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Zamora Navarro, Mazarrón (Murcia), Spain" "etiqueta" => "n" "identificador" => "aff0070" ] 14 => array:3 [ "entidad" => "Comité Ejecutivo de GEMA, Asociación Española de Pediatría de Atención Primaria (AEPAP), Universidad de Sevilla, Sevilla, Spain" "etiqueta" => "o" "identificador" => "aff0075" ] 15 => array:3 [ "entidad" => "Comité Ejecutivo de GEMA, Asociación Española de Pediatría de Atención Primaria (AEPAP), Atención Primaria, Madrid, Spain" "etiqueta" => "p" "identificador" => "aff0080" ] 16 => array:3 [ "entidad" => "Comité Ejecutivo de GEMA, Sociedad Española de Inmunología Clínica, Alergología y Asma Pediátrica (SEICAP), Unidad de Alergia y Neumología Infantil, Hospital Universitario Casa de Salud, Valencia, Spain" "etiqueta" => "q" "identificador" => "aff0085" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Discrepancias en la clasificación de los glucocorticoides inhalados entre GEMA y GINA" ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">We read with interest the letter signed by Doctors Entrenas-Costa and Entrenas-Castillo<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> in which they suggest that the classification of the dose of 100<span class="elsevierStyleHsp" style=""></span>μg of fluticasone furoate (FF) once a day (OD) that appears in the GEMA guidelines as medium dose<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> should be “corrected” and classified in line with the GINA guidelines as low dose.<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">GEMA is a clinical practice guideline drawn up by independent experts from 15 different scientific societies.<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> The classification of 100<span class="elsevierStyleHsp" style=""></span>μg FF OD as a medium dose is evidence-based and consistent with the approved Summary of Product Characteristics (SPC) for FF<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a> and with the classifications of other relevant international guidelines, such as SIGN 158 in the UK and the Australian Asthma Handbook. Few direct comparisons are available with FF and other inhaled glucocorticoids, particularly at low doses, so it is difficult to establish the exact equipotent dose (equivalent in efficacy and safety) of FF. According to the SPC, a daily dose of 100<span class="elsevierStyleHsp" style=""></span>μg of FF in asthma is approximately equivalent to 250<span class="elsevierStyleHsp" style=""></span>μg of fluticasone propionate (FP) twice a day (BID, medium dose), while 200<span class="elsevierStyleHsp" style=""></span>μg FF OD is approximately equivalent to 500<span class="elsevierStyleHsp" style=""></span>μg FP BID (high dose).<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a> A low dose of FF is not approved in asthma. Evidence of efficacy and safety with 50<span class="elsevierStyleHsp" style=""></span>μg of FF OD in mild-moderate asthma is low and inconsistent, although at least one of the published studies indicates greater efficacy than placebo and approximately similar efficacy to that of low-dose FP (100<span class="elsevierStyleHsp" style=""></span>μg BID) in mild asthma.<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">With regard to safety, the authors comment that the dose of 100<span class="elsevierStyleHsp" style=""></span>μg FF does not suppress cortisol, based on a pharmacokinetic/pharmacodynamic model and limited data from a 6-week study.<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> However, in a 52-week study of 503 adults and adolescents with asthma specifically designed to assess safety, 24-h urinary cortisol excretion at the medium dose of 100<span class="elsevierStyleHsp" style=""></span>μg FF OD was similar to that obtained at the high dose of 500<span class="elsevierStyleHsp" style=""></span>μg FP BID after 1 year of treatment, and about 10% of patients treated with 100<span class="elsevierStyleHsp" style=""></span>μg FF had persistently low urinary cortisol levels (<40<span class="elsevierStyleHsp" style=""></span>nmol/24<span class="elsevierStyleHsp" style=""></span>h) during treatment.<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a> All inhaled glucocorticoids present a risk of systemic (e.g. pneumonia, cortico-adrenal axis suppression, osteoporosis, glaucoma, etc.) and local (candidiasis, etc.) adverse effects, all of which are dose-dependent.</p><p id="par0020" class="elsevierStylePara elsevierViewall">As a result, until new data become available, we believe that the classification of 100<span class="elsevierStyleHsp" style=""></span>μg FF as a medium dose is the most correct and prudent option. Treatment for asthma maintenance should be administered at the minimum dose required to maintain disease control<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> in order to minimize the risk of adverse effects.</p></span>" "pdfFichero" => "main.pdf" "tienePdf" => true "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as: Plaza Moral V, Gómez-Outes A, Quirce Gancedo S, Alobid I, Álvarez Rodríguez C, Blanco Aparicio M, et al. Discrepancias en la clasificación de los glucocorticoides inhalados entre GEMA y GINA. 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Andersen" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1136/thoraxjnl-2012-2026.06" "Revista" => array:6 [ "tituloSerie" => "Thorax" "fecha" => "2013" "volumen" => "68" "paginaInicial" => "513" "paginaFinal" => "520" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/23440247" "web" => "Medline" ] ] ] ] ] ] ] ] ] ] ] ] ] "idiomaDefecto" => "en" "url" => "/15792129/0000005600000007/v1_202007070735/S1579212920300884/v1_202007070735/en/main.assets" "Apartado" => array:4 [ "identificador" => "45358" "tipo" => "SECCION" "en" => array:2 [ "titulo" => "Letters to the Editor" "idiomaDefecto" => true ] "idiomaDefecto" => "en" ] "PDF" => "https://static.elsevier.es/multimedia/15792129/0000005600000007/v1_202007070735/S1579212920300884/v1_202007070735/en/main.pdf?idApp=UINPBA00003Z&text.app=https://archbronconeumol.org/" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S1579212920300884?idApp=UINPBA00003Z" ]
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