Risk of Pneumonia in Patients with COPD Initiating Fixed Dose Inhaled Corticosteroid (ICS) / Long-Acting Bronchodilator (LABD) Formulations Containing Extrafine Beclometasone Dipropionate versus Patients Initiating LABD Without ICS.

Background: Combined ICS and long-acting bronchodilators (LABD) more effectively reduce COPD exacerbations than LABD therapy alone. Corticosteroid-related adverse effects, including pneumonia, limit ICS use. Previous data suggest this risk is lower for extrafine beclometasone (ef-BDP). We compared pneumonia risk among new users of fixed dose ICS/LABD formulations containing ef-BDP, versus patients initiating LABD without any ICS. Methods: A propensity-matched historical cohort study design used data from OPCRD. COPD patients with ≥1 year of continuous data who initiated LABD or ICS/LABD formulations containing ef-BDP were matched. Primary outcome was time to pneumonia event, as treated, using either sensitive (physician diagnosed) or specific (physician diagnosed and x-ray or hospital admission confirmed) definitions, with non-inferiority boundary of 15%. Results: 23,898 COPD patients were matched, who were 68±11 years, 54.3% male and 56% current-smokers, while 43% were former-smokers. Initiation of ef-BDP/LABD was not associated with an increased risk of pneumonia versus LABD, for either a sensitive 0.89 (0.78-1.02), P = 0.08 or a specific 0.91 (0.78-1.05), P = 0.18 definition of pneumonia. The probability of remaining pneumonia free 1-year after ef-BDP/LABD was 98.4%, which was comparable to LABD at 97.7%, and was sustained up to 6 years of observation; non-inferiority criterion was met for both definitions. Initiation of ef-BDP/LABD was also associated with a reduced risk of developing LRTIs in the propensity matched cohort. Conclusion: Risk of pneumonia when using ICS for the management of COPD reported in several randomised controlled trials may not be relevant with ef-BDP in a diverse real-world clinical population.

The economic impact of asthma on private healthcare system in Brazil: Economic impact of asthma in Brazil.

To assess healthcare resource utilization and costs of patients with asthma in Brazilian Supplementary Healthcare System, focusing on hospitalization data. Retrospective cohort study, using data from an administrative database of a private company (Orizon). Patients aged ≥ 12 years with at least one record of emergency visit/hospitalization in the database with the ICD-10 J45 between January/2010 and June/2015 were included and followed until June/2016, death or inactivation of health plan. Sociodemographic characteristics, emergency visit and hospital admission per patient per year (exacerbation rate), physician visit with a procedure, exams, length of hospitalization (with/without intensive care unit (ICU)), and in-hospital treatments were assessed. A total of 54,568 patients were included in this analysis. Regarding resource utilization, emergency visit and hospital admission rates of 0.34 and 0.04 per person-year were observed, respectively. Mean length of hospital stay were 8.82 (SD = 36.48), 5.24 (SD = 19.06) and 19.53 (63.89) days for hospitalizations in general, without and with ICU, respectively. An exacerbation rate of 0.36 per person year was observed with a mean cost per episode of 3178 Brazilian Real (BRL) (SD = 31,667). Mean cost related to emergency department visits was estimated at 293 BRL (SD = 328). Hospitalization costs were stratified by the need of ICU and values observed were of 9307 BRL (SD = 18,979) without ICU, and 75,252 BRL (SD = 174,248) with ICU need. Asthma exacerbations may cost ~75,000 BRL for an ICU-dependent event in the Supplementary Healthcare System. To improve disease control may reduce disease burden for both healthcare system and patients.

Interclass Difference in Pneumonia Risk in COPD Patients Initiating Fixed Dose Inhaled Treatment Containing Extrafine Particle Beclometasone versus Fine Particle Fluticasone.

BACKGROUND: Inhaled corticosteroids (ICS) afford therapeutic benefits in some COPD patients, but their widespread use is cautioned due to an increased risk of developing pneumonia. Subclass variations exist, and the risk profile differs for individual ICS. Formulation particle size has been identified as a potential effect modifier. The present study compared the risk of pneumonia among new COPD users of fixed-dose combination inhalers containing fine-particle fluticasone (fp-FDC-F) versus extrafine particle beclometasone (ef-FDC-BDP). METHODS: A propensity matched historical cohort study was conducted using data from the Optimum Patient Care Research Database. COPD patients aged ≥40 years with ≥1 year of continuous medical data who initiated fp-FDC-F or ef-FDC-BDP were compared. The primary outcome was time to pneumonia event, as treated, using either sensitive (physician diagnosed) or specific (physician diagnosed and x-ray or hospital admission confirmed) definitions. RESULTS: A total of 13,316 patients were matched. Initiation of fp-FDC-F (mean dosage furoate 99 µg; propionate 710 µg) was associated with an increased risk of pneumonia versus ef-FDC-BDP (mean beclometasone dose 395 µg), irrespective of definition (sensitive HR 1.38 95% CI 1.14-1.68; specific HR 1.31 95% CI 1.05-1.62). CONCLUSION: In the current investigation, we found that in comparison to extrafine beclomethasone, commencing a formulation containing fluticasone is associated with an increased risk of developing pneumonia. These observations support the idea that not all ICS are equal in their adverse effects and subclass variations exist and should be carefully considered in the treatment choice.

2021 Brazilian Thoracic Association recommendations for the management of severe asthma.

Advances in the understanding that severe asthma is a complex and heterogeneous disease and in the knowledge of the pathophysiology of asthma, with the identification of different phenotypes and endotypes, have allowed new approaches for the diagnosis and characterization of the disease and have resulted in relevant changes in pharmacological management. In this context, the definition of severe asthma has been established, being differentiated from difficult-to-control asthma. These recommendations address this topic and review advances in phenotyping, use of biomarkers, and new treatments for severe asthma. Emphasis is given to topics regarding personalized management of the patient and selection of biologicals, as well as the importance of evaluating the response to treatment. These recommendations apply to adults and children with severe asthma and are targeted at physicians involved in asthma treatment. A panel of 17 Brazilian pulmonologists was invited to review recent evidence on the diagnosis and management of severe asthma, adapting it to the Brazilian reality. Each of the experts was responsible for reviewing a topic or question relevant to the topic. In a second phase, four experts discussed and structured the texts produced, and, in the last phase, all experts reviewed and approved the present manuscript and its recommendations.

Environmental air pollution: respiratory effects.

Environmental air pollution is a major risk factor for morbidity and mortality worldwide. Environmental air pollution has a direct impact on human health, being responsible for an increase in the incidence of and number of deaths due to cardiopulmonary, neoplastic, and metabolic diseases; it also contributes to global warming and the consequent climate change associated with extreme events and environmental imbalances. In this review, we present articles that show the impact that exposure to different sources and types of air pollutants has on the respiratory system; we present the acute effects-such as increases in symptoms and in the number of emergency room visits, hospitalizations, and deaths-and the chronic effects-such as increases in the incidence of asthma, COPD, and lung cancer, as well as a rapid decline in lung function. The effects of air pollution in more susceptible populations and the effects associated with physical exercise in polluted environments are also presented and discussed. Finally, we present the major studies on the subject conducted in Brazil. Health care and disease prevention services should be aware of this important risk factor in order to counsel more susceptible individuals about protective measures that can facilitate their treatment, as well as promoting the adoption of environmental measures that contribute to the reduction of such emissions.

Environmental air pollution: respiratory effects / Poluição do ar ambiental: efeitos respiratórios

ABSTRACT Environmental air pollution is a major risk factor for morbidity and mortality worldwide. Environmental air pollution has a direct impact on human health, being responsible for an increase in the incidence of and number of deaths due to cardiopulmonary, neoplastic, and metabolic diseases; it also contributes to global warming and the consequent climate change associated with extreme events and environmental imbalances. In this review, we present articles that show the impact that exposure to different sources and types of air pollutants has on the respiratory system; we present the acute effects—such as increases in symptoms and in the number of emergency room visits, hospitalizations, and deaths—and the chronic effects—such as increases in the incidence of asthma, COPD, and lung cancer, as well as a rapid decline in lung function. The effects of air pollution in more susceptible populations and the effects associated with physical exercise in polluted environments are also presented and discussed. Finally, we present the major studies on the subject conducted in Brazil. Health care and disease prevention services should be aware of this important risk factor in order to counsel more susceptible individuals about protective measures that can facilitate their treatment, as well as promoting the adoption of environmental measures that contribute to the reduction of such emissions.

RESUMO A poluição do ar ambiental é um dos principais fatores de risco de morbidade e mortalidade global. Ela tem impacto direto na saúde humana, sendo responsável pelo aumento de incidência e de óbitos por doenças cardiorrespiratórias, neoplásicas e metabólicas; também contribui para o aquecimento global e para as consequentes alterações do clima associadas a eventos extremos e aos desequilíbrios ambientais. Nesta revisão, apresentamos artigos que evidenciam o impacto da exposição a diferentes fontes e tipos de poluentes do ar no sistema respiratório; apresentamos os efeitos agudos — como aumento de sintomas e no número de atendimentos em serviços de emergência, internações e óbitos — e crônicos — como o aumento da incidência de asma, DPOC e câncer de pulmão, assim como o declínio acelerado da função pulmonar. Também são apresentados e discutidos os efeitos da poluição atmosférica em populações mais suscetíveis e dos efeitos associados à realização de exercícios físicos em ambientes poluídos. Por fim, apresentamos os principais estudos brasileiros sobre o assunto. Os serviços de atenção à saúde e de prevenção de doenças devem ficar atentos a esse importante fator de risco para orientar indivíduos mais suscetíveis sobre medidas de proteção que possam facilitar seu tratamento, além de estimular a adoção de medidas ambientais que contribuam para a redução dessas emissões.

2020 Brazilian Thoracic Association recommendations for the management of asthma.

The pharmacological management of asthma has changed considerably in recent decades, as it has come to be understood that it is a complex, heterogeneous disease with different phenotypes and endotypes. It is now clear that the goal of asthma treatment should be to achieve and maintain control of the disease, as well as to minimize the risks (of exacerbations, disease instability, accelerated loss of lung function, and adverse treatment effects). That requires an approach that is personalized in terms of the pharmacological treatment, patient education, written action plan, training in correct inhaler use, and review of the inhaler technique at each office visit. A panel of 22 pulmonologists was invited to perform a critical review of recent evidence of pharmacological treatment of asthma and to prepare this set of recommendations, a treatment guide tailored to use in Brazil. The topics or questions related to the most significant changes in concepts, and consequently in the management of asthma in clinical practice, were chosen by a panel of experts. To formulate these recommendations, we asked each expert to perform a critical review of a topic or to respond to a question, on the basis of evidence in the literature. In a second phase, three experts discussed and structured all texts submitted by the others. That was followed by a third phase, in which all of the experts reviewed and discussed each recommendation. These recommendations, which are intended for physicians involved in the treatment of asthma, apply to asthma patients of all ages.

2020 Brazilian Thoracic Association recommendations for the management of asthma / Recomendações para o manejo da asma da Sociedade Brasileira de Pneumologia e Tisiologia - 2020

ABSTRACT The pharmacological management of asthma has changed considerably in recent decades, as it has come to be understood that it is a complex, heterogeneous disease with different phenotypes and endotypes. It is now clear that the goal of asthma treatment should be to achieve and maintain control of the disease, as well as to minimize the risks (of exacerbations, disease instability, accelerated loss of lung function, and adverse treatment effects). That requires an approach that is personalized in terms of the pharmacological treatment, patient education, written action plan, training in correct inhaler use, and review of the inhaler technique at each office visit. A panel of 22 pulmonologists was invited to perform a critical review of recent evidence of pharmacological treatment of asthma and to prepare this set of recommendations, a treatment guide tailored to use in Brazil. The topics or questions related to the most significant changes in concepts, and consequently in the management of asthma in clinical practice, were chosen by a panel of experts. To formulate these recommendations, we asked each expert to perform a critical review of a topic or to respond to a question, on the basis of evidence in the literature. In a second phase, three experts discussed and structured all texts submitted by the others. That was followed by a third phase, in which all of the experts reviewed and discussed each recommendation. These recommendations, which are intended for physicians involved in the treatment of asthma, apply to asthma patients of all ages.

RESUMO O manejo farmacológico da asma mudou consideravelmente nas últimas décadas, com base no entendimento de que a asma é uma doença heterogênea e complexa, com diferentes fenótipos e endótipos. Agora está claro que o objetivo do tratamento da asma deve ser alcançar e manter o controle da doença e evitar riscos futuros (exacerbações, instabilidade da doença, perda acelerada da função pulmonar e efeitos adversos do tratamento). Isso implica em uma abordagem personalizada, incluindo tratamento farmacológico, educação do paciente, plano de ação por escrito, treinamento para uso do dispositivo inalatório e revisão da técnica inalatória a cada visita ao consultório. Um painel de 22 pneumologistas brasileiros foi convidado a revisar criticamente evidências recentes de tratamento farmacológico da asma e a preparar esta recomendação, um guia de tratamento adaptado à nossa realidade. A escolha dos tópicos ou questões relacionadas às mudanças mais significativas nos conceitos e, consequentemente, no manejo da asma na prática clínica foi realizada por um painel de especialistas. Foi solicitado a cada especialista que revisasse criticamente um tópico ou respondesse a uma pergunta, com base em evidências, para estas recomendações. Numa segunda fase, três especialistas discutiram e estruturaram todos os textos submetidos pelos demais e, na última fase, todos revisaram e discutiram cada recomendação. As presentes recomendações se aplicam a adultos e crianças com asma e destinam-se a médicos envolvidos no tratamento da doença.

Respira project: Humanistic and economic burden of asthma in Brazil.

OBJECTIVE: To determine the association of asthma on health-related quality of life (QoL), productivity, and use of healthcare resources among adults in Brazil. METHODS: Data were analyzed from the 2015 Brazil National Health and Wellness Survey, a cross-sectional survey with 12,000 adult respondents. Asthma and control groups were compared with respect to health-related QoL, asthma control, work productivity, and adherence. Generalized linear models were developed to compare asthma-related associations controlling for potential confounding factors. RESULTS: Among respondents, 4.1% (n = 494) reported an asthma diagnosis; those without asthma symptoms were used as the control group (n = 11,487). Regarding asthma control, 51.2% of patients had uncontrolled asthma, 36.4% partially controlled asthma, and 12.3% were fully controlled. Short-acting ß2 agonists were the most commonly used class of drugs (38.5%). Approximately 32.4% of asthma patients were considered fully adherent to their treatment. In multivariable analyses, asthma patients presented lower health-related QoL and had more frequent visits with medical healthcare providers (6.1 versus 4.2) emergency room visits (1.0 versus 0.5), and more hospitalizations (0.4 versus 0.2), than control respondents six months prior to the study (p < 0.05). Rates of absenteeism and presenteeism varied between 11.5% and 7.4% (p < 0.05) and 30.4% and 20.9% (p < 0.001) between asthma patients and controls, respectively. CONCLUSIONS: Asthma had a negative association on health-related QoL, work productivity, and use of healthcare resources. Excessive use of short-acting ß2 agonists and poor treatment adherence reflect poor asthma control and suggest the need to implement new strategies for asthma treatment in Brazil.

Recommendations for the pharmacological treatment of COPD: questions and answers / Recomendações para o tratamento farmacológico da DPOC: perguntas e respostas

ABSTRACT The treatment of COPD has become increasingly effective. Measures that range from behavioral changes, reduction in exposure to risk factors, education about the disease and its course, rehabilitation, oxygen therapy, management of comorbidities, and surgical and pharmacological treatments to end-of-life care allow health professionals to provide a personalized and effective therapy. The pharmacological treatment of COPD is one of the cornerstones of COPD management, and there have been many advances in this area in recent years. Given the greater availability of drugs and therapeutic combinations, it has become increasingly challenging to know the indications for, limitations of, and potential risks and benefits of each treatment modality. In order to critically evaluate recent evidence and systematize the major questions regarding the pharmacological treatment of COPD, 24 specialists from all over Brazil gathered to develop the present recommendations. A visual guide was developed for the classification and treatment of COPD, both of which were adapted to fit the situation in Brazil. Ten questions were selected on the basis of their relevance in clinical practice. They address the classification, definitions, treatment, and evidence available for each drug or drug combination. Each question was answered by two specialists, and then the answers were consolidated in two phases: review and consensus by all participants. The questions answered are practical questions and help select from among the many options the best treatment for each patient and his/her peculiarities.

RESUMO O tratamento da DPOC vem se tornando cada vez mais eficaz. Medidas que envolvem desde mudanças comportamentais, redução de exposições a fatores de risco, educação sobre a doença e seu curso, reabilitação, oxigenoterapia, manejo de comorbidades, tratamentos cirúrgicos e farmacológicos até os cuidados de fim de vida permitem ao profissional oferecer uma terapêutica personalizada e efetiva. O tratamento farmacológico da DPOC constitui um dos principais pilares desse manejo, e muitos avanços têm sido atingidos na área nos últimos anos. Com a maior disponibilidade de medicações e combinações terapêuticas fica cada vez mais desafiador conhecer as indicações, limitações, potenciais riscos e benefícios de cada tratamento. Com o intuito de avaliar criticamente a evidência recente e sistematizar as principais dúvidas referentes ao tratamento farmacológico da DPOC, foram reunidos 24 especialistas de todo o Brasil para elaborar a presente recomendação. Foi elaborado um guia visual para a classificação e tratamento adaptados à nossa realidade. Dez perguntas foram selecionadas pela relevância na prática clínica. Abordam a classificação, definições, tratamento e evidências disponíveis para cada medicação ou combinação. Cada pergunta foi respondida por dois especialistas e depois consolidadas em duas fases: revisão e consenso entre todos os participantes. As questões respondidas são dúvidas práticas e ajudam a selecionar qual o melhor tratamento, entre as muitas opções, para cada paciente com suas particularidades.

Recommendations for the pharmacological treatment of COPD: questions and answers.

The treatment of COPD has become increasingly effective. Measures that range from behavioral changes, reduction in exposure to risk factors, education about the disease and its course, rehabilitation, oxygen therapy, management of comorbidities, and surgical and pharmacological treatments to end-of-life care allow health professionals to provide a personalized and effective therapy. The pharmacological treatment of COPD is one of the cornerstones of COPD management, and there have been many advances in this area in recent years. Given the greater availability of drugs and therapeutic combinations, it has become increasingly challenging to know the indications for, limitations of, and potential risks and benefits of each treatment modality. In order to critically evaluate recent evidence and systematize the major questions regarding the pharmacological treatment of COPD, 24 specialists from all over Brazil gathered to develop the present recommendations. A visual guide was developed for the classification and treatment of COPD, both of which were adapted to fit the situation in Brazil. Ten questions were selected on the basis of their relevance in clinical practice. They address the classification, definitions, treatment, and evidence available for each drug or drug combination. Each question was answered by two specialists, and then the answers were consolidated in two phases: review and consensus by all participants. The questions answered are practical questions and help select from among the many options the best treatment for each patient and his/her peculiarities.

Air pollution from biomass burning and asthma hospital admissions in a sugar cane plantation area in Brazil.

OBJECTIVE: To evaluate the association between the total suspended particles (TSPs) generated from preharvest sugar cane burning and hospital admission due to asthma (asthma hospital admissions) in the city of Araraquara. DESIGN: An ecological time-series study. Total daily records of asthma hospital admissions (ICD 10th J15) were obtained from one of the main hospitals in Araraquara, São Paulo State, Brazil, from 23 March 2003 to 27 July 2004. The daily concentration of TSP (microg/m(3)) was obtained using Handi-vol equipment (Energética, Brazil) placed in downtown Araraquara. The local airport provided the daily mean figures of temperature and humidity. The daily number of asthma hospital admissions was considered as the dependent variable in Poisson's regression models and the daily concentration of TSP was considered the independent variable. The generalised linear model with natural cubic spline was adopted to control for long-time trend. Linear terms were used for weather variables. RESULTS: TSP had an acute effect on asthma admissions, starting 1 day after TSP concentrations increased and remaining almost unchanged for the next four days. A 10 microg/m(3) increase in the 5-day moving average (lag1-5) of TSP concentrations was associated with an increase of 11.6% (95% CI 5.4 to 17.7) in asthma hospital admissions. CONCLUSION: Increases in TSP concentrations were definitely associated with asthma hospital admissions in Araraquara and, despite using sugar cane alcohol to reduce air pollution from automotive sources in large Brazilian urban centres, the cities where sugar cane is harvested pay a high toll in terms of public health.