L\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) a publi\u00e9 un rapport public d\u2019\u00e9valuation (EPAR) sur Mysimba, m\u00e9dicament autoris\u00e9 dans l\u2019Union europ\u00e9enne pour la prise en charge du surpoids et de l\u2019ob\u00e9sit\u00e9 chez l\u2019adulte. Ce rapport d\u00e9crit l\u2019\u00e9valuation scientifique ayant conduit \u00e0 l\u2019autorisation de mise sur le march\u00e9, ainsi que les conditions d\u2019utilisation du m\u00e9dicament. Il ne fournit pas de recommandations pratiques pour les patients, renvoy\u00e9s \u00e0 la notice ou \u00e0 leur m\u00e9decin ou pharmacien.<\/p>\n
Mysimba est indiqu\u00e9 en compl\u00e9ment d\u2019un r\u00e9gime alimentaire et de l\u2019exercice physique chez les adultes ob\u00e8ses (indice de masse corporelle, IMC, \u2265 30) ou en surpoids (IMC entre 27 et 30) pr\u00e9sentant des complications li\u00e9es au poids, telles que diab\u00e8te, hyperlipid\u00e9mie ou hypertension art\u00e9rielle. Le m\u00e9dicament associe deux substances actives, la naltrexone et le bupropion, d\u00e9j\u00e0 autoris\u00e9es individuellement dans l\u2019UE pour d\u2019autres indications. Mysimba se pr\u00e9sente sous forme de comprim\u00e9s \u00e0 lib\u00e9ration prolong\u00e9e contenant 7,2 mg de naltrexone et 78 mg de bupropion, soumis \u00e0 prescription m\u00e9dicale obligatoire.<\/p>\n
Le sch\u00e9ma th\u00e9rapeutique pr\u00e9voit un d\u00e9but de traitement \u00e0 un comprim\u00e9 chaque matin, avec augmentation progressive des doses sur quatre semaines jusqu\u2019\u00e0 la posologie recommand\u00e9e de deux comprim\u00e9s deux fois par jour, de pr\u00e9f\u00e9rence au cours des repas. La r\u00e9ponse au traitement et la tol\u00e9rance doivent \u00eatre surveill\u00e9es r\u00e9guli\u00e8rement. Le traitement doit \u00eatre interrompu en cas d\u2019effets ind\u00e9sirables sp\u00e9cifiques, notamment une augmentation de la pression art\u00e9rielle, ou en l\u2019absence d\u2019une perte d\u2019au moins 5 % du poids initial apr\u00e8s quatre mois de traitement.<\/p>\n
Le mode d\u2019action pr\u00e9cis de Mysimba n\u2019est pas enti\u00e8rement \u00e9lucid\u00e9. Selon l\u2019EPAR, la naltrexone et le bupropion agissent sur des zones du cerveau impliqu\u00e9es dans la r\u00e9gulation de la prise alimentaire et de l\u2019\u00e9quilibre \u00e9nerg\u00e9tique, et att\u00e9nuent la composante de plaisir associ\u00e9e \u00e0 l\u2019alimentation. Leur association contribuerait \u00e0 r\u00e9duire l\u2019app\u00e9tit, diminuer les quantit\u00e9s ing\u00e9r\u00e9es et augmenter la d\u00e9pense \u00e9nerg\u00e9tique, facilitant ainsi l\u2019adh\u00e9sion \u00e0 un r\u00e9gime hypocalorique et la r\u00e9duction du poids corporel.<\/p>\n
L\u2019efficacit\u00e9 sur la r\u00e9duction pond\u00e9rale a \u00e9t\u00e9 \u00e9valu\u00e9e dans quatre \u00e9tudes principales portant au total sur environ 4 500 patients ob\u00e8ses ou en surpoids, dans lesquelles Mysimba \u00e9tait compar\u00e9 \u00e0 un placebo. Tous les patients b\u00e9n\u00e9ficiaient d\u2019un programme de perte de poids comprenant un accompagnement et des conseils sur l\u2019alimentation et l\u2019activit\u00e9 physique. Les principaux crit\u00e8res d\u2019\u00e9valuation \u00e9taient la r\u00e9duction en pourcentage du poids corporel sur 28 ou 56 semaines et la proportion de patients atteignant au moins 5 % de perte de poids. Les \u00e9tudes examinaient \u00e9galement la proportion de patients atteignant au moins 10 % de perte de poids. Les r\u00e9sultats ont \u00e9t\u00e9 analys\u00e9s avec diff\u00e9rentes m\u00e9thodes pour tenir compte des abandons en cours d\u2019\u00e9tude. Le rapport souligne ainsi le cadre m\u00e9thodologique et les limites li\u00e9es au suivi incomplet de certains participants, sans d\u00e9tailler dans ce passage les r\u00e9sultats chiffr\u00e9s.<\/p>\n
Ce dispositif s\u2019inscrit dans le cadre r\u00e9glementaire europ\u00e9en de l\u2019\u00e9valuation et de l\u2019autorisation des traitements du surpoids et de l\u2019ob\u00e9sit\u00e9, pathologies fr\u00e9quentes et associ\u00e9es \u00e0 des comorbidit\u00e9s m\u00e9taboliques et cardiovasculaires. Les exigences de suivi de la tol\u00e9rance, de v\u00e9rification de l\u2019efficacit\u00e9 individuelle (seuil de 5 % de perte de poids \u00e0 quatre mois) et de recours concomitant \u00e0 des mesures hygi\u00e9no-di\u00e9t\u00e9tiques constituent des \u00e9l\u00e9ments importants pour l\u2019usage encadr\u00e9 de ce type de m\u00e9dicament dans les syst\u00e8mes de sant\u00e9 europ\u00e9ens. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" L\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) a publi\u00e9 un rapport public d\u2019\u00e9valuation (EPAR) sur Mysimba, m\u00e9dicament autoris\u00e9 dans l\u2019Union europ\u00e9enne pour la prise en charge du surpoids et de l\u2019ob\u00e9sit\u00e9 chez […]<\/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-20141","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\/20141","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=20141"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/20141\/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=20141"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=20141"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=20141"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}