Eszopiclone versus zopiclone in the treatment of insomnia

OBJECTIVE: To determine the therapeutic effects of two selective GABA-A agonists, zopiclone and eszopiclone, in the treatment of insomnia. METHODS: This study comprised a phase III, single-center, randomized, double-blind, double-dummy, parallel-group, non-inferiority trial. Patients were randomized to receive zopiclone 7.5 mg or eszopiclone 3 mg, both orally, for four weeks. In total, 199 patients were evaluated during two visits and then followed for at least six weeks. The primary endpoint was the Insomnia Severity Index after four weeks of treatment. Secondary endpoints were obtained through polysomnography data, including total sleep time, sleep latency and sleep efficiency. The frequency of adverse events was also analyzed. ClinicalTrials.gov: NCT01100164. RESULTS: The primary efficacy analysis demonstrated the non-inferiority of eszopiclone over zopiclone. Analysis of objective parameters assessed by polysomnography showed that eszopiclone increased total sleep time and also improved sleep efficiency. The safety profile of both study treatments was similar and the most common events reported in both groups were dysgeusia, headache, dizziness, irritability and nausea. Adverse events were observed in 223 patients, 109 (85.2%) in the eszopiclone group and 114 (87.7%) in the zopiclone group. CONCLUSION: Based on the Insomnia Severity Index at the end of four weeks of treatment, eszopiclone demonstrated efficacy comparable to that of zopiclone in the treatment of insomnia, increasing total sleep time as well as sleep efficiency according to polysomnography

Cerebrovascular Response to Carbon Dioxide in women with Pulmonary Arterial Hypertension and Healthy Controls: implications for Sleep Disordered Breathing and Ventilatory Response

Fundamentacao: O dioxido de carbono (CO2) tem relevancia crucial no controle ventilatorio ja que alteracoes nas suas pressoes parciais influenciam o grau de estimulacao dos quimiorreceptores - particularmente os centrais - e o tonus vascular cerebral. A hipertensao arterial pulmonar (HAP) caracteriza-se por hiperventilacao alveolar e consequente hipocapnia, tanto no repouso quanto no exercicio. A hipocapnia cronica tem o potencial de instabilizar o controle ventilatorio via embotamento da reatividade cerebrovascular ao CO2 (RCVCO2). Neste contexto, o comprometimento da capacidade vasodilatadora permitiria excessiva estimulacao ventilatoria na hipercapnia e a vasoconstricao deficiente levaria a insuficiente estimulacao ventilatoria na hipocapnia. Tais anormalidades tendem a ser particularmente importantes quando as influencias humorais tem papel preponderante no controle ventilatorio, e.g., no sono e no exercicio. Portanto, torna-se licito supor que, se presente, o comprometimento da RCVCO2 seria particularmente deleterio na HAP induzindo a disturbios respiratorios do sono (DRS) e excessiva resposta ventilatoria ao CO2. Objetivos: Investigar a RCVCO2 e suas possiveis interrelacoes com os DRS e a resposta ventilatoria no repouso e no exercicio em pacientes com HAP e individuos saudaveis de mesma idade e sexo. Hipotese: A menor RCVCO2, nas pacientes com HAP, estaria associada com maior frequencia de DRS e resposta ventilatoria excessiva tanto no repouso quanto no exercicio comparativamente as controles. Metodos: A RCVCO2 foi medida em 25 pacientes do sexo feminino com HAP e 10 controles pareadas por idade. Um indice de fluxo sanguineo cerebral (IFS, Mol.l-1.s-1) foi obtido pela taxa de incremento do corante indocianina verde mensurada pela espectroscopia por raios quasi-infravermelhos (NIRO 200, Hamamatsu Inc, Japan) sobre o cortex pre-frontal. A razao entre variacoes no IFS e na PCO2 trancutanea (PCO2tc, mmHg) estimou a RCVCO2 durante dois testes em hipercapnia (CO2 3% e 5%) e dois em hipocapnia (leve e moderada). A investigacao de DRS foi realizada pela polissonografia de noite inteira e a resposta ventilatoria avaliada durante o repouso e no exercicio cardiorrespiratorio incremental em cicloergometroBV UNIFESP: Teses e dissertaçõe

Eszopiclone versus zopiclone in the treatment of insomnia

OBJECTIVE: To determine the therapeutic effects of two selective GABA-A agonists, zopiclone and eszopiclone, in the treatment of insomnia. METHODS: This study comprised a phase III, single-center, randomized, double-blind, double-dummy, parallel-group, non-inferiority trial. Patients were randomized to receive zopiclone 7.5 mg or eszopiclone 3 mg, both orally, for four weeks. In total, 199 patients were evaluated during two visits and then followed for at least six weeks. The primary endpoint was the Insomnia Severity Index after four weeks of treatment. Secondary endpoints were obtained through polysomnography data, including total sleep time, sleep latency and sleep efficiency. The frequency of adverse events was also analyzed. ClinicalTrials.gov: NCT01100164. RESULTS: The primary efficacy analysis demonstrated the non-inferiority of eszopiclone over zopiclone. Analysis of objective parameters assessed by polysomnography showed that eszopiclone increased total sleep time and also improved sleep efficiency. The safety profile of both study treatments was similar and the most common events reported in both groups were dysgeusia, headache, dizziness, irritability and nausea. Adverse events were observed in 223 patients, 109 (85.2%) in the eszopiclone group and 114 (87.7%) in the zopiclone group. CONCLUSION: Based on the Insomnia Severity Index at the end of four weeks of treatment, eszopiclone demonstrated efficacy comparable to that of zopiclone in the treatment of insomnia, increasing total sleep time as well as sleep efficiency according to polysomnography.Associacao Fundo de Incentivo a Pesquisa (AFIP)Universidade Federal de São Paulo (UNIFESP), Departamento de Psicobiologia, São Paulo/, SP, BrazilUniversidade Federal de São Paulo (UNIFESP), Departamento de Psicobiologia, São Paulo/, SP, BrazilWeb of Scienc

Patients admitted to the ICU for acute exacerbation of COPD : two-year mortality and functional status

Objetivo: Determinar a taxa de mortalidade de pacientes com DPOC e avaliar o estado funcional dos sobreviventes dois anos após a alta da UTI. Métodos: Estudo de coorte prospectiva realizada nas UTIs de dois hospitais na cidade de Porto Alegre (RS) com pacientes com exacerbação aguda de DPOC e internados em UTI entre julho de 2005 e julho de 2006. Dois anos após a alta, os sobreviventes foram entrevistados via telefone. Os dados obtidos foram utilizados na determinação dos escores da escala de Karnofsky e de uma escala de atividades de vida diária (AVD). Resultados: Foram incluídos 231 pacientes. A mortalidade hospitalar foi de 37,7% e a mortalidade extra-hospitalar foi de 30,3%. Dos 74 sobreviventes, foram entrevistados 66 (89%). A média de idade dos pacientes no momento da internação na UTI era de 74 ± 10 anos e a do escore Acute Physiology and Chronic Health Evaluation II era de 18 ± 7. Tinham duas ou mais comorbidades 87,8% dos pacientes. Dos 66 entrevistados, 57 (86,3%) viviam em suas casas, 58 (87,8%) eram capazes de realizar seu autocuidado, 12 (18,1%) utilizavam oxigenoterapia, e 4 (6,1%) necessitavam suporte ventilatório. Houve uma significante redução na qualidade de vida e na autonomia, segundo os escores da escala de Karnofsky (85 ± 9 vs. 79 ± 11; p = 0,03) e de AVD (29 ± 5 vs. 25 ± 7; p = 0,01), respectivamente. Conclusões: A mortalidade desta amostra de pacientes foi muito elevada nos primeiros dois anos. Embora houvesse evidente redução do estado funcional dos sobreviventes, os mesmos preservaram a capacidade de realizar seu autocuidado.Objective: To assess ICU patients with COPD, in terms of in-hospital characteristics, two-year mortality and two-year functional status of survivors. Methods: A prospective cohort study involving patients with acute exacerbation of COPD admitted to the ICUs of two hospitals in the city of Porto Alegre, Brazil, between July of 2005 and July of 2006. At two years after discharge, survivors were interviewed by telephone in order to determine Karnofsky scores and scores on a scale regarding activities of daily living (ADL). Results: The sample comprised 231 patients. In-hospital mortality was 37.7%, and two-year post-discharge mortality was 30.3%. Of the 74 survivors, 66 were interviewed (89%). The mean age at ICU admission was 74 ± 10 years, and the mean Acute Physiology and Chronic Health Evaluation II score was 18 ± 7. Two or more comorbidities were present in 87.8% of the patients. Of the 66 interviewees, 57 (86.3%) lived at home, 58 (87.8%) were self-sufficient, 12 (18.1%) required oxygen therapy, and 4 (6.1%) still required ventilatory support. There was a significant reduction in the quality of life and autonomy of the survivors, as evidenced by the Karnofsky scores (85 ± 9 vs. 79 ± 11, p = 0.03) and ADL scale scores (29 ± 5 vs. 25 ± 7; p = 0.01), respectively. Conclusions: In this patient sample, two-year mortality was quite high. Although there was a noticeable reduction in the functional status of the survivors, they remained self-sufficient

Patients admitted to the ICU for acute exacerbation of COPD : two-year mortality and functional status

Objetivo: Determinar a taxa de mortalidade de pacientes com DPOC e avaliar o estado funcional dos sobreviventes dois anos após a alta da UTI. Métodos: Estudo de coorte prospectiva realizada nas UTIs de dois hospitais na cidade de Porto Alegre (RS) com pacientes com exacerbação aguda de DPOC e internados em UTI entre julho de 2005 e julho de 2006. Dois anos após a alta, os sobreviventes foram entrevistados via telefone. Os dados obtidos foram utilizados na determinação dos escores da escala de Karnofsky e de uma escala de atividades de vida diária (AVD). Resultados: Foram incluídos 231 pacientes. A mortalidade hospitalar foi de 37,7% e a mortalidade extra-hospitalar foi de 30,3%. Dos 74 sobreviventes, foram entrevistados 66 (89%). A média de idade dos pacientes no momento da internação na UTI era de 74 ± 10 anos e a do escore Acute Physiology and Chronic Health Evaluation II era de 18 ± 7. Tinham duas ou mais comorbidades 87,8% dos pacientes. Dos 66 entrevistados, 57 (86,3%) viviam em suas casas, 58 (87,8%) eram capazes de realizar seu autocuidado, 12 (18,1%) utilizavam oxigenoterapia, e 4 (6,1%) necessitavam suporte ventilatório. Houve uma significante redução na qualidade de vida e na autonomia, segundo os escores da escala de Karnofsky (85 ± 9 vs. 79 ± 11; p = 0,03) e de AVD (29 ± 5 vs. 25 ± 7; p = 0,01), respectivamente. Conclusões: A mortalidade desta amostra de pacientes foi muito elevada nos primeiros dois anos. Embora houvesse evidente redução do estado funcional dos sobreviventes, os mesmos preservaram a capacidade de realizar seu autocuidado.Objective: To assess ICU patients with COPD, in terms of in-hospital characteristics, two-year mortality and two-year functional status of survivors. Methods: A prospective cohort study involving patients with acute exacerbation of COPD admitted to the ICUs of two hospitals in the city of Porto Alegre, Brazil, between July of 2005 and July of 2006. At two years after discharge, survivors were interviewed by telephone in order to determine Karnofsky scores and scores on a scale regarding activities of daily living (ADL). Results: The sample comprised 231 patients. In-hospital mortality was 37.7%, and two-year post-discharge mortality was 30.3%. Of the 74 survivors, 66 were interviewed (89%). The mean age at ICU admission was 74 ± 10 years, and the mean Acute Physiology and Chronic Health Evaluation II score was 18 ± 7. Two or more comorbidities were present in 87.8% of the patients. Of the 66 interviewees, 57 (86.3%) lived at home, 58 (87.8%) were self-sufficient, 12 (18.1%) required oxygen therapy, and 4 (6.1%) still required ventilatory support. There was a significant reduction in the quality of life and autonomy of the survivors, as evidenced by the Karnofsky scores (85 ± 9 vs. 79 ± 11, p = 0.03) and ADL scale scores (29 ± 5 vs. 25 ± 7; p = 0.01), respectively. Conclusions: In this patient sample, two-year mortality was quite high. Although there was a noticeable reduction in the functional status of the survivors, they remained self-sufficient

Factors influencing physical functional status in intensive care unit survivors two years after discharge

Background: Studies suggest that in patients admitted to intensive care units (ICU), physical functional status (PFS) improves over time, but does not return to the same level as before ICU admission. The goal of this study was to assess physical functional status two years after discharge from an ICU and to determine factors influencing physical status in this population. Methods: The study reviewed all patients admitted to two non-trauma ICUs during a one-year period and included patients with age ≥ 18 yrs, ICU stay ≥ 24 h, and who were alive 24 months after ICU discharge. To assess PFS, Karnofsky Performance Status Scale scores and Lawton-Instrumental Activities of Daily Living (IADL) scores at ICU admission (K-ICU and L-ICU) were compared to the scores at the end of 24 months (K-24mo and L-24mo). Data at 24 months were obtained through telephone interviews. Results: A total of 1,216 patients were eligible for the study. Twenty-four months after ICU discharge, 499 (41.6%) were alive, agreed to answer the interview, and had all hospital data available. PFS (K-ICU: 86.6 ± 13.8 vs. K-24mo: 77.1 ± 19.6, p < 0.001) and IADL (L-ICU: 27.0 ± 11.7 vs. L-24mo: 22.5 ± 11.5, p < 0.001) declined in patients with medical and unplanned surgical admissions. Most strikingly, the level of dependency increased in neurological patients (K-ICU: 86 ± 12 vs. K-24mo: 64 ± 21, relative risk [RR] 2.6, 95% CI, 1.8–3.6, p < 0.001) and trauma patients (K-ICU: 99 ± 2 vs. K-24mo: 83 ± 21, RR 2.7, 95% CI, 1.6–4.6, p < 0.001). The largest reduction in the ability to perform ADL occurred in neurological patients (L-ICU: 27 ± 7 vs. L-24mo: 15 ± 12, RR 3.3, 95% CI, 2.3–4.6 p < 0.001), trauma patients (L-ICU: 32 ± 0 vs. L-24mo: 25 ± 11, RR 2.8, 95% CI, 1.5–5.1, p < 0.001), patients aged ≥ 65 years (RR 1.4, 95% CI, 1.07–1.86, p = 0.01) and those who received mechanical ventilation for ≥ 8 days (RR 1.48, 95% CI, 1.02–2.15, p = 0.03). Conclusions: Twenty-four months after ICU discharge, PFS was significantly poorer in patients with neurological injury, trauma, age ≥ 65 tears, and mechanical ventilation ≥ 8 days. Future studies should focus on the relationship between PFS and health-related quality of life in this population

Doença mental, mulheres e transformação social: um perfil evolutivo institucional de 1931 a 2000 Mental health, women and social change: a progressive institutional profile from 1931 to 2000

INTRODUÇÃO: No século XX, as mulheres vivenciaram inúmeras transformações e alcançaram uma participação mais ativa na sociedade.O estudo visa descrever o perfil da clientela feminina, admitida em um serviço de internação psiquiátrica com as transformações históricas, sociais e demográficas.Oferece um retrato comparativo das condições epidemológicas existentes no decorrer da série histórica e os aspectos do meio da condição sociocultural das mulheres do estado. MATERIAIS E MÉTODOS: Estudo epidemiológico descritivo, longitudinal, tipo série histórica de dados, baseado na coleta de dados efetuada no serviço de arquivo médico e de estatísticas de um hospital. Foram analisadas as seguintes variáveis: idade, estado civil, cor, setor profissional, ocupação, classe social e diagnóstico psiquiátrico, todos padronizados conforme os critérios da Classificação Internacional de Doenças, edições 9 e 10. Para identificação dos casos, utilizaram-se todas as primeiras internações de mulheres. RESULTADOS: No decorrer de 70 anos, obteve-se um total de 9.629 indivíduos/casos. Observou-se o predomínio de mulheres na faixa etária de 26 a 45 anos (47,9%), brancas (91,3%), pertencentes ao subproletariado (86,8%), fora da população economicamente ativa (96,7%) e com diagnóstico de transtornos afetivos (28,6%) e psicoses esquizofrênicas (25,2%). Quanto ao estado civil, verificou-se maior presença de mulheres casadas (44,9%). Todavia, na década de 90, as mulheres solteiras representaram 54,4%, enquanto que as casadas perfizeram 39,7% das pacientes. CONCLUSÃO: Foram detectadas mudanças significativas nos motivos para admissão de mulheres nos últimos anos. Sugere-se que as variações tenham sido influenciadas pelos determinantes biológicos das doenças mentais graves e, também de maneira significativa, pelas pressões sociais advindas do novo papel da mulher na sociedade.<br>INTRODUCTION: Along the 20th century, women underwent numerous changes and reached a more active participation in society. This study aims at describing the profile of the female patients admitted to a service of psychiatric hospitalization from May 1931 to December 2000. In addition, it relates the profile of psychiatric morbidity with the historical, social and demographic changes. It also offers a comparison between the epidemiological conditions throughout the historical series and the aspects regarding the environment and the sociocultural status of women from a Southern Brazilian state. MATERIALS AND METHODS: Descriptive, longitudinal, epidemiological study including historical data and based on data collected from the medical files and statistics of a hospital. The following variables were assessed: age, marital status, race, professional area, occupation, social class and psychiatric diagnosis, all standardized according to the International Classification of Diseases (ICD-9 and ICD-10) criteria. To identify the cases, all first hospitalizations of women were used. RESULTS: Along 70 years, a total of 9,629 individuals/cases was obtained. There was a predominance of women in the age group between 26-45 years (47.9%), white (91.3%), belonging to the subproletariat (86.8%), not belonging to the economically active part of the population (96.7%) and with diagnosis of affective disorders (28.6%) and schizophrenic psychoses (25.2%). With regard to marital status, married women were prevalent (44.9%). However, in the 1990's, single women represented 54.4%, whereas married women accounted for 39.7% of the patients. CONCLUSION: Significant changes were detected in the reasons for admitting women to psychiatric services over the past years. It is suggested that the variations might have been influenced by biological determinants of severe mental diseases, and especially by the social pressure resulting from the new role of women in society

Exacerbação aguda da DPOC: mortalidade e estado funcional dois anos após a alta da UTI Patients admitted to the ICU for acute exacerbation of COPD: two-year mortality and functional status

OBJETIVO: Determinar a taxa de mortalidade de pacientes com DPOC e avaliar o estado funcional dos sobreviventes dois anos após a alta da UTI. MÉTODOS: Estudo de coorte prospectiva realizada nas UTIs de dois hospitais na cidade de Porto Alegre (RS) com pacientes com exacerbação aguda de DPOC e internados em UTI entre julho de 2005 e julho de 2006. Dois anos após a alta, os sobreviventes foram entrevistados via telefone. Os dados obtidos foram utilizados na determinação dos escores da escala de Karnofsky e de uma escala de atividades de vida diária (AVD). RESULTADOS: Foram incluídos 231 pacientes. A mortalidade hospitalar foi de 37,7% e a mortalidade extra-hospitalar foi de 30,3%. Dos 74 sobreviventes, foram entrevistados 66 (89%). A média de idade dos pacientes no momento da internação na UTI era de 74 ± 10 anos e a do escore Acute Physiology and Chronic Health Evaluation II era de 18 ± 7. Tinham duas ou mais comorbidades 87,8% dos pacientes. Dos 66 entrevistados, 57 (86,3%) viviam em suas casas, 58 (87,8%) eram capazes de realizar seu autocuidado, 12 (18,1%) utilizavam oxigenoterapia, e 4 (6,1%) necessitavam suporte ventilatório. Houve uma significante redução na qualidade de vida e na autonomia, segundo os escores da escala de Karnofsky (85 ± 9 vs. 79 ± 11; p = 0,03) e de AVD (29 ± 5 vs. 25 ± 7; p = 0,01), respectivamente. CONCLUSÕES: A mortalidade desta amostra de pacientes foi muito elevada nos primeiros dois anos. Embora houvesse evidente redução do estado funcional dos sobreviventes, os mesmos preservaram a capacidade de realizar seu autocuidado<br>OBJECTIVE: To assess ICU patients with COPD, in terms of in-hospital characteristics, two-year mortality and two-year functional status of survivors. METHODS: A prospective cohort study involving patients with acute exacerbation of COPD admitted to the ICUs of two hospitals in the city of Porto Alegre, Brazil, between July of 2005 and July of 2006. At two years after discharge, survivors were interviewed by telephone in order to determine Karnofsky scores and scores on a scale regarding activities of daily living (ADL). RESULTS: The sample comprised 231 patients. In-hospital mortality was 37.7%, and two-year post-discharge mortality was 30.3%. Of the 74 survivors, 66 were interviewed (89%). The mean age at ICU admission was 74 ± 10 years, and the mean Acute Physiology and Chronic Health Evaluation II score was 18 ± 7. Two or more comorbidities were present in 87.8% of the patients. Of the 66 interviewees, 57 (86.3%) lived at home, 58 (87.8%) were self-sufficient, 12 (18.1%) required oxygen therapy, and 4 (6.1%) still required ventilatory support. There was a significant reduction in the quality of life and autonomy of the survivors, as evidenced by the Karnofsky scores (85 ± 9 vs. 79 ± 11, p = 0.03) and ADL scale scores (29 ± 5 vs. 25 ± 7; p = 0.01), respectively. CONCLUSIONS: In this patient sample, two-year mortality was quite high. Although there was a noticeable reduction in the functional status of the survivors, they remained self-sufficien