RESUMO
Little information exists regarding the epidemiology of the chronic bronchitis phenotype in unselected chronic obstructive pulmonary disease (COPD) populations. We examined the prevalence of the chronic bronchitis phenotype in COPD and non-COPD subjects from the PLATINO study, and investigated how it is associated with important outcomes. Post-bronchodilator forced expiratory volume in 1 s/forced vital capacity <0.70 was used to define COPD. Chronic bronchitis was defined as phlegm on most days, at least 3 months per year for ≥ 2 yrs. We also analysed another definition: cough and phlegm on most days, at least 3 months per year for ≥ 2 yrs. Spirometry was performed in 5,314 subjects (759 with and 4,554 without COPD). The proportion of subjects with and without COPD with chronic bronchitis defined as phlegm on most days, at least 3 months per year for ≥ 2 yrs was 14.4 and 6.2%, respectively. Using the other definition the prevalence was lower: 7.4% with and 2.5% without COPD. Among subjects with COPD, those with chronic bronchitis had worse lung function and general health status, and had more respiratory symptoms, physical activity limitation and exacerbations. Our study helps to understand the prevalence of the chronic bronchitis phenotype in an unselected COPD population at a particular time-point and suggests that chronic bronchitis in COPD is possibly associated with worse outcomes.
Assuntos
Bronquite Crônica/epidemiologia , Doença Pulmonar Obstrutiva Crônica/complicações , Bronquite Crônica/complicações , Feminino , Volume Expiratório Forçado , Humanos , Masculino , México/epidemiologia , Fenótipo , Prevalência , América do Sul/epidemiologia , EspirometriaRESUMO
OBJECTIVES: Biosimilars are increasingly attractive to payers around the globe because of mounting financial pressure. Many Latin American governments are developing abbreviated regulatory pathways for biosimilars. There are limited data regarding how certain regulatory agencies in the region plan to address biosimilar access. This study explores potential opportunities and challenges for biosimilar drugs in Brazil, Mexico, Argentina, Chile, and Venezuela. METHODS: We conducted targeted literature reviews, followed by key informant interviews, to understand the expected regulatory environment for biosimilars. We also asked questions about the economic, political, and historical factors that could play a role in the extent to which biosimilar-specific pathways have been developed across countries to date, and will continue to evolve in the future. RESULTS: Brazil has led the development of biosimilar regulation in Latin America, with two distinct pathways, one for more complex molecules such as monoclonal antibodies and a less rigorous path for simpler molecules such as pegylated interferon and low molecular weight heparin. Other countries have been slower to respond, in part because of the degree of emphasis within each country for the advancement of biosimilar regulatory standards. Signs of relaxed standards akin to those seen in Brazil's "individual development" pathway were found in other countries. CONCLUSIONS: The example of the two-pathway system coupled with governmental prioritization of local manufacturing capabilities in Brazil should promote increased biosimilar utilization within the country. Assuming that the two-pathway system demonstrates success in Brazil, we hypothesize that other Latin American countries may adapt aspects of this "local" model for developing a regulatory pathway for biosimilars.
RESUMO
BACKGROUND: Acute bronchodilator responsiveness is an area of discussion in COPD. No information exists regarding this aspect of the disease from an unselected COPD population. We assessed acute bronchodilator responsiveness and factors influencing it in subjects with and without airway obstruction in an epidemiologic sample. METHODS: COPD was defined by GOLD criteria (post-bronchodilator FEV(1)/FVC<0.70). In this analysis, subjects with pre-bronchodilator FEV(1)/FVC <0.70 but > or =0.70 post-bronchodilator were considered to have reversible obstruction. Bronchodilator responsiveness after albuterol 200microg was assessed using three definitions: a) FVC and/or FEV(1) increment > or =12% plus > or =200mL over baseline; b) FEV(1)> or =15% increase over baseline; and c) FEV(1) increase > or =10% of predicted value. RESULTS: There were 756 healthy respiratory subjects, 481 subjects with reversible obstruction and 759 COPD subjects. Depending on the criterion used the proportion of person with acute bronchodilator responsiveness ranged between 15.0-28.2% in COPD, 11.4-21.6% in reversible obstructed and 2.7-7.2% in respiratory healthy. FEV(1) changes were lower (110.6+/-7.40 vs. 164.7+/-11.8mL) and FVC higher (146.5+/-14.2mL vs. -131.0+/-19.6mL) in COPD subjects compared with reversible obstructed. Substantial overlap in FEV(1) and FVC changes was observed among the groups. Acute bronchodilator responsiveness in COPD persons was associated with less obstruction and never smoking. CONCLUSIONS: Over two-thirds of persons with COPD did not demonstrate acute bronchodilator responsiveness. The overall response was small and less than that considered as significant by ATS criteria. The overlap in FEV(1) and FVC changes after bronchodilator among the groups makes it difficult to determine a threshold for separating them.
Assuntos
Brônquios/fisiopatologia , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Idoso , Feminino , Volume Expiratório Forçado , Humanos , Masculino , Pessoa de Meia-Idade , Análise MultivariadaRESUMO
BACKGROUND: COPD is a highly prevalent disease but underdiagnosed, undertreated and possibly under-recognized by patients. Limited information exists regarding patients' perception of COPD severity. We compared patients' general health status perception, degree of breathlessness and physical activity limitation with the severity of their respiratory condition measured by airway obstruction, in a population-based sample. METHODS: We used postbronchodilator FEV(1)/FVC<0.70 to define COPD. Patients' perception of their general health status was derived from the question "in general you would say that your health is: excellent, very good, good, fair or poor?" RESULTS: Spirometry was performed in 5314 subjects: an FEV(1)/FVC ratio below 0.70 was found in 759 subjects. In persons with COPD, general health status decreased with increasing GOLD stages. Over one-half of subjects with stage 2 and one third of those with stages 3 and 4 reported their health status as good to excellent. There was also a disparity between airway obstruction severity and breathlessness intensity. Although the more severe COPD stages were frequently associated with significant compromise of work and everyday activities, patients often tended to provide an optimistic self evaluation of their health status. CONCLUSIONS: The discrepancy observed between general health status, dyspnea severity, physical activity limitation and airway obstruction most likely reflect patients' underperception of disease severity, emphasizing the need for improving case-finding measures and multi-component evaluation of COPD subjects.
Assuntos
Obstrução das Vias Respiratórias/fisiopatologia , Dispneia/fisiopatologia , Nível de Saúde , Obstrução das Vias Respiratórias/diagnóstico , Dispneia/diagnóstico , Feminino , Conhecimentos, Atitudes e Prática em Saúde , Humanos , América Latina , Masculino , Pessoa de Meia-Idade , Prevalência , Doença Pulmonar Obstrutiva Crônica/diagnóstico , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Fatores de Risco , Autoimagem , Índice de Gravidade de Doença , Espirometria , Inquéritos e Questionários , Saúde da População UrbanaRESUMO
BACKGROUND: There is scanty information regarding respiratory medication prescription pattern in Latin America. We examined the use of bronchodilators and corticosteroids in a population-based study conducted in five Latin American cities. METHODS: Medication use was derived from questions regarding the use of medication "to help breathing" within the previous 12 months, type of medicine, and frequency of use. To minimize the possibility of overdiagnosis, we used postbronchodilator FEV(1)/FVC<0.70 plus FEV(1)<80% as the definition of obstruction. RESULTS: Interviews were completed in 5571 subjects from 6711 eligible individuals, and spirometry was performed in 5314 subjects. There were 360 (6.5%) treated subjects and 5211 not treated. Treated subjects were more likely to be older, women, unemployed, have higher tobacco consumption, higher body mass index, higher FEV(1) reversibility and airway obstruction. They were also more likely to report prior spirometry, prior diagnosis of COPD, asthma or tuberculosis, and more respiratory symptoms. Over half of treated subjects had neither obstruction nor FEV(1) reversibility, and approximately 30% reported no prior diagnosis of asthma or COPD. Prior respiratory diagnoses and wheezing were more strongly associated with treatment than objective measures of airway obstruction. CONCLUSIONS: The use of bronchodilators and/or corticosteroids is common in the general population aged 40 years or older, with over one-half of treated subjects using them without being obstructed.
Assuntos
Corticosteroides/uso terapêutico , Broncodilatadores/uso terapêutico , Vigilância da População/métodos , Saúde da População Urbana/estatística & dados numéricos , Fatores Etários , Idoso , Asma/diagnóstico , Asma/tratamento farmacológico , Asma/fisiopatologia , Índice de Massa Corporal , Cidades , Tosse/diagnóstico , Revisão de Uso de Medicamentos/métodos , Revisão de Uso de Medicamentos/estatística & dados numéricos , Feminino , Fluxo Expiratório Forçado/efeitos dos fármacos , Volume Expiratório Forçado/efeitos dos fármacos , Humanos , Entrevistas como Assunto , América Latina , Masculino , Pessoa de Meia-Idade , Doença Pulmonar Obstrutiva Crônica/diagnóstico , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Fatores Sexuais , Espirometria , Inquéritos e Questionários , Tuberculose/diagnóstico , População Urbana/estatística & dados numéricosRESUMO
BACKGROUND: The body mass index (BMI) is a prognostic factor for chronic obstructive pulmonary disease (COPD). Despite its importance, little information is available regarding BMI alteration in COPD from a population-based study. We examined characteristics by BMI categories in the total and COPD populations in five Latin-American cities, and explored the factors influencing BMI in COPD. METHODS: COPD was defined as a postbronchodilator forced expiratory volume in the first second/forced vital capacity (FEV(1)/FVC) <0.70. BMI was categorized as underweight (< 20 kg/m(2)), normal weight (20-24.9 kg/m(2)), overweight (25.0-29.9 kg/m(2)), and obese (> or = 30.0 kg/m(2)). RESULTS: Interviews were completed in 5571 subjects from 6711 eligible individuals, and spirometry was performed in 5314 subjects. There were 759 subjects with COPD and 4555 without COPD. Compared with the non-COPD group, there was a higher proportion of COPD subjects in the underweight and normal weight categories, and a lower proportion in the obese category. Over one-half COPD subjects had BMI over 25 kg/m(2). No differences in BMI strata among countries were found in COPD subjects. Factors associated with lower BMI in males with COPD were aging, current smoking, and global initiative for chronic obstructive lung disease (GOLD) stages III-IV, whereas wheeze and residing in Santiago and Montevideo were associated with higher BMI. In females with COPD, current smoking, lower education, and GOLD stages II-IV were associated with lower BMI, while dyspnea and wheeze were associated with higher BMI. CONCLUSIONS: BMI alterations are common in COPD with no significant differences among countries. Current smoking, age, GOLD stages, education level, residing in Santiago and Montevideo, dyspnea and wheeze were independently associated with BMI in COPD.