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      Risk for pneumonia requiring hospitalization or emergency room visit according to delivery device for inhaled corticosteroid/long-acting beta-agonist in patients with chronic airway diseases as real-world evidence

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          Abstract

          A fixed-dose combination of inhaled corticosteroid and long-acting beta agonist (ICS/LABA) may increase the risk of pneumonia in patients with chronic airway diseases including chronic obstructive pulmonary disease and asthma. Although lung deposition of ICS/LABA is dependent on the inhaler device and inhalation technique, there have been few studies comparing the risk for pneumonia according to the type of device used to deliver ICS/LABA in real-world practice. A retrospective cohort study was performed using the National Health Insurance Database of the Korean Health Insurance Review & Assessment Service. New users who began ICS/LABA were selected and followed-up 180 days after ICS/LABA initiation. The risk for pneumonia requiring emergency room (ER) visit or admission was compared according to inhaler device used—pressurized metered-dose inhaler (pMDI) or dry powder inhaler (DPI)—after individual exact matching (1:5). Among the eligible cohort of 245,477 new ICS/LABA users, 7,942 patients who used pMDI only were matched with 39,690 patients who used DPI only. The incidence of pneumonia was higher in the pMDI group (1.6%) than the DPI group (1.1%); the adjusted hazard ratio (HR) for pneumonia was 1.6 (95% CI 1.3–2.0; p < 0.0001). In subgroup analyses, a significantly higher risk for pneumonia was found in the pMDI group compared with the DPI group regardless of the presence of history of pneumonia (HR 1.7 [95% CI 1.2–2.3]; p = 0.002), COPD (HR 1.6 [95% CI 1.2–2.0]; p = 0.0007), or asthma (HR 1.6 [95% CI 1.2–2.2]; p = 0.0008). In analyses of real-world data, pMDI users incurred a higher risk for pneumonia requiring hospitalization or ER visit compared with DPI users.

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          A critical appraisal of propensity-score matching in the medical literature between 1996 and 2003.

          Propensity-score methods are increasingly being used to reduce the impact of treatment-selection bias in the estimation of treatment effects using observational data. Commonly used propensity-score methods include covariate adjustment using the propensity score, stratification on the propensity score, and propensity-score matching. Empirical and theoretical research has demonstrated that matching on the propensity score eliminates a greater proportion of baseline differences between treated and untreated subjects than does stratification on the propensity score. However, the analysis of propensity-score-matched samples requires statistical methods appropriate for matched-pairs data. We critically evaluated 47 articles that were published between 1996 and 2003 in the medical literature and that employed propensity-score matching. We found that only two of the articles reported the balance of baseline characteristics between treated and untreated subjects in the matched sample and used correct statistical methods to assess the degree of imbalance. Thirteen (28 per cent) of the articles explicitly used statistical methods appropriate for the analysis of matched data when estimating the treatment effect and its statistical significance. Common errors included using the log-rank test to compare Kaplan-Meier survival curves in the matched sample, using Cox regression, logistic regression, chi-squared tests, t-tests, and Wilcoxon rank sum tests in the matched sample, thereby failing to account for the matched nature of the data. We provide guidelines for the analysis and reporting of studies that employ propensity-score matching. Copyright (c) 2007 John Wiley & Sons, Ltd.
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            Pneumonia risk in COPD patients receiving inhaled corticosteroids alone or in combination: TORCH study results.

            Inhaled corticosteroids (ICS) are important in reducing exacerbation frequency associated with chronic obstructive pulmonary disease (COPD). However, little is known about the risk of associated infections. In a post hoc analysis of the TOwards a Revolution in COPD Health (TORCH) study, we analysed and identified potential risk factors for adverse event reports of pneumonia in this randomised, double-blind trial comparing twice-daily inhaled salmeterol (SAL) 50 microg, fluticasone propionate (FP) 500 microg, and the combination (SFC) with placebo in 6,184 patients with moderate-to-severe COPD over 3 yrs. Despite a higher withdrawal rate in the placebo arm, after adjusting for time on treatment, a greater rate of pneumonia was reported in the FP and SFC treatment arms (84 and 88 per 1,000 treatment-yrs, respectively) compared with SAL and placebo (52 and 52 per 1,000 treatment-yrs, respectively). Risk factors for pneumonia were age > or =55 yrs, forced expiratory volume in 1 s <50% predicted, COPD exacerbations in the year prior to the study, worse Medical Research Council dyspnoea scores and body mass index <25 kg.m(-2). No increase in pneumonia deaths with SFC was observed; this could not be concluded for FP. Despite the benefits of ICS-containing regimens in COPD management, healthcare providers should remain vigilant regarding the possible development of pneumonia as a complication in COPD patients receiving such therapies.
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              Corticosteroid suppression of antiviral immunity increases bacterial loads and mucus production in COPD exacerbations

              Inhaled corticosteroids (ICS) have limited efficacy in reducing chronic obstructive pulmonary disease (COPD) exacerbations and increase pneumonia risk, through unknown mechanisms. Rhinoviruses precipitate most exacerbations and increase susceptibility to secondary bacterial infections. Here, we show that the ICS fluticasone propionate (FP) impairs innate and acquired antiviral immune responses leading to delayed virus clearance and previously unrecognised adverse effects of enhanced mucus, impaired antimicrobial peptide secretion and increased pulmonary bacterial load during virus-induced exacerbations. Exogenous interferon-β reverses these effects. FP suppression of interferon may occur through inhibition of TLR3- and RIG-I virus-sensing pathways. Mice deficient in the type I interferon-α/β receptor (IFNAR1 −/−) have suppressed antimicrobial peptide and enhanced mucin responses to rhinovirus infection. This study identifies type I interferon as a central regulator of antibacterial immunity and mucus production. Suppression of interferon by ICS during virus-induced COPD exacerbations likely mediates pneumonia risk and raises suggestion that inhaled interferon-β therapy may protect.
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                Author and article information

                Contributors
                dextro70@gmail.com
                kimdkmd@snu.ac.kr
                Journal
                Sci Rep
                Sci Rep
                Scientific Reports
                Nature Publishing Group UK (London )
                2045-2322
                19 August 2019
                19 August 2019
                2019
                : 9
                : 12004
                Affiliations
                [1 ]GRID grid.412479.d, Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, , Seoul Metropolitan Government-Seoul National University Boramae Medical Center, ; Seoul, Republic of Korea
                [2 ]National Evidence-based Healthcare Collaborating Agency, Seoul, Republic of Korea
                [3 ]GRID grid.454124.2, National Health Insurance Service, ; Wonju, Republic of Korea
                [4 ]ISNI 0000 0001 2299 2686, GRID grid.252211.7, Department of Information Statistics, College of Natural Science, , Andong National University, ; Andong, Republic of Korea
                [5 ]ISNI 0000 0001 0840 2678, GRID grid.222754.4, Department of Health Policy and Hospital Management, Graduate School of Public Health, , Korea University, ; Seoul, Republic of Korea
                [6 ]ISNI 0000 0001 0302 820X, GRID grid.412484.f, Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, , Seoul National University Hospital, ; Seoul, Republic of Korea
                [7 ]ISNI 0000 0004 0470 5905, GRID grid.31501.36, Department of Internal Medicine, , Seoul National University College of Medicine, ; Seoul, Republic of Korea
                [8 ]ISNI 0000 0004 0647 3378, GRID grid.412480.b, Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, , Seoul National University Bundang Hospital, ; Seongnam-Si, Republic of Korea
                Author information
                http://orcid.org/0000-0001-9379-8098
                Article
                48355
                10.1038/s41598-019-48355-2
                6700062
                31427602
                8294a0e4-1c99-4a13-892b-ea7e8d01eca9
                © The Author(s) 2019

                Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/.

                History
                : 8 March 2019
                : 2 August 2019
                Funding
                Funded by: FundRef https://doi.org/10.13039/501100003670, National Evidence-based Healthcare Collaborating Agency (NECA);
                Award ID: NA13-004
                Award ID: NA13-004
                Award ID: NA13-004
                Award ID: NA13-004
                Award ID: NA 13-004
                Award Recipient :
                Categories
                Article
                Custom metadata
                © The Author(s) 2019

                Uncategorized
                asthma,chronic obstructive pulmonary disease
                Uncategorized
                asthma, chronic obstructive pulmonary disease

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