Letter to the Editor
Response to the GEMA Executive Committee
Respuesta al Comité ejecutivo de GEMA
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GEMA's positioning is therefore in line with the indications of the Summary of Product Characteristics and the therapeutic positioning report recently published by the AEMPS.<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">2</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">In their argument in favor of classifying a dose of 100<span class="elsevierStyleHsp" style=""></span>μg/24<span class="elsevierStyleHsp" style=""></span>h fluticasone furoate (FF) as medium, they cite the 2 papers that constitute the few references that compare ICGs in terms of equipotency. In the Bateman study,<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">3</span></a> different doses of FF versus fluticasone propionate (FP) 100<span class="elsevierStyleHsp" style=""></span>μg/12<span class="elsevierStyleHsp" style=""></span>h (low dose) were compared over a period of 8 weeks. The dose of FF 100<span class="elsevierStyleHsp" style=""></span>μg/24<span class="elsevierStyleHsp" style=""></span>h was not inferior that of FP 100<span class="elsevierStyleHsp" style=""></span>μg/12<span class="elsevierStyleHsp" style=""></span>h in terms of FEV<span class="elsevierStyleInf">1</span>, and did not produce a significant decrease in cortisol. The study of Busse et al.,<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">4</span></a> specifically designed to assess safety at 52 weeks, showed that urinary cortisol values for FF 100<span class="elsevierStyleHsp" style=""></span>μg/24<span class="elsevierStyleHsp" style=""></span>h were normal for 90% of patients at baseline. Throughout the study, urinary cortisol at all visits was normal in 72% of cases, low in 10%, and high in 17%.</p><p id="par0015" class="elsevierStylePara elsevierViewall">GEMA positioning on the medium dose is consistent with most clinical practice guidelines. However, an example of the difficulty that persists in establishing the exact equipotent dose of FF is that the UK guidelines (SIGN 158),<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">5</span></a> published by the British Thoracic Society (BTS), use 3 categories (low, medium and high dose) to classify ICG. Specifically, they situate FF/vilanterol 100<span class="elsevierStyleHsp" style=""></span>μg/24<span class="elsevierStyleHsp" style=""></span>h in the medium dose section, while simultaneously including it in half of the low-dose step. The BTS standpoint is a very good reflection of the limitations we still encounter in establishing the exact equipotent dose of FF.</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: Entrenas Costa LM, Entrenas Castillo M. Respuesta al Comité ejecutivo de GEMA. Arch Bronconeumol. Arch Bronconeumol. 2020;56:473.</p>" ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0015" "bibliografiaReferencia" => array:5 [ 0 => array:3 [ "identificador" => "bib0030" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Discrepancias en la clasificación de los glucocorticoides inhalados entre GEMA y GINA" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:2 [ 0 => "L.M. Entrenas Costa" 1 => "M. Entrenas Castillo" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1016/j.arbres.2019.06.018" "Revista" => array:5 [ "tituloSerie" => "Arch Bronconeumol" "fecha" => "2019" "volumen" => "55" "paginaInicial" => "667" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/31377109" "web" => "Medline" ] ] ] ] ] ] ] ] 1 => array:3 [ "identificador" => "bib0035" "etiqueta" => "2" "referencia" => array:1 [ 0 => array:1 [ "referenciaCompleta" => "Agencia Española del Medicamento y Productos Sanitarios. Informe de Posicionamiento Terapéutico de Furoato de Fluticasona/Vilanterol (Relvar Ellipta®, Revinty Ellipta®) en asma y EPOC. Dsiponible en: <a target="_blank" href="https://www.aemps.gob.es/medicamentosUsoHumano/informesPublicos/docs/IPT_fluticasona-vilanterol_revlar-v2.pdf?x27726">https://www.aemps.gob.es/medicamentosUsoHumano/informesPublicos/docs/IPT_fluticasona-vilanterol_revlar-v2.pdf?x27726</a> [consultado 13.03.20]" ] ] ] 2 => array:3 [ "identificador" => "bib0040" "etiqueta" => "3" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Dose effect of once-daily fluticasone furoate in persistent asthma: a randomized trial" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "E.D. Bateman" 1 => "E.R. Bleecker" 2 => "J. Lötvall" 3 => "A. Woodcock" 4 => "R. Forth" 5 => "H. Medley" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1016/j.rmed.2012.01.004" "Revista" => array:6 [ "tituloSerie" => "Respir Med" "fecha" => "2012" "volumen" => "106" "paginaInicial" => "642" "paginaFinal" => "650" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/22342538" "web" => "Medline" ] ] ] ] ] ] ] ] 3 => array:3 [ "identificador" => "bib0045" "etiqueta" => "4" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Safety and tolerability of the novel inhaled corticosteroid fluticasone furoate in combination with the β2 agonist vilanterol administered once daily for 52 weeks in patients >=12 years old with asthma: a randomised trial" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "W.W. Busse" 1 => "P.M. O’Byrne" 2 => "E.R. Bleecker" 3 => "J. Lötvall" 4 => "A. Woodcock" 5 => "L. Andersen" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1136/thoraxjnl-2012-202606" "Revista" => array:5 [ "tituloSerie" => "Thorax" "fecha" => "2013" "volumen" => "68" "paginaInicial" => "513" "paginaFinal" => "520" ] ] ] ] ] ] 4 => array:3 [ "identificador" => "bib0050" "etiqueta" => "5" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "SIGN158 British guideline on the management of asthma" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:1 [ 0 => "British Thoracic Society. NHS Scotland" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Libro" => array:1 [ "fecha" => "July 2019" ] ] ] ] ] ] ] ] ] ] ] "idiomaDefecto" => "en" "url" => "/15792129/0000005600000007/v1_202007070735/S157921292030135X/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/S157921292030135X/v1_202007070735/en/main.pdf?idApp=UINPBA00003Z&text.app=https://archbronconeumol.org/" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S157921292030135X?idApp=UINPBA00003Z" ]
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