adversos , Anti-Hipertensivos/uso terapêutico , Fármacos Cardiovasculares/administração & dosagem , Fármacos Cardiovasculares/efeitos adversos , Dalteparina/administração & dosagem , Dalteparina/efeitos adversos , Epoprostenol/análogos & derivados , Epoprostenol/uso terapêutico , Feminino , Hemorragia Gastrointestinal/induzido quimicamente , Humanos , Gravidez , Citrato de Sildenafila/uso terapêutico , Vasodilatadores/uso terapêutico
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