{"id":3253,"date":"2025-01-04T17:56:58","date_gmt":"2025-01-04T16:56:58","guid":{"rendered":"https:\/\/rvh-synergie.org\/actualites\/la-fda-approuve-gemtesa-pour-le-traitement-de-lhyperactivite-vesicale-chez-les-hommes-atteints-dhyperplasie-benigne-de-la-prostate\/"},"modified":"2025-01-04T17:56:59","modified_gmt":"2025-01-04T16:56:59","slug":"la-fda-approuve-gemtesa-pour-le-traitement-de-lhyperactivite-vesicale-chez-les-hommes-atteints-dhyperplasie-benigne-de-la-prostate","status":"publish","type":"post","link":"https:\/\/rvh-synergie.org\/actualites\/la-fda-approuve-gemtesa-pour-le-traitement-de-lhyperactivite-vesicale-chez-les-hommes-atteints-dhyperplasie-benigne-de-la-prostate\/","title":{"rendered":"La FDA approuve Gemtesa pour le traitement de l&rsquo;hyperactivit\u00e9 v\u00e9sicale chez les hommes atteints d&rsquo;hyperplasie b\u00e9nigne de la prostate"},"content":{"rendered":"<div>\n<div class=\"article-gallery lightGallery\">\n<div data-thumb=\"https:\/\/scx1.b-cdn.net\/csz\/news\/tmb\/2025\/fda-approves-gemtesa-f.jpg\" data-src=\"https:\/\/scx2.b-cdn.net\/gfx\/news\/2025\/fda-approves-gemtesa-f.jpg\" data-sub-html=\"\">\n<figure class=\"article-img\">\n<\/figure><\/div>\n<\/div>\n<p>Gemtesa (vibegron) de Sumitomo Pharma a \u00e9t\u00e9 approuv\u00e9 par la Food and Drug Administration des \u00c9tats-Unis pour les hommes pr\u00e9sentant des sympt\u00f4mes d&rsquo;hyperactivit\u00e9 v\u00e9sicale (OAB) recevant un traitement pharmacologique pour l&rsquo;hyperplasie b\u00e9nigne de la prostate (HBP).<\/p>\n<p>Gemtesa, un \u03b2<sub>3<\/sub> L&rsquo;agoniste des r\u00e9cepteurs adr\u00e9nergiques, administr\u00e9 une fois par jour (75 mg), a \u00e9t\u00e9 approuv\u00e9 pour les hommes pr\u00e9sentant des sympt\u00f4mes d&rsquo;hyperactivit\u00e9 v\u00e9sicale, notamment l&rsquo;incontinence urinaire, l&rsquo;urgence et la fr\u00e9quence urinaire, qui re\u00e7oivent un traitement pharmacologique pour l&rsquo;HBP.<\/p>\n<p>L&rsquo;approbation \u00e9tait bas\u00e9e sur les r\u00e9sultats d&rsquo;une \u00e9tude de phase III de 24 semaines comparant Gemtesa \u00e0 un placebo chez environ 1 100 hommes pr\u00e9sentant des sympt\u00f4mes d&rsquo;hyperactivit\u00e9 v\u00e9sicale et recevant un traitement pharmacologique pour l&rsquo;HBP.<\/p>\n<p>Tous les crit\u00e8res d&rsquo;\u00e9valuation co-primaires \u00e0 la semaine 12 ont \u00e9t\u00e9 atteints, avec des r\u00e9ductions significatives par rapport aux valeurs initiales observ\u00e9es dans le nombre moyen d&rsquo;\u00e9pisodes de miction par jour et dans le nombre moyen d&rsquo;\u00e9pisodes d&rsquo;urgence quotidiens avec Gemtesa par rapport au placebo.<\/p>\n<p>De plus, \u00e0 12 semaines, il y avait une r\u00e9duction des cas d\u2019\u00e9pisodes d\u2019incontinence urinaire par imp\u00e9riosit\u00e9 par jour. Des effets ind\u00e9sirables d&rsquo;hypertension et d&rsquo;infection des voies urinaires d\u00e9passant le taux du placebo sont survenus chez \u22652 pour cent des patients trait\u00e9s par Gemtesa.<\/p>\n<p>\u00ab L&rsquo;approbation \u00e9largie de Gemtesa par la FDA est une \u00e9tape importante pour les hommes pr\u00e9sentant des sympt\u00f4mes non r\u00e9solus d&rsquo;hyperactivit\u00e9 v\u00e9sicale alors qu&rsquo;ils sont trait\u00e9s pour une HBP, ce qui souligne notre urgence \u00e0 r\u00e9pondre aux besoins des personnes touch\u00e9es par des pathologies dont les besoins ne sont pas satisfaits \u00bb, Tsutomu Nakagawa, Ph.D., pr\u00e9sident et PDG de Sumitomo Pharma America Inc., a d\u00e9clar\u00e9 dans un communiqu\u00e9.<\/p>\n<p>                                        <!-- print only --><\/p><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Gemtesa (vibegron) de Sumitomo Pharma a \u00e9t\u00e9 approuv\u00e9 par la Food and Drug Administration des<\/p>\n","protected":false},"author":1,"featured_media":3254,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[86],"tags":[321,282,1357,56,3354,447,3353,924,49,1283,8,1358,261,1284],"class_list":["post-3253","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-les-maladies","tag-approuve","tag-atteints","tag-benigne","tag-chez","tag-dhyperplasie","tag-fda","tag-gemtesa","tag-hommes","tag-les","tag-lhyperactivite","tag-pour","tag-prostate","tag-traitement","tag-vesicale","generate-columns","tablet-grid-50","mobile-grid-100","grid-parent","grid-50","resize-featured-image"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.4 - 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