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1.
PLoS Negl Trop Dis ; 14(8): e0008529, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32804966

RESUMO

Chagas disease is a neglected disease that remains a public health threat, particularly in Latin America. The most important treatment options are nitroimidazole derivatives, such as nifurtimox and benznidazole (BZN). Some studies suggest that for adults seropositive to T. cruzi but without clinically evident chronic Chagas cardiomyopathy (CCC), a simple fixed-dose scheme of BZN could be equivalent to a weight-adjusted dose. We compared the efficacy and safety of a fixed dose of BZN with an adjusted dose for T. cruzi seropositive adults without CCC. We used the Cochrane methods, and reported according to the PRISMA statement. We included randomized controlled trials (RCTs) allocating participants to fixed and/or adjusted doses of BZN for T. cruzi seropositive adults without CCC. We searched (December 2019) Cochrane, MEDLINE, EMBASE, LILACS, Clinicaltrials.gov, and International Clinical Trials Registry Platform (ICTRP), and contacted Chagas experts. Selection, data extraction, and risk of bias assessment, using the Cochrane tool, were performed independently by pairs of reviewers. Discrepancies were solved by consensus within the team. Primary outcomes were parasite-related outcomes and efficacy or patient-related safety outcomes. We conducted a meta-analysis using RevMan 5.3 software and used GRADE summary of finding tables to present the certainty of evidence by outcome. We identified 655 records through our search strategy and 10 studies (four of them ongoing) met our inclusion criteria. We did not find any study directly comparing fixed vs adjusted doses of BZN, however, some outcomes allowed subgroup comparisons between fixed and adjusted doses of BZN against placebo. Moderate-certainty evidence suggests no important subgroup differences for positive PCR at one year and for three safety outcomes (drug discontinuation, peripheral neuropathy, and mild rash). The same effect was observed for any serious adverse events (low-certainty evidence). All subgroups showed similar effects (I2 0% for all these subgroup comparisons but 32% for peripheral neuropathy), supporting the equivalence of BZN schemes. We conclude that there is no direct evidence comparing fixed and adjusted doses of BZN. Based on low to very low certainty of evidence for critical clinical outcomes and moderate certainty of evidence for important outcomes, fixed and adjusted doses may be equivalent in terms of safety and efficacy. An individual patient data network meta-analysis could better address this issue.


Assuntos
Cardiomiopatias , Doença de Chagas/tratamento farmacológico , Nitroimidazóis/administração & dosagem , Nitroimidazóis/uso terapêutico , Adulto , Bases de Dados Factuais , Humanos , Nifurtimox/uso terapêutico , Segurança do Paciente , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento , Triazóis/uso terapêutico , Trypanosoma cruzi/efeitos dos fármacos
2.
J Bone Joint Surg Am ; 102(10): 880-888, 2020 May 20.
Artigo em Inglês | MEDLINE | ID: mdl-32118652

RESUMO

BACKGROUND: Myocardial injury after noncardiac surgery (MINS) is common and of prognostic importance. Little is known about MINS in orthopaedic surgery. The diagnostic criterion for MINS was a level of ≥0.03 ng/mL on a non-high-sensitivity troponin T (TnT) assay due to myocardial ischemia. METHODS: We undertook an international, prospective study of 15,103 patients ≥45 years of age who had inpatient noncardiac surgery; 3,092 underwent orthopaedic surgery. Non-high-sensitivity TnT assays were performed on postoperative days 0, 1, 2, and 3. Among orthopaedic patients, we determined (1) the prognostic relevance of the MINS diagnostic criteria, (2) the 30-day mortality rate for those with and without MINS, and (3) the probable proportion of MINS cases that would go undetected without troponin monitoring because of a lack of an ischemic symptom. RESULTS: Three hundred and sixty-seven orthopaedic patients (11.9%) had MINS. MINS was associated independently with 30-day mortality including among those who had had orthopaedic surgery. Orthopaedic patients without and with MINS had a 30-day mortality rate of 1.0% and 9.8%, respectively (odds ratio [OR], 11.28; 95% confidence interval [CI], 6.72 to 18.92). The 30-day mortality rate was increased for patients with MINS who had an ischemic feature (i.e., symptoms, or evidence of ischemia on electrocardiography or imaging) (OR, 18.25; 95% CI, 10.06 to 33.10) and for those who did not have an ischemic feature (OR, 7.35; 95% CI, 3.37 to 16.01). The proportion of orthopaedic patients with MINS who were asymptomatic and in whom the myocardial injury would have probably gone undetected without TnT monitoring was 81.3% (95% CI, 76.3% to 85.4%). CONCLUSIONS: One in 8 orthopaedic patients in our study had MINS, and MINS was associated with a higher mortality rate regardless of symptoms. Troponin levels should be measured after surgery in at-risk patients because most MINS cases (>80%) are asymptomatic and would go undetected without routine measurements. LEVEL OF EVIDENCE: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.

3.
Anesthesiology ; 132(4): 692-701, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-32022771

RESUMO

BACKGROUND: The authors previously reported that perioperative aspirin and/or clonidine does not prevent a composite of death or myocardial infarction 30 days after noncardiac surgery. Moreover, aspirin increased the risk of major bleeding and clonidine caused hypotension and bradycardia. Whether these complications produce harm at 1 yr remains unknown. METHODS: The authors randomized 10,010 patients with or at risk of atherosclerosis and scheduled for noncardiac surgery in a 1:1:1:1 ratio to clonidine/aspirin, clonidine/aspirin placebo, clonidine placebo/aspirin, or clonidine placebo/aspirin placebo. Patients started taking aspirin or placebo just before surgery; those not previously taking aspirin continued daily for 30 days, and those taking aspirin previously continued for 7 days. Patients were also randomly assigned to receive clonidine or placebo just before surgery, with the study drug continued for 72 h. RESULTS: Neither aspirin nor clonidine had a significant effect on the primary 1-yr outcome, a composite of death or nonfatal myocardial infarction, with a 1-yr hazard ratio for aspirin of 1.00 (95% CI, 0.89 to 1.12; P = 0.948; 586 patients [11.8%] vs. 589 patients [11.8%]) and a hazard ratio for clonidine of 1.07 (95% CI, 0.96 to 1.20; P = 0.218; 608 patients [12.1%] vs. 567 patients [11.3%]), with effect on death or nonfatal infarction. Reduction in death and nonfatal myocardial infarction from aspirin in patients who previously had percutaneous coronary intervention at 30 days persisted at 1 yr. Specifically, the hazard ratio was 0.58 (95% CI, 0.35 to 0.95) in those with previous percutaneous coronary intervention and 1.03 (95% CI, 0.91to 1.16) in those without (interaction P = 0.033). There was no significant effect of either drug on death, cardiovascular complications, cancer, or chronic incisional pain at 1 yr (all P > 0.1). CONCLUSIONS: Neither perioperative aspirin nor clonidine have significant long-term effects after noncardiac surgery. Perioperative aspirin in patients with previous percutaneous coronary intervention showed persistent benefit at 1 yr, a plausible sub-group effect.


Assuntos
Analgésicos/administração & dosagem , Anti-Inflamatórios não Esteroides/administração & dosagem , Aspirina/administração & dosagem , Clonidina/administração & dosagem , Assistência Perioperatória/métodos , Complicações Pós-Operatórias/diagnóstico , Idoso , Analgésicos/efeitos adversos , Anti-Inflamatórios não Esteroides/efeitos adversos , Aspirina/efeitos adversos , Clonidina/efeitos adversos , Feminino , Seguimentos , Humanos , Internacionalidade , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/epidemiologia , Infarto do Miocárdio/prevenção & controle , Assistência Perioperatória/efeitos adversos , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/prevenção & controle , Fatores de Tempo
4.
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.

5.
Rev. colomb. cardiol ; 26(4): 198-204, jul.-ago. 2019. tab, graf
Artigo em Espanhol | LILACS-Express | LILACS | ID: biblio-1092926

RESUMO

Resumen Introducción: la hipertensión arterial es responsable de gran parte de la carga de enfermedad cardiovascular; sin embargo, el papel del sueño en su etiología aun es controversial. Objetivo: determinar la asociación entre atributos del sueño y cambio de la presión arterial. Métodos: estudio de cohorte prospectiva, de base comunitaria, en adultos jóvenes asintomáticos para enfermedad cardiovascular, seguidos por 12,4 años. En la línea de base se determinaron factores sociodemográficos y del comportamiento, y se caracterizó el sueño nocturno usual en términos de calidad, duración y presencia de ronquido. Se realizó medición estandarizada de índices antropométricos y presión arterial. La hipertensión arterial se definió como reporte de tratamiento antihipertensivo o cifras de presión arterial ≥140/90 mm Hg. Resultados: se evaluaron de manera prospectiva 1.032 participantes (media de edad: 36,8 años, 64% hombres; en la línea de base). La incidencia de hipertensión arterial fue de 15,1% (IC95%: 12,8 - 17,4), con evidencia de mayor riesgo en los roncadores, atenuado posteriormente al ajuste por adiposidad (p>0,05). Se observó un gradiente entre la duración del sueño y el cambio en la presión arterial sistólica/diastólica (2,2/1,3 mm Hg en quienes reportaron 6-8 horas/día y 2,7/1,6 mm Hg en quienes reportaron > 8 horas/día, respecto a < 6 horas/día). Ni la calidad subjetiva del sueño ni el reporte de siesta se asociaron con la presión arterial. Conclusión: los resultados sugieren que la duración prolongada del sueño podría incrementar la presión arterial en la población.


Abstract Introduction: Arterial hypertension is responsible for large part of the cardiovascular disease load. However, the role of sleep in its aetiology remains controversial. Objective: To determine the relationship between sleep attributes and the change in blood pressure. Methods: A prospective cohort study was carried out on a community basis in young adults asymptomatic for cardiovascular disease, followed up for 12.4 years. At baseline, sociodemographic and behavioural factors were determined. At the same, time nocturnal sleep was characterised in terms of quality, duration and presence of snoring. Standardised anthropometric indices and blood pressure were measured. Arterial hypertension was defined as a report of anti-hypertension treatment or blood pressure figures ≥140/90 mm Hg. Results: A total of 1,032 participants were prospectively evaluated (mean age 36.8 years, 64% males; at baseline). The incidence of arterial hypertension was 15.1% (95% CI: 12.8 - 17. 4), with evidence of a higher risk in snorers, with a subsequent reduction on adjusting for adiposity (P>.05). A gradient was observed between the duration of sleep and the change in systolic/diastolic arterial pressure (2.2/1.3 mmHg in those who reported 6-8 hours/day, and 2.7/1.6 mmHg in those who reported > 8 hours/day, compared to < 6 horas/day). Neither the subjective quality of the sleep nor the report of a siesta was associated with the blood pressure. Conclusion: The results suggest that the prolonged duration of sleep could increase blood pressure in the population.

6.
CMAJ ; 191(30): E830-E837, 2019 07 29.
Artigo em Inglês | MEDLINE | ID: mdl-31358597

RESUMO

BACKGROUND: Among adults undergoing contemporary noncardiac surgery, little is known about the frequency and timing of death and the associations between perioperative complications and mortality. We aimed to establish the frequency and timing of death and its association with perioperative complications. METHODS: We conducted a prospective cohort study of patients aged 45 years and older who underwent inpatient noncardiac surgery at 28 centres in 14 countries. We monitored patients for complications until 30 days after surgery and determined the relation between these complications and 30-day mortality using a Cox proportional hazards model. RESULTS: We included 40 004 patients. Of those, 715 patients (1.8%) died within 30 days of surgery. Five deaths (0.7%) occurred in the operating room, 500 deaths (69.9%) occurred after surgery during the index admission to hospital and 210 deaths (29.4%) occurred after discharge from the hospital. Eight complications were independently associated with 30-day mortality. The 3 complications with the largest attributable fractions (AF; i.e., potential proportion of deaths attributable to these complications) were major bleeding (6238 patients, 15.6%; adjusted hazard ratio [HR] 2.6, 95% confidence interval [CI] 2.2-3.1; AF 17.0%); myocardial injury after noncardiac surgery [MINS] (5191 patients, 13.0%; adjusted HR 2.2, 95% CI 1.9-2.6; AF 15.9%); and sepsis (1783 patients, 4.5%; adjusted HR 5.6, 95% CI 4.6-6.8; AF 12.0%). INTERPRETATION: Among adults undergoing noncardiac surgery, 99.3% of deaths occurred after the procedure and 44.9% of deaths were associated with 3 complications: major bleeding, MINS and sepsis. Given these findings, focusing on the prevention, early identification and management of these 3 complications holds promise for reducing perioperative mortality. Study registration: ClinicalTrials.gov, no. NCT00512109.


Assuntos
Complicações Pós-Operatórias/mortalidade , Procedimentos Cirúrgicos Operatórios/mortalidade , Idoso , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Hemorragia Pós-Operatória/mortalidade , Estudos Prospectivos , Sepse/mortalidade
7.
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.


Assuntos
Doença de Chagas/tratamento farmacológico , Nifurtimox/uso terapêutico , Nitroimidazóis/uso terapêutico , Tripanossomicidas/uso terapêutico , Trypanosoma cruzi/efeitos dos fármacos , Adulto , Idoso , Doenças Assintomáticas , Doença de Chagas/diagnóstico , Doença de Chagas/parasitologia , Colômbia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Nifurtimox/efeitos adversos , Nitroimidazóis/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Equivalência Terapêutica , Fatores de Tempo , Resultado do Tratamento , Tripanossomicidas/efeitos adversos , Trypanosoma cruzi/patogenicidade , Adulto Jovem
8.
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.


Assuntos
Serviço Hospitalar de Emergência/estatística & dados numéricos , Mortalidade Hospitalar , Tempo de Internação/estatística & dados numéricos , Período Perioperatório/estatística & dados numéricos , Idoso , Colômbia/epidemiologia , Procedimentos Cirúrgicos do Sistema Digestório , Tratamento de Emergência , Feminino , Hospitais Universitários , Humanos , Masculino , Pessoa de Meia-Idade , Procedimentos Ortopédicos , Estudos Retrospectivos , Fatores de Risco
9.
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
10.
Cad. Saúde Pública (Online) ; 35(1): e00059218, 2019. tab, graf
Artigo em Espanhol | LILACS | 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.


Assuntos
Humanos , Masculino , Adulto , Seleção de Pacientes , Pesquisa Biomédica/organização & administração , Doadores de Sangue , Estudos de Coortes , Seguimentos , Colômbia
11.
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
12.
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.


Assuntos
Análise Custo-Benefício , Isquemia Miocárdica , Avaliação de Resultados em Cuidados de Saúde , Cuidados Pós-Operatórios , Complicações Pós-Operatórias , Procedimentos Cirúrgicos Operatórios/efeitos adversos , Troponina T/sangue , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Isquemia Miocárdica/sangue , Isquemia Miocárdica/diagnóstico , Isquemia Miocárdica/economia , Isquemia Miocárdica/mortalidade , Avaliação de Resultados em Cuidados de Saúde/economia , Cuidados Pós-Operatórios/economia , Cuidados Pós-Operatórios/métodos , Cuidados Pós-Operatórios/normas , Complicações Pós-Operatórias/sangue , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/economia , Complicações Pós-Operatórias/mortalidade , Risco
13.
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
14.
Ann Intern Med ; 168(4): 237-244, 2018 02 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.


Assuntos
Aspirina/uso terapêutico , Intervenção Coronária Percutânea , Inibidores da Agregação de Plaquetas/uso terapêutico , Procedimentos Cirúrgicos Operatórios , Idoso , Anti-Hipertensivos/uso terapêutico , Aspirina/efeitos adversos , Biomarcadores/sangue , Clonidina/uso terapêutico , Esquema de Medicação , Quimioterapia Combinada , Feminino , Hemorragia/induzido quimicamente , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/prevenção & controle , Inibidores da Agregação de Plaquetas/efeitos adversos , Complicações Pós-Operatórias/induzido quimicamente , Complicações Pós-Operatórias/prevenção & controle , Resultado do Tratamento
15.
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
16.
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
17.
Acta méd. colomb ; 40(4): 279-287, oct.-dic. 2015. ilus, tab
Artigo em Espanhol | LILACS-Express | LILACS | 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).

18.
Lancet ; 386(10000): 1243-1253, 2015.
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1064577

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...


Assuntos
Circulação Extracorpórea , Metilprednisolona
19.
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
20.
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
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