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1.
Trials ; 20(1): 516, 2019 Aug 20.
Artigo em Inglês | MEDLINE | ID: mdl-31429793

RESUMO

Following publication of the original article [1], the authors notified us of a few requested editions that were not implemented adequately during proofing. The publisher apologizes for the inconvenience caused to our authors and readers.

2.
Trials ; 20(1): 431, 2019 Jul 15.
Artigo em Inglês | MEDLINE | ID: mdl-31307503

RESUMO

BACKGROUND: Either benznidazole (BZN) or nifurtimox (NFX) is recommended as equivalent to treat Trypanosoma cruzi infection. Nonetheless, supportive data from randomised trials is limited to individuals treated with BZN in southern cone countries of Latin America. METHODS: The goal of this randomised, concealed, blind, parallel-group trial is to inform the trypanocidal efficacy and safety of NFX and its equivalence to BZN among individuals with T. cruzi positive serology (TC+). Eligible individuals are TC+, 20-65 years old, with no apparent symptoms/signs or uncontrolled risk factors for cardiomyopathy and at negligible risk of re-infection. Consenting individuals (adherent to a 10-day placebo run-in phase) receive a 120-day BID blinded treatment with NFX, BZN or matching placebo (2:2:1 ratio). The four active medication arms include (1) a randomly allocated sequence of 60-day, conventional-dose (60CD) regimes (BZN 300 mg/day or NFX 480 mg/day, ratio 1:1), followed or preceded by a 60-day placebo treatment, or (2) 120-day half-dose (120HD) regimes (BZN 150 mg/day or NFX 240 mg/day, ratio 1:1). The primary efficacy outcome is the proportion of participants testing positive at least once for up to three polymerase chain reaction (PCR) assays (1 + PCR) 12-18 months after randomisation. A composite safety outcome includes moderate to severe adverse reactions, consistent blood marker abnormalities or treatment abandons. The trial outside Colombia (expected to recruit at least 60% of participants) is pragmatic; it may be open-label and not include all treatment groups, but it must adhere to the randomisation and data administration system and guarantee a blinded efficacy outcome evaluation. Our main comparisons include NFX groups with placebo (for superiority), NFX versus BZN groups and 60CD versus 120HD groups (for non-inferiority) and testing for the agent-dose and group-region interactions. Assuming a 1 + PCR ≥ 75% in the placebo group, up to 25% among BZN-treated and an absolute difference of up to ≥ 25% with NFX to claim its trypanocidal effect, 60-80 participants per group (at least 300 from Colombia) are needed to test our hypotheses (80-90% power; one-sided alpha level 1%). DISCUSSION: The EQUITY trial will inform the trypanocidal effect and equivalence of nitroderivative agents NFX and BZN, particularly outside southern cone countries. Its results may challenge current recommendations and inform choices for these agents. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02369978 . Registered on 24 February 2015.

3.
BMC Emerg Med ; 19(1): 27, 2019 04 17.
Artigo em Inglês | MEDLINE | ID: mdl-30995927

RESUMO

BACKGROUND: In low- and middle-income countries emergency surgery represents a higher proportion of the total number of surgeries and is associated with greater morbidity/mortality. Study aims were to determine if emergency department length of stay (ED-LOS) was associated with adverse perioperative outcomes and if such association varied across patient's risk categories. METHODS: A retrospective cohort study was conducted of adult patients who underwent orthopedic or abdominal emergency surgery at two Colombian University hospitals. The population comprised a mix of a representative sample of eligible cases, with unselected patients (2/3), enriched with a high-risk subset (1/3). ED-LOS was defined as the interval between emergency department arrival and surgery start time. Our primary outcome was an adverse perioperative outcome during hospitalization, which was a composite of in-hospital mortality or severe complications such as major cardiovascular adverse events, infection, renal failure and bleeding. RESULTS: Among 1487 patients analyzed, there were 519 adverse perioperative outcomes including 150 deaths. In the unselected sample (n = 998) 17.9% of patients presented an adverse perioperative outcome with a mortality of 4.9%. The median ED-LOS was 24.6 (IQR 12.5-53.2) hours. ED-LOS was associated with age, comorbidities and known risk factors for 30-day mortality. Patients developing an adverse perioperative outcome started surgery 27.1 h later than their counterparts. Prolonged ED-LOS increased the risk of an adverse perioperative outcome in patients without risk factors (covariate-adjusted OR = 2.52), while having 1-2 or 3+ risk factors was negatively associated (OR = 0.87 and 0.72, respectively, p < 0.001 for the interaction). CONCLUSION: Prolonged ED-LOS is associated with increased adverse perioperative outcome for patients without risk factors for mortality, but seems protective and medically justified for more complex cases.

4.
Cad Saude Publica ; 35(1): e00059218, 2019.
Artigo em Espanhol | MEDLINE | ID: mdl-30652812

RESUMO

This article seeks to describe the results of a participant recovery protocol in the CHICAMOCHA cohort after 12 years of follow-up and to identify factors associated with re-contact. In a prospective cohort study with 1,644 participants in Bucaramanga, Colombia (mean age 36 years; standard deviation = 8.5 years; 63% men), we implemented a participant recovery protocol that included 4 sequential strategies: (1) phone contact; (2) sending mail; (3) visiting the household; and (4) Publishing notices in the press local. Following steps 1-2, we attempted to update contact information through government databases in order to once again apply steps 1-2 for individuals who had not been contacted. We calculated crude and weighted rates of contact by participant recovery protocol strategy and overall return. We estimated the association between baseline participant characteristics and their state after participant recovery protocol through multiple logistical regression. We contacted 1,258 (76.4%) participants; 65% (n = 825) through phone contact. Weighted rates of contact were: 41% phone contact, 14.6% mail and 31% visits. Contact through newspaper ads was practically null. Age > 36 years (OR = 1.48); low socioeconomic stratum (OR = 1.42) or being a home owner at baseline (OR = 2.05) were associated with re-contact. Consistent with other descriptions, phone contact is the re-contacting strategy with greatest returns in longitudinal studies. Individuals with characteristics that increase geographical mobility may require shorter follow-up periods and additional contact strategies.


Assuntos
Pesquisa Biomédica/organização & administração , Seleção de Pacientes , Adulto , Doadores de Sangue , Estudos de Coortes , Colômbia , Feminino , Seguimentos , Humanos , Masculino
5.
Cad. Saúde Pública (Online) ; 35(1): e00059218, 2019. tab, graf
Artigo em Espanhol | LILACS-Express | ID: biblio-974619

RESUMO

Resumen: Este artículo describe los resultados de un protocolo de recuperación de participantes (PRP) en la cohorte CHICAMOCHA, tras 12 años desde el último seguimiento, e identificar factores asociados al re-contacto. En un estudio de cohorte prospectiva de 1.644 participantes en Bucaramanga, Colombia (edad media 36 años; desviación estándar = 8.5 años; 63% hombres), se implementó el PRP que incluyó 4 estrategias secuenciales: (1) contacto telefónico; (2) envío de correspondencia; (3) visita al domicilio; y (4) publicación de avisos de prensa. Luego de los pasos 1-2, se buscó refrescar la información de contacto en bases de datos gubernamentales para reaplicar paralelamente la secuencia 1-2 en no contactados. Se calcularon tasas de contacto crudas y ponderadas por estrategia del PRP y el rendimiento global. Se estimó la asociación entre las características de los participantes en línea de base y su estado después del PRP mediante regresión logística múltiple. Se contactaron 1.258 (76,4%) participantes; el 65% (n = 825) por contacto telefónico. Las tasas de contacto ponderadas fueron: 41% contacto telefónico, 14,6% correspondencia y 31% visitas. El contacto por avisos de prensa fue virtualmente nulo. Una edad > 36 años (OR = 1,48); estrato socioeconómico bajo (OR = 1,42) y ser propietario de vivienda en la línea de base (OR = 2,05) se asociaron al re-contacto. Consistente con otros reportes, el contacto telefónico es la estrategia de re-contacto con mayor rendimiento en estudios longitudinales. Los individuos con características que aumentan la movilidad geográfica podrían requerir de periodos de seguimiento más estrechos y estrategias de contacto adicionales.


Abstract: This article seeks to describe the results of a participant recovery protocol in the CHICAMOCHA cohort after 12 years of follow-up and to identify factors associated with re-contact. In a prospective cohort study with 1,644 participants in Bucaramanga, Colombia (mean age 36 years; standard deviation = 8.5 years; 63% men), we implemented a participant recovery protocol that included 4 sequential strategies: (1) phone contact; (2) sending mail; (3) visiting the household; and (4) Publishing notices in the press local. Following steps 1-2, we attempted to update contact information through government databases in order to once again apply steps 1-2 for individuals who had not been contacted. We calculated crude and weighted rates of contact by participant recovery protocol strategy and overall return. We estimated the association between baseline participant characteristics and their state after participant recovery protocol through multiple logistical regression. We contacted 1,258 (76.4%) participants; 65% (n = 825) through phone contact. Weighted rates of contact were: 41% phone contact, 14.6% mail and 31% visits. Contact through newspaper ads was practically null. Age > 36 years (OR = 1.48); low socioeconomic stratum (OR = 1.42) or being a home owner at baseline (OR = 2.05) were associated with re-contact. Consistent with other descriptions, phone contact is the re-contacting strategy with greatest returns in longitudinal studies. Individuals with characteristics that increase geographical mobility may require shorter follow-up periods and additional contact strategies.


Resumo: Este artigo trata de descrever os resultados de um protocolo de recuperação dos participantes na coorte CHICAMOCHA, após 12 anos sem acompanhamento, e identificar fatores associados ao re-contato. Em um estudo de coorte prospectiva com 1.644 participantes em Bucaramanga, Colômbia (idade media 36 anos; desvio padrão = 8.5 anos; 63% homens), foi implementado protocolo de recuperação dos participantes que incluiu quatro estratégias sequenciais: (1) contato telefônico; (2) envio de correspondência; (3) visita ao domicílio; e (4) publicação de avisos na imprensa. Depois dos passos 1-2, tentou-se refrescar a informação de contato em bases de dados governamentais para voltar a aplicar paralelamente a sequência 1-2 nas pessoas que não foram contatadas. Foram calculadas as taxas de contacto brutas e ponderadas por estratégia do protocolo de recuperação dos participantes e o rendimento global. Foi estimada a associação entre as características dos participantes na linha de base e o seu estado depois do protocolo de recuperação dos participantes por meio de regressão logística múltipla. Foram contatados 1.258 (76,4%) participantes; o 65% (n = 825) através de contacto telefônico. As taxas de contato ponderadas foram: 41% contato telefônico, 14,6% correspondência e 31% visitas. O contato através de avisos no jornal foi virtualmente nulo. Uma idade > 36 anos (OR = 1,48); estrato socioeconômico baixo (OR = 1,42) ou ser proprietário de casa na linha de base (OR = 2,05) foram associados ao re-contato. Consistente com outras descrições, o contato telefônico é a estratégia do re-contato com maior rendimento em estudos longitudinais. Os indivíduos com características que aumentam a mobilidade geográfica poderiam precisar de períodos de acompanhamento mais estreitos e estratégias de contacto adicionais.

6.
Lancet ; 391(10137): 2325-2334, 2018 06 09.
Artigo em Inglês | MEDLINE | ID: mdl-29900874

RESUMO

BACKGROUND: Myocardial injury after non-cardiac surgery (MINS) increases the risk of cardiovascular events and deaths, which anticoagulation therapy could prevent. Dabigatran prevents perioperative venous thromboembolism, but whether this drug can prevent a broader range of vascular complications in patients with MINS is unknown. The MANAGE trial assessed the potential of dabigatran to prevent major vascular complications among such patients. METHODS: In this international, randomised, placebo-controlled trial, we recruited patients from 84 hospitals in 19 countries. Eligible patients were aged at least 45 years, had undergone non-cardiac surgery, and were within 35 days of MINS. Patients were randomly assigned (1:1) to receive dabigatran 110 mg orally twice daily or matched placebo for a maximum of 2 years or until termination of the trial and, using a partial 2-by-2 factorial design, patients not taking a proton-pump inhibitor were also randomly assigned (1:1) to omeprazole 20 mg once daily, for which results will be reported elsewhere, or matched placebo to measure its effect on major upper gastrointestinal complications. Research personnel randomised patients through a central 24 h computerised randomisation system using block randomisation, stratified by centre. Patients, health-care providers, data collectors, and outcome adjudicators were masked to treatment allocation. The primary efficacy outcome was the occurrence of a major vascular complication, a composite of vascular mortality and non-fatal myocardial infarction, non-haemorrhagic stroke, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism. The primary safety outcome was a composite of life-threatening, major, and critical organ bleeding. Analyses were done according to the intention-to-treat principle. This trial is registered with ClinicalTrials.gov, number NCT01661101. FINDINGS: Between Jan 10, 2013, and July 17, 2017, we randomly assigned 1754 patients to receive dabigatran (n=877) or placebo (n=877); 556 patients were also randomised in the omeprazole partial factorial component. Study drug was permanently discontinued in 401 (46%) of 877 patients allocated to dabigatran and 380 (43%) of 877 patients allocated to placebo. The composite primary efficacy outcome occurred in fewer patients randomised to dabigatran than placebo (97 [11%] of 877 patients assigned to dabigatran vs 133 [15%] of 877 patients assigned to placebo; hazard ratio [HR] 0·72, 95% CI 0·55-0·93; p=0·0115). The primary safety composite outcome occurred in 29 patients (3%) randomised to dabigatran and 31 patients (4%) randomised to placebo (HR 0·92, 95% CI 0·55-1·53; p=0·76). INTERPRETATION: Among patients who had MINS, dabigatran 110 mg twice daily lowered the risk of major vascular complications, with no significant increase in major bleeding. Patients with MINS have a poor prognosis; dabigatran 110 mg twice daily has the potential to help many of the 8 million adults globally who have MINS to reduce their risk of a major vascular complication [corrected]. FUNDING: Boehringer Ingelheim and Canadian Institutes of Health Research.


Assuntos
Dabigatrana/farmacologia , Hemorragia/complicações , Infarto do Miocárdio/tratamento farmacológico , Doença Arterial Periférica/complicações , Acidente Vascular Cerebral/complicações , Tromboembolia Venosa/tratamento farmacológico , Idoso , Idoso de 80 Anos ou mais , Antitrombinas/farmacologia , Dabigatrana/administração & dosagem , Dabigatrana/efeitos adversos , Feminino , Hemorragia/tratamento farmacológico , Hemorragia/prevenção & controle , Humanos , Masculino , Infarto do Miocárdio/epidemiologia , Infarto do Miocárdio/mortalidade , Omeprazol/administração & dosagem , Omeprazol/uso terapêutico , Período Perioperatório/mortalidade , Doença Arterial Periférica/tratamento farmacológico , Doença Arterial Periférica/prevenção & controle , Efeito Placebo , Inibidores da Bomba de Prótons/uso terapêutico , Acidente Vascular Cerebral/tratamento farmacológico , Acidente Vascular Cerebral/prevenção & controle , Trombose/patologia , Resultado do Tratamento , Troponina/efeitos dos fármacos , Troponina/metabolismo , Tromboembolia Venosa/prevenção & controle
7.
Can J Surg ; 61(3): 185-194, 2018 06.
Artigo em Inglês | MEDLINE | ID: mdl-29806816

RESUMO

BACKGROUND: Myocardial injury after noncardiac surgery (MINS) is a mostly asymptomatic condition that is strongly associated with 30-day mortality; however, it remains mostly undetected without systematic troponin T monitoring. We evaluated the cost and consequences of postoperative troponin T monitoring to detect MINS. METHODS: We conducted a model-based cost-consequence analysis to compare the impact of routine troponin T monitoring versus standard care (troponin T measurement triggered by ischemic symptoms) on the incidence of MINS detection. Model inputs were based on Canadian patients enrolled in the Vascular Events in Noncardiac Surgery Patients Cohort Evaluation (VISION) study, which enrolled patients aged 45 years or older undergoing inpatient noncardiac surgery. We conducted probability analyses with 10 000 iterations and extensive sensitivity analyses. RESULTS: The data were based on 6021 patients (48% men, mean age 65 [standard deviation 12] yr). The 30-day mortality rate for MINS was 9.6%. We determined the incremental cost to avoid missing a MINS event as $1632 (2015 Canadian dollars). The cost-effectiveness of troponin monitoring was higher in patient subgroups at higher risk for MINS, e.g., those aged 65 years or more, or with a history of atherosclerosis or diabetes ($1309). CONCLUSION: The costs associated with a troponin T monitoring program to detect MINS were moderate. Based on the estimated incremental cost per health gain, implementation of postoperative troponin T monitoring seems appealing, particularly in patients at high risk for MINS.

8.
Can J Cardiol ; 34(3): 295-302, 2018 03.
Artigo em Inglês | MEDLINE | ID: mdl-29398173

RESUMO

BACKGROUND: Worldwide approximately 200 million adults undergo major surgery annually, of whom 8 million are estimated to suffer a myocardial injury after noncardiac surgery (MINS). There is currently no trial data informing the management of MINS. Antithrombotic agents such as direct oral anticoagulants might prevent major vascular complications in patients with MINS. METHODS: The Management of Myocardial Injury After Noncardiac Surgery (MANAGE) trial is a large international blinded randomized controlled trial of dabigatran vs placebo in patients who suffered MINS. We used a partial factorial design to also determine the effect of omeprazole vs placebo in reducing upper gastrointestinal bleeding and complications. Both study drugs were initiated in eligible patients within 35 days of suffering MINS and continued for a maximum of 2 years. The primary outcome is a composite of major vascular complications for the dabigatran trial and a composite of upper gastrointestinal complications for the omeprazole trial. We present the rationale and design of the trial and baseline characteristics of enrolled patients. RESULTS: The trial randomized 1754 patients between January 2013 and July 2017. Patients' mean age was 69.9 years, 51.1% were male, 14.3% had a history of peripheral artery disease, 6.6% had a history of stroke or transient ischemic attack, 12.9% had a previous myocardial infarction, and 26.0% had diabetes. The diagnosis of MINS was on the basis of an isolated ischemic troponin elevation in 80.4% of participants. CONCLUSION: MANAGE is the first randomized controlled trial to evaluate a potential treatment of patients who suffered MINS.


Assuntos
Causas de Morte , Dabigatrana/uso terapêutico , Infarto do Miocárdio/tratamento farmacológico , Infarto do Miocárdio/etiologia , Omeprazol/uso terapêutico , Complicações Pós-Operatórias/epidemiologia , Procedimentos Cirúrgicos Operatórios/efeitos adversos , Idoso , Método Duplo-Cego , Feminino , Seguimentos , Humanos , Internacionalidade , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/mortalidade , Complicações Pós-Operatórias/prevenção & controle , Modelos de Riscos Proporcionais , Medição de Risco , Procedimentos Cirúrgicos Operatórios/métodos , Análise de Sobrevida , Resultado do Tratamento
9.
Ann Intern Med ; 168(4): 237-244, 2018 Feb 20.
Artigo em Inglês | MEDLINE | ID: mdl-29132159

RESUMO

Background: Uncertainty remains about the effects of aspirin in patients with prior percutaneous coronary intervention (PCI) having noncardiac surgery. Objective: To evaluate benefits and harms of perioperative aspirin in patients with prior PCI. Design: Nonprespecified subgroup analysis of a multicenter factorial trial. Computerized Internet randomization was done between 2010 and 2013. Patients, clinicians, data collectors, and outcome adjudicators were blinded to treatment assignment. (ClinicalTrials.gov: NCT01082874). Setting: 135 centers in 23 countries. Patients: Adults aged 45 years or older who had or were at risk for atherosclerotic disease and were having noncardiac surgery. Exclusions were placement of a bare-metal stent within 6 weeks, placement of a drug-eluting stent within 1 year, or receipt of nonstudy aspirin within 72 hours before surgery. Intervention: Aspirin therapy (overall trial, n = 4998; subgroup, n = 234) or placebo (overall trial, n = 5012; subgroup, n = 236) initiated within 4 hours before surgery and continued throughout the perioperative period. Of the 470 subgroup patients, 99.9% completed follow-up. Measurements: The 30-day primary outcome was death or nonfatal myocardial infarction; bleeding was a secondary outcome. Results: In patients with prior PCI, aspirin reduced the risk for the primary outcome (absolute risk reduction, 5.5% [95% CI, 0.4% to 10.5%]; hazard ratio [HR], 0.50 [CI, 0.26 to 0.95]; P for interaction = 0.036) and for myocardial infarction (absolute risk reduction, 5.9% [CI, 1.0% to 10.8%]; HR, 0.44 [CI, 0.22 to 0.87]; P for interaction = 0.021). The effect on the composite of major and life-threatening bleeding in patients with prior PCI was uncertain (absolute risk increase, 1.3% [CI, -2.6% to 5.2%]). In the overall population, aspirin increased the risk for major bleeding (absolute risk increase, 0.8% [CI, 0.1% to 1.6%]; HR, 1.22 [CI, 1.01 to 1.48]; P for interaction = 0.50). Limitation: Nonprespecified subgroup analysis with small sample. Conclusion: Perioperative aspirin may be more likely to benefit rather than harm patients with prior PCI. Primary Funding Source: Canadian Institutes of Health Research.

10.
JAMA ; 317(16): 1642-1651, 2017 Apr 25.
Artigo em Inglês | MEDLINE | ID: mdl-28444280

RESUMO

Importance: Little is known about the relationship between perioperative high-sensitivity troponin T (hsTnT) measurements and 30-day mortality and myocardial injury after noncardiac surgery (MINS). Objective: To determine the association between perioperative hsTnT measurements and 30-day mortality and potential diagnostic criteria for MINS (ie, myocardial injury due to ischemia associated with 30-day mortality). Design, Setting, and Participants: Prospective cohort study of patients aged 45 years or older who underwent inpatient noncardiac surgery and had a postoperative hsTnT measurement. Starting in October 2008, participants were recruited at 23 centers in 13 countries; follow-up finished in December 2013. Exposures: Patients had hsTnT measurements 6 to 12 hours after surgery and daily for 3 days; 40.4% had a preoperative hsTnT measurement. Main Outcomes and Measures: A modified Mazumdar approach (an iterative process) was used to determine if there were hsTnT thresholds associated with risk of death and had an adjusted hazard ratio (HR) of 3.0 or higher and a risk of 30-day mortality of 3% or higher. To determine potential diagnostic criteria for MINS, regression analyses ascertained if postoperative hsTnT elevations required an ischemic feature (eg, ischemic symptom or electrocardiography finding) to be associated with 30-day mortality. Results: Among 21 842 participants, the mean age was 63.1 (SD, 10.7) years and 49.1% were female. Death within 30 days after surgery occurred in 266 patients (1.2%; 95% CI, 1.1%-1.4%). Multivariable analysis demonstrated that compared with the reference group (peak hsTnT <5 ng/L), peak postoperative hsTnT levels of 20 to less than 65 ng/L, 65 to less than 1000 ng/L, and 1000 ng/L or higher had 30-day mortality rates of 3.0% (123/4049; 95% CI, 2.6%-3.6%), 9.1% (102/1118; 95% CI, 7.6%-11.0%), and 29.6% (16/54; 95% CI, 19.1%-42.8%), with corresponding adjusted HRs of 23.63 (95% CI, 10.32-54.09), 70.34 (95% CI, 30.60-161.71), and 227.01 (95% CI, 87.35-589.92), respectively. An absolute hsTnT change of 5 ng/L or higher was associated with an increased risk of 30-day mortality (adjusted HR, 4.69; 95% CI, 3.52-6.25). An elevated postoperative hsTnT (ie, 20 to <65 ng/L with an absolute change ≥5 ng/L or hsTnT ≥65 ng/L) without an ischemic feature was associated with 30-day mortality (adjusted HR, 3.20; 95% CI, 2.37-4.32). Among the 3904 patients (17.9%; 95% CI, 17.4%-18.4%) with MINS, 3633 (93.1%; 95% CI, 92.2%-93.8%) did not experience an ischemic symptom. Conclusions and Relevance: Among patients undergoing noncardiac surgery, peak postoperative hsTnT during the first 3 days after surgery was significantly associated with 30-day mortality. Elevated postoperative hsTnT without an ischemic feature was also associated with 30-day mortality.


Assuntos
Infarto do Miocárdio/mortalidade , Isquemia Miocárdica/mortalidade , Troponina T/sangue , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias , Período Pós-Operatório , Estudos Prospectivos , Medição de Risco
11.
Lancet ; 386(10000): 1243-1253, 2015 Sep 26.
Artigo em Inglês | MEDLINE | ID: mdl-26460660

RESUMO

BACKGROUND: Cardiopulmonary bypass initiates a systemic inflammatory response syndrome that is associated with postoperative morbidity and mortality. Steroids suppress inflammatory responses and might improve outcomes in patients at high risk of morbidity and mortality undergoing cardiopulmonary bypass. We aimed to assess the effects of steroids in patients at high risk of morbidity and mortality undergoing cardiopulmonary bypass. METHODS: The Steroids In caRdiac Surgery (SIRS) study is a double-blind, randomised, controlled trial. We used a central computerised phone or interactive web system to randomly assign (1:1) patients at high risk of morbidity and mortality from 80 hospital or cardiac surgery centres in 18 countries undergoing cardiac surgery with the use of cardiopulmonary bypass to receive either methylprednisolone (250 mg at anaesthetic induction and 250 mg at initiation of cardiopulmonary bypass) or placebo. Patients were assigned with block randomisation with random block sizes of 2, 4, or 6 and stratified by centre. Patients aged 18 years or older were eligible if they had a European System for Cardiac Operative Risk Evaluation of at least 6. Patients were excluded if they were taking or expected to receive systemic steroids in the immediate postoperative period or had a history of bacterial or fungal infection in the preceding 30 days. Patients, caregivers, and those assessing outcomes were masked to allocation. The primary outcomes were 30-day mortality and a composite of death and major morbidity (ie, myocardial injury, stroke, renal failure, or respiratory failure) within 30 days, both analysed by intention to treat. Safety outcomes were also analysed by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00427388. FINDINGS: Patients were recruited between June 21, 2007, and Dec 19, 2013. Complete 30-day data was available for all 7507 patients randomly assigned to methylprednisolone (n=3755) and to placebo (n=3752). Methylprednisolone, compared with placebo, did not reduce the risk of death at 30 days (154 [4%] vs 177 [5%] patients; relative risk [RR] 0·87, 95% CI 0·70-1·07, p=0·19) or the risk of death or major morbidity (909 [24%] vs 885 [24%]; RR 1·03, 95% CI 0·95-1·11, p=0·52). The most common safety outcomes in the methylprednisolone and placebo group were infection (465 [12%] vs 493 [13%]), surgical site infection (151 [4%] vs 151 [4%]), and delirium (295 [8%] vs 289 [8%]). INTERPRETATION: Methylprednisolone did not have a significant effect on mortality or major morbidity after cardiac surgery with cardiopulmonary bypass. The SIRS trial does not support the routine use of methylprednisolone for patients undergoing cardiopulmonary bypass. FUNDING: Canadian Institutes of Health Research.


Assuntos
Anti-Inflamatórios/uso terapêutico , Ponte Cardiopulmonar/métodos , Metilprednisolona/uso terapêutico , Síndrome de Resposta Inflamatória Sistêmica/prevenção & controle , Idoso , Idoso de 80 Anos ou mais , Ponte Cardiopulmonar/efeitos adversos , Ponte Cardiopulmonar/mortalidade , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Síndrome de Resposta Inflamatória Sistêmica/etiologia
12.
Acta méd. colomb ; 40(4): 279-287, oct.-dic. 2015. ilus, tab
Artigo em Espanhol | LILACS-Express | ID: lil-791065

RESUMO

Objetivo: en el año 2012 se desarrolló para Colombia la guía de práctica clínica para manejo de la hipertensión arterial (HTA). Esta evaluación económica (EE) fue desarrollada para identificar la costo-efectividad de los diferentes tratamientos farmacológicos usados como monoterapia, y soportar las recomendaciones en la guía. Diseño: se simuló una cohorte de pacientes adultos, con diagnóstico de hipertensión arterial. La EE se basó en un modelo desarrollado para el National Institute for Clinical Excellence (NICE) del Reino Unido. Este modelo fue adaptado para Colombia en consumo de recursos y costos. La efectividad de las intervenciones y probabilidades de transición fueron actualizadas para 2012. Resultados: los resultados del análisis del caso de referencia (hombre y mujer de 65 años, 2% de riesgo anual de enfermedad CV, 1% de falla cardiaca, 1.1% de diabetes, 20 años de seguimiento), mostraron que los años de vida ajustados por calidad (QALY) obtenidos con la terapia de diuréticos, inhibidores de enzima convertidora/bloqueadores del receptor de angiotensina (ACEi/ARB) y calcioantagonistas fue 9.24, 9.24 y 9.26, respectivamente. Los costos favorecen a los diuréticos (COP $6 498 624), en comparación con ACEi/ARB o calcioantagonistas (COP $13 178 919, y COP $27 774 098), respectivamente. La terapia con betabloqueadores y la no intervención fueron dominadas. Conclusiones: la opción de tratamiento con diuréticos tipo tiazidas como mono-terapia inicial es la más costo-efectiva. La principal diferencia entre las alternativas está dada especialmente por las diferencias en el costo de los medicamentos, ya que la efectividad es similar entre los tratamientos con diuréticos y ACEi/ARB, y sólo discretamente mejor con calcio-antagonistas. (Acta Med Colomb 2015; 40: 279-287).


Objective: in 2012 the guide of clinical practice for management of arterial hypertension (AHT) was developed for Colombia. This economic evaluation (EE) was developed to identify the cost effectiveness of different pharmacological treatments used as monotherapy, and to support the recommendations in the guidelines. Design: a cohort of adult patients with a diagnosis of hypertension was simulated. The EE was based on a model developed for the National Institute for Clinical Excellence (NICE) in the UK. This model was adapted for Colombia in resource consumption and costs. The effectiveness of interventions and transition probabilities were updated for 2012. Results: the results of the analysis of the reference case (man and woman of 65.2% annual risk of cardiovascular disease, 1% of heart failure, 1.1% of diabetes, 20 years of follow-up) showed that quality-adjusted life year (QALY) obtained with diuretic therapy, converting enzyme inhibitors / angiotensin receptor blockers (ACEi / ARB) and calcium antagonists was 9.24, 9.24 and 9.26, respectively. Costs favor diuretics (COP $6 498 624) compared with ACEi / ARB or calcium antagonists (COP $ 13 178 919 and $ 27 774 098 COP), respectively. Therapy with beta-blockers and non-intervention were dominated. Conclusions: the choice of treatment with thiazide-type diuretics as initial monotherapy is the most cost-effective. The main difference between alternatives is given especially by differences in drug costs, since the effectiveness is similar between treatments with diuretics and ACEi / ARB, and only slightly better with calcium antagonists. (Acta Med Colomb 2015; 40: 279-287).

13.
The Lancet ; 386(10000): 1243-1253, 2015.
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: ses-32878

RESUMO

BACKGROUND:Cardiopulmonary bypass initiates a systemic inflammatory response syndrome that is associated with postoperative morbidity and mortality. Steroids suppress inflammatory responses and might improve outcomes in patients at high risk of morbidity and mortality undergoing cardiopulmonary bypass. We aimed to assess the effects of steroids in patients at high risk of morbidity and mortality undergoing cardiopulmonary bypass.METHODS:The Steroids In caRdiac Surgery (SIRS) study is a double-blind, randomised, controlled trial. We used a central computerised phone or interactive web system to randomly assign (1:1) patients at high risk of morbidity and mortality from 80 hospital or cardiac surgery centres in 18 countries undergoing cardiac surgery with the use of cardiopulmonary bypass to receive either methylprednisolone (250 mg at anaesthetic induction and 250 mg at initiation of cardiopulmonary bypass) or placebo. Patients were assigned with block randomisation with random block sizes of 2, 4, or 6 and stratified by centre. Patients aged 18 years or older were eligible if they had a European System for Cardiac Operative Risk Evaluation of at least 6. Patients were excluded if they were taking or expected to receive systemic steroids in the immediate postoperative period or had a history of bacterial or fungal infection in the preceding 30 days. Patients, caregivers, and those assessing outcomes were masked to allocation. The primary outcomes were 30-day mortality and a composite of death and major morbidity (ie, myocardial injury, stroke, renal failure, or respiratory failure) within 30 days, both analysed by intention to treat. Safety outcomes were also analysed by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00427388... (AU)


Assuntos
Metilprednisolona , Circulação Extracorpórea
14.
Bogotá; IETS; dic. 2014. tab, ilus.
Monografia em Espanhol | LILACS, BRISA/RedTESA | ID: biblio-847132

RESUMO

Introducción: La angina de pecho es el dolor causado por la isquemia miocárdica que por lo general es debida a enfermedad coronaria. Los antianginosos recomendados para el tratamiento inicial son los betabloqueadores y los calcioantagonistas y por lo general se requiere combinarlos con un nitrato para aliviar los episodios de dolor. Cuando los medicamentos de primera línea no son bien tolerados, están contraindicados, o no logran controlar los síntomas es necesario utilizar otros como la trimetazidina (TMZ). Objetivos: Evaluar la evidencia científica sobre los beneficios y riesgos del uso de TMZ para el tratamiento de pacientes con angina estable (AE), como uno de los criterios para informar la toma de decisiones relacionada con la posible inclusión de tecnologías en el Plan Obligatorio de Salud, en el marco de su actualización ordinaria para el año 2015. Métodos: Se buscaron estudios en los que se hubiera probado el uso de TMZ en pacientes con AE. Los comparadores podían ser placebo u otros antianginosos como calcioantagonistas, betabloqueadores, nitratos o ivabradina. No se usaron límites de tiempo y solamente se incluyeron estudios en inglés o español. Resultados: No se encontró evidencia de que el tratamiento con TMZ tenga efecto sobre la mortalidad y los eventos cardiovasculares en pacientes con AE. La capacidad funcional como tal no fue evaluada en ninguno de los estudios encontrados. Un estudio primario de baja calidad metodológica demostró que la TMZ mejora la calidad de vida al comparar con el estado basal. Evidencia de buena calidad demostró que el medicamento disminuye los episodios semanales de angina cuando se compara con placebo, pero evidencia de moderada calidad demostró que no hay diferencias al comparar con otros antianginosos. No se observaron diferencias en la frecuencia de eventos adversos al comparar con placebo. Conclusiones: En pacientes con AE el tratamiento con TMZ no tiene impacto sobre la muerte y los eventos cardiovasculares, no se conoce el efecto sobre la capacidad funcional. El medicamento disminuye el número de ataques semanales de angina cuando se compara con placebo y podría mejorar la calidad de vida pero se necesitan más estudios para demostrarlo.(AU)


Assuntos
Humanos , Angina Estável/tratamento farmacológico , Tecnologia Biomédica , Colômbia , Cardiopatias , Resultado do Tratamento , Trimetazidina/administração & dosagem
15.
Bogotá; IETS; dic. 2014. tab, ilus.
Monografia em Espanhol | LILACS, BRISA/RedTESA | ID: biblio-847184

RESUMO

Introducción: Se define como arritmia cardiaca a cualquier ritmo diferente al sinusal en presencia de un sistema de conducción atrioventricular normal y como taquiarritmia, a los ritmos cardiacos anormales con frecuencia ventricular mayor a 100 por minuto. Las taquiarritmias supraventriculares (TSV) son aquellas cuyo sitio de formación del impulso se origina por encima de la bifurcación del haz de His; pueden ser repetitivas, persistentes y algunas veces poner en riesgo la vida. Objetivo: Evaluar la evidencia científica sobre los beneficios y riesgos del uso de metoprolol succinato en el tratamiento de pacientes con TSV como uno de los criterios para informar la toma de decisiones relacionada con la posible inclusión de tecnologías en el Plan Obligatorio de Salud, en el marco de su actualización ordinaria para el año 2015. Metodología: Se buscaron revisiones sistemáticas y estudios primarios en los que se hubiera evaluado el uso de metoprolol succinato para evitar episodios de una TSV o para controlar la frecuencia ventricular en el caso de la fibrilación y el flutter auricular. El comparador podía ser placebo, cualquier otro betabloqueador (incluso el metoprolol tartrato) o calcioantagonistas no dihidropiridínicos (verapamilo o diltiazem). No se restringió por fecha de publicación y se buscaron estudios en inglés o español. Resultados: No se encontraron revisiones sistemáticas ni estudios primarios de buena calidad diseñados específicamente para evaluar el impacto del metoprolol succinato sobre los desenlaces clínicamente importantes en pacientes con TSV. Evidencia de baja calidad demostró que en pacientes con FA y falla cardiaca sistólica el uso de metoprolol succinato no disminuye la mortalidad ni las hospitalizaciones y tampoco mejora la calidad de vida. En pacientes con falla cardiaca sistólica en ritmo sinusal, el uso del medicamento succinato se asoció con una disminución en la incidencia de FA. Evidencia de moderada calidad demostró que en pacientes con FA persistente el uso de metoprolol succinato retrasa el tiempo hasta la recaída después de una cardioversión exitosa. Evidencia de muy baja calidad demostró que en pacientes con taquicardia sinusal inapropiada el metoprolol succinato es tan efectivo como la ivabradina para disminuir la frecuencia cardiaca en reposo. Conclusiones: Se necesitan estudios de buena calidad metodológica diseñados específicamente para evaluar la efectividad del metoprolol succinato sobre desenlaces clínicamente importantes en pacientes con TSV.(AU)


Assuntos
Humanos , Metoprolol/administração & dosagem , Taquicardia Supraventricular/tratamento farmacológico , Tecnologia Biomédica , Colômbia , Resultado do Tratamento
16.
Bogotá; IETS; dic. 2014.
Monografia em Espanhol | LILACS, BRISA/RedTESA | ID: biblio-847235

RESUMO

Introducción: el uso de los nuevos anticoagulantes orales como Dabigatran, Ribaroxaban y Apixaban en pacientes con FA no valvular ha sido evaluado en los estudios RELY, ROCKET-AF y ARISTOTELE, respectivamente. En ellos se demuestra su eficacia en la prevención de embolia, con un perfil de seguridad similar o incluso mejor que la terapia estándar con Warfarina. En los últimos tres años es significativo el número de estudios (revisiones sistemáticas, más que ECA) que se han publicado con estos nuevos anticoagulantes orales. Dada su relativa recién aparición e indicación por las Guías de Práctica Clínica, se hace necesario adelantar una revisión de literatura que permita sintetizar todos estos nuevos conocimientos y poder generar una o varias recomendaciones aplicables a la población colombiana. Objetivos: sintetizar y evaluar la eficacia y seguridad de Rivaroxaban y Dabigatran en adultos con fibrilación auricular no valvular. Métodos: revisión sistemática de literatura. Se incluyeron estudios de pacientes con fibrilación auricular no valvular en quienes se interviniera con Warfarina o alguno de los nuevos anticoagulantes aprobados en Colombia (Dabigatran, Rivaroxaban, Apixaban). El Apixaban solo se tuvo en cuenta como medicamento comparador. Serealizó una búsqueda en los principales recursos bibliográficos (Cochrane, Medline, Embase, LILACS) para revisiones sistemáticas con meta-análisis y meta-análisis en red. Adicionalmente se realizó una búsqueda de ECA y estudios observacionales para meta-analizar y reportar las medidas de efecto que no fueran descritas por las revisiones sistemáticas elegidas, según los desenlaces propuestos por el grupo desarrollador. Resultados: se seleccionaron 15 estudios de un total de 1840. Se encontraron comparaciones directas entre Rivaroxaban y Dabigatran con Warfarina, así como comparaciones indirectas entre los nuevos anticoagulantes orales para la mayoría de desenlaces propuestos. Para el desenlace primario (ACV isquémico) se encontró beneficio con Dabigatran 150mg en comparación con Warfarina y con Dabigatran 110mg (OR=0,76 (0,58-0,98) y 0,67 (0,53-0,86) respectivamente). Ninguna comparación indirecta fue estadísticamente significativa para eficacia. Tanto Dabigatran (150mg y 110mg) como Rivaroxaban son más seguros que Warfarina para la prevención de hemorragias intracraneales (OR=0,42 (0,28-0,61); 0,30 (0,19-0,46) y 0,64 (0,46-0,88) respectivamente). Conclusiones: Dabigatran (150 mg) es más eficaz que Warfarina para la prevención de ACV isquémico. Rivaroxaban es más eficaz que Warfarina para la prevención de embolismos sistémicos. El uso de Dabigatran (150 o 110 mg) o de Rivaroxaban es más seguro que Warfarina para la prevención de hemorragias intracraneanas. Debido a la falta de comparaciones directas, no es posible afirmar que la eficacia de uno de los NACOS aprobados para su uso en Colombia sea más eficaz que otro. Sin embargo, Dabigatran parece brindar un mayor beneficio clínico neto que Rivaroxaban para esta indicación terapéutica.(AU)


Assuntos
Humanos , Fibrilação Atrial/tratamento farmacológico , Dabigatrana/administração & dosagem , Rivaroxabana/administração & dosagem , Anticoagulantes/administração & dosagem , Colômbia , Reprodutibilidade dos Testes , Avaliação da Tecnologia Biomédica , Resultado do Tratamento , Varfarina/administração & dosagem
17.
JAMA ; 312(21): 2254-64, 2014 Dec 03.
Artigo em Inglês | MEDLINE | ID: mdl-25399007

RESUMO

IMPORTANCE: Acute kidney injury, a common complication of surgery, is associated with poor outcomes and high health care costs. Some studies suggest aspirin or clonidine administered during the perioperative period reduces the risk of acute kidney injury; however, these effects are uncertain and each intervention has the potential for harm. OBJECTIVE: To determine whether aspirin compared with placebo, and clonidine compared with placebo, alters the risk of perioperative acute kidney injury. DESIGN, SETTING, AND PARTICIPANTS: A 2 × 2 factorial randomized, blinded, clinical trial of 6905 patients undergoing noncardiac surgery from 88 centers in 22 countries with consecutive patients enrolled between January 2011 and December 2013. INTERVENTIONS: Patients were assigned to take aspirin (200 mg) or placebo 2 to 4 hours before surgery and then aspirin (100 mg) or placebo daily up to 30 days after surgery, and were assigned to take oral clonidine (0.2 mg) or placebo 2 to 4 hours before surgery, and then a transdermal clonidine patch (which provided clonidine at 0.2 mg/d) or placebo patch that remained until 72 hours after surgery. MAIN OUTCOMES AND MEASURES: Acute kidney injury was primarily defined as an increase in serum creatinine concentration from the preoperative concentration by either an increase of 0.3 mg/dL or greater (≥26.5 µmol/L) within 48 hours of surgery or an increase of 50% or greater within 7 days of surgery. RESULTS: Aspirin (n = 3443) vs placebo (n = 3462) did not alter the risk of acute kidney injury (13.4% vs 12.3%, respectively; adjusted relative risk, 1.10; 95% CI, 0.96-1.25). Clonidine (n = 3453) vs placebo (n = 3452) did not alter the risk of acute kidney injury (13.0% vs 12.7%, respectively; adjusted relative risk, 1.03; 95% CI, 0.90-1.18). Aspirin increased the risk of major bleeding. In a post hoc analysis, major bleeding was associated with a greater risk of subsequent acute kidney injury (23.3% when bleeding was present vs 12.3% when bleeding was absent; adjusted hazard ratio, 2.20; 95% CI, 1.72-2.83). Similarly, clonidine increased the risk of clinically important hypotension. In a post hoc analysis, clinically important hypotension was associated with a greater risk of subsequent acute kidney injury (14.3% when hypotension was present vs 11.8% when hypotension was absent; adjusted hazard ratio, 1.34; 95% CI, 1.14-1.58). CONCLUSIONS AND RELEVANCE: Among patients undergoing major noncardiac surgery, neither aspirin nor clonidine administered perioperatively reduced the risk of acute kidney injury. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01082874.


Assuntos
Lesão Renal Aguda/prevenção & controle , Agonistas de Receptores Adrenérgicos alfa 2/administração & dosagem , Aspirina/administração & dosagem , Aspirina/efeitos adversos , Clonidina/administração & dosagem , Inibidores da Agregação de Plaquetas/administração & dosagem , Administração Cutânea , Administração Oral , Agonistas de Receptores Adrenérgicos alfa 2/efeitos adversos , Idoso , Clonidina/efeitos adversos , Creatinina/sangue , Esquema de Medicação , Feminino , Hemorragia/induzido quimicamente , Humanos , Hipotensão/induzido quimicamente , Masculino , Pessoa de Meia-Idade , Assistência Perioperatória , Inibidores da Agregação de Plaquetas/efeitos adversos , Complicações Pós-Operatórias , Risco
18.
Cochrane Database Syst Rev ; (5): CD003463, 2014 May 27.
Artigo em Inglês | MEDLINE | ID: mdl-24867876

RESUMO

BACKGROUND: Prevention of chronic chagasic cardiomyopathy (CCC) by treating infected populations with trypanocidal therapy (TT) remains a challenge. Despite a renewed enthusiasm for TT, uncertainty regarding its efficacy, concerns about its safety and limited availability remain barriers for a wider use of conventional drugs. We have updated a previous version of this review. OBJECTIVES: To systematically search, appraise, identify and extract data from eligible studies comparing the outcome of cohorts of seropositive individuals to Trypanosoma cruzi exposed to TT versus placebo or no treatment. SEARCH METHODS: We sought eligible studies in electronic databases (Cochrane Central Register of Controlled Trials (CENTRAL), Issue 1, 2014); MEDLINE (Ovid, 1946 to January week 5 2014); EMBASE (Ovid, 1980 to 2014 week 6) and LILACS (up to 6 May 2010)) by combining terms related with the disease and the treatment. The search also included a Google search, handsearch for references in review or selected articles, and search of expert files. We applied no language restrictions. SELECTION CRITERIA: Review authors screened the retrieved references for eligibility (those dealing with human participants treated with TT) and then assessed the pre-selected studies in full for inclusion. We included randomised controlled trials (RCTs) and observational studies that provided data on either mortality or clinical progression of CCC after at least four years of follow-up. DATA COLLECTION AND ANALYSIS: Teams of two review authors independently carried out the study selection, data extraction and risk of bias assessment, with a referee resolving disagreement within the pairs. Data collection included study design, characteristics of the population and interventions or exposures and outcome measures. We defined categories of outcome data as parasite-related (positive serology, xenodiagnosis or polymerase chain reaction (PCR) after TT) and participant-related (including efficacy outcomes such as progression towards CCC, all-cause mortality and side effects of TT). We reported pooled outcome data as Mantel-Haenszel odds ratios (OR) or standardised mean differences (SMD) along with 95% confidence intervals (CI), using a random-effects model. I(2) statistics provided an estimate of heterogeneity across studies. We conducted an exploratory meta-regression analysis of the relationship between positive-serology and progression of CCC or mortality. MAIN RESULTS: We included 13 studies involving 4229 participants (six RCTs, n = 1096, five RCTs of intermediate risk of bias, one RCT of high risk of bias; four non-randomised experiments, n = 1639 and three observational studies, n = 1494). Ten studies tested nitroderivative drugs nifurtimox or benznidazole (three exposed participants to allopurinol, one to itraconazole). Five studies were conducted in Brazil, five in Argentina, one in Bolivia, one in Chile and one in Venezuela.TT was associated with substantial, but heterogeneous reductions on parasite-related outcomes such as positive serology (9 studies, OR 0.21, 95% CI 0.10 to 0.44, I(2) = 76%), positive PCR (2 studies, OR 0.50, 95% CI 0.27 to 0.92, I(2) = 0%), positive xenodiagnosis after treatment (6 studies, OR 0.35, 95% CI 0.14 to 0.86, I(2) = 79%), or reduction on antibody titres (3 studies, SMD -0.56, 95% CI -0.89 to -0.23, I(2) = 28%). Efficacy data on patient-related outcomes was largely from non-RCTs. TT with nitroderivatives was associated with potentially important, but imprecise and inconsistent reductions in progression of CCC (4 studies, 106 events, OR 0.74, 95% CI 0.32 to 1.73, I(2) = 66%) and mortality after TT (6 studies, 99 events, OR 0.55, 95% CI 0.26 to 1.14, I(2) = 48%). The overall median incidence of any severe side effects among 1475 individuals from five studies exposed to TT was 2.7%, and the overall discontinuation of this two-month therapy in RCTs (5 studies, 134 events) was 20.5% (versus 4.3% among controls) and 10.4% in other five studies (125 events). AUTHORS' CONCLUSIONS: Despite the evidence that TT reduced parasite-related outcomes, the low quality and inconsistency of the data for patient-important outcomes must be treated with caution. More geographically diverse RCTs testing newer forms of TT are warranted in order to 1. estimate efficacy more precisely, 2. explore factors potentially responsible for the heterogeneity of results and 3. increase knowledge on the efficacy/tolerance balance of conventional TT.


Assuntos
Doença de Chagas/tratamento farmacológico , Tripanossomicidas/uso terapêutico , Animais , Cardiomiopatia Chagásica/prevenção & controle , Doença Crônica , Humanos , Estudos Observacionais como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Trypanosoma cruzi
19.
Am Heart J ; 167(5): 660-5, 2014 May.
Artigo em Inglês | MEDLINE | ID: mdl-24766975

RESUMO

BACKGROUND: Steroids may improve outcomes in high-risk patients undergoing cardiac surgery with the use of cardiopulmonary bypass (CBP). There is a need\ for a large randomized controlled trial to clarify the effect of steroids in such patients. METHODS: We plan to randomize 7,500 patients with elevated European System for Cardiac Operative Risk Evaluation who are undergoing cardiac surgery with the use of CBP to methylprednisolone or placebo. The first coprimary outcome is 30-day all-cause mortality, and the most second coprimary outcome is a composite of death, MI, stroke, renal failure, or respiratory failure within 30 days. Other outcomes include a composite of MI or mortality at 30 days, new onset atrial fibrillation, bleeding and transfusion requirements, length of intensive care unit stay and hospital stay, infection, stroke, wound complications, gastrointestinal complications, delirium, postoperative insulin use and peak blood glucose, and all-cause mortality at 6 months. RESULTS: As of October 22, 2013, 7,034 patients have been recruited into SIRS in 82 centers from 18 countries. Patient's mean age is 67.3 years, and 60.4% are male. The average European System for Cardiac Operative Risk Evaluation is 7.0 with 22.1% having an isolated coronary artery bypass graft procedure, and 66.1% having a valve procedure. CONCLUSIONS: SIRS will lead to a better understanding of the safety and efficacy of prophylactic steroids for cardiac surgery requiring CBP.


Assuntos
Procedimentos Cirúrgicos Cardíacos , Cardiopatias/cirurgia , Metilprednisolona/administração & dosagem , Complicações Pós-Operatórias/prevenção & controle , Cuidados Pré-Operatórios/métodos , Idoso , Idoso de 80 Anos ou mais , Causas de Morte/tendências , Relação Dose-Resposta a Droga , Feminino , Seguimentos , Saúde Global , Glucocorticoides/administração & dosagem , Humanos , Incidência , Injeções Intravenosas , Masculino , Complicações Pós-Operatórias/epidemiologia , Estudos Retrospectivos , Fatores de Risco , Taxa de Sobrevida/tendências , Resultado do Tratamento
20.
N Engl J Med ; 370(16): 1494-503, 2014 Apr 17.
Artigo em Inglês | MEDLINE | ID: mdl-24679062

RESUMO

BACKGROUND: There is substantial variability in the perioperative administration of aspirin in patients undergoing noncardiac surgery, both among patients who are already on an aspirin regimen and among those who are not. METHODS: Using a 2-by-2 factorial trial design, we randomly assigned 10,010 patients who were preparing to undergo noncardiac surgery and were at risk for vascular complications to receive aspirin or placebo and clonidine or placebo. The results of the aspirin trial are reported here. The patients were stratified according to whether they had not been taking aspirin before the study (initiation stratum, with 5628 patients) or they were already on an aspirin regimen (continuation stratum, with 4382 patients). Patients started taking aspirin (at a dose of 200 mg) or placebo just before surgery and continued it daily (at a dose of 100 mg) for 30 days in the initiation stratum and for 7 days in the continuation stratum, after which patients resumed their regular aspirin regimen. The primary outcome was a composite of death or nonfatal myocardial infarction at 30 days. RESULTS: The primary outcome occurred in 351 of 4998 patients (7.0%) in the aspirin group and in 355 of 5012 patients (7.1%) in the placebo group (hazard ratio in the aspirin group, 0.99; 95% confidence interval [CI], 0.86 to 1.15; P=0.92). Major bleeding was more common in the aspirin group than in the placebo group (230 patients [4.6%] vs. 188 patients [3.8%]; hazard ratio, 1.23; 95% CI, 1.01, to 1.49; P=0.04). The primary and secondary outcome results were similar in the two aspirin strata. CONCLUSIONS: Administration of aspirin before surgery and throughout the early postsurgical period had no significant effect on the rate of a composite of death or nonfatal myocardial infarction but increased the risk of major bleeding. (Funded by the Canadian Institutes of Health Research and others; POISE-2 ClinicalTrials.gov number, NCT01082874.).


Assuntos
Aspirina/uso terapêutico , Infarto do Miocárdio/prevenção & controle , Inibidores da Agregação de Plaquetas/uso terapêutico , Complicações Pós-Operatórias/prevenção & controle , Hemorragia Pós-Operatória/induzido quimicamente , Procedimentos Cirúrgicos Operatórios/mortalidade , Idoso , Aspirina/efeitos adversos , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/epidemiologia , Assistência Perioperatória , Inibidores da Agregação de Plaquetas/efeitos adversos , Falha de Tratamento
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