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      Intravenous iron and chronic obstructive pulmonary disease: a randomised controlled trial

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          Abstract

          Background

          Increased iron availability modifies cardiorespiratory function in healthy volunteers and improves exercise capacity and quality of life in patients with heart failure or pulmonary hypertension. We hypothesised that intravenous iron would produce improvements in oxygenation, exercise capacity and quality of life in patients with chronic obstructive pulmonary disease (COPD).

          Methods

          We performed a randomised, placebo-controlled, double-blind trial in 48 participants with COPD (mean±SD: age 69±8 years, haemoglobin 144.8±13.2 g/L, ferritin 97.1±70.0 µg/L, transferrin saturation 31.3%±15.2%; GOLD grades II–IV), each of whom received a single dose of intravenous ferric carboxymaltose (FCM; 15 mg/kg bodyweight) or saline placebo. The primary endpoint was peripheral oxygen saturation (SpO 2) at rest after 1 week. The secondary endpoints included daily SpO 2, overnight SpO 2, exercise SpO 2, 6 min walk distance, symptom and quality of life scores, serum iron indices, spirometry, echocardiographic measures, and exacerbation frequency.

          Results

          SpO 2 was unchanged 1 week after FCM administration (difference between groups 0.8%, 95% CI −0.2% to 1.7%). However, in secondary analyses, exercise capacity increased significantly after FCM administration, compared with placebo, with a mean difference in 6 min walk distance of 12.6 m (95% CI 1.6 to 23.5 m). Improvements of ≥40 m were observed in 29.2% of iron-treated and 0% of placebo-treated participants after 1 week (p=0.009). Modified MRC Dyspnoea Scale score was also significantly lower after FCM, and fewer participants reported scores ≥2 in the FCM group, compared with placebo (33.3% vs 66.7%, p=0.02). No significant differences were observed in other secondary endpoints. Adverse event rates were similar between groups, except for hypophosphataemia, which occurred more frequently after FCM (91.7% vs 8.3%, p<0.001).

          Conclusions

          FCM did not improve oxygenation over 8 weeks in patients with COPD. However, this treatment was well tolerated and produced improvements in exercise capacity and functional limitation caused by breathlessness. These effects on secondary endpoints require confirmation in future studies.

          Trial registration number

          ISRCTN09143837.

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          Most cited references24

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          Pulmonary hypertension in COPD.

          Mild-to-moderate pulmonary hypertension is a common complication of chronic obstructive pulmonary disease (COPD); such a complication is associated with increased risks of exacerbation and decreased survival. Pulmonary hypertension usually worsens during exercise, sleep and exacerbation. Pulmonary vascular remodelling in COPD is the main cause of increase in pulmonary artery pressure and is thought to result from the combined effects of hypoxia, inflammation and loss of capillaries in severe emphysema. A small proportion of COPD patients may present with "out-of-proportion" pulmonary hypertension, defined by a mean pulmonary artery pressure >35-40 mmHg (normal is no more than 20 mmHg) and a relatively preserved lung function (with low to normal arterial carbon dioxide tension) that cannot explain prominent dyspnoea and fatigue. The prevalence of out-of-proportion pulmonary hypertension in COPD is estimated to be very close to the prevalence of idiopathic pulmonary arterial hypertension. Cor pulmonale, defined as right ventricular hypertrophy and dilatation secondary to pulmonary hypertension caused by respiratory disorders, is common. More studies are needed to define the contribution of cor pulmonale to decreased exercise capacity in COPD. These studies should include improved imaging techniques and biomarkers, such as the B-type natriuretic peptide and exercise testing protocols with gas exchange measurements. The effects of drugs used in pulmonary arterial hypertension should be tested in chronic obstructive pulmonary disease patients with severe pulmonary hypertension. In the meantime, the treatment of cor pulmonale in chronic obstructive pulmonary disease continues to rest on supplemental oxygen and a variety of measures aimed at the relief of airway obstruction.
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            Quantification of dyspnoea using descriptors: development and initial testing of the Dyspnoea-12

            Rationale: Dyspnoea is a debilitating and distressing symptom that is reflected in different verbal descriptors. Evidence suggests that dyspnoea, like pain perception, consists of sensory quality and affective components. The objective of this study was to develop an instrument that measures overall dyspnoea severity using descriptors that reflect its different aspects. Methods: 81 dyspnoea descriptors were administered to 123 patients with chronic obstructive pulmonary disease (COPD), 129 with interstitial lung disease and 106 with chronic heart failure. These were reduced to 34 items using hierarchical methods. Rasch analysis informed decisions regarding further item removal and fit to the unidimensional model. Principal component analysis (PCA) explored the underlying structure of the final item set. Validity and reliability of the new instrument were further assessed in a separate group of 53 patients with COPD. Results: After removal of items with hierarchical methods (n = 47) and items that failed to fit the Rasch model (n = 22), 12 were retained. The “Dyspnoea-12” had good internal reliability (Cronbach’s alpha = 0.9) and fit to the Rasch model (χ2 p = 0.08). Items patterned into two groups called “physical”(n = 7) and “affective”(n = 5). In the separate validation study, Dyspnoea-12 correlated with the Hospital Anxiety and Depression Scale (anxiety r = 0.51; depression r = 0.44, p<0.001, respectively), 6-minute walk distance (r = −0.38, p<0.01) and MRC (Medical Research Council) grade (r = 0.48, p<0.01), and had good stability over time (intraclass correlation coefficient = 0.9, p<0.001). Conclusion: Dyspnoea-12 fulfills modern psychometric requirements for measurement. It provides a global score of breathlessness severity that incorporates both “physical” and “affective” aspects, and can measure dyspnoea in a variety of diseases.
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              Effects of intravenous iron therapy in iron-deficient patients with systolic heart failure: a meta-analysis of randomized controlled trials.

              The aim of this study was to assess the net clinical and prognostic effects of intravenous (i.v.) iron therapy in patients with systolic heart failure (HF) and iron deficiency (ID).
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                Author and article information

                Journal
                BMJ Open Respir Res
                BMJ Open Respir Res
                bmjresp
                bmjopenrespres
                BMJ Open Respiratory Research
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2052-4439
                2020
                21 June 2020
                : 7
                : 1
                : e000577
                Affiliations
                [1 ]departmentDepartment of Physiology, Anatomy and Genetics , University of Oxford , Oxford, UK
                [2 ]departmentOxford Respiratory Trials Unit , University of Oxford , Oxford, UK
                [3 ]departmentOxford Centre for Respiratory Medicine , Oxford University Hospitals NHS Foundation Trust , Oxford, UK
                [4 ]departmentNuffield Department of Medicine , University of Oxford , Oxford, UK
                [5 ]departmentNuffield Department of Primary Care Health Sciences , University of Oxford , Oxford, UK
                Author notes
                [Correspondence to ] Peter A Robbins; peter.robbins@ 123456dpag.ox.ac.uk
                Author information
                http://orcid.org/0000-0002-1735-0774
                http://orcid.org/0000-0001-5575-2531
                http://orcid.org/0000-0002-9186-8950
                http://orcid.org/0000-0002-9993-2478
                http://orcid.org/0000-0002-4975-0609
                Article
                bmjresp-2020-000577
                10.1136/bmjresp-2020-000577
                7311010
                32565444
                662408de-ef70-4a0a-be33-f3f563902e66
                © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See:  https://creativecommons.org/licenses/by/4.0/.

                History
                : 15 February 2020
                : 24 May 2020
                : 29 May 2020
                Funding
                Funded by: National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC);
                Categories
                Chronic Obstructive Pulmonary Disease
                1506
                2215
                Custom metadata
                unlocked

                copd pathology,exercise,lung physiology
                copd pathology, exercise, lung physiology

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