Le document pr\u00e9sente l\u2019\u00e9valuation r\u00e9alis\u00e9e par l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) dans le cadre du rapport europ\u00e9en public d\u2019\u00e9valuation (EPAR) pour le m\u00e9dicament Duaklir Genuair, et les conditions associ\u00e9es \u00e0 son autorisation de mise sur le march\u00e9 dans l\u2019Union europ\u00e9enne. Duaklir Genuair est indiqu\u00e9 chez l\u2019adulte pour le traitement d\u2019entretien des sympt\u00f4mes de la bronchopneumopathie chronique obstructive (BPCO), une maladie respiratoire de longue dur\u00e9e caract\u00e9ris\u00e9e par une obstruction des voies a\u00e9riennes entra\u00eenant des difficult\u00e9s respiratoires. Le m\u00e9dicament est soumis \u00e0 prescription m\u00e9dicale.<\/p>\n
Duaklir Genuair se pr\u00e9sente sous forme de poudre pour inhalation administr\u00e9e au moyen d\u2019un dispositif portable. Chaque inhalation d\u00e9livre 340 microgrammes de bromure d\u2019aclidinium et 12 microgrammes de fumarate de formot\u00e9rol dihydrat\u00e9. La posologie recommand\u00e9e est d\u2019une inhalation deux fois par jour. Les informations pratiques d\u2019utilisation rel\u00e8vent de la notice destin\u00e9e aux patients ou des professionnels de sant\u00e9.<\/p>\n
Le produit associe deux principes actifs bronchodilatateurs de longue dur\u00e9e d\u2019action, d\u00e9j\u00e0 utilis\u00e9s s\u00e9par\u00e9ment dans la prise en charge de la BPCO dans l\u2019UE. Le bromure d\u2019aclidinium, autoris\u00e9 depuis 2012 dans l\u2019Union sous les noms Bretaris Genuair et Eklira Genuair, est un antagoniste muscarinique de longue dur\u00e9e d\u2019action qui bloque des r\u00e9cepteurs muscariniques situ\u00e9s dans les cellules musculaires des voies respiratoires, entra\u00eenant une relaxation des muscles bronchiques et un maintien de l\u2019ouverture des voies a\u00e9riennes. Le formot\u00e9rol, agoniste b\u00eata-2 de longue dur\u00e9e d\u2019action commercialis\u00e9 dans l\u2019UE depuis les ann\u00e9es 1990, se fixe aux r\u00e9cepteurs b\u00eata-2 des muscles des voies respiratoires et provoque \u00e9galement leur relaxation. L\u2019association de ces deux classes (antagonistes muscariniques de longue dur\u00e9e d\u2019action et agonistes b\u00eata-2 de longue dur\u00e9e d\u2019action) est d\u00e9crite comme couramment utilis\u00e9e dans la prise en charge de la BPCO.<\/p>\n
L\u2019efficacit\u00e9 de Duaklir Genuair a \u00e9t\u00e9 \u00e9tudi\u00e9e dans deux essais cliniques principaux portant sur plus de 3 400 patients atteints de BPCO, comparant Duaklir Genuair \u00e0 l\u2019aclidinium seul, au formot\u00e9rol seul et \u00e0 un placebo. Le crit\u00e8re principal d\u2019\u00e9valuation reposait sur la variation du volume expiratoire maximal seconde (VEMS ou FEV1), c\u2019est\u2011\u00e0\u2011dire le volume maximal d\u2019air expir\u00e9 en une seconde, apr\u00e8s six mois de traitement. Les r\u00e9sultats indiquent qu\u2019apr\u00e8s six mois, l\u2019augmentation du VEMS mesur\u00e9e une heure apr\u00e8s une inhalation \u00e9tait sup\u00e9rieure de 293 ml avec Duaklir Genuair par rapport au placebo. L\u2019EPAR met ainsi en \u00e9vidence un gain fonctionnel respiratoire significatif \u00e0 six mois, dans un cadre m\u00e9thodologique comparatif incluant un traitement factice et les monoth\u00e9rapies correspondantes.<\/p>\n
Les \u00e9l\u00e9ments fournis par l\u2019EMA concernent principalement l\u2019\u00e9valuation scientifique, les indications, le r\u00e9gime de prescription et le sch\u00e9ma posologique, sans d\u00e9tailler les aspects organisationnels ou \u00e9conomiques. Les informations peuvent \u00eatre utiles pour le suivi des politiques pharmaceutiques et de prise en charge de la BPCO au niveau europ\u00e9en, notamment en ce qui concerne les strat\u00e9gies de traitement par associations fixes de bronchodilatateurs de longue dur\u00e9e d\u2019action. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Le document pr\u00e9sente l\u2019\u00e9valuation r\u00e9alis\u00e9e par l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) dans le cadre du rapport europ\u00e9en public d\u2019\u00e9valuation (EPAR) pour le m\u00e9dicament Duaklir Genuair, et les conditions associ\u00e9es \u00e0 […]<\/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-21868","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\/21868","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=21868"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21868\/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=21868"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21868"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21868"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}