{"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-prometedores-resultados-del-ensayo-clinico-de-tesomet-en-el-tratamiento-de-la-obesidad-hipotalamica","status":"publish","type":"post","link":"https:\/\/www.rawoodfoundation.org\/es\/2020\/04\/27\/2020-4-27-promising-results-from-clinical-trial-of-tesomet-in-treatment-of-hypothalamic-obesity\/","title":{"rendered":"Resultados prometedores del ensayo cl\u00ednico de Tesomet en el tratamiento de la obesidad hipotal\u00e1mica"},"content":{"rendered":"<div class=\"sqs-html-content\">\n<p class=\"\" style=\"white-space:pre-wrap;\">La semana pasada, <a href=\"https:\/\/saniona.com\/\" target=\"_blank\" rel=\"noopener\">Saniona<\/a>La compa\u00f1\u00eda biofarmac\u00e9utica Tesomet, centrada en las enfermedades raras, ha anunciado los resultados de su ensayo de fase 2, doble ciego, aleatorizado y controlado con placebo, de 24 semanas de duraci\u00f3n, que eval\u00faa la seguridad y eficacia de Tesomet en pacientes con obesidad hipotal\u00e1mica (HO).<\/p>\n<p class=\"\" style=\"white-space:pre-wrap;\"><a href=\"https:\/\/saniona.com\/proprietary-pipeline\/tesomet\/\" target=\"_blank\" rel=\"noopener\">Tesomet <\/a>es una combinaci\u00f3n a dosis fija de tesofensina y metoprolol, actualmente en fase media\/tard\u00eda de desarrollo para el tratamiento de ensayos cl\u00ednicos para el tratamiento del S\u00edndrome de Prader-Willi y la Obesidad Hipotal\u00e1mica.<\/p>\n<p class=\"\" style=\"white-space:pre-wrap;\">La obesidad hipotal\u00e1mica (HO) es un efecto secundario potencialmente devastador de los tumores cerebrales de la regi\u00f3n pituitaria\/hipotal\u00e1mica. Cuando el hipot\u00e1lamo se ve afectado por estos tumores o por su tratamiento, puede perder la capacidad de mantener los procesos metab\u00f3licos del organismo. Esto a menudo puede resultar en un r\u00e1pido aumento de peso y hambre insaciable conocida como hiperfagia. El aumento de peso en pacientes con HO grave no puede controlarse con dieta y ejercicio y puede causar otras comorbilidades, como diabetes de tipo II y enfermedad hep\u00e1tica grasa no alcoh\u00f3lica. Hasta la fecha, no existe un tratamiento real para esta afecci\u00f3n, que puede afectar gravemente a la salud y la calidad de vida de los pacientes, que se enfrentan a muchos otros retos posttumorales.<\/p>\n<p class=\"\" style=\"white-space:pre-wrap;\">Los resultados del estudio demostraron que Tesomet era seguro y bien tolerado. Adem\u00e1s, tambi\u00e9n se comunicaron datos s\u00f3lidos de eficacia, con mejoras estad\u00edsticamente significativas en el peso corporal, el per\u00edmetro de la cintura y el control gluc\u00e9mico observadas con el tratamiento con Tesomet en comparaci\u00f3n con el placebo.<\/p>\n<h3 style=\"white-space:pre-wrap;\">Criterios de inclusi\u00f3n en el ensayo cl\u00ednico:<\/h3>\n<ul data-rte-list=\"default\">\n<li>\n<p class=\"\" style=\"white-space:pre-wrap;\">Obtenci\u00f3n del consentimiento informado antes de cualquier actividad relacionada con el ensayo<\/p>\n<\/li>\n<li>\n<p class=\"\" style=\"white-space:pre-wrap;\">Hombres y mujeres, de 18 a 75 a\u00f1os<\/p>\n<\/li>\n<li>\n<p class=\"\" style=\"white-space:pre-wrap;\">Diagn\u00f3stico confirmado de HO<\/p>\n<\/li>\n<li>\n<p class=\"\" style=\"white-space:pre-wrap;\">IMC \u226527 kg\/m2 (donde el sobrepeso est\u00e1 relacionado con el HO).<\/p>\n<\/li>\n<\/ul>\n<h3 style=\"white-space:pre-wrap;\">Criterios de exclusi\u00f3n del ensayo cl\u00ednico:<\/h3>\n<ul data-rte-list=\"default\">\n<li>\n<p class=\"\" style=\"white-space:pre-wrap;\">PA \u2265160\/90 mmHg FC \u2265 90, &lt;50 lpm<\/p>\n<\/li>\n<li>\n<p class=\"\" style=\"white-space:pre-wrap;\">Diabetes de tipo 1, enfermedad de Cushings, acromegalia, hipofisitis, enfermedades infiltrativas o s\u00edndrome de Prader-Willi.<\/p>\n<\/li>\n<li>\n<p class=\"\" style=\"white-space:pre-wrap;\">Insuficiencia card\u00edaca Nivel II o superior de la New York Heart Association (NYHA), insuficiencia card\u00edaca descompensada<\/p>\n<\/li>\n<li>\n<p class=\"\" style=\"white-space:pre-wrap;\">Infarto de miocardio o ictus previo en los \u00faltimos 5 a\u00f1os<\/p>\n<\/li>\n<\/ul>\n<p class=\"\" style=\"white-space:pre-wrap;\">Consulte todos los criterios de inclusi\u00f3n y exclusi\u00f3n del estudio en&nbsp;<a href=\"http:\/\/clinicaltrials.gov\/\">clinicaltrials.gov<\/a>.<\/p>\n<h3 style=\"white-space:pre-wrap;\">Entre los datos m\u00e1s destacados del estudio se incluyen<\/h3>\n<ul data-rte-list=\"default\">\n<li>\n<p class=\"\" style=\"white-space:pre-wrap;\">Tesomet result\u00f3 ser seguro y bien tolerado. Los efectos secundarios observados con mayor frecuencia en los pacientes tratados incluyen problemas de sue\u00f1o, sequedad de boca y cefalea, que son efectos secundarios bien conocidos asociados a la tesofensina y\/o el metoprolol.<\/p>\n<\/li>\n<li>\n<p class=\"\" style=\"white-space:pre-wrap;\">Se notific\u00f3 un \u00fanico caso de ansiedad\/paranoia relacionada con Tesomet como Efecto Adverso Grave (EFG), que mejor\u00f3 tras la interrupci\u00f3n del tratamiento.<\/p>\n<\/li>\n<li>\n<p class=\"\" style=\"white-space:pre-wrap;\">No hubo diferencias cl\u00ednicamente significativas en la frecuencia cardiaca o la presi\u00f3n arterial entre los grupos de tratamiento. 18 de los 21 participantes en el estudio completaron la parte del estudio controlada con placebo (2 abandonos en el grupo placebo; 1 abandono en el grupo de tratamiento) y han entrado en la extensi\u00f3n abierta para un per\u00edodo adicional de 24 semanas.<\/p>\n<\/li>\n<li>\n<p class=\"\" style=\"white-space:pre-wrap;\">El tratamiento con Tesomet produjo una reducci\u00f3n media estad\u00edsticamente significativa de 6,8% del peso corporal en comparaci\u00f3n con el placebo (p &lt; 0,001). El per\u00edmetro medio de la cintura de los pacientes tratados con Tesomet se redujo significativamente en 7,9% en comparaci\u00f3n con el placebo (p &lt; 0,001). El tratamiento con Tesomet mejor\u00f3 el control gluc\u00e9mico, medido por una reducci\u00f3n estad\u00edsticamente significativa de 14,6% en la hemoglobina A1c (HbA1c) en comparaci\u00f3n con el placebo (p = 0,015).<\/p>\n<\/li>\n<\/ul>\n<p class=\"\" style=\"white-space:pre-wrap;\">Este ensayo de fase 2 aleatorizado, doble ciego y controlado con placebo evalu\u00f3 Tesomet (tesofensina 0,5 mg + metoprolol 50 mg) administrado diariamente en pacientes con HO, realizado en el Rigshospitalet de Copenhague, Dinamarca.<\/p>\n<p class=\"\" style=\"white-space:pre-wrap;\">\"Estamos muy animados por la prometedora seguridad y eficacia observadas en nuestro ensayo controlado aleatorizado de fase 2\", declar\u00f3 Rami Levin, presidente y consejero delegado de Saniona. \"Se trata de un logro importante que consideramos un paso adelante hacia un posible primer tratamiento aprobado para la HO. Reconocemos la importancia de descubrir un tratamiento para esta devastadora enfermedad rara y estamos comprometidos con el r\u00e1pido avance de Tesomet para los pacientes con HO. Estamos evaluando los pr\u00f3ximos pasos para el desarrollo de Tesomet en la obesidad hipotal\u00e1mica y tenemos la intenci\u00f3n de llevar a cabo una reuni\u00f3n al final de la fase 2 con la FDA para definir un camino reglamentario a seguir.\"<\/p>\n<p class=\"\" style=\"white-space:pre-wrap;\">El investigador principal presentar\u00e1 los resultados del estudio por Internet ma\u00f1ana, 28 de abril de 2020, a las 10.00 h EDT.&nbsp;<a href=\"https:\/\/ml-eu.globenewswire.com\/Resource\/Download\/15f97654-22b2-424e-bfa8-f99c447e11bc\" target=\"_blank\" rel=\"noopener\">M\u00e1s informaci\u00f3n \" <\/a><\/p>\n<p class=\"\" style=\"white-space:pre-wrap;\"><\/div>","protected":false},"excerpt":{"rendered":"<p class=\"\">La semana pasada, <a href=\"https:\/\/saniona.com\/\" target=\"_blank\" rel=\"noopener\">Saniona<\/a>La compa\u00f1\u00eda biofarmac\u00e9utica Tesomet, centrada en las enfermedades raras, ha anunciado los resultados de su ensayo de fase 2, doble ciego, aleatorizado y controlado con placebo, de 24 semanas de duraci\u00f3n, que eval\u00faa la seguridad y eficacia de Tesomet en pacientes con obesidad hipotal\u00e1mica (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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