Le document pr\u00e9sente les \u00e9l\u00e9ments principaux de l\u2019\u00e9valuation europ\u00e9enne ayant conduit \u00e0 l\u2019autorisation d\u2019Eklira Genuair dans l\u2019Union europ\u00e9enne pour le traitement de la broncho-pneumopathie chronique obstructive (BPCO) chez l\u2019adulte. Il s\u2019agit d\u2019un m\u00e9dicament de traitement d\u2019entretien visant \u00e0 soulager les sympt\u00f4mes de cette maladie respiratoire chronique caract\u00e9ris\u00e9e par une atteinte et une obstruction des voies respiratoires et des alv\u00e9oles pulmonaires, entra\u00eenant des difficult\u00e9s respiratoires.<\/p>\n
Eklira Genuair contient comme substance active le bromure d\u2019aclidinium, un bronchodilatateur antimuscarinique. Son mode d\u2019action repose sur le blocage des r\u00e9cepteurs muscariniques qui contr\u00f4lent la contraction des muscles lisses bronchiques, ce qui entra\u00eene une relaxation de ces muscles, un \u00e9largissement des voies a\u00e9riennes et une am\u00e9lioration de la respiration. Le m\u00e9dicament est disponible sous forme de poudre pour inhalation dans un dispositif portable. Chaque inhalation d\u00e9livre 375 microgrammes de bromure d\u2019aclidinium, correspondant \u00e0 322 microgrammes d\u2019aclidinium. La posologie recommand\u00e9e est d\u2019une inhalation deux fois par jour. Le m\u00e9dicament est soumis \u00e0 prescription m\u00e9dicale et l\u2019utilisation correcte de l\u2019inhalateur est d\u00e9taill\u00e9e dans la notice destin\u00e9e aux patients.<\/p>\n
L\u2019\u00e9valuation a \u00e9t\u00e9 r\u00e9alis\u00e9e par l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA), via son Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP), dans le cadre de la proc\u00e9dure d\u2019autorisation de mise sur le march\u00e9 dans l\u2019UE. Le CHMP s\u2019est fond\u00e9 notamment sur une \u00e9tude principale incluant 828 patients atteints de BPCO, comparant deux doses d\u2019Eklira Genuair (200 et 400 microgrammes, deux fois par jour) \u00e0 un placebo. Le crit\u00e8re principal d\u2019efficacit\u00e9 \u00e9tait l\u2019am\u00e9lioration du volume expiratoire maximal en une seconde (VEMS\/FEV1). Apr\u00e8s six mois de traitement, le VEMS des patients trait\u00e9s a augment\u00e9 par rapport au placebo de 99 ml pour la dose de 200 microgrammes et de 128 ml pour la dose de 400 microgrammes, cette derni\u00e8re correspondant \u00e0 une inhalation d\u00e9livrant 322 microgrammes d\u2019aclidinium. Selon le CHMP, les effets b\u00e9n\u00e9fiques sur les sympt\u00f4mes de la BPCO sont maintenus jusqu\u2019\u00e0 un an de traitement et aucun signal majeur de s\u00e9curit\u00e9 n\u2019a \u00e9t\u00e9 identifi\u00e9 dans les donn\u00e9es pr\u00e9sent\u00e9es.<\/p>\n
Les effets ind\u00e9sirables les plus fr\u00e9quents (plus de 5 % des patients) sont les c\u00e9phal\u00e9es et la rhinopharyngite. D\u2019autres effets ind\u00e9sirables fr\u00e9quents (plus de 1 % des patients) incluent sinusite, toux, naus\u00e9es et diarrh\u00e9e. La liste compl\u00e8te des effets ind\u00e9sirables et des restrictions d\u2019utilisation figure dans la notice. Le document pr\u00e9cise que les informations fournies ne remplacent pas les recommandations pratiques d\u2019utilisation, qui rel\u00e8vent du m\u00e9decin ou du pharmacien et de la notice destin\u00e9e aux patients. Les \u00e9l\u00e9ments pr\u00e9sent\u00e9s sont pertinents pour le suivi des politiques de sant\u00e9 au niveau europ\u00e9en, notamment en mati\u00e8re d\u2019acc\u00e8s \u00e0 de nouvelles options th\u00e9rapeutiques pour la BPCO et de surveillance de leur efficacit\u00e9 et de leur s\u00e9curit\u00e9 \u00e0 l\u2019\u00e9chelle de l\u2019UE. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Le document pr\u00e9sente les \u00e9l\u00e9ments principaux de l\u2019\u00e9valuation europ\u00e9enne ayant conduit \u00e0 l\u2019autorisation d\u2019Eklira Genuair dans l\u2019Union europ\u00e9enne pour le traitement de la broncho-pneumopathie chronique obstructive (BPCO) chez l\u2019adulte. Il […]<\/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-21879","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\/21879","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=21879"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21879\/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=21879"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21879"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21879"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}