{"id":22416,"date":"2026-10-27T16:29:17","date_gmt":"2026-10-27T16:29:17","guid":{"rendered":"https:\/\/veilles-affaires-sociales.fr\/?p=22416"},"modified":"2026-10-27T16:29:17","modified_gmt":"2026-10-27T16:29:17","slug":"rapport-europeen-public-devaluation-epar-pour-les-medicaments-a-usage-humain-sitagliptin-sun-fumarate-de-sitagliptine-date-dautorisation-09-12-2021-revision-4-statut-au","status":"publish","type":"post","link":"https:\/\/veilles-affaires-sociales.fr\/?p=22416","title":{"rendered":"Rapport europ\u00e9en public d\u2019\u00e9valuation (EPAR) pour les m\u00e9dicaments \u00e0 usage humain : Sitagliptin SUN, fumarate de sitagliptine, Date d\u2019autorisation : 09\/12\/2021, R\u00e9vision : 4, Statut : Autoris\u00e9\u00a0(titre traduit en fran\u00e7ais par l&rsquo;IA)"},"content":{"rendered":"<p>Sitagliptin SUN est un m\u00e9dicament \u00e0 base de sitagliptine indiqu\u00e9 dans le traitement du diab\u00e8te de type 2. Il est disponible sous forme de comprim\u00e9s, soumis \u00e0 prescription m\u00e9dicale, avec une posologie recommand\u00e9e de 100 mg une fois par jour. La dose doit \u00eatre r\u00e9duite chez certains patients pr\u00e9sentant une insuffisance r\u00e9nale. En cas d\u2019association avec une sulfamide hypoglyc\u00e9miante ou avec l\u2019insuline, une diminution de la dose de ces derniers peut \u00eatre n\u00e9cessaire afin de limiter le risque d\u2019hypoglyc\u00e9mie.<\/p>\n<p>La sitagliptine est un inhibiteur de la dipeptidyl-peptidase-4 (DPP-4) qui agit en emp\u00eachant la d\u00e9gradation des hormones incr\u00e9tines. Celles-ci, lib\u00e9r\u00e9es apr\u00e8s les repas, stimulent la s\u00e9cr\u00e9tion d\u2019insuline par le pancr\u00e9as lorsque la glyc\u00e9mie est \u00e9lev\u00e9e et r\u00e9duisent la production h\u00e9patique de glucose via une augmentation de l\u2019insuline et une diminution du glucagon. La sitagliptine n\u2019agit pas lorsque la glyc\u00e9mie est basse. L\u2019ensemble de ces m\u00e9canismes contribue \u00e0 la baisse de la glyc\u00e9mie et au contr\u00f4le du diab\u00e8te de type 2.<\/p>\n<p>Sitagliptin SUN est un m\u00e9dicament g\u00e9n\u00e9rique du m\u00e9dicament de r\u00e9f\u00e9rence Januvia. Les \u00e9tudes d\u2019efficacit\u00e9 et de s\u00e9curit\u00e9 d\u00e9j\u00e0 r\u00e9alis\u00e9es avec Januvia dans les indications autoris\u00e9es n\u2019ont pas \u00e9t\u00e9 r\u00e9p\u00e9t\u00e9es. Le titulaire de l\u2019autorisation a fourni des donn\u00e9es de qualit\u00e9 pharmaceutique et men\u00e9 une \u00e9tude d\u00e9montrant la bio\u00e9quivalence avec Januvia, c\u2019est\u2011\u00e0\u2011dire des concentrations sanguines de principe actif et des effets attendus similaires.<\/p>\n<p>L\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) a conclu que Sitagliptin SUN pr\u00e9sentait une qualit\u00e9 comparable et une bio\u00e9quivalence avec le m\u00e9dicament de r\u00e9f\u00e9rence, conform\u00e9ment aux exigences de l\u2019Union europ\u00e9enne. Elle a estim\u00e9 que, comme pour Januvia, le rapport b\u00e9n\u00e9fices\/risques de Sitagliptin SUN \u00e9tait favorable et a recommand\u00e9 son autorisation de mise sur le march\u00e9 dans l\u2019UE. L\u2019autorisation de mise sur le march\u00e9 valable dans l\u2019ensemble de l\u2019Union europ\u00e9enne a \u00e9t\u00e9 d\u00e9livr\u00e9e le 9 d\u00e9cembre 2021.<\/p>\n<p>Les recommandations et pr\u00e9cautions pour un usage s\u00fbr et efficace de Sitagliptin SUN sont d\u00e9finies dans le r\u00e9sum\u00e9 des caract\u00e9ristiques du produit et la notice destin\u00e9s aux professionnels de sant\u00e9 et aux patients. Comme pour tout m\u00e9dicament, les donn\u00e9es d\u2019utilisation de Sitagliptin SUN font l\u2019objet d\u2019une surveillance continue, les effets ind\u00e9sirables suspect\u00e9s \u00e9tant \u00e9valu\u00e9s et pouvant conduire, le cas \u00e9ch\u00e9ant, \u00e0 des mesures de protection des patients. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l&rsquo;IA)\u00a0\u200b<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/sitagliptin-sun\" target=\"_blank\" class=\"feedzy-rss-link-icon\">Lire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Sitagliptin SUN est un m\u00e9dicament \u00e0 base de sitagliptine indiqu\u00e9 dans le traitement du diab\u00e8te de type 2. Il est disponible sous forme de comprim\u00e9s, soumis \u00e0 prescription m\u00e9dicale, avec [&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-22416","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\/22416","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=22416"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/22416\/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=22416"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=22416"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=22416"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}