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class="elsevierStyleTextfn">Editorial</span>" "titulo" => "The Need for a Research and Development Strategy" "tienePdf" => "en" "tieneTextoCompleto" => "en" "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "55" "paginaFinal" => "56" ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "La necesidad de una estrategia en investigación y desarrollo" ] ] "contieneTextoCompleto" => array:1 [ "en" => true ] "contienePdf" => array:1 [ "en" => true ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0005" "etiqueta" => "Fig. 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 1208 "Ancho" => 1391 "Tamanyo" => 80647 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">The Triple Helix model of university–industry–government relations.</p>" ] ] ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "José Antonio Gutiérrez Fuentes" "autores" => array:1 [ 0 => array:2 [ "nombre" => "José Antonio Gutiérrez" "apellidos" => "Fuentes" ] ] ] ] ] "idiomaDefecto" => "en" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S1579212914003735?idApp=UINPBA00003Z" "url" => "/15792129/0000005100000002/v2_201810230610/S1579212914003735/v2_201810230610/en/main.assets" ] "en" => array:13 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Editorial</span>" "titulo" => "Inhaled Corticosteroids Withdrawal in Severe Patients With Chronic Obstructive Pulmonary Disease: A Wisdom Decision?" "tieneTextoCompleto" => true "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "57" "paginaFinal" => "58" ] ] "autores" => array:1 [ 0 => array:4 [ "autoresLista" => "Robert Rodriguez Roisin, Ebymar Arismendi" "autores" => array:2 [ 0 => array:4 [ "nombre" => "Robert" "apellidos" => "Rodriguez Roisin" "email" => array:1 [ 0 => "rororo@clinic.ub.es" ] "referencia" => array:3 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] 2 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "cor0005" ] ] ] 1 => array:3 [ "nombre" => "Ebymar" "apellidos" => "Arismendi" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] ] ] ] "afiliaciones" => array:2 [ 0 => array:3 [ "entidad" => "Servei de Pneumologia, Institut del Tòrax, Hospital Clínic, Barcelona, Spain" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), CIBER Enfermedades Respiratorias (CIBERES), Universitat de Barcelona, Barcelona, Spain" "etiqueta" => "b" "identificador" => "aff0010" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Retirada de corticoesteroides inhalados en pacientes graves con enfermedad pulmonar obstructiva crónica: ¿es una propuesta razonable?" ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">According to <span class="elsevierStyleItalic">Global Initiative for Obstructive Lung Disease</span> (<span class="elsevierStyleItalic">GOLD</span>) <span class="elsevierStyleItalic">2014 Update</span>, pharmacologic therapy for stable chronic obstructive pulmonary disease (COPD) is used to reduce symptoms, improve health status and exercise tolerance, and decrease the frequency and severity of exacerbations.<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> In this context, long-acting (LA) bronchodilators are central to symptom management in COPD. The dose-response curve and long-term safety of inhaled corticosteroids (ICs) in COPD are not known, and their effects on pulmonary and systemic inflammation are controversial. Likewise, the <span class="elsevierStyleItalic">National Institute of Clinical Excellence (NICE)</span> states that none of the ICs currently available are licensed for use alone in the treatment of COPD.<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> GOLD underlines that regular treatment with ICs improves symptoms, lung function and quality of life, and reduces the frequency of exacerbations in stable COPD patients with an FEV<span class="elsevierStyleInf">1</span> <60% predicted (Evidence A).<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> Similar recommendations have been made by the <span class="elsevierStyleItalic">American Thoracic Society</span> (ATS) and the <span class="elsevierStyleItalic">European Respiratory Society</span> (ERS),<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a> NICE and the Spanish guidelines for the treatment of COPD (<span class="elsevierStyleItalic">Guía Española de la EPOC</span> –[GesEPOC] from the <span class="elsevierStyleItalic">Sociedad de Neumología y Cirugía Torácica</span> [SEPAR]).<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a> An IC combined with a LA beta<span class="elsevierStyleInf">2</span>-agonist (LABA) is more effective than the individual components in improving lung function and health status and reducing exacerbations in patients with moderate (Evidence B) to very severe COPD (Evidence A). The <span class="elsevierStyleItalic">GOLD 2014 Update</span><a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> underlined that the addition of a LABA<span class="elsevierStyleHsp" style=""></span>+<span class="elsevierStyleHsp" style=""></span>IC combination to LA anticholinergic or antimuscarinic agents (LAMA) improves lung function and quality of life and may further reduce exacerbations (Evidence B) but more triple therapy studies are needed. In patients with COPD, however, regular IC use is associated with higher prevalence of oral thrush, hoarse voice, bruising and increased risk of pneumonia.</p><p id="par0010" class="elsevierStylePara elsevierViewall">In the WISDOM (<span class="elsevierStyleItalic"><span class="elsevierStyleBold"><span class="elsevierStyleUnderline">W</span></span>ithdrawal of <span class="elsevierStyleBold"><span class="elsevierStyleUnderline">I</span></span>nhaled <span class="elsevierStyleBold"><span class="elsevierStyleUnderline">S</span></span>teroids <span class="elsevierStyleBold"><span class="elsevierStyleUnderline">d</span></span>uring <span class="elsevierStyleBold"><span class="elsevierStyleUnderline">O</span></span>ptimised bronchodilator <span class="elsevierStyleBold"><span class="elsevierStyleUnderline">M</span></span>anagement</span>) trial, it was hypothesized that with a controlled stepwise withdrawal of ICs, the risk of exacerbation would be similar to the continued use of ICs in patients with severe or very severe COPD (GOLD 3–4) and a history of exacerbations who were receiving LABA (salmeterol)<span class="elsevierStyleHsp" style=""></span>+<span class="elsevierStyleHsp" style=""></span>LAMA (tiotropium).<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a> More than 4000 patients enrolled in a 12-month, double-blind, parallel-group, active-controlled trial received triple therapy (LAMA tiotropium 18<span class="elsevierStyleHsp" style=""></span>μg once daily, LABA salmeterol 50<span class="elsevierStyleHsp" style=""></span>μg twice daily and IC fluticasone 500<span class="elsevierStyleHsp" style=""></span>μg twice daily) in a run-in period of 6 weeks and were then randomized to continued triple therapy or IC withdrawal in three steps over 12 weeks. Exacerbations (primary end-point), spirometric findings, dyspnea and health status were assessed. Ultimately, ICs were withdrawn in 1242 patients and continued in 1243 patients. Compared with continued IC use, IC withdrawal met the pre-specified non-inferiority margin of 1.20 for the upper limit of the 95% confidence interval with respect to the first moderate or severe on-treatment COPD exacerbation. Analysis of data from several previous randomized controlled trials using tiotropium indicated that the outcome for tiotropium compared to placebo was higher than 1.20 (time to exacerbation, patients with ≥1 exacerbation, number of exacerbations per patient per year; all expressed as a treatment ratio). Accordingly, since the increased risk of exacerbations did not reach the hazard ratio of 1.20, i.e. a 20% increase in the odds of having an exacerbation, it was concluded that withdrawal of ICs was not inferior to continuation. Likewise, withdrawal of ICs resulted in no change in dyspnea and only a minor variation in quality of life at week 52 (<span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0.06). Notwithstanding, after withdrawal of ICs at week 18, the adjusted mean decrease from baseline in trough FEV<span class="elsevierStyleInf">1</span> was 38<span class="elsevierStyleHsp" style=""></span>mL greater in the glucocorticoid-withdrawal group than in the glucocorticoid-continuation group (<span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0.001), and 43<span class="elsevierStyleHsp" style=""></span>mL greater at the end of the trial (week 52) (<span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0.001). Patients performed regular spirometry at home from weeks 0–52 and the analysis of the slope confirmed that the between-group FEV<span class="elsevierStyleInf">1</span> differences remained similar during this follow-up period (unpublished data). Previous attempts at abrupt IC stepping down not associated with regular dual LA bronchodilation resulted in similar lung function impairment, more worsening of symptoms, poorer quality of life and/or recurrence of exacerbations.<a class="elsevierStyleCrossRefs" href="#bib0030"><span class="elsevierStyleSup">6,7</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">The mechanisms by which corticosteroids improve lung function in patients with COPD remain poorly understood. Up to 3 different mechanisms have been invoked. First, bronchodilation may be enhanced by up-regulation of beta<span class="elsevierStyleInf">2</span>-adrenergic receptors located in the airway walls and bronchial vessels. It is known that in patients with asthma fluticasone reduces bronchial blood flow within less than 2<span class="elsevierStyleHsp" style=""></span>h following inhalation.<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a> Second, airway wall edema may be reduced by the anti-exudative effects of ICs together with vasoconstriction of the bronchial circulation. Third, ICs may reduce the release of inflammatory mediators and induce vasoconstriction of the pulmonary vasculature.</p><p id="par0020" class="elsevierStylePara elsevierViewall">To conclude, while the risk of moderate or severe exacerbations was similar among those who discontinued ICs and those who continued IC treatment, there was a greater decrease in lung function following the final step of IC withdrawal. For clinicians considering re-evaluating maintenance COPD therapy in their stable COPD patients with GOLD 3–4, the WISDOM findings show that a stepwise withdrawal of ICs is not associated with an increased risk of exacerbations.</p><p id="par0025" class="elsevierStylePara elsevierViewall">Although experts concluded that the trial design was well executed, results were internally consistent and met the pre-specified non-inferiority statistical limit, concerns may be raised about the significance of the findings. In the absence of increased side effects of triple therapy (ICs<span class="elsevierStyleHsp" style=""></span>+<span class="elsevierStyleHsp" style=""></span>LABA<span class="elsevierStyleHsp" style=""></span>+<span class="elsevierStyleHsp" style=""></span>LAMA) compared with dual bronchodilation, the WISDOM observations provide robust information but insufficient clinical direction regarding the choice between double and triple therapy in severe COPD. Several issues need to be addressed. What is the clinical relevance of the between-group FEV<span class="elsevierStyleInf">1</span> differences at the end of the trial? A longer study follow-up would have certainly provided more insights, but this needs to be balanced against the fear caused by the degree of COPD severity in these patients. Was the IC withdrawal timeframe appropriate? It could be probably have been shortened, but this still needs to be proven. Can the current dosage of ICs for COPD patients be reconsidered? The WISDOM trial suggests that a reduction in IC dosage should be seriously considered. As rightly pointed out by the accompanying editorial,<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">10</span></a> can we consider the use of alternative therapies to ICs, such as azithromycin or phosphodiesterase-4 inhibitors,<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">9</span></a> to reinforce the effects of stepping down ICs? This seems likely, but further research is required. Last but not least, are we seeing the beginning of the end of ICs in stable COPD? If this is not the case, which COPD patients would benefit more from the regular use of combination therapy with ICs? Currently, at least, patients with coexisting asthma and COPD overlap syndrome (ACOS), the real prevalence of which is still far from certain, remain the most appropriate subjects for the regular use of ICs in combination with mono or dual bronchodilation.<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> So, are we facing a paradigm shift in the management and therapy of COPD? Certainly such a breakthrough has not yet been achieved.</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflict of Interests</span><p id="par0030" class="elsevierStylePara elsevierViewall">RRR (2011-14) lectured for Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, Ferrer, Menarini, Novartis, Pfizer, Takeda and TEVA; consulted with AstraZeneca, Boehringer Ingelheim, Foster, Merck, Sharp & Dome, Mylan, Novartis, Pearl Therapeutics, Pfizer, Takeda, and TEVA, and received grant support from Almirall. He is a member of the GOLD Science Committee.EA (2011-14) has no conflict of interests to declare.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:2 [ 0 => array:2 [ "identificador" => "sec0005" "titulo" => "Conflict of Interests" ] 1 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "NotaPie" => array:2 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as: Rodriguez Roisin R, Arismendi E. Retirada de corticoesteroides inhalados en pacientes graves con enfermedad pulmonar obstructiva crónica: ¿es una propuesta razonable? Arch Bronconeumol. 2015;51:57–58.</p>" ] 1 => array:2 [ "etiqueta" => "☆☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0010">RRR and EA were WISDOM study investigators. RRR was a member of the WISDOM Steering Committee</p>" ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:10 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:3 [ "comentario" => "Available from: <a class="elsevierStyleInterRef" target="_blank" id="intr0010" href="http://www.goldcopd.org/">www.goldcopd.org</a> [accessed 20.10.14]" "contribucion" => array:1 [ 0 => array:1 [ "titulo" => "Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease. 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Year/Month | Html | Total | |
---|---|---|---|
2024 October | 32 | 19 | 51 |
2024 September | 50 | 25 | 75 |
2024 August | 57 | 59 | 116 |
2024 July | 45 | 28 | 73 |
2024 June | 59 | 44 | 103 |
2024 May | 84 | 36 | 120 |
2024 April | 30 | 30 | 60 |
2024 March | 36 | 18 | 54 |
2024 February | 31 | 21 | 52 |
2023 March | 10 | 3 | 13 |
2023 February | 25 | 24 | 49 |
2023 January | 38 | 29 | 67 |
2022 December | 35 | 27 | 62 |
2022 November | 51 | 29 | 80 |
2022 October | 36 | 33 | 69 |
2022 September | 30 | 31 | 61 |
2022 August | 30 | 43 | 73 |
2022 July | 35 | 42 | 77 |
2022 June | 20 | 37 | 57 |
2022 May | 38 | 43 | 81 |
2022 April | 39 | 36 | 75 |
2022 March | 23 | 41 | 64 |
2022 February | 34 | 29 | 63 |
2022 January | 30 | 36 | 66 |
2021 December | 21 | 35 | 56 |
2021 November | 30 | 38 | 68 |
2021 October | 50 | 54 | 104 |
2021 September | 31 | 44 | 75 |
2021 August | 28 | 34 | 62 |
2021 July | 22 | 26 | 48 |
2021 June | 43 | 28 | 71 |
2021 May | 37 | 35 | 72 |
2021 April | 113 | 61 | 174 |
2021 March | 61 | 18 | 79 |
2021 February | 50 | 23 | 73 |
2021 January | 35 | 18 | 53 |
2020 December | 37 | 15 | 52 |
2020 November | 27 | 17 | 44 |
2020 October | 19 | 18 | 37 |
2020 September | 25 | 13 | 38 |
2020 August | 24 | 18 | 42 |
2020 July | 26 | 20 | 46 |
2020 June | 34 | 11 | 45 |
2020 May | 26 | 15 | 41 |
2020 April | 30 | 13 | 43 |
2020 March | 24 | 12 | 36 |
2020 February | 26 | 16 | 42 |
2020 January | 27 | 17 | 44 |
2019 December | 32 | 16 | 48 |
2019 November | 33 | 21 | 54 |
2019 October | 18 | 17 | 35 |
2019 September | 13 | 8 | 21 |
2019 August | 24 | 16 | 40 |
2019 July | 26 | 18 | 44 |
2019 June | 13 | 12 | 25 |
2019 May | 18 | 10 | 28 |
2019 April | 32 | 34 | 66 |
2019 March | 32 | 20 | 52 |
2019 February | 28 | 15 | 43 |
2019 January | 28 | 25 | 53 |
2018 December | 23 | 16 | 39 |
2018 November | 67 | 21 | 88 |
2018 October | 64 | 22 | 86 |
2018 September | 14 | 13 | 27 |
2018 May | 16 | 0 | 16 |
2018 April | 62 | 11 | 73 |
2018 March | 64 | 7 | 71 |
2018 February | 44 | 11 | 55 |
2018 January | 179 | 9 | 188 |
2017 December | 151 | 6 | 157 |
2017 November | 44 | 6 | 50 |
2017 October | 30 | 7 | 37 |
2017 September | 37 | 14 | 51 |
2017 August | 43 | 11 | 54 |
2017 July | 55 | 15 | 70 |
2017 June | 63 | 16 | 79 |
2017 May | 59 | 20 | 79 |
2017 April | 42 | 15 | 57 |
2017 March | 55 | 12 | 67 |
2017 February | 33 | 8 | 41 |
2017 January | 19 | 11 | 30 |
2016 December | 38 | 13 | 51 |
2016 November | 54 | 12 | 66 |
2016 October | 63 | 17 | 80 |
2016 September | 82 | 21 | 103 |
2016 August | 62 | 8 | 70 |
2016 July | 33 | 13 | 46 |
2016 March | 2 | 0 | 2 |
2016 February | 3 | 0 | 3 |
2015 December | 3 | 0 | 3 |
2015 October | 72 | 4 | 76 |
2015 September | 65 | 9 | 74 |
2015 August | 60 | 14 | 74 |
2015 July | 38 | 13 | 51 |
2015 June | 51 | 9 | 60 |
2015 May | 55 | 22 | 77 |
2015 April | 1 | 1 | 2 |
2015 March | 0 | 1 | 1 |
2015 February | 3 | 2 | 5 |