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      Neumonías adquiridas en la comunidad en pacientes con enfermedad pulmonar obstructiva crónica tratados con corticoides inhalados u otros broncodilatadores. Estudio PNEUMOCORT Translated title: Community-acquired pneumonia in patients with chronic obstructive pulmonary disease treated with inhaled corticosteroids or other bronchodilators. Study PNEUMOCORT

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          Resumen

          Objetivos

          Analizar el riesgo de neumonía y/o exacerbaciones en pacientes con enfermedad pulmonar obstructiva crónica (EPOC) tratados con corticoides inhalados (CI) y no tratados con CI (NCI). Estimar el riesgo de neumonía según la dosis de CI.

          Diseño

          Estudio de cohortes de base poblacional.

          Emplazamiento

          Atención Primaria. Institut Català de la Salut.

          Participantes

          Pacientes ≥ 45 años diagnosticados de EPOC entre 2007 y 2009 en el Sistema de Información para el Desarrollo de la Investigación en Atención Primaria (SIDIAP).

          Intervención

          Dos cohortes; pacientes que inician CI y pacientes que inician broncodilatadores NCI después del diagnóstico de EPOC.

          Mediciones principales

          Sociodemográficas, tabaquismo, antecedentes patológicos, neumonías, exacerbaciones, vacunaciones y tratamientos farmacológicos.

          Resultados

          Se incluyeron 3.837 pacientes: el 58% en el grupo CI y el 42% en el grupo NCI. Se detectaron incidencias superiores de neumonía y exacerbaciones en el grupo CI respecto al NCI (2,18 vs. 1,37). El riesgo de neumonía y de exacerbaciones graves no fue significativamente diferente entre grupos: HR de 1,17 (IC 95%: 0,87-1,56) y de 1,06 (IC 95%: 0,87-1,31), respectivamente. En el grupo CI presentaron mayor riesgo de exacerbaciones leves, con HR de 1,28 (IC 95%: 1,10-1,50). Las variables asociadas a mayor riesgo de neumonías fueron: edad, diabetes, neumonías y bronquitis previas, EPOC muy grave, tratamiento con β 2-adrenérgicos o anticolinérgicos a dosis bajas, y tratamiento previo con corticoides orales.

          Conclusiones

          No hubo diferencias entre cohortes en el riesgo de NAC ni exacerbaciones graves. Las exacerbaciones leves fueron superiores en el grupo CI. Tanto NAC como exacerbaciones graves fueron más frecuentes en pacientes con EPOC grave y en pacientes tratados con dosis altas de CI.

          Translated abstract

          Objectives

          To analyse the risk of pneumonia and/or exacerbations in patients with chronic obstructive pulmonary disease (COPD) who receive treatment with inhaled corticosteroids (CI), in comparison with those who are not treated with inhaled corticosteroids (NCI). To estimate the risk of pneumonia according to CI dose.

          Design

          Population-based cohort study.

          Setting

          Primary Healthcare. Institut Català de la Salut.

          Participants

          Patients ≥ 45 years-old diagnosed with COPD between 2007 and 2009 in the Information System for Research in Primary Care (SIDIAP).

          Intervention

          Two cohorts; patients initiating CI and patients initiating bronchodilators after COPD diagnosis.

          Main measurements

          Demographics, smoking, medical history, pneumonias, exacerbations, vaccinations, and drug therapy.

          Results

          A total of 3,837 patients were included, 58% in the CI and 42% in the NCI group. Higher incidence rates of pneumonia and exacerbations were detected in the CI group compared with the NCI (2.18 vs. 1.37). The risk of pneumonia and severe exacerbations was not significantly different between groups, HR; 1.17 (95% CI; 0.87-1.56) and 1.06 (95% CI; 0.87-1.31), respectively. Patients in the CI group had a higher risk of mild exacerbations, HR; 1.28 (95% CI; 1.10-1.50). Variables associated with a higher risk of pneumonia were age, diabetes, previous pneumonias and bronchitis, very severe COPD, treatment with low doses of β 2-adrenergic or anticholinergic agents, and previous treatment with oral corticosteroids.

          Conclusions

          There were no differences between cohorts in the risk of pneumonia and severe exacerbations. The risk of mild exacerbations was higher in the CI group. Pneumonias and severe exacerbations were more frequent in patients with severe COPD and in patients receiving high doses of CI.

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          Most cited references15

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          Prevalence of COPD in Spain: impact of undiagnosed COPD on quality of life and daily life activities.

          This study aimed to determine the prevalence of chronic obstructive pulmonary disease (COPD) in Spain and identify the level of undiagnosed disease and its impact on health-related quality of life (HRQL) and activities of daily living (ADL). A population-based sample of 4274 adults aged 40-80 years was surveyed. They were invited to answer a questionnaire and undergo prebrochodilator and postbronchodilator spirometry. COPD was defined as a postbronchodilator FEV(1)/FVC (forced expiratory volume in 1 s/forced vital capacity) ratio of <0.70. For 3802 participants with good-quality postbronchodilator spirometry, the overall prevalence of COPD was 10.2% (95% CI 9.2% to 11.1%) and was higher in men (15.1%) than in women (5.6%). The prevalence of COPD stage II or higher was 4.4% (95%CI; 3.8%-5.1%). The prevalence of COPD increased with age and with cigarette smoking and was higher in those with a low educational level. A previous diagnosis of COPD was reported by only 27% of those with COPD. Diagnosed patients had more severe disease, higher cumulative tobacco consumption and more severely impaired HRQL compared with undiagnosed subjects. However, even patients with undiagnosed COPD stage I+ already showed impairment in HRQL and in some aspects of ADL compared with participants without COPD. The prevalence of COPD in individuals between 40 and 80 years of age in Spain is 10.2% and increases with age, tobacco consumption and lower educational levels. The rate of diagnosised COPD is very high and undiagnosed individuals with COPD already have a significant impairment in HRQL and ADL.
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            Inhaled steroids and risk of pneumonia for chronic obstructive pulmonary disease.

            Inhaled corticosteroids (ICS) are anti-inflammatory drugs that have proven benefits for people with worsening symptoms of chronic obstructive pulmonary disease (COPD) and repeated exacerbations. They are commonly used as combination inhalers with long-acting beta2-agonists (LABA) to reduce exacerbation rates and all-cause mortality, and to improve lung function and quality of life. The most common combinations of ICS and LABA used in combination inhalers are fluticasone and salmeterol, budesonide and formoterol and a new formulation of fluticasone in combination with vilanterol, which is now available. ICS have been associated with increased risk of pneumonia, but the magnitude of risk and how this compares with different ICS remain unclear. Recent reviews conducted to address their safety have not compared the relative safety of these two drugs when used alone or in combination with LABA. To assess the risk of pneumonia associated with the use of fluticasone and budesonide for COPD. We identified trials from the Cochrane Airways Group Specialised Register of trials (CAGR), clinicaltrials.gov, reference lists of existing systematic reviews and manufacturer websites. The most recent searches were conducted in September 2013. We included parallel-group randomised controlled trials (RCTs) of at least 12 weeks' duration. Studies were included if they compared the ICS budesonide or fluticasone versus placebo, or either ICS in combination with a LABA versus the same LABA as monotherapy for people with COPD. Two review authors independently extracted study characteristics, numerical data and risk of bias information for each included study.We looked at direct comparisons of ICS versus placebo separately from comparisons of ICS/LABA versus LABA for all outcomes, and we combined these with subgroups when no important heterogeneity was noted. After assessing for transitivity, we conducted an indirect comparison to compare budesonide versus fluticasone monotherapy, but we could not do the same for the combination therapies because of systematic differences between the budesonide and fluticasone combination data sets.When appropriate, we explored the effects of ICS dose, duration of ICS therapy and baseline severity on the primary outcome. Findings of all outcomes are presented in 'Summary of findings' tables using GRADEPro. We found 43 studies that met the inclusion criteria, and more evidence was provided for fluticasone (26 studies; n = 21,247) than for budesonide (17 studies; n = 10,150). Evidence from the budesonide studies was more inconsistent and less precise, and the studies were shorter. The populations within studies were more often male with a mean age of around 63, mean pack-years smoked over 40 and mean predicted forced expiratory volume of one second (FEV1) less than 50%.High or uneven dropout was considered a high risk of bias in almost 40% of the trials, but conclusions for the primary outcome did not change when the trials at high risk of bias were removed in a sensitivity analysis.Fluticasone increased non-fatal serious adverse pneumonia events (requiring hospital admission) (odds ratio (OR) 1.78, 95% confidence interval (CI) 1.50 to 2.12; 18 more per 1000 treated over 18 months; high quality), and no evidence suggested that this outcome was reduced by delivering it in combination with salmeterol or vilanterol (subgroup differences: I(2) = 0%, P value 0.51), or that different doses, trial duration or baseline severity significantly affected the estimate. Budesonide also increased non-fatal serious adverse pneumonia events compared with placebo, but the effect was less precise and was based on shorter trials (OR 1.62, 95% CI 1.00 to 2.62; six more per 1000 treated over nine months; moderate quality). Some of the variation in the budesonide data could be explained by a significant difference between the two commonly used doses: 640 mcg was associated with a larger effect than 320 mcg relative to placebo (subgroup differences: I(2) = 74%, P value 0.05).An indirect comparison of budesonide versus fluticasone monotherapy revealed no significant differences with respect to serious adverse events (pneumonia-related or all-cause) or mortality. The risk of any pneumonia event (i.e. less serious cases treated in the community) was higher with fluticasone than with budesonide (OR 1.86, 95% CI 1.04 to 3.34); this was the only significant difference reported between the two drugs. However, this finding should be interpreted with caution because of possible differences in the assignment of pneumonia diagnosis, and because no trials directly compared the two drugs.No significant difference in overall mortality rates was observed between either of the inhaled steroids and the control interventions (both high-quality evidence), and pneumonia-related deaths were too rare to permit conclusions to be drawn. Budesonide and fluticasone, delivered alone or in combination with a LABA, are associated with increased risk of serious adverse pneumonia events, but neither significantly affected mortality compared with controls. The safety concerns highlighted in this review should be balanced with recent cohort data and established randomised evidence of efficacy regarding exacerbations and quality of life. Comparison of the two drugs revealed no statistically significant difference in serious pneumonias, mortality or serious adverse events. Fluticasone was associated with higher risk of any pneumonia when compared with budesonide (i.e. less serious cases dealt with in the community), but variation in the definitions used by the respective manufacturers is a potential confounding factor in their comparison.Primary research should accurately measure pneumonia outcomes and should clarify both the definition and the method of diagnosis used, especially for new formulations such as fluticasone furoate, for which little evidence of the associated pneumonia risk is currently available. Similarly, systematic reviews and cohorts should address the reliability of assigning 'pneumonia' as an adverse event or cause of death and should determine how this affects the applicability of findings.
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              Long-term use of inhaled corticosteroids and the risk of pneumonia in chronic obstructive pulmonary disease: a meta-analysis.

              Recent studies have suggested a possible association between pneumonia and the use of inhaled corticosteroids. We aimed to ascertain the risk of pneumonia with long-term inhaled corticosteroid use among patients with chronic obstructive pulmonary disease (COPD). We performed systematic searches with no date restrictions through June 30, 2008, of MEDLINE, EMBASE, the Cochrane Database of Systematic Reviews, regulatory documents, and trial registries. We included randomized controlled trials of any inhaled corticosteroid vs a control treatment for COPD, with at least 24 weeks of follow-up and reporting of pneumonia as an adverse event. Outcomes evaluated included any pneumonia, serious pneumonia, pneumonia-related mortality, and overall mortality. Eighteen randomized controlled trials (n = 16 996) with 24 to 156 weeks of follow-up were included after a detailed screening of 97 articles. Inhaled corticosteroids were associated with a significantly increased risk of any pneumonia (relative risk [RR], 1.60; 95% confidence interval [CI], 1.33-1.92 [P < .001]; I(2) = 16%) and serious pneumonia (1.71; 1.46-1.99 [P < .001]; I(2) = 0%) but without a significantly increased risk of pneumonia-related mortality (1.27; 0.80-2.03 [P = .31]; I(2) = 0%) or overall mortality (0.96; 0.86-1.08 [P = .51]; I(2) = 0%). Inhaled corticosteroids were associated with a significantly increased risk of serious pneumonia when compared with placebo (RR, 1.81; 95% CI, 1.44-2.29 [P < .001]) or when the combination of inhaled corticosteroids and long-acting beta-agonists was compared with long-acting beta-agonists (1.68; 1.20-2.34 [P = .002]). Among patients with COPD, inhaled corticosteroid use for at least 24 weeks is associated with a significantly increased risk of serious pneumonia, without a significantly increased risk of death.
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                Author and article information

                Contributors
                Journal
                Aten Primaria
                Aten Primaria
                Atencion Primaria
                Elsevier
                0212-6567
                1578-1275
                13 April 2018
                Jun-Jul 2019
                13 April 2018
                : 51
                : 6
                : 333-340
                Affiliations
                [a ]Institut Universitari d’Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, España
                [b ]Universitat Autònoma de Barcelona, Bellaterra, Cerdanyola del Vallès, España
                [c ]Institut Català de la Salut, Generalitat de Catalunya, Barcelona, España
                [d ]Unitat de Farmàcia, Servei d’Atenció Primària Barcelonès Nord i Maresme, Institut Català de la Salut, Badalona, España
                [e ]ISGlobal, Barcelona Ctr. Int. Health Res. (CRESIB), Hospital Clínic-Universitat de Barcelona, Barcelona, España
                [f ]Àmbit d’Atenció Barcelona Ciutat, Institut Català de la Salut, Barcelona, España
                [g ]Centre de Salut la Marina, Institut Català de la Salut, Barcelona, España
                Author notes
                [* ]Autor para correspondencia. cvedia.bnm.ics@ 123456gencat.cat
                [◊]

                Los investigadores del proyecto PNEUMOCORT se relacionan en el anexo.

                Article
                S0212-6567(17)30358-X
                10.1016/j.aprim.2018.02.007
                6837040
                29661670
                8a2422e5-5cd8-4e09-b1d4-68d336f91b95
                © 2018 The Authors

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

                History
                : 14 May 2017
                : 9 February 2018
                Categories
                Originales

                corticoides inhalados,epoc,neumonía,exacerbaciones,broncodilatadores,inhaled corticosteroids,copd,pneumonia,exacerbations,bronchodilators

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