{"id":371186,"date":"2024-02-02T00:01:00","date_gmt":"2024-02-01T23:01:00","guid":{"rendered":"https:\/\/medizinonline.com\/?p=371186"},"modified":"2024-01-24T17:32:53","modified_gmt":"2024-01-24T16:32:53","slug":"le-semaglutide-en-administration-orale-convainc-dans-la-pratique-quotidienne","status":"publish","type":"post","link":"https:\/\/medizinonline.com\/fr\/le-semaglutide-en-administration-orale-convainc-dans-la-pratique-quotidienne\/","title":{"rendered":"Le semaglutide en administration orale convainc dans la pratique quotidienne"},"content":{"rendered":"\n<p><strong>Dans l&#8217;\u00e9tude non interventionnelle PIONEER REAL Suisse, les adultes diab\u00e9tiques de type 2 trait\u00e9s par le semaglutide oral dans le cadre des soins cliniques de routine ont obtenu une am\u00e9lioration cliniquement significative du contr\u00f4le glyc\u00e9mique, sans que de nouveaux signaux de s\u00e9curit\u00e9 ne soient apparus. Les r\u00e9sultats ont \u00e9t\u00e9 pr\u00e9sent\u00e9s \u00e0 l&#8217;occasion de la r\u00e9union annuelle de la SSED et renforcent les r\u00e9sultats prometteurs des \u00e9tudes cliniques r\u00e9glementaires.<\/strong><\/p>\n\n<!--more-->\n\n<p>Le semaglutide est \u00e9galement commercialis\u00e9 en Suisse depuis 2020 sous forme orale pour le traitement du diab\u00e8te de type 2 (DT2), sous le nom commercial de Rybelsus\u00ae [1]. Comme d&#8217;autres agonistes du r\u00e9cepteur du glucagon-like peptide-1 (GLP-1-RA), le s\u00e9maglutide se lie au r\u00e9cepteur du GLP-1, ce qui favorise la s\u00e9cr\u00e9tion d&#8217;insuline et inhibe la s\u00e9cr\u00e9tion de glucagon. Le programme d&#8217;\u00e9tudes de phase III PIONEER a connu un grand succ\u00e8s. L&#8217;une des principales \u00e9tudes a montr\u00e9 que le Rybelsus\u00ae permettait non seulement d&#8217;am\u00e9liorer le contr\u00f4le m\u00e9tabolique et de r\u00e9duire le poids corporel, mais aussi de diminuer le nombre de crises cardiaques et m\u00eame de d\u00e9c\u00e8s[1,2]. L&#8217;objectif de l&#8217;\u00e9tude internationale de phase IV PIONEER REAL est d&#8217;observer syst\u00e9matiquement comment le m\u00e9dicament agit et est tol\u00e9r\u00e9 dans les conditions de la vie quotidienne [2].  <\/p>\n\n<h3 id=\"etude-multicentrique-dans-le-monde-reel\" class=\"wp-block-heading\">\u00c9tude multicentrique dans le monde r\u00e9el<\/h3>\n\n<p>PIONEER REAL Suisse fait partie d&#8217;un projet d&#8217;\u00e9tude men\u00e9 dans 13 pays \u2013 il s&#8217;agit d&#8217;une \u00e9tude prospective multicentrique, \u00e0 un seul bras, en ouvert et d&#8217;une dur\u00e9e de 34 \u00e0 44 semaines, chez des adultes atteints de DT2. Les participants \u00e9taient adeptes des traitements par injection visant \u00e0 r\u00e9duire le taux de glucose \u00e0 l&#8217;\u00e9tat de r\u00e9f\u00e9rence et recevaient du semaglutide par voie orale une fois par jour dans le cadre des soins de routine habituels [3]. Outre les modifications de l&#8217;HbA<sub>1c<\/sub> (crit\u00e8re d&#8217;\u00e9valuation principal) et du poids corporel (crit\u00e8re d&#8217;\u00e9valuation secondaire), nous avons enregistr\u00e9 la proportion de patients qui, \u00e0 la fin de l&#8217;\u00e9tude, avaient atteint un taux d&#8217;HbA<sub>1c<\/sub> &lt;7% et\/ou un crit\u00e8re d&#8217;\u00e9valuation composite comprenant une r\u00e9duction de l&#8217;HbA<sub>1c<\/sub> \u22651% associ\u00e9e \u00e0 une r\u00e9duction du poids corporel (PC) \u22653% ou \u22655%. <\/p>\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full is-resized\"><a href=\"https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/abb1_CV4_s58.png\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1458\" height=\"1205\" src=\"https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/abb1_CV4_s58.png\" alt=\"\" class=\"wp-image-371008\" style=\"width:500px\" srcset=\"https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/abb1_CV4_s58.png 1458w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/abb1_CV4_s58-800x661.png 800w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/abb1_CV4_s58-1160x959.png 1160w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/abb1_CV4_s58-120x99.png 120w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/abb1_CV4_s58-90x74.png 90w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/abb1_CV4_s58-320x264.png 320w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/abb1_CV4_s58-560x463.png 560w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/abb1_CV4_s58-240x198.png 240w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/abb1_CV4_s58-180x149.png 180w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/abb1_CV4_s58-640x529.png 640w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/abb1_CV4_s58-1120x926.png 1120w\" sizes=\"(max-width: 1458px) 100vw, 1458px\" \/><\/a><\/figure>\n<\/div>\n<h3 id=\"apercu-des-principaux-resultats\" class=\"wp-block-heading\">Aper\u00e7u des principaux r\u00e9sultats  <\/h3>\n\n<p>Sur les 185 participants (TN) inclus, 90,8% ont termin\u00e9 l&#8217;\u00e9tude et 77,3% ont poursuivi le traitement par semaglutide jusqu&#8217;\u00e0 la fin de l&#8217;\u00e9tude [3]. A l&#8217;\u00e2ge de r\u00e9f\u00e9rence, l&#8217;\u00e2ge moyen \u00e9tait de 62 ans (\u00e9cart-type 10,4), l&#8217;<sub>HbA1c<\/sub> \u00e9tait de 7,7% (\u00e9cart-type 1,5%) et le poids corporel de 95,6 kg (\u00e9cart-type 17,6 kg). L&#8217;IMC moyen document\u00e9 \u00e9tait de 33,2 <sup>kg\/m2<\/sup> (4,8 <sup>kg\/m2<\/sup>). 56,2% des sujets recevaient \u00e9galement d&#8217;autres m\u00e9dicaments hypoglyc\u00e9miants.  <\/p>\n\n<p class=\"has-small-font-size\"><em>** SD = \u00e9cart-type<\/em><br\/>IC=intervalle de confiance<\/p>\n\n<p>Les changements moyens estim\u00e9s entre la ligne de base et la fin de l&#8217;\u00e9tude \u00e9taient les suivants [3] :  <\/p>\n\n<ul class=\"wp-block-list\">\n<li><em>Valeurs<\/em><sub>HbA1c<\/sub>: variation de -0,9% (IC 95% : -1,1 ; -0,7, p&lt;0,0001)  <\/li>\n\n\n\n<li><em>poids corporel absolu<\/em>: variation de 4,7 kg (IC \u00e0 95% : -5,6 ; -3,8, p&lt;0,0001)  <\/li>\n\n\n\n<li><em>poids corporel relatif<\/em>: r\u00e9duction de -4,9% (IC \u00e0 95% : -5,7 ; -4,0, les deux p&lt;0,0001)  <\/li>\n\n\n\n<li>\u00c0 la fin de l&#8217;\u00e9tude, 64,2% des sujets avaient un taux d&#8217;<sub>HbA1c<\/sub> &lt;7% et 37,8% et 28,3% ont atteint le crit\u00e8re d&#8217;\u00e9valuation composite d&#8217;une r\u00e9duction de l&#8217;<sub>HbA1c<\/sub> \u22651% plus une r\u00e9duction du poids corporel \u22653% et \u22655% respectivement.  <\/li>\n<\/ul>\n\n<p>Au total, 139 \u00e9v\u00e9nements ind\u00e9sirables (AE, <em>adverse events)<\/em> ont \u00e9t\u00e9 rapport\u00e9s chez 65 TN (35,1%) [3]. La plupart d&#8217;entre eux \u00e9taient l\u00e9gers ou mod\u00e9r\u00e9s, les plus fr\u00e9quents \u00e9tant les troubles gastro-intestinaux (89 \u00e9v\u00e9nements pour 50 TN). 31 EI chez 20 (10,8%) sujets ont entra\u00een\u00e9 l&#8217;arr\u00eat du semaglutide oral. Au total, six EI graves ont \u00e9t\u00e9 signal\u00e9s, qui n&#8217;\u00e9taient probablement pas li\u00e9s au traitement par semaglutide.<\/p>\n\n<p><em>Source : Novo Nordisk<\/em><\/p>\n\n<p>Litt\u00e9rature :<\/p>\n\n<ol class=\"wp-block-list\">\n<li>Swissmedic: Arzneimittelinformation,<br\/><a href=\"http:\/\/www.swissmedicinfo.ch\" target=\"_blank\" rel=\"noopener\">www.swissmedicinfo.ch,<\/a>(dernier appel 21.11.2023)  <\/li>\n\n\n\n<li>Husain M, et al.: PIONEER 6 Investigators. Oral Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. NEJM 2019; 381(9): 841\u2013851. <\/li>\n\n\n\n<li>Kick A, et al.: Real-world use of oral semaglutide in adults with type 2 diabetes: Results from the PIONEER REAL Switzerland multicenter, prospective, observational study. Abstractband, Annual Meeting SGED\/SSED, 16. \u201317.11.2023.<\/li>\n<\/ol>\n\n<p><\/p>\n\n<p class=\"has-small-font-size\"><em>CARDIOVASC 2023; 22(4): 58<\/em><br\/><em>HAUSARZT PRAXIS 2023: 18(12): 37<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Dans l&#8217;\u00e9tude non interventionnelle PIONEER REAL Suisse, les adultes diab\u00e9tiques de type 2 trait\u00e9s par le semaglutide oral dans le cadre des soins cliniques de routine ont obtenu une am\u00e9lioration&hellip;<\/p>\n","protected":false},"author":7,"featured_media":371187,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"pmpro_default_level":"","cat_1_feature_home_top":false,"cat_2_editor_pick":false,"csco_eyebrow_text":"Diab\u00e8te de type 2 : \u00e9tude PIONEER REAL Suisse  ","footnotes":""},"category":[11404,11527,11531,11545,11535,11549],"tags":[15907,12050,73049,73045,73047,17458,73046,73048],"powerkit_post_featured":[],"class_list":["post-371186","post","type-post","status-publish","format-standard","has-post-thumbnail","category-endocrinologie-et-diabetologie","category-etudes","category-formation-continue","category-marche-medecine","category-rapports-de-congres","category-rx-fr","tag-controle-glycemique","tag-diabete-de-type-2","tag-mode-dadministration","tag-pioneer-real-fr","tag-rybelsus-fr","tag-semaglutid-fr","tag-semaglutide-par-voie-orale","tag-societe-suisse-dendocrinologie-et-de-diabetologie","pmpro-has-access"],"acf":[],"publishpress_future_action":{"enabled":false,"date":"2026-04-10 20:15:50","action":"change-status","newStatus":"draft","terms":[],"taxonomy":"category","extraData":[]},"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"wpml_current_locale":"fr_FR","wpml_translations":{"it_IT":{"locale":"it_IT","id":371189,"slug":"la-semaglutide-in-forma-orale-convince-nella-pratica-quotidiana","post_title":"La semaglutide in forma orale convince nella pratica quotidiana","href":"https:\/\/medizinonline.com\/it\/la-semaglutide-in-forma-orale-convince-nella-pratica-quotidiana\/"},"pt_PT":{"locale":"pt_PT","id":371192,"slug":"o-semaglutido-na-forma-oral-convence-na-pratica-quotidiana","post_title":"O semaglutido na forma oral convence na pr\u00e1tica quotidiana","href":"https:\/\/medizinonline.com\/pt-pt\/o-semaglutido-na-forma-oral-convence-na-pratica-quotidiana\/"},"es_ES":{"locale":"es_ES","id":371195,"slug":"la-semaglutida-en-forma-oral-convence-en-la-practica-diaria","post_title":"La semaglutida en forma oral convence en la pr\u00e1ctica diaria","href":"https:\/\/medizinonline.com\/es\/la-semaglutida-en-forma-oral-convence-en-la-practica-diaria\/"}},"_links":{"self":[{"href":"https:\/\/medizinonline.com\/fr\/wp-json\/wp\/v2\/posts\/371186","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/medizinonline.com\/fr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/medizinonline.com\/fr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/medizinonline.com\/fr\/wp-json\/wp\/v2\/users\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/medizinonline.com\/fr\/wp-json\/wp\/v2\/comments?post=371186"}],"version-history":[{"count":3,"href":"https:\/\/medizinonline.com\/fr\/wp-json\/wp\/v2\/posts\/371186\/revisions"}],"predecessor-version":[{"id":374297,"href":"https:\/\/medizinonline.com\/fr\/wp-json\/wp\/v2\/posts\/371186\/revisions\/374297"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/medizinonline.com\/fr\/wp-json\/wp\/v2\/media\/371187"}],"wp:attachment":[{"href":"https:\/\/medizinonline.com\/fr\/wp-json\/wp\/v2\/media?parent=371186"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/medizinonline.com\/fr\/wp-json\/wp\/v2\/category?post=371186"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/medizinonline.com\/fr\/wp-json\/wp\/v2\/tags?post=371186"},{"taxonomy":"powerkit_post_featured","embeddable":true,"href":"https:\/\/medizinonline.com\/fr\/wp-json\/wp\/v2\/powerkit_post_featured?post=371186"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}