{"id":22077,"date":"2026-10-23T10:56:27","date_gmt":"2026-10-23T10:56:27","guid":{"rendered":"https:\/\/veilles-affaires-sociales.fr\/?p=22077"},"modified":"2026-10-23T10:56:27","modified_gmt":"2026-10-23T10:56:27","slug":"rapport-europeen-public-devaluation-epar-pour-les-medicaments-a-usage-humain-trixeo-aerosphere-formoterol-bromure-de-glycopyrronium-budesonide-date-dautorisation-09-12-2020","status":"publish","type":"post","link":"https:\/\/veilles-affaires-sociales.fr\/?p=22077","title":{"rendered":"Rapport europ\u00e9en public d\u2019\u00e9valuation (EPAR) pour les m\u00e9dicaments \u00e0 usage humain : Trixeo Aerosphere, formot\u00e9rol, bromure de glycopyrronium, bud\u00e9sonide, Date d\u2019autorisation : 09\/12\/2020, R\u00e9vision : 8, Statut : Autoris\u00e9\u00a0(titre traduit en fran\u00e7ais par l&rsquo;IA)"},"content":{"rendered":"<p>Trixeo Aerosphere est un m\u00e9dicament indiqu\u00e9 dans le traitement de la bronchopneumopathie chronique obstructive (BPCO) et de l\u2019asthme. Il est destin\u00e9 au traitement de fond de la BPCO mod\u00e9r\u00e9e \u00e0 s\u00e9v\u00e8re chez l\u2019adulte lorsque la maladie n\u2019est pas suffisamment contr\u00f4l\u00e9e par une bith\u00e9rapie inhal\u00e9e associant un b\u00eata-2 agoniste de longue dur\u00e9e d\u2019action et soit un cortico\u00efde inhal\u00e9, soit un antagoniste muscarinique de longue dur\u00e9e d\u2019action. Il est \u00e9galement indiqu\u00e9 dans le traitement de l\u2019asthme chez les patients de 12 ans et plus lorsque la maladie n\u2019est pas suffisamment contr\u00f4l\u00e9e par une association inhal\u00e9e de cortico\u00efde et de b\u00eata-2 agoniste de longue dur\u00e9e d\u2019action.<\/p>\n<p>Le m\u00e9dicament contient trois substances actives : le formot\u00e9rol (b\u00eata-2 agoniste de longue dur\u00e9e d\u2019action), le bromure de glycopyrronium (antagoniste muscarinique de longue dur\u00e9e d\u2019action) et la bud\u00e9sonide (cortico\u00efde anti\u2011inflammatoire). Ces trois compos\u00e9s agissent de fa\u00e7on compl\u00e9mentaire pour induire une bronchodilatation (relaxation des muscles des voies respiratoires) et r\u00e9duire l\u2019inflammation des voies a\u00e9riennes en modulant la r\u00e9ponse immunitaire.<\/p>\n<p>Trixeo Aerosphere est disponible uniquement sur prescription m\u00e9dicale, sous forme d\u2019inhalateur portable. La posologie recommand\u00e9e est de deux inhalations deux fois par jour (matin et soir). L\u2019apprentissage de la bonne utilisation de l\u2019inhalateur par un professionnel de sant\u00e9 est requis, les informations pratiques \u00e9tant renvoy\u00e9es \u00e0 la notice et aux prescripteurs.<\/p>\n<p>Les donn\u00e9es cliniques mentionn\u00e9es proviennent de deux \u00e9tudes principales conduites aupr\u00e8s de plus de 10 000 patients atteints de BPCO mod\u00e9r\u00e9e \u00e0 tr\u00e8s s\u00e9v\u00e8re. Elles montrent une am\u00e9lioration du VEMS (volume expiratoire maximal en une seconde) et une r\u00e9duction du nombre d\u2019exacerbations. Dans la premi\u00e8re \u00e9tude, apr\u00e8s 24 semaines de traitement, l\u2019augmentation du VEMS \u00e9tait d\u2019environ 147 ml chez les patients trait\u00e9s par Trixeo Aerosphere, contre 125 ml chez ceux recevant l\u2019association glycopyrronium\u2013formot\u00e9rol, et 73 ml avec une autre comparaison (non pr\u00e9cis\u00e9e dans l\u2019extrait). Ces r\u00e9sultats soutiennent l\u2019int\u00e9r\u00eat clinique de la trith\u00e9rapie inhal\u00e9e dans la BPCO insuffisamment contr\u00f4l\u00e9e par les associations existantes.<\/p>\n<p>Aucun pays ni autorit\u00e9 sanitaire sp\u00e9cifique n\u2019est mentionn\u00e9 dans l\u2019extrait, mais les \u00e9l\u00e9ments fournis sont directement pertinents pour la surveillance des strat\u00e9gies th\u00e9rapeutiques en BPCO et en asthme, en particulier l\u2019usage croissant de trith\u00e9rapies inhal\u00e9es chez des patients insuffisamment contr\u00f4l\u00e9s par les combinaisons classiques. L\u2019information peut \u00eatre utile pour le suivi des pratiques de prescription, l\u2019\u00e9valuation m\u00e9dico-\u00e9conomique et la veille sur l\u2019organisation des soins en pneumologie. L\u2019extrait ne fournit toutefois pas de donn\u00e9es sur les effets ind\u00e9sirables, la s\u00e9curit\u00e9 \u00e0 long terme, les co\u00fbts ou les impacts organisationnels. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l&rsquo;IA)\u00a0\u200b<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/trixeo-aerosphere\" target=\"_blank\" class=\"feedzy-rss-link-icon\">Lire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Trixeo Aerosphere est un m\u00e9dicament indiqu\u00e9 dans le traitement de la bronchopneumopathie chronique obstructive (BPCO) et de l\u2019asthme. Il est destin\u00e9 au traitement de fond de la BPCO mod\u00e9r\u00e9e \u00e0 [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":17698,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[7],"tags":[257,227,226],"class_list":["post-22077","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicaments-et-produits-de-sante","tag-ema","tag-ia","tag-sources-etrangeres"],"_links":{"self":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/22077","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=22077"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/22077\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/media\/17698"}],"wp:attachment":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=22077"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=22077"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=22077"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}