{"id":57,"date":"2020-04-27T13:50:00","date_gmt":"2020-04-27T13:50:00","guid":{"rendered":"https:\/\/live-rawf.pantheonsite.io\/2020\/04\/27\/2020-4-27-promising-results-from-clinical-trial-of-tesomet-in-treatment-of-hypothalamic-obesity\/"},"modified":"2023-08-22T20:24:30","modified_gmt":"2023-08-22T20:24:30","slug":"2020-4-27-resultats-prometteurs-de-lessai-clinique-du-tesomet-dans-le-traitement-de-lobesite-hypothalamique","status":"publish","type":"post","link":"https:\/\/www.rawoodfoundation.org\/fr\/2020\/04\/27\/2020-4-27-promising-results-from-clinical-trial-of-tesomet-in-treatment-of-hypothalamic-obesity\/","title":{"rendered":"R\u00e9sultats prometteurs de l'essai clinique du Tesomet dans le traitement de l'ob\u00e9sit\u00e9 hypothalamique"},"content":{"rendered":"<div class=\"sqs-html-content\">\n<p class=\"\" style=\"white-space:pre-wrap;\">La semaine derni\u00e8re, <a href=\"https:\/\/saniona.com\/\" target=\"_blank\" rel=\"noopener\">Saniona<\/a>soci\u00e9t\u00e9 biopharmaceutique sp\u00e9cialis\u00e9e dans les maladies rares, a annonc\u00e9 les premiers r\u00e9sultats de son essai de phase 2 en double aveugle, randomis\u00e9 et contr\u00f4l\u00e9 par placebo, d'une dur\u00e9e de 24 semaines, \u00e9valuant la s\u00e9curit\u00e9 et l'efficacit\u00e9 du Tesomet chez des patients souffrant d'ob\u00e9sit\u00e9 hypothalamique (HO).<\/p>\n<p class=\"\" style=\"white-space:pre-wrap;\"><a href=\"https:\/\/saniona.com\/proprietary-pipeline\/tesomet\/\" target=\"_blank\" rel=\"noopener\">Tesomet <\/a>est une combinaison \u00e0 dose fixe de t\u00e9sofensine et de m\u00e9toprolol, actuellement en phase interm\u00e9diaire\/finale de d\u00e9veloppement pour le traitement du syndrome de Prader-Willi et de l'ob\u00e9sit\u00e9 hypothalamique.<\/p>\n<p class=\"\" style=\"white-space:pre-wrap;\">L'ob\u00e9sit\u00e9 hypothalamique (HO) est un effet secondaire potentiellement d\u00e9vastateur des tumeurs c\u00e9r\u00e9brales de la r\u00e9gion hypophysaire\/hypothalamique. Lorsque l'hypothalamus est affect\u00e9 par ces tumeurs ou leur traitement, il peut perdre la capacit\u00e9 de maintenir les processus m\u00e9taboliques de l'organisme. Il en r\u00e9sulte souvent une prise de poids rapide et une faim insatiable, appel\u00e9e hyperphagie. La prise de poids chez les patients atteints d'une HO s\u00e9v\u00e8re ne peut \u00eatre contr\u00f4l\u00e9e par un r\u00e9gime et de l'exercice et peut entra\u00eener d'autres comorbidit\u00e9s, notamment le diab\u00e8te de type II et la st\u00e9atose h\u00e9patique non alcoolique. \u00c0 ce jour, il n'existe pas de v\u00e9ritable traitement pour cette affection qui peut gravement affecter la sant\u00e9 et la qualit\u00e9 de vie des patients qui doivent faire face \u00e0 de nombreux autres d\u00e9fis post-tumoraux.<\/p>\n<p class=\"\" style=\"white-space:pre-wrap;\">Les r\u00e9sultats de l'\u00e9tude ont montr\u00e9 que Tesomet \u00e9tait s\u00fbr et bien tol\u00e9r\u00e9. En outre, des donn\u00e9es d'efficacit\u00e9 solides ont \u00e9galement \u00e9t\u00e9 rapport\u00e9es, avec des am\u00e9liorations statistiquement significatives du poids corporel, du tour de taille et du contr\u00f4le de la glyc\u00e9mie observ\u00e9es avec le traitement Tesomet par rapport au placebo.<\/p>\n<h3 style=\"white-space:pre-wrap;\">Crit\u00e8res d'inclusion de l'essai clinique :<\/h3>\n<ul data-rte-list=\"default\">\n<li>\n<p class=\"\" style=\"white-space:pre-wrap;\">Consentement \u00e9clair\u00e9 obtenu avant toute activit\u00e9 li\u00e9e \u00e0 l'essai<\/p>\n<\/li>\n<li>\n<p class=\"\" style=\"white-space:pre-wrap;\">Hommes et femmes, \u00e2g\u00e9s de 18 \u00e0 75 ans<\/p>\n<\/li>\n<li>\n<p class=\"\" style=\"white-space:pre-wrap;\">Diagnostic confirm\u00e9 d'HO<\/p>\n<\/li>\n<li>\n<p class=\"\" style=\"white-space:pre-wrap;\">IMC \u226527 kg\/m2 (le surpoids \u00e9tant li\u00e9 \u00e0 l'HO)<\/p>\n<\/li>\n<\/ul>\n<h3 style=\"white-space:pre-wrap;\">Crit\u00e8res d'exclusion de l'essai clinique :<\/h3>\n<ul data-rte-list=\"default\">\n<li>\n<p class=\"\" style=\"white-space:pre-wrap;\">TA \u2265160\/90 mmHg FC \u2265 90, &lt;50 bpm<\/p>\n<\/li>\n<li>\n<p class=\"\" style=\"white-space:pre-wrap;\">Diab\u00e8te de type 1, maladie de Cushings, acrom\u00e9galie, hypophysite, maladies infiltrantes ou syndrome de Prader-Willi<\/p>\n<\/li>\n<li>\n<p class=\"\" style=\"white-space:pre-wrap;\">Insuffisance cardiaque New York Heart Association (NYHA) niveau II ou plus, insuffisance cardiaque d\u00e9compens\u00e9e<\/p>\n<\/li>\n<li>\n<p class=\"\" style=\"white-space:pre-wrap;\">Infarctus du myocarde ou accident vasculaire c\u00e9r\u00e9bral au cours des 5 derni\u00e8res ann\u00e9es<\/p>\n<\/li>\n<\/ul>\n<p class=\"\" style=\"white-space:pre-wrap;\">Voir les crit\u00e8res complets d'inclusion et d'exclusion de l'\u00e9tude, tels qu'ils figurent sur le site web de l'UE.&nbsp;<a href=\"http:\/\/clinicaltrials.gov\/\">clinicaltrials.gov<\/a>.<\/p>\n<h3 style=\"white-space:pre-wrap;\">Les points saillants des donn\u00e9es de l'\u00e9tude sont les suivants<\/h3>\n<ul data-rte-list=\"default\">\n<li>\n<p class=\"\" style=\"white-space:pre-wrap;\">Tesomet s'est av\u00e9r\u00e9 s\u00fbr et bien tol\u00e9r\u00e9. Les effets secondaires les plus fr\u00e9quemment observ\u00e9s chez les patients trait\u00e9s sont les troubles du sommeil, la s\u00e9cheresse de la bouche et les maux de t\u00eate, qui sont des effets secondaires bien connus associ\u00e9s \u00e0 la t\u00e9sofensine et\/ou au m\u00e9toprolol.<\/p>\n<\/li>\n<li>\n<p class=\"\" style=\"white-space:pre-wrap;\">Un seul cas d'anxi\u00e9t\u00e9\/parano\u00efa li\u00e9e au Tesomet a \u00e9t\u00e9 signal\u00e9 comme un \u00e9v\u00e9nement ind\u00e9sirable grave (EIG), qui s'est am\u00e9lior\u00e9 apr\u00e8s l'arr\u00eat du traitement.<\/p>\n<\/li>\n<li>\n<p class=\"\" style=\"white-space:pre-wrap;\">Il n'y a pas eu de diff\u00e9rences cliniquement significatives dans la fr\u00e9quence cardiaque ou la pression art\u00e9rielle entre les groupes de traitement. 18 des 21 participants \u00e0 l'\u00e9tude ont termin\u00e9 la partie de l'\u00e9tude contr\u00f4l\u00e9e par placebo (2 abandons dans le groupe placebo ; 1 abandon dans le groupe de traitement) et sont entr\u00e9s dans l'extension ouverte pour une p\u00e9riode suppl\u00e9mentaire de 24 semaines.<\/p>\n<\/li>\n<li>\n<p class=\"\" style=\"white-space:pre-wrap;\">Le traitement par Tesomet a conduit \u00e0 une r\u00e9duction moyenne du poids corporel statistiquement significative de 6,8% par rapport au placebo (p &lt; 0,001). Le tour de taille moyen des patients trait\u00e9s par Tesomet a \u00e9t\u00e9 significativement r\u00e9duit de 7,9% par rapport au placebo (p &lt; 0,001). Le traitement par Tesomet a am\u00e9lior\u00e9 le contr\u00f4le de la glyc\u00e9mie comme mesur\u00e9 par une r\u00e9duction statistiquement significative de 14,6% de l&#039;h\u00e9moglobine A1c (HbA1c) par rapport au placebo (p = 0,015).<\/p>\n<\/li>\n<\/ul>\n<p class=\"\" style=\"white-space:pre-wrap;\">Cette \u00e9tude de phase 2 randomis\u00e9e, \u00e0 double insu et contr\u00f4l\u00e9e par placebo a \u00e9valu\u00e9 le Tesomet (tesofensine 0,5 mg + m\u00e9toprolol 50 mg) administr\u00e9 quotidiennement chez des patients atteints d'HO, men\u00e9e au Rigshospitalet \u00e0 Copenhague, au Danemark.<\/p>\n<p class=\"\" style=\"white-space:pre-wrap;\">\"Nous sommes tr\u00e8s encourag\u00e9s par la s\u00e9curit\u00e9 et l'efficacit\u00e9 prometteuses observ\u00e9es dans notre essai contr\u00f4l\u00e9 randomis\u00e9 de phase 2\", a d\u00e9clar\u00e9 Rami Levin, pr\u00e9sident et directeur g\u00e9n\u00e9ral de Saniona. \"Il s'agit d'une r\u00e9alisation importante qui, selon nous, constitue un pas en avant vers un \u00e9ventuel premier traitement approuv\u00e9 pour l'HO. Nous reconnaissons l'importance de d\u00e9couvrir un traitement pour cette maladie rare d\u00e9vastatrice et nous nous engageons \u00e0 faire progresser rapidement le Tesomet pour les patients atteints d'HO. Nous \u00e9valuons les prochaines \u00e9tapes du d\u00e9veloppement du Tesomet dans l'ob\u00e9sit\u00e9 hypothalamique et avons l'intention de demander une r\u00e9union de fin de phase 2 avec la FDA afin de d\u00e9finir la voie r\u00e9glementaire \u00e0 suivre.\"<\/p>\n<p class=\"\" style=\"white-space:pre-wrap;\">Un webcast des r\u00e9sultats de l'\u00e9tude sera pr\u00e9sent\u00e9 demain, 28 avril 2020 \u00e0 10 heures EDT par l'investigateur principal.&nbsp;<a href=\"https:\/\/ml-eu.globenewswire.com\/Resource\/Download\/15f97654-22b2-424e-bfa8-f99c447e11bc\" target=\"_blank\" rel=\"noopener\">Plus d'informations \" <\/a><\/p>\n<p class=\"\" style=\"white-space:pre-wrap;\"><\/div>","protected":false},"excerpt":{"rendered":"<p class=\"\">La semaine derni\u00e8re, <a href=\"https:\/\/saniona.com\/\" target=\"_blank\" rel=\"noopener\">Saniona<\/a>soci\u00e9t\u00e9 biopharmaceutique sp\u00e9cialis\u00e9e dans les maladies rares, a annonc\u00e9 les premiers r\u00e9sultats de son essai de phase 2 en double aveugle, randomis\u00e9 et contr\u00f4l\u00e9 par placebo, d'une dur\u00e9e de 24 semaines, \u00e9valuant la s\u00e9curit\u00e9 et l'efficacit\u00e9 du Tesomet chez des patients souffrant d'ob\u00e9sit\u00e9 hypothalamique (HO).<\/p>","protected":false},"author":6,"featured_media":58,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[29],"tags":[],"class_list":["post-57","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-hypothalamic-obesity","generate-columns","tablet-grid-50","mobile-grid-100","grid-parent","grid-33","no-featured-image-padding"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Promising Results from Clinical Trial of Tesomet in Treatment of Hypothalamic Obesity - Raymond A. 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