RESUMO
INTRODUCTION: There is an interest in the role of blood eosinophils for predicting inhaled corticosteroid (ICS) response in chronic obstructive pulmonary disease (COPD). Most data are from interventional clinical studies; data from unselected real-world populations may help better inform treatment decisions. DACCORD is a non-interventional real-world study. Cohort 3 recruited patients with COPD who had received triple therapy for ≥ 6 months; prior to entry patients either continued triple therapy, or switched to a long-acting muscarinic antagonist/long-acting beta2-agonist (LABA/LAMA), and were followed for 12 months. METHODS: For these post-hoc analyses, patients were divided into four groups based on exacerbation history and baseline blood eosinophil count (< 100 vs. > 300 cells/µL). Exacerbation rates were calculated overall and for the two treatments. RESULTS: Among the 430 patients in the current analyses, the largest groups had low exacerbation history with high (44.2%) or low eosinophils (36.7%). Most patients did not exacerbate during follow-up (68.8% overall; 83.2% and 63.7% with LABA/LAMA and triple therapy). The highest exacerbation rates were in groups with high exacerbation history, differing significantly in the overall analyses from those with low exacerbation history (matched by eosinophil count); rates did not differ when grouped by eosinophil count (matched by exacerbation history). CONCLUSIONS: Although most patients in these analyses did not exacerbate during follow-up, whereas exacerbation history is a predictor of future exacerbations, blood eosinophil count is not. This suggests that although eosinophil count may help to guide ICS initiation, this is less of a consideration when 'stepping-down' from triple therapy to a LABA/LAMA.
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Eosinófilos , Doença Pulmonar Obstrutiva Crônica , Humanos , Quimioterapia Combinada , Agonistas de Receptores Adrenérgicos beta 2 , Administração por Inalação , Progressão da Doença , Doença Pulmonar Obstrutiva Crônica/diagnóstico , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Doença Pulmonar Obstrutiva Crônica/induzido quimicamente , Antagonistas Muscarínicos , Corticosteroides/uso terapêutico , BroncodilatadoresRESUMO
Tobacco dependence is a common comorbidity in patients with COPD (Chronic Obstructive Pulmonary Disease) that negatively affects the course of the disease. However, clinically relevant improvement in COPD can only be achieved by complete and permanent abstinence. Therefore, abstinence from tobacco use is a central therapeutic concept in smoking patients with COPD and requires specific and targeted treatment.After detailed documentation of smoking behaviour and motivational counseling outlining the risks of smoking, all such patients shall be offered a structured therapy for tobacco cessation. There is high-quality evidence for the effectiveness of a combination therapy of behavioral therapy and medication (to treat the withdrawal syndrome). Due to insufficient data, there is currently no recommendation for the use of e-cigarettes as a primary option for a cessation attempt.Smoking is the most important cause of COPD. Smoking cessation is the most effective and cost-efficient single intervention to reduce the risk of developing and progressing COPD.
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Sistemas Eletrônicos de Liberação de Nicotina , Doença Pulmonar Obstrutiva Crônica , Abandono do Hábito de Fumar , Tabagismo , Humanos , Fumar/efeitos adversos , Fumar/psicologia , Tabagismo/terapiaRESUMO
The management of asthma has fundamentally changed during the past decades. The present guideline for the diagnosis and treatment of asthma was developed for respiratory specialists who need detailed and evidence-based information on the new diagnostic and therapeutic options in asthma. The guideline shows the new role of biomarkers, especially blood eosinophils and fractional exhaled NO (FeNO), in diagnostic algorithms of asthma. Of note, this guideline is the first worldwide to announce symptom prevention and asthma remission as the ultimate goals of asthma treatment, which can be achieved by using individually tailored, disease-modifying anti-asthmatic drugs such as inhaled steroids, allergen immunotherapy or biologics. In addition, the central role of the treatment of comorbidities is emphasized. Finally, the document addresses several challenges in asthma management, including asthma treatment during pregnancy, treatment of severe asthma or the diagnosis and treatment of work-related asthma.
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Antiasmáticos , Asma , Feminino , Gravidez , Humanos , Óxido Nítrico , Asma/terapia , Asma/tratamento farmacológico , Antiasmáticos/uso terapêutico , Biomarcadores , Dessensibilização ImunológicaRESUMO
INTRODUCTION: Chronic obstructive pulmonary disease (COPD) guidelines recommend reserving triple therapy of inhaled corticosteroid (ICS), long-acting ß2-agonist (LABA) and long-acting muscarinic antagonist (LAMA) for patients with exacerbations despite dual therapy. However, many patients receive triple therapy without a clear indication. For these patients, it would be useful to know whether ICS can be withdrawn. METHODS: DACCORD was a longitudinal, non-interventional 'real-world' study in three cohorts. This manuscript describes the results of Cohort 3, which recruited patients with COPD who had received triple therapy for ≥ 6 months. Prior to entry, each patient's physician decided to continue triple therapy, or switch to a LABA/LAMA; patients were then followed for 12 months, with exacerbations and COPD Assessment Test (CAT) data recorded every 3 months. The primary endpoint was the time until COPD worsening, defined as the occurrence of a moderate/severe exacerbation or clinically relevant CAT worsening. RESULTS: Of the 1192 patients recruited into the study, 967 completed the end-of-study visit and ≥ 2 of the three interim visits, 292 and 675 receiving LABA/LAMA and triple therapy, respectively. Most baseline demographics were similar between the two groups. A lower proportion of patients in the LABA/LAMA group had COPD worsening than with triple therapy (32.5% vs 55.7% at 12 months), with the time to worsening extended in the LABA/LAMA group (hazard ratio 2.004, p < 0.001). In addition, a significantly lower proportion of patients in the LABA/LAMA group exacerbated (18.5% vs 28.7%; p < 0.001), accompanied by a greater improvement from baseline in CAT total score. Overall, fewer patients in the LABA/LAMA group reported adverse events than in the triple therapy group (12.9% vs 15.1%). CONCLUSIONS: These results suggest that in a real world setting physicians are able to identify patients who can be 'stepped down' from triple therapy to LABA/LAMA. Following step down, there was no overall decline in COPD-indeed, some patients had better outcomes.
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Agonistas de Receptores Adrenérgicos beta 2 , Doença Pulmonar Obstrutiva Crônica , Administração por Inalação , Corticosteroides/efeitos adversos , Agonistas de Receptores Adrenérgicos beta 2/efeitos adversos , Quimioterapia Combinada , Humanos , Antagonistas Muscarínicos/efeitos adversos , Doença Pulmonar Obstrutiva Crônica/complicações , Doença Pulmonar Obstrutiva Crônica/diagnóstico , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológicoRESUMO
BACKGROUND: Oxygen (O2) is a drug with specific biochemical and physiological properties, a range of effective doses and may have side effects. In 2015, 14% of over 55,000 hospital patients in the UK were using oxygen. 42% of patients received this supplemental oxygen without a valid prescription. Health care professionals are frequently uncertain about the relevance of hypoxemia and have low awareness about the risks of hyperoxemia. Numerous randomized controlled trials about targets of oxygen therapy have been published in recent years. A national guideline is urgently needed. METHODS: A national S3 guideline was developed and published within the Program for National Disease Management Guidelines (AWMF) with participation of 10 medical associations. A literature search was performed until February 1, 2021, to answer 10 key questions. The Oxford Centre for Evidence-Based Medicine (CEBM) System ("The Oxford 2011 Levels of Evidence") was used to classify types of studies in terms of validity. Grading of Recommendations, Assessment, Development and Evaluation (GRADE) was used for assessing the quality of evidence and for grading guideline recommendation, and a formal consensus-building process was performed. RESULTS: The guideline includes 34 evidence-based recommendations about indications, prescription, monitoring and discontinuation of oxygen therapy in acute care. The main indication for O2 therapy is hypoxemia. In acute care both hypoxemia and hyperoxemia should be avoided. Hyperoxemia also seems to be associated with increased mortality, especially in patients with hypercapnia. The guideline provides recommended target oxygen saturation for acute medicine without differentiating between diagnoses. Target ranges for oxygen saturation are based depending on ventilation status risk for hypercapnia. The guideline provides an overview of available oxygen delivery systems and includes recommendations for their selection based on patient safety and comfort. CONCLUSION: This is the first national guideline on the use of oxygen in acute care. It addresses health care professionals using oxygen in acute out-of-hospital and in-hospital settings.
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Hipercapnia , Oxigenoterapia , Adulto , Cuidados Críticos , Humanos , Hipóxia/terapia , Oxigênio/uso terapêuticoRESUMO
Assessing the risk for specific patient groups to suffer from severe courses of COVID-19 is of major importance in the current SARS-CoV-2 pandemic. This review focusses on the risk for specific patient groups with chronic respiratory conditions, such as patients with asthma, chronic obstructive pulmonary disease, cystic fibrosis (CF), sarcoidosis, interstitial lung diseases, lung cancer, sleep apnea, tuberculosis, neuromuscular diseases, a history of pulmonary embolism, and patients with lung transplants. Evidence and recommendations are detailed in exemplary cases. While some patient groups with chronic respiratory conditions have an increased risk for severe courses of COVID-19, an increasing number of studies confirm that asthma is not a risk factor for severe COVID-19. However, other risk factors such as higher age, obesity, male gender, diabetes, cardiovascular diseases, chronic kidney or liver disease, cerebrovascular and neurological disease, and various immunodeficiencies or treatments with immunosuppressants need to be taken into account when assessing the risk for severe COVID-19 in patients with chronic respiratory diseases.
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COVID-19 , Médicos , Humanos , Masculino , Pandemias , Medição de Risco , SARS-CoV-2RESUMO
BACKGROUND: Oxygen (O2) is a drug with specific biochemical and physiologic properties, a range of effective doses and may have side effects. In 2015, 14â% of over 55â000 hospital patients in the UK were using oxygen. 42â% of patients received this supplemental oxygen without a valid prescription. Healthcare professionals are frequently uncertain about the relevance of hypoxemia and have low awareness about the risks of hyperoxemia. Numerous randomized controlled trials about targets of oxygen therapy have been published in recent years. A national guideline is urgently needed. METHODS: A S3-guideline was developed and published within the Program for National Disease Management Guidelines (AWMF) with participation of 10 medical associations. Literature search was performed until Feb 1st 2021 to answer 10 key questions. The Oxford Centre for Evidence-Based Medicine (CEBM) System ("The Oxford 2011 Levels of Evidence") was used to classify types of studies in terms of validity. Grading of Recommendations, Assessment, Development and Evaluation (GRADE) was used and for assessing the quality of evidence and for grading guideline recommendation and a formal consensus-building process was performed. RESULTS: The guideline includes 34 evidence-based recommendations about indications, prescription, monitoring and discontinuation of oxygen therapy in acute care. The main indication for O2 therapy is hypoxemia. In acute care both hypoxemia and hyperoxemia should be avoided. Hyperoxemia also seems to be associated with increased mortality, especially in patients with hypercapnia. The guideline provides recommended target oxygen saturation for acute medicine without differentiating between diagnoses. Target ranges for oxygen saturation are depending on ventilation status risk for hypercapnia. The guideline provides an overview of available oxygen delivery systems and includes recommendations for their selection based on patient safety and comfort. CONCLUSION: This is the first national guideline on the use of oxygen in acute care. It addresses healthcare professionals using oxygen in acute out-of-hospital and in-hospital settings. The guideline will be valid for 3 years until June 30, 2024.
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Cuidados Críticos , Oxigenoterapia , Adulto , Humanos , Hipóxia/diagnóstico , Hipóxia/terapia , Oxigênio/uso terapêutico , Guias de Prática Clínica como AssuntoRESUMO
BACKGROUND: Overuse of short-acting beta-2 agonists (SABA), which do not treat the underlying inflammation of asthma, is linked to poor clinical outcomes such as increased exacerbation risk. This study, as part of the SABINA program, estimated the prevalence of SABA overuse and associated variables in outpatients in Germany. METHODS: This retrospective study used anonymized electronic healthcare data from the Disease Analyzer database (IQVIA). A total of 15,640 patients aged ≥ 12 years with asthma who received ≥ 1 SABA prescription(s) between July 2017 and June 2018 in 924 general physician and 22 pneumologist (PN) practices were included. SABA overuse was defined as ≥ 3 prescribed inhalers (~ 200 puffs each) during the study period. The associations between SABA overuse and physician specialty, Global Initiative for Asthma (GINA) steps (based on asthma medications), age, sex, and inhaled corticosteroid (ICS)/long-acting beta agonist (LABA) use were estimated using multivariable regression for patients with probable moderate (GINA step 2) and probable severe (GINA steps 3-5) asthma. RESULTS: Annually, 36% of all patients (GINA steps 1-5) in general and 38% in PN practices received ≥ 3 SABA inhalers. The risk of SABA overuse was 14% higher in patients treated by a general practitioner vs. a PN; 34% and 85% higher in GINA steps 4 and 5, respectively, vs. GINA step 3; and 40% higher in male vs. female patients. CONCLUSIONS: SABA overuse is prevalent among patients with asthma across all GINA steps in Germany, which may indicate suboptimal asthma control. Further studies are needed to investigate the reasons behind SABA overuse.
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Agonistas de Receptores Adrenérgicos beta 2/administração & dosagem , Asma/epidemiologia , Uso Excessivo de Medicamentos Prescritos/tendências , Administração por Inalação , Adolescente , Adulto , Idoso , Asma/tratamento farmacológico , Criança , Estudos Transversais , Feminino , Alemanha/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Prevalência , Estudos Retrospectivos , Adulto JovemRESUMO
PURPOSE: A number of analyses have shown the immediate impact of COPD exacerbations on health status. However, none evaluated the long-term correlation between health status and the occurrence of exacerbations. METHODS: DACCORD is an observational study in patients with COPD recruited across Germany following initiation or change in COPD maintenance medication. Data collected include COPD Assessment Test (CAT) total score on entry and after 1 and 2 years, and the occurrence of exacerbations. We analysed the correlation between change from baseline in CAT total score and exacerbations, after excluding patients who exacerbated during the quarter immediately prior to the CAT assessment of interest. RESULTS: The initial correlation analysis was performed in 6075 patients, 28% with ≥ 1 exacerbation over the 2-year follow-up, and 58% with a clinically relevant CAT improvement. There was a significant correlation between exacerbations over 2 years and CAT change from baseline at Year 2 (p = 0.0041). The Spearman's correlation coefficient was 0.03711, indicating very weak correlation-potentially driven by the high proportion of non-exacerbating patients. In a subsequent logistic regression, the probability of experiencing frequent (≥ 2 per year) or severe exacerbations was higher in patients with worsening in CAT total score (p < 0.001). However, the probability of a patient exacerbating in Year 1 or Year 2 did not correlate with CAT change. CONCLUSIONS: In this population (initiating or changing maintenance COPD medication), patients with frequent or severe exacerbations had a long-term worsening in health status (beyond the acute effect of an exacerbation) compared with patients who do not exacerbate.
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Volume Expiratório Forçado/fisiologia , Nível de Saúde , Doença Pulmonar Obstrutiva Crônica/epidemiologia , Idoso , Progressão da Doença , Feminino , Seguimentos , Alemanha/epidemiologia , Humanos , Masculino , Morbidade/tendências , Estudos Prospectivos , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Índice de Gravidade de DoençaRESUMO
In Germany, 10,000 cases of spontaneous pneumothorax are treated inpatient every year. The German Society for Thoracic Surgery, in co-operation with the German Society for Pulmonology, the German Radiological Society, and the German Society of Internal Medicine has developed an S3 guideline on spontaneous pneumothorax and post-interventional pneumothorax moderated by the German Association of Scientific Medical Societies. METHOD: Based on the source guideline of the British Thoracic Society (2010) for spontaneous pneumothorax, a literature search on spontaneous pneumothorax was carried out from 2008 onwards, for post-interventional pneumothorax from 1960 onwards. Evidence levels according to the Oxford Center for Evidence-Based Medicine (2011) were assigned to the relevant studies found. Recommendations according to grade (A: "we recommend"/"we do not recommend," B: "we suggest"/"we do not suggest") were determined in 3 consensus conferences by the nominal group process. RESULTS: The algorithms for primary and secondary pneumothorax differ in the indication for CT scan as well as in the indication for chest drainage application and video-assisted thoracic surgery. Indication for surgery is recommended individually taking into account the risk of recurrence, life circumstances, patient preferences, and procedure risks. For some forms of secondary pneumothorax, a reserved indication for surgery is recommended. Therapy of post-interventional spontaneous pneumothorax is similar to that of primary spontaneous pneumothorax. DISCUSSION: The recommendations of the S3 Guideline provide assistance in managing spontaneous pneumothorax and post-interventional pneumothorax. Whether this will affect existing deviant diagnostic and therapeutic measures will be demonstrated by future epidemiological studies.
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Pneumotórax/terapia , Drenagem , Alemanha , Humanos , Pneumotórax/diagnóstico por imagem , Pneumotórax/epidemiologia , Radiografia Torácica , Cirurgia Torácica VídeoassistidaRESUMO
In Germany, 10,000 cases of spontaneous pneumothorax are treated inpatient every year. The German Society for Thoracic Surgery (DGT), in co-operation with the German Society for Pulmonology (DGP), the German Radiological Society (DRG) and the German Society of Internal Medicine (DGIM) has developed an S3 guideline on spontaneous pneumothorax and postinterventional pneumothorax moderated by the German Association of Scientific Medical Societies (AWMF). METHOD: Based on the source guideline of the British Thoracic Society (BTS2010) for spontaneous pneumothorax, a literature search on spontaneous pneumothorax was carried out from 2008 onwards, for post-interventional pneumothorax from 1960 onwards. Evidence levels according to the Oxford Center for Evidence-Based Medicine (2011) were assigned to the relevant studies found. Recommendations according to GRADE (A: "we recommend"/"we do not recommend", B: "we suggest"/"we do not suggest") were determined in three consensus conferences by the nominal group process. RESULTS: The algorithms for primary and secondary pneumothorax differ in the indication for CT scan as well as in the indication for chest drainage application and video-assisted thoracic surgery (VATS). Indication for surgery is recommended individually taking into account the risk of recurrence, life circumstances, patient preferences and procedure risks. For some forms of secondary pneumothorax, a reserved indication for surgery is recommended. Therapy of postinterventional spontaneous pneumothorax is similar to that of primary spontaneous pneumothorax. DISCUSSION: The recommendations of the S3 Guideline provide assistance in managing spontaneous pneumothorax and post-interventional pneumothorax. Whether this will affect existing deviant diagnostic and therapeutic measures will be demonstrated by future epidemiological studies.
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Pneumotórax , Alemanha , Humanos , Pneumotórax/diagnóstico , Pneumotórax/epidemiologia , Pneumotórax/terapia , Sociedades MédicasRESUMO
BACKGROUND: According to the Global Initiative of Asthma, the aim of asthma treatment is to gain and maintain control. In the INTERNATIONAL CROSS-SECTIONAL AND LONGITUDINAL ASSESSMENT ON ASTHMA CONTROL (LIAISON) study, we evaluated the level of asthma control and quality of life (QoL), as well as their determinants and impact in a population consulting specialist settings. METHODS: LIAISON is a prospective, multicentre, observational study with a cross-sectional and a 12-month longitudinal phase. Adults with an asthma diagnosis since at least 6 months, receiving the same asthma treatment in the 4 weeks before enrolment were included. Asthma control was assessed with the 6-item Asthma Control Questionnaire (ACQ) and QoL with the MiniAsthma Quality of Life Questionnaire (MiniAQLQ). RESULTS: Overall, 8111 asthmatic patients were enrolled in 12 European countries. Asthma control was suboptimal in 56.5 % of patients and it was associated with poorer asthma-related QoL, higher risk of exacerbations and greater consumption of healthcare resources. Variables associated with suboptimal control were age, gender, obesity, smoking and comorbidities. Major determinants of poor asthma control were seasonal worsening and persisting exposure to allergens/irritants/triggers, followed by treatment-related issues. CONCLUSIONS: The cross-sectional phase results confirm that suboptimal control is frequent and has a high individual and economic impact. TRIAL REGISTRATION: The clinicaltrials.gov identifier is NCT01567280 .
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Antiasmáticos/uso terapêutico , Asma/tratamento farmacológico , Pulmão/efeitos dos fármacos , Qualidade de Vida , Adulto , Fatores Etários , Idoso , Antiasmáticos/economia , Asma/economia , Asma/epidemiologia , Asma/fisiopatologia , Comorbidade , Estudos Transversais , Progressão da Doença , Custos de Medicamentos , Europa (Continente)/epidemiologia , Feminino , Recursos em Saúde/economia , Recursos em Saúde/estatística & dados numéricos , Humanos , Estudos Longitudinais , Pulmão/fisiopatologia , Masculino , Adesão à Medicação , Pessoa de Meia-Idade , Obesidade/epidemiologia , Estudos Prospectivos , Fatores de Risco , Estações do Ano , Fatores Sexuais , Fumar/efeitos adversos , Fumar/epidemiologia , Inquéritos e Questionários , Fatores de Tempo , Resultado do TratamentoRESUMO
This observational study assessed the relationship between nighttime, early-morning and daytime chronic obstructive pulmonary disease (COPD) symptoms and exacerbations and healthcare resource use. COPD symptoms were assessed at baseline in patients with stable COPD using a standardised questionnaire during routine clinical visits. Information was recorded on exacerbations and healthcare resource use during the year before baseline and during a 6-month follow-up period. The main objective of the analysis was to determine the predictive nature of current symptoms for future exacerbations and healthcare resource use. 727 patients were eligible (65.8% male, mean age: 67.2 years, % predicted forced expiratory volume in 1 second: 52.8%); 698 patients (96.0%) provided information after 6 months. Symptoms in any part of the day were associated with a prior history of exacerbations (all p < 0.05) and nighttime and early-morning symptoms were associated with the frequency of primary care visits in the year before baseline (both p < 0.01). During follow-up, patients with baseline symptoms during any part of the 24-hour day had more exacerbations than patients with no symptoms in each period (all p < 0.05); there was also an association between 24-hour symptoms and the frequency of primary care visits (all p ≤ 0.01). Although there was a significant association between early-morning and daytime symptoms and exacerbations during follow-up (both p < 0.01), significance was not maintained when adjusted for potential confounders. Prior exacerbations were most strongly associated with future risk of exacerbation. The results suggest 24-hour COPD symptoms do not independently predict future exacerbation risk.
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Progressão da Doença , Recursos em Saúde/estatística & dados numéricos , Atenção Primária à Saúde/estatística & dados numéricos , Doença Pulmonar Obstrutiva Crônica/complicações , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Idoso , Feminino , Seguimentos , Volume Expiratório Forçado , Previsões , Humanos , Masculino , Pessoa de Meia-Idade , Visita a Consultório Médico/estatística & dados numéricos , Inquéritos e Questionários , Avaliação de Sintomas , Exacerbação dos Sintomas , Fatores de TempoRESUMO
BACKGROUND: A variety of large randomized controlled trials (RCT's) evaluating pharmacotherapy in chronic obstructive pulmonary disease (COPD) patients does exist. One of the drugs that has been tested is the new long-acting anticholinergic glycopyrronium bromide. METHODS: As the generalizability of results from RCT's is questionable we designed a longitudinal, prospective non-interventional study (DACCORD) of two years duration plus two years extension with at least 6000 participants in approximately 500 primary and secondary care practices in Germany (within the new established COPD National Prospective Registry), to assess patient reported outcomes (PRO's), lung function, adherence and drug safety. To circumvent the hurdle of inappropriate COPD diagnosis in a non-interventional trial, patients have to fulfill the inclusion criteria of the COPD disease management program (DMP) of the German statutory health insurances. Patient management should follow the German national COPD guidelines, which are based on Global Initiative for Chronic Obstructive Lung Disease 2007 (GOLD) report. Labels of prescribed drugs should also be taken into account. Patients received treatment as part of their standard care: at the discretion of the investigator patients were included in one of two arms. A: standard care with glycopyrronium containing regimen, and arm B: standard care without glycopyrronium. DISCUSSION: For 2016 we expect important results regarding longitudinal development of PRO's including exacerbations, lung function, adherence and side effects. We also investigate applicability of the new GOLD staging system in usual care. Data on diagnostic and treatment modalities in current German primary and secondary care, as well as pharmaco-economic data will be generated. TRIAL REGISTRATION: 1. German Register for non-interventional studies: http://www.vfa.de/de/arzneimittel-forschung/datenbanken-zu-arzneimitteln/nisdb . 2. EMA EnCePP http://www.encepp.eu/ .
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Agonistas de Receptores Adrenérgicos beta 2/uso terapêutico , Broncodilatadores/uso terapêutico , Glicopirrolato/uso terapêutico , Pacientes Ambulatoriais , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Sistema de Registros , Adulto , Feminino , Seguimentos , Alemanha , Humanos , Masculino , Estudos Prospectivos , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Resultado do TratamentoRESUMO
We evaluated the effect of QVA149, a dual bronchodilator combining indacaterol and glycopyrronium, on direct patient-reported dyspnoea in patients with moderate-to-severe chronic obstructive pulmonary disease. In this multicentre, blinded, double-dummy, three-period crossover study, 247 patients were randomised to once-daily QVA149 110/50 µg, placebo or tiotropium 18 µg. Superiority of QVA149 versus placebo (primary objective) and tiotropium (secondary objective) was assessed for improvement in dyspnoea via the self-administered computerised (SAC) version of the Baseline and Transition Dyspnoea Index after 6 weeks. Secondary end-points included lung function, rescue medication use and safety. After 6 weeks, the SAC Transition Dyspnoea Index total score was significantly higher with QVA149 versus placebo (least squares mean (LSM) treatment difference 1.37, p<0.001) and tiotropium (LSM treatment difference 0.49, p=0.021). QVA149 provided significant improvements in lung function, with higher forced expiratory volume in 1 s area under the curve from 0-4 h post-dose versus placebo and tiotropium at day 1 and week 6 (all p<0.001). Rescue medication use was significantly lower with QVA149 versus placebo (p<0.001) and tiotropium (p=0.002). All treatments were well tolerated. Once-daily QVA149 provided superior improvements in patient-reported dyspnoea and lung function versus placebo and tiotropium. These benefits were associated with improvements in other symptoms and reduced use of rescue medication.
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Broncodilatadores/administração & dosagem , Dispneia/complicações , Dispneia/tratamento farmacológico , Glicopirrolato/análogos & derivados , Indanos/administração & dosagem , Doença Pulmonar Obstrutiva Crônica/complicações , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Quinolonas/administração & dosagem , Adulto , Idoso , Área Sob a Curva , Estudos Cross-Over , Combinação de Medicamentos , Feminino , Volume Expiratório Forçado , Glicopirrolato/administração & dosagem , Humanos , Masculino , Pessoa de Meia-Idade , Pós , Derivados da Escopolamina/administração & dosagem , Espirometria , Brometo de Tiotrópio , Resultado do TratamentoRESUMO
BACKGROUND: Few studies have investigated the 24-hour symptom profile in patients with COPD or how symptoms during the 24-hour day are inter-related. This observational study assessed the prevalence, severity and relationship between night-time, early morning and daytime COPD symptoms and explored the relationship between 24-hour symptoms and other patient-reported outcomes. METHODS: The study enrolled patients with stable COPD in clinical practice. Baseline night-time, early morning and daytime symptoms (symptom questionnaire), severity of airflow obstruction (FEV1), dyspnoea (modified Medical Research Council Dyspnoea Scale), health status (COPD Assessment Test), anxiety and depression levels (Hospital Anxiety and Depression Scale), sleep quality (COPD and Asthma Sleep Impact Scale) and physical activity level (sedentary, moderately active or active) were recorded. RESULTS: The full analysis set included 727 patients: 65.8% male, mean ± standard deviation age 67.2 ± 8.8 years, % predicted FEV1 52.8 ± 20.5%. In each part of the 24-hour day, >60% of patients reported experiencing ≥1 symptom in the week before baseline. Symptoms were more common in the early morning and daytime versus night-time (81.4%, 82.7% and 63.0%, respectively). Symptom severity was comparable for each period assessed. Overall, in the week before baseline, 56.7% of patients had symptoms throughout the whole 24-hour day (3 parts of the day); 79.9% had symptoms in ≥2 parts of the 24-hour day. Symptoms during each part of the day were inter-related, irrespective of disease severity (all p < 0.001). Early morning and daytime symptoms were associated with the severity of airflow obstruction (p < 0.05 for both). Night-time, early morning and daytime symptoms were all associated with worse dyspnoea, health status and sleep quality, and higher anxiety and depression levels (all p < 0.001 versus patients without symptoms in each corresponding period). In each part of the 24-hour day, there was also an association between symptoms and a patient's physical activity level (p < 0.05 for each period). CONCLUSIONS: More than half of patients experienced COPD symptoms throughout the whole 24-hour day. There was a significant relationship between night-time, early morning and daytime symptoms. In each period, symptoms were associated with worse patient-reported outcomes, suggesting that improving 24-hour symptoms should be an important consideration in the management of COPD.
Assuntos
Ritmo Circadiano , Pulmão/fisiopatologia , Doença Pulmonar Obstrutiva Crônica/diagnóstico , Idoso , Ansiedade/epidemiologia , Ansiedade/psicologia , Depressão/epidemiologia , Depressão/psicologia , Dispneia/epidemiologia , Dispneia/fisiopatologia , Europa (Continente)/epidemiologia , Feminino , Volume Expiratório Forçado , Nível de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Atividade Motora , Prevalência , Doença Pulmonar Obstrutiva Crônica/epidemiologia , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Doença Pulmonar Obstrutiva Crônica/psicologia , Índice de Gravidade de Doença , Sono , Inquéritos e Questionários , Fatores de TempoRESUMO
BACKGROUND: According to international guidelines, the goal of asthma management is to achieve and maintain control of the disease, which can be assessed using composite measures. Prospective studies are required to determine how these measures are associated with asthma outcomes and/or future risk. The 'InternationaL cross-sectIonAl and longItudinal assessment on aSthma cONtrol (LIAISON)' observational study has been designed to evaluate asthma control and its determinants, including components of asthma management. METHODS/DESIGN: The LIAISON study will be conducted in 12 European countries and comprises a cross-sectional phase and a 12-month prospective phase. Both phases will aim at assessing asthma control (six-item Asthma Control Questionnaire, ACQ), asthma-related quality of life (Mini Asthma Quality of Life Questionnaire, Mini-AQLQ), risk of non-adherence to treatment (four-item Morisky Medication Adherence Scale, MMAS-4), potential reasons for poor control, treatment strategies and associated healthcare costs.The cross-sectional phase will recruit > 8,000 adult patients diagnosed with asthma for at least 6 months and receiving the same asthma treatment in the 4 weeks before enrolment.The prospective phase will include all patients with uncontrolled/poorly controlled asthma at the initial visit to assess the proportion reaching control during follow-up and to examine predictors of future risk. Visits will take place after 3, 6 and 12 months. DISCUSSION: The LIAISON study will provide important information on the prevalence of asthma control and on the quality of life in a broad spectrum of real-life patient populations from different European countries and will also contribute to evaluate differences in management strategies and their impact on healthcare costs over 12 months of observation. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT01567280.
Assuntos
Antiasmáticos/uso terapêutico , Asma/tratamento farmacológico , Asma/fisiopatologia , Nível de Saúde , Qualidade de Vida , Adulto , Estudos Transversais , Europa (Continente) , Feminino , Humanos , Classificação Internacional de Doenças , Estudos Longitudinais , Masculino , Avaliação de Resultados em Cuidados de Saúde , Estudos Prospectivos , Projetos de Pesquisa , Inquéritos e QuestionáriosRESUMO
BACKGROUND AND AIMS: Cineole is the main constituent of eucalyptus oil, and it is mainly used as a mucolytic agent in inflammatory airway diseases. With its known mucolytic, bronchodilating, and anti-inflammatory effects, cineole reduces the exacerbation rate in patients suffering from chronic obstructive pulmonary disease. Based on these pharmacodynamic effects, we arrived at the hypothesis that asthma patients would benefit from concomitant therapy with cineole. METHODS: As part of a double-blind, placebo-controlled, multicenter study, 247 patients with confirmed asthma were randomly selected according to the guidelines for this study. All patients were administered 200 mg of cineole, or a placebo, three times per day as a concomitant therapy over a period of 6 months. The combined primary outcome measures, which were implemented as a multiple criteria testing process, were improvement of lung function, asthma symptoms, and quality of life. RESULTS: Following the completion of the 6-month treatment period, it was noted that the patient group treated with cineole showed significantly more improvements to the multiple testing criteria than the patients in the placebo group (p = .0027). The statistical significance of the individual outcome measures could also be proven in accordance with the Wei-Lachin procedure (i.e., for Forced expiratory Volume 1 Second, p = .0398; for asthma symptoms, p = .0325; and for Asthma Quality of Life Questionnaire (AQLQ), p = .0475). CONCLUSION: Concomitant therapy using cineole can lead to notable improvement in lung function and health condition as well as to reduce dyspnea in asthma patients.
Assuntos
Asma/tratamento farmacológico , Cicloexanóis/uso terapêutico , Monoterpenos/uso terapêutico , Adolescente , Adulto , Idoso , Asma/imunologia , Asma/fisiopatologia , Método Duplo-Cego , Eucaliptol , Feminino , Volume Expiratório Forçado/efeitos dos fármacos , Humanos , Masculino , Pessoa de Meia-Idade , Qualidade de Vida , Estatísticas não Paramétricas , Adulto JovemRESUMO
BACKGROUND: Oxygen is a drug with specific properties, a defined dose-effect range and side effects. In 2015, in a sample of UK hospital patients, 14% were treated with oxygen, of which only 42% had a prescription. Health care workers are often uncertain about the relevance of hypoxemia, and there is limited awareness of the risks of hyperoxemia. Numerous randomized controlled trials on oxygen therapy have recently been published. METHODS: As part of the guideline program of the Working Group of Scientific Medical Societies e.â¯V. (AWMF), this S3 guideline was developed with the participation of 10 medical societies on the basis of a literature search up to 02/01/2021. The system of the Oxford Centre for Evidence-Based Medicine (CEBM) (The Oxford 2011 Levels of Evidence) was used to evaluate the literature. The quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE), and a formal consensus process of recommendations was performed. RESULTS: The guideline contains 34 evidence-based recommendations on the indication, prescription, monitoring, and discontinuation of oxygen therapy in acute care. The indication for oxygen is mainly hypoxemia. Hypoxemia and hyperoxemia should be avoided, since both increase mortality. The guideline recommends target ranges of oxygen saturation for acute oxygen therapy without differentiating between different diagnoses. Target areas depend on the risk for hypercapnia and ventilation status. The guideline provides an overview of available oxygen delivery systems and contains recommendations for their selection based on patient safety and comfort. CONCLUSION: This is the first German guideline on the use of oxygen in acute care. It is aimed at medical professionals who use oxygen in and outside hospitals and is valid until June 30th, 2024.