Vydura est un m\u00e9dicament \u00e0 base de rimeg\u00e9pant indiqu\u00e9 chez l\u2019adulte pour le traitement de la crise de migraine, avec ou sans aura, et pour la pr\u00e9vention chez les patients pr\u00e9sentant au moins quatre crises de migraine par mois. Il se pr\u00e9sente sous forme de lyophilisat oral \u00e0 placer sur ou sous la langue, \u00e0 raison d\u2019une prise par jour en traitement de crise et d\u2019une prise un jour sur deux en pr\u00e9vention. Le m\u00e9dicament est soumis \u00e0 prescription m\u00e9dicale, avec renvoi au r\u00e9sum\u00e9 des caract\u00e9ristiques et \u00e0 la notice pour les modalit\u00e9s pr\u00e9cises d\u2019utilisation, effets ind\u00e9sirables et contre-indications.<\/p>\n
Sur le plan pharmacologique, le rimeg\u00e9pant agit en se fixant sur le r\u00e9cepteur du peptide li\u00e9 au g\u00e8ne de la calcitonine (CGRP), impliqu\u00e9 dans la survenue des migraines, emp\u00eachant la liaison du CGRP et contribuant ainsi au traitement et \u00e0 la pr\u00e9vention des crises.<\/p>\n
L\u2019\u00e9valuation repose principalement sur plusieurs essais cliniques randomis\u00e9s versus placebo. Trois \u00e9tudes de traitement de crise ont inclus environ 3 500 adultes pr\u00e9sentant des c\u00e9phal\u00e9es d\u2019intensit\u00e9 mod\u00e9r\u00e9e \u00e0 s\u00e9v\u00e8re. Deux heures apr\u00e8s la prise, en moyenne 20 % des patients trait\u00e9s par Vydura \u00e9taient totalement indemnes de douleur (score 0 sur une \u00e9chelle de 0 \u00e0 3), contre 12 % avec le placebo. Environ 36 % des patients sous Vydura \u00e9taient \u00e9galement lib\u00e9r\u00e9s de sympt\u00f4mes associ\u00e9s (photophobie, phonophobie ou naus\u00e9es) deux heures apr\u00e8s la prise, contre 27 % sous placebo. Une autre \u00e9tude de pr\u00e9vention a inclus 747 adultes ayant entre 4 et 18 crises de migraine par mois, trait\u00e9s par Vydura ou placebo un jour sur deux pendant jusqu\u2019\u00e0 12 semaines. Dans les quatre derni\u00e8res semaines de l\u2019\u00e9tude, la r\u00e9duction moyenne du nombre de jours avec migraine \u00e9tait de 4,3 jours sous Vydura contre 3,5 jours sous placebo. Les autorit\u00e9s europ\u00e9ennes jugent ces effets positifs mais d\u2019ampleur mod\u00e9r\u00e9e.<\/p>\n
Les effets ind\u00e9sirables les plus fr\u00e9quents sont les naus\u00e9es (jusqu\u2019\u00e0 1 patient sur 10). Des r\u00e9actions d\u2019hypersensibilit\u00e9, incluant dyspn\u00e9e et \u00e9ruptions cutan\u00e9es s\u00e9v\u00e8res, peuvent survenir chez jusqu\u2019\u00e0 1 patient sur 100. La liste compl\u00e8te des effets ind\u00e9sirables et des restrictions figure dans la notice.<\/p>\n
L\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) a conclu que le rapport b\u00e9n\u00e9fice\/risque de Vydura est favorable et a d\u00e9cid\u00e9 son autorisation de mise sur le march\u00e9 dans l\u2019Union europ\u00e9enne. Cette d\u00e9cision s\u2019inscrit dans les politiques europ\u00e9ennes de prise en charge de la migraine, pathologie \u00e0 fort impact fonctionnel et professionnel, en ajoutant une option th\u00e9rapeutique pr\u00e9sentant un effet jug\u00e9 modeste mais cliniquement pertinent, avec un profil de s\u00e9curit\u00e9 globalement acceptable. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Vydura est un m\u00e9dicament \u00e0 base de rimeg\u00e9pant indiqu\u00e9 chez l\u2019adulte pour le traitement de la crise de migraine, avec ou sans aura, et pour la pr\u00e9vention chez les patients […]<\/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-21889","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\/21889","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=21889"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21889\/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=21889"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21889"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21889"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}