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2.
J. vasc. bras ; 17(4)out.-dez. 2018. graf, tab
Artigo em Português | LILACS | ID: biblio-969128

RESUMO

A number of limitations of standard therapy with warfarin for deep vein thrombosis (DVT) have been established. This overview of systematic reviews presents the baseline results for efficacy and safety of the new direct oral anticoagulants (DOACs) thrombin inhibitors, and activated factor X (Xa) inhibitors in patients with DVT. Searches were run on PubMed and the Cochrane Database of Systematic Reviews. Twenty-three studies were retrieved, and one systematic review was judged eligible. This review scored maximum according to AMSTAR criteria and included 7,596 patients for analysis of thrombin inhibitors and 16,356 patients for analysis of factor Xa inhibitors. The results of the meta-analysis indicate that DOACs are similar for DVT treatment when compared to standard treatment with warfarin. The incidence of major bleeding is somewhat lower in patients treated with factor Xa inhibitors and similar to standard therapy when treated with direct thrombin inhibitors


A terapia padrão com varfarina para a trombose venosa profunda (TVP) tem uma série de limitações já estabelecidas. Essa revisão de revisões sistemáticas elenca os principais resultados de eficácia e segurança dos anticoagulantes orais diretos (DOACs), inibidores da trombina e do fator X ativado (Xa), em pacientes com TVP. A pesquisa foi realizada nas bases PubMed e Cochrane Database of Systematic Reviews. Foram recuperados 23 estudos, e uma revisão sistemática foi considerada elegível. Essa revisão atingiu escore máximo no AMSTAR e incluiu 7.596 pacientes para análise dos inibidores da trombina e 16.356 pacientes para a análise dos inibidores do fator Xa. Os resultados da metanálise indicam que os DOACs apresentam eficácia similar à terapia padrão no tratamento da TVP. A incidência de sangramento maior é um pouco menor nos pacientes tratados com os inibidores do fator Xa e similar à terapia padrão no tratamento com inibidores diretos da trombina


Assuntos
Humanos , Masculino , Feminino , Revisão , Trombose Venosa/terapia , Anticoagulantes/uso terapêutico , Varfarina/uso terapêutico , Heparina/uso terapêutico , Trombina , Fatores de Risco , Interações de Medicamentos , Tromboembolia Venosa/terapia , Inibidores do Fator Xa/uso terapêutico , Rivaroxabana/uso terapêutico , Dabigatrana/uso terapêutico , Hemorragia
3.
Cochrane Database Syst Rev ; 12: CD011782, 2017 12 02.
Artigo em Inglês | MEDLINE | ID: mdl-29199766

RESUMO

BACKGROUND: Standard treatment of deep vein thrombosis (DVT) is based on antithrombotic therapy, initially with parenteral administration of unfractionated heparin or low molecular weight heparins (LMWH) for five to seven days, then subsequent long-term therapy with oral vitamin K antagonists (e.g. warfarin). Pentasaccharides are novel anticoagulants that may be favourable over standard therapy due to their predictable effect, no need for frequent monitoring or re-dosing, and few known drug interactions. Heparin-induced thrombocytopenia, a harmful effect of heparins, appears to be rare during treatment with pentasaccharides. OBJECTIVES: To assess the efficacy and harms of pentasaccharides for the treatment of deep vein thrombosis. SEARCH METHODS: The Cochrane Vascular Information Specialist (CIS) searched the Specialised Register (22 March 2017) and the Cochrane Central Register of Controlled Trials (CENTRAL) (2017, Issue 2) (searched 22 March 2017). We searched clinical trials databases for details of ongoing or unpublished studies and the reference lists of relevant articles for additional citations. SELECTION CRITERIA: We included randomised controlled trials in which people 18 years of age or older with a DVT confirmed by standard imaging techniques were allocated to receive a pentasaccharide (fondaparinux, idraparinux, or idrabiotaparinux) for the treatment of DVT in comparison with standard therapy or other treatments. DATA COLLECTION AND ANALYSIS: We extracted data characterising the included trials according to the methods, participants, interventions, and outcomes. We assessed risk of bias using Cochrane's 'Risk of bias' tool and employed the GRADE methodology to evaluate the quality of the evidence.The main primary outcome for efficacy was recurrent venous thromboembolism (VTE), and the main primary outcome for harm was major and clinically relevant bleeding. Since our outcomes were dichotomous, we calculated the risk ratio (RR) with a 95% confidence interval (CI). We combined the effects of different comparisons through a meta-analysis using a fixed-effect model. MAIN RESULTS: We included five randomised controlled trials of 6981 participants comparing pentasaccharides with standard therapy or other pentasaccharides. The quality of the evidence varied depending on the outcome and was judged as of moderate to very low quality. We downgraded the quality of the evidence due to risk of bias or imprecision, or both.Two studies evaluated fondaparinux, at doses of 5.0 mg, 7.5 mg, and 10.0 mg, plus vitamin K antagonist in comparison with standard therapy. A meta-analysis of these two studies showed no clear difference in the risk of recurrent VTE (RR 0.80, 95% CI 0.43 to 1.47; 2658 participants); moderate-quality evidence. The frequencies of major bleeding were similar between interventions in the initial period of treatment (approximately five days) (RR 1.15, 95% CI 0.39 to 3.44; 2645 participants) and at three months' follow-up (RR 1.05, 95% CI 0.64 to 1.71; 2645 participants). We judged the quality of the evidence as moderate.One study (757 participants) compared idrabiotaparinux (3.0 mg) with idraparinux (2.5 mg) and demonstrated no clear difference in the risk of recurrent VTE at six months' follow-up (RR 0.72, 95% CI 0.31 to 1.69); low-quality evidence. Major bleeding during the initial treatment period was not reported. Major bleeding at six-month follow-up was less frequent in participants receiving idrabiotaparinux versus participants treated with idraparinux (RR 0.21, 95% CI 0.06 to 0.71); low-quality evidence.The effect of an initial treatment with LMWH followed by three months of idraparinux (10 mg) showed no clear difference from standard therapy for risk of recurrent VTE (RR 1.51, 95% CI 0.26 to 8.90; 263 participants); very low-quality evidence; one study. Major bleeding during the initial treatment period was not reported. The frequency of major and other clinically relevant bleeding at three months' follow-up ranged from 2% to 15% in participants receiving LMWH and increasing doses of idraparinux of 2.5 mg, 5 mg, 7.5 mg, or 10 mg. When dosage groups were combined, there was no clear difference in major plus other clinically relevant bleeding or in major bleeding alone between the idraparinux treatment group and the standard therapy group (RR 1.30, 95% CI 0.70 to 2.40; 659 participants; RR 3.76, 95% CI 0.50 to 28.19; 659 participants, respectively); very low-quality evidence.One study (2904 participants) compared idraparinux (2.5 mg) to standard therapy. There was no clear difference in the risk of recurrent VTE at three months' follow-up (RR 0.98, 95% CI 0.64 to 1.48); low-quality evidence. Major bleeding during the initial treatment period was not reported. Major bleeding at three months of follow-up appeared to be similar in the idraparinux group and the standard therapy group (RR 0.71, 95% CI 0.34 to 1.47); very low-quality evidence. AUTHORS' CONCLUSIONS: We found moderate-quality evidence that the effects of fondaparinux at doses of 5.0 mg, 7.5 mg, and 10.0 mg plus vitamin K antagonist are similar in terms of recurrent VTE and risk of major bleeding compared with standard treatment for DVT.Low-quality evidence suggests equal efficacy of idraparinux at 2.5 mg and the equimolar dose of 3.0 mg of idrabiotaparinux with regard to recurrent VTE, but a higher frequency of major bleeding was observed in participants treated with idraparinux.We judged evidence on the effectiveness of idraparinux compared with standard therapy, with or without initial treatment with LMWH, and on associated bleeding risk to be low to very low quality, therefore we have very limited confidence in the estimated effects.The observed similar effectiveness in terms of recurrent DVT and harmful effects in terms of bleeding risk with fondaparinux plus vitamin K antagonist compared to standard treatment for DVT suggest that it may be an alternative to conventional anticoagulants for the treatment of DVT in certain circumstances.


Assuntos
Anticoagulantes/uso terapêutico , Biotina/análogos & derivados , Oligossacarídeos/uso terapêutico , Polissacarídeos/uso terapêutico , Trombose Venosa/tratamento farmacológico , Anticoagulantes/administração & dosagem , Anticoagulantes/efeitos adversos , Biotina/administração & dosagem , Biotina/efeitos adversos , Biotina/uso terapêutico , Fondaparinux , Hemorragia/induzido quimicamente , Heparina de Baixo Peso Molecular/uso terapêutico , Humanos , Oligossacarídeos/administração & dosagem , Oligossacarídeos/efeitos adversos , Polissacarídeos/administração & dosagem , Polissacarídeos/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Recidiva , Fatores de Tempo
5.
Cochrane Database Syst Rev ; 4: CD007557, 2017 04 21.
Artigo em Inglês | MEDLINE | ID: mdl-28431186

RESUMO

BACKGROUND: Heparin-induced thrombocytopenia (HIT) is an adverse drug reaction presenting as a prothrombotic disorder related to antibody-mediated platelet activation. It is a paradoxical immune reaction resulting in thrombin generation in vivo, which leads to a hypercoagulable state and the potential to initiate venous or arterial thrombosis. A number of factors are thought to influence the incidence of HIT including the type and preparation of heparin (unfractionated heparin (UFH) or low molecular weight heparin (LMWH)) and the heparin-exposed patient population, with the postoperative patient population at higher risk.Although LMWH has largely replaced UFH as a front-line therapy, there is evidence supporting a lack of superiority of LMWH compared with UFH regarding prevention of deep vein thrombosis and pulmonary embolism following surgery, and similar frequencies of bleeding have been described with LMWH and UFH. The decision as to which of these two preparations of heparin to use may thus be influenced by harmful effects such as HIT. We therefore sought to determine the relative impact of UFH and LMWH on HIT in postoperative patients receiving thromboembolism prophylaxis. This is an update of a review first published in 2012. OBJECTIVES: The objective of this review was to compare the incidence of heparin-induced thrombocytopenia (HIT) and HIT complicated by venous thromboembolism in postoperative patients exposed to unfractionated heparin (UFH) versus low molecular weight heparin (LMWH). SEARCH METHODS: For this update, the Cochrane Vascular Information Specialist searched the Specialised Register (May 2016), CENTRAL (2016, Issue 4) and trials registries. The authors searched Lilacs (June 2016) and additional trials were sought from reference lists of relevant publications. SELECTION CRITERIA: We included randomised controlled trials (RCTs) in which participants were postoperative patients allocated to receive prophylaxis with UFH or LMWH, in a blinded or unblinded fashion. Studies were excluded if they did not use the accepted definition of HIT. This was defined as a relative reduction in the platelet count of 50% or greater from the postoperative peak (even if the platelet count at its lowest remained greater than 150 x 109/L) occurring within five to 14 days after the surgery, with or without a thrombotic event occurring in this timeframe. Additionally, we required circulating antibodies associated with the syndrome to have been investigated through laboratory assays. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed the risk of bias. Disagreements were resolved by consensus with participation of a third author. MAIN RESULTS: In this update, we included three trials involving 1398 postoperative participants. Participants were submitted to general surgical procedures, minor and major, and the minimum mean age was 49 years. Pooled analysis showed a significant reduction in the risk of HIT with LMWH compared with UFH (risk ratio (RR) 0.23, 95% confidence interval (CI) 0.07 to 0.73); low-quality evidence. The number needed to treat for an additional beneficial outcome (NNTB) was 59. The risk of HIT was consistently reduced comparing participants undergoing major surgical procedures exposed to LMWH or UFH (RR 0.22, 95% CI 0.06 to 0.75); low-quality evidence. The occurrence of HIT complicated by venous thromboembolism was significantly lower in participants receiving LMWH compared with UFH (RR 0.22, 95% CI 0.06 to 0.84); low-quality evidence. The NNTB was 75. Arterial thrombosis occurred in only one participant who received UFH. There were no amputations or deaths documented. Although limited evidence is available, it appears that HIT induced by both types of heparins is common in people undergoing major surgical procedures (incidence greater than 1% and less than 10%). AUTHORS' CONCLUSIONS: This updated review demonstrated low-quality evidence of a lower incidence of HIT, and HIT complicated by venous thromboembolism, in postoperative patients undergoing thromboprophylaxis with LMWH compared with UFH. Similarily, the risk of HIT in people undergoing major surgical procedures was lower when treated with LMWH compared to UFH (low-quality evidence). The quality of the evidence was downgraded due to concerns about the risk of bias in the included studies and imprecision of the study results. These findings may support current clinical use of LMWH over UFH as front-line heparin therapy. However, our conclusions are limited and there was an unexpected paucity of RCTs including HIT as an outcome. To address the scarcity of clinically-relevant information on HIT, HIT must be included as a core harmful outcome in future RCTs of heparin.


Assuntos
Anticoagulantes/administração & dosagem , Heparina de Baixo Peso Molecular/administração & dosagem , Heparina/administração & dosagem , Complicações Pós-Operatórias/prevenção & controle , Trombocitopenia/prevenção & controle , Trombose/prevenção & controle , Anticoagulantes/efeitos adversos , Heparina/efeitos adversos , Heparina de Baixo Peso Molecular/efeitos adversos , Humanos , Números Necessários para Tratar , Complicações Pós-Operatórias/induzido quimicamente , Ensaios Clínicos Controlados Aleatórios como Assunto , Procedimentos Cirúrgicos Operatórios/estatística & dados numéricos , Trombocitopenia/induzido quimicamente , Trombocitopenia/complicações , Trombose/etiologia , Trombose Venosa/etiologia , Trombose Venosa/prevenção & controle
6.
Twin Res Hum Genet ; 19(6): 687-691, 2016 12.
Artigo em Inglês | MEDLINE | ID: mdl-27852353

RESUMO

The Brazilian Twin Registry (BTR) was established in 2013 and has impelled twin research in South America. The main aim of the initiative was to create a resource that would be accessible to the Brazilian scientific community as well as international researchers interested in the investigation of the contribution of genetic and environmental factors in the development of common diseases, phenotypes, and human behavior traits. The BTR is a joint effort between academic and governmental institutions from Brazil and Australia. The collaboration includes the Federal University of Minas Gerais (UFMG) in Brazil, the University of Sydney and University of Melbourne in Australia, the Australian Twin Registry, as well as the research foundations CNPq and CAPES in Brazil. The BTR is a member of the International Network of Twin Registries. Recruitment strategies used to register twins have been through participation in a longitudinal study investigating genetic and environmental factors for low back pain occurrence, and from a variety of sources including media campaigns and social networking. Currently, 291 twins are registered in the BTR, with data on demographics, zygosity, anthropometrics, and health history having been collected from 151 twins using a standardized self-reported questionnaire. Future BTR plans include the registration of thousands of Brazilian twins identified from different sources and collaborate nationally and internationally with other research groups interested on twin studies.


Assuntos
Doenças em Gêmeos/epidemiologia , Sistema de Registros , Gêmeos Dizigóticos/genética , Gêmeos Monozigóticos/genética , Adulto , Austrália , Brasil , Doenças em Gêmeos/genética , Feminino , Humanos , Estudos Longitudinais , Masculino , Inquéritos e Questionários
8.
Eur Spine J ; 23(10): 2083-9, 2014 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-24619607

RESUMO

PURPOSE: To evaluate the association between domestic and recreational physical activity (PA) and low back pain (LBP) after adjusting for genetic and environmental influences. METHODS: Twins were recruited through the Australian twin registry. LBP prevalence and domestic (vigorous gardening/heavy yard work) and recreational (light walking, moderate/vigorous) PA were assessed by a validated questionnaire. Associations were analysed using a cross-sectional analysis of the complete sample of 486 twins, including a matched case-control analysis of 69 twin pairs discordant for LBP. Logistic regression and the lincom post-estimation method were used for the analysis. Odds ratios (OR) with 95 % confidence intervals (CIs) were calculated. RESULTS: The case-control analysis showed that LBP was significantly associated with heavy domestic PA (OR 2.88, 95 % CI 1.29-6.43), whereas no significant association was found with any form of recreational PA. The results of the lincom command indicated that being engaged in both heavy domestic and recreational PA (light walking or moderate/vigorous) was associated with a significantly increased probability of LBP compared with being engaged only in recreational PA (light walking or moderate/vigorous, ORs 3.48-4.22). Using the whole sample, we found weaker associations but in the same direction. CONCLUSIONS: We found evidence that heavy domestic PA is associated with an increased probability of LBP, and the combination of heavy domestic and recreational PA might increase the probability of LBP more so than heavy domestic or recreational PA alone. Associations being greater when using the co-twin case-control analysis indicate that genetic and environmental factors influence the relationship between PA and LBP, and demonstrate the value of a twin design.


Assuntos
Atividades de Lazer , Dor Lombar/epidemiologia , Dor Lombar/fisiopatologia , Atividade Motora/fisiologia , Adolescente , Adulto , Idoso , Austrália/epidemiologia , Estudos de Casos e Controles , Estudos Transversais , Feminino , Humanos , Modelos Logísticos , Dor Lombar/genética , Masculino , Pessoa de Meia-Idade , Razão de Chances , Prevalência , Sistema de Registros , Inquéritos e Questionários , Caminhada , Adulto Jovem
10.
Cochrane Database Syst Rev ; (9): CD007557, 2012 Sep 12.
Artigo em Inglês | MEDLINE | ID: mdl-22972111

RESUMO

BACKGROUND: Heparin-induced thrombocytopenia (HIT) is an adverse drug reaction presenting as a prothrombotic disorder related to antibody-mediated platelet activation. It is a poorly understood paradoxical immune reaction resulting in thrombin generation in vivo, which leads to a hypercoagulable state and the potential to initiate venous or arterial thrombosis. A number of factors are thought to influence the incidence of HIT including the type and preparation of heparin (unfractionated heparin (UFH) or low molecular weight heparin (LMWH)) and the heparin-exposed patient population, with the postoperative patient population presenting a higher risk.Although LMWH has largely replaced UFH as a front-line therapy, there is evidence supporting a lack of superiority of LMWH compared with UFH regarding prevention of deep vein thrombosis and pulmonary embolism following surgery, and similar frequencies of bleeding have been described with LMWH and UFH. The decision as to which of these two preparations of heparin to use may thus be influenced by adverse reactions such as HIT. We therefore sought to determine the relative impact of UFH and LMWH specifically on HIT in postoperative patients receiving thromboembolism prophylaxis. OBJECTIVES: The objective of this review was to compare the incidence of HIT and HIT complicated by thrombosis in patients exposed to UFH versus LMWH in randomised controlled trials (RCTs) of postoperative heparin therapy. SEARCH METHODS: The Cochrane Peripheral Vascular Diseases Group searched their Specialised Register (March 2012) and CENTRAL (2012, Issue 2). In addition, the authors searched LILACS (March 2012) and additional trials were sought from reference lists of relevant publications. SELECTION CRITERIA: We were interested in comparing the incidence of HIT occurring during exposure to UFH or LMWH after any surgical intervention. Therefore, we studied RCTs in which participants were postoperative patients allocated to receive UFH or LMWH, in a blinded or unblinded fashion. Eligible studies were required to have as an outcome clinically diagnosed HIT, defined as a relative reduction in the platelet count of 50% or greater from the postoperative peak (even if the platelet count at its lowest remained > 150 x 10(9)/L) occurring within five to 14 days after the surgery, with or without a thrombotic event occurring in this timeframe. Additionally, circulating antibodies associated with the syndrome were required to have been investigated through laboratory assays. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed the risk of bias. Disagreements were resolved by consensus with participation of a third author. MAIN RESULTS: In total two studies involving 923 participants met all the inclusion criteria and were included in the review. Pooled analysis showed a statistically significant reduction in the risk of HIT with LMWH compared with UFH (risk ratio (RR) 0.24, 95% confidence interval (CI) 0.07 to 0.82; P = 0.02). This result suggests that patients treated with LMWH would have a relative risk reduction (RRR) of 76% in the probability of developing HIT compared with patients treated with UFH.Venous thromboembolism (VTE) complicating HIT occurred in 12 of 17 patients who developed HIT. Pooled analysis showed a statistically significant reduction in HIT complicated by VTE with LMWH compared with UFH (RR 0.20, 95% CI 0.04 to 0.90; P = 0.04). This result indicates that patients using LMWH would have a RRR of 80% for developing HIT complicated by VTE compared with patients using UFH. Arterial thrombosis occurred in only one patient who received UFH and there were no amputations or deaths documented. AUTHORS' CONCLUSIONS: There was a lower incidence of HIT and HIT complicated by VTE in postoperative patients undergoing thromboprophylaxis with LMWH compared with UFH. This is consistent with the current clinical use of LMWH over UFH as front-line heparin therapy. However, conclusions are limited by a scarcity of high quality evidence. We did not expect the paucity of RCTs including HIT as an outcome as heparin is one of the most commonly used drugs worldwide and HIT is a life-threatening adverse drug reaction. To address the scarcity of clinically-relevant information on the topic of HIT as a whole, HIT should be included as an outcome in future RCTs of heparin, and HIT as an adverse drug reaction should be considered in clinical recommendations regarding monitoring of the platelet count for HIT.


Assuntos
Complicações Pós-Operatórias/prevenção & controle , Trombocitopenia/prevenção & controle , Trombose/prevenção & controle , Anticoagulantes/administração & dosagem , Anticoagulantes/efeitos adversos , Heparina/administração & dosagem , Heparina/efeitos adversos , Heparina de Baixo Peso Molecular/administração & dosagem , Heparina de Baixo Peso Molecular/efeitos adversos , Humanos , Complicações Pós-Operatórias/induzido quimicamente , Ensaios Clínicos Controlados Aleatórios como Assunto , Trombocitopenia/induzido quimicamente , Trombocitopenia/complicações , Trombose/etiologia , Trombose Venosa/etiologia , Trombose Venosa/prevenção & controle
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