{"id":1899,"date":"2023-07-13T15:33:00","date_gmt":"2023-07-13T13:33:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1899"},"modified":"2024-04-10T15:38:33","modified_gmt":"2024-04-10T13:38:33","slug":"37a-liecivo-kanabidiol-epidyolex-v-kombinacii-s-klobazamom-na-liecbu-zachvatov-spojenych-s-dravetovej-syndromom-a-lennox-gastautovym-syndromom-u-pacientov-od-2-rokov37a","status":"publish","type":"post","link":"https:\/\/www.niho.sk\/en\/37a-liecivo-kanabidiol-epidyolex-v-kombinacii-s-klobazamom-na-liecbu-zachvatov-spojenych-s-dravetovej-syndromom-a-lennox-gastautovym-syndromom-u-pacientov-od-2-rokov37a\/","title":{"rendered":"37A: Lie\u010divo kanabidiol (Epidyolex) v kombin\u00e1cii s klobazamom na lie\u010dbu z\u00e1chvatov spojeny\u0301ch s Dravetovej syndr\u00f3mom a Lennox-Gastautovy\u0301m syndr\u00f3mom u pacientov od 2 rokov37A:"},"content":{"rendered":"<ol class=\"wp-block-list\">\n<li><strong>Ak\u00e1 je z\u00e1\u0165a\u017e ochorenia pre pacienta? Ako z\u00e1sadn\u00e9 je ochorenie?<\/strong><\/li>\n<\/ol>\n\n\n\n<p class=\"wp-block-paragraph\">Dravetovej syndr\u00f3m (DS) a Lennox-Gastautov syndr\u00f3m (LGS) s\u00fa nevylie\u010dite\u013en\u00e9 epileptick\u00e9 encefalopatie, ktor\u00e9 pretrv\u00e1vaj\u00fa od \u00fatleho detstva do konca \u017eivota. Typick\u00e9 pre tieto ochorenia s\u00fa epileptick\u00e9 z\u00e1chvaty, ktor\u00e9 sa \u0165a\u017eko daj\u00fa kontrolova\u0165 s\u00fa\u010dasnou lie\u010dbou. Pr\u00edtomn\u00fd b\u00fdva aj ur\u010dit\u00fd stupe\u0148 ment\u00e1lneho postihnutia a zv\u00fd\u0161en\u00e9 riziko \u00famrtia. Pacienti zost\u00e1vaj\u00fa v\u00fdrazne z\u00e1visl\u00ed na rodi\u010doch alebo in\u00fdch opatrovate\u013eoch po cel\u00fd \u017eivot. Pre \u010dast\u00e9 z\u00e1chvaty mus\u00ed by\u0165 t\u00e1to starostlivos\u0165 nepretr\u017eit\u00e1 a m\u00f4\u017ee u opatrovate\u013eov vyvol\u00e1va\u0165 ve\u013ek\u00fa mieru stresu. Negat\u00edvne ovplyv\u0148uje aj s\u00farodencov t\u00fdchto pacientov. Z vyjadrenia odborn\u00edkov vypl\u00fdva, \u017ee pova\u017euj\u00fa zaradenie Epidyolexu do Zoznamu kategorizovan\u00fdch liekov za potrebn\u00e9, ke\u010f\u017ee dostupn\u00e1 lie\u010dba je \u010dasto nedostato\u010dn\u00e1 na kontrolu z\u00e1chvatov a kanabidiol je s\u00fa\u010das\u0165ou aktu\u00e1lnych medzin\u00e1rodn\u00fdch postupov pri lie\u010dbe t\u00fdchto ochoren\u00ed.<\/p>\n\n\n\n<ol class=\"wp-block-list\" start=\"2\">\n<li><strong>O ak\u00fd liek ide?<\/strong><\/li>\n<\/ol>\n\n\n\n<p class=\"wp-block-paragraph\">Epidyolex obsahuje kanabidiol, liek, ktor\u00fd sa m\u00f4\u017ee pou\u017e\u00edva\u0165 na lie\u010dbu epilepsie, ochorenia, pri ktorom m\u00e1 \u010dlovek z\u00e1chvaty alebo k\u0155\u010de.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Epidyolex sa pou\u017e\u00edva v kombin\u00e1cii s klobazamom alebo s klobazamom a in\u00fdmi antiepileptikami na lie\u010dbu z\u00e1chvatov, ktor\u00e9 sa vyskytuj\u00fa pri dvoch zriedkav\u00fdch ochoreniach naz\u00fdvan\u00fdch Dravetovej syndr\u00f3m a Lennox-Gastautov syndr\u00f3m. M\u00f4\u017ee sa pou\u017e\u00edva\u0165 u dospel\u00fdch, dospievaj\u00facich a det\u00ed vo veku najmenej 2 roky.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Epidyolex sa tie\u017e pou\u017e\u00edva v kombin\u00e1cii s in\u00fdmi antiepileptikami na lie\u010dbu z\u00e1chvatov, ktor\u00e9 sa vyskytuj\u00fa pri genetickej poruche naz\u00fdvanej komplex tuber\u00f3znej skler\u00f3zy (TSC). M\u00f4\u017ee sa pou\u017e\u00edva\u0165 u dospel\u00fdch, dospievaj\u00facich a det\u00ed vo veku najmenej 2 roky.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Epidyolex je v EMA (Eur\u00f3pskej liekovej agent\u00fare) registrovan\u00fd:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>od j\u00fala 2019 \u2013 na adjuvantn\u00fa lie\u010dbu z\u00e1chvatov spojen\u00fdch s DS a LGS v kombin\u00e1cii s klobazamom pre pacientov od 2 rokov\u00a0<\/li>\n\n\n\n<li>od febru\u00e1ru 2021 \u2013 na adjuvantn\u00fa lie\u010dbu z\u00e1chvatov spojen\u00fdch s komplexom tuber\u00f3znej skler\u00f3zy (TSC) pre pacientov od 2 rokov<\/li>\n<\/ul>\n\n\n\n<ol class=\"wp-block-list\" start=\"3\">\n<li><strong>Ako sa na hodnoten\u00e9 lie\u010divo pozeraj\u00fa odborn\u00edci?\u00a0<\/strong><\/li>\n<\/ol>\n\n\n\n<p class=\"wp-block-paragraph\">Odborn\u00edk sa pre NIHO vyjadril, \u017ee DS a LGS s\u00fa diagn\u00f3zy spojen\u00e9 s v\u00fdraznou farmakorezistenciou. Zavedenie Epidyolexu do klinickej praxe pova\u017euje za potrebn\u00e9 roz\u0161\u00edrenie terapeutick\u00e9ho arzen\u00e1lu.<\/p>\n\n\n\n<ol class=\"wp-block-list\" start=\"4\">\n<li><strong>\u010co hodnotilo NIHO a ak\u00fd je v\u00fdsledok?<\/strong><\/li>\n<\/ol>\n\n\n\n<p class=\"wp-block-paragraph\">Dr\u017eite\u013e registr\u00e1cie (Jazz Pharmaceuticals Ireland Ltd (IRL)) podal \u017eiados\u0165 o zaradenie lie\u010diva kanabidiol (Epidyolex) v kombin\u00e1cii s klobazamom na lie\u010dbu z\u00e1chvatov spojen\u00fdch s Dravetovej syndr\u00f3mom a Lennox-Gastautov\u00fdm syndr\u00f3mom u pacientov od 2 rokov.<\/p>\n\n\n\n<p class=\"has-custom-highlight-background-color has-background wp-block-paragraph\">NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Epidyolex v predmetnej indik\u00e1ci\u00ed.&nbsp;<\/p>\n\n\n\n<p class=\"has-custom-highlight-background-color has-background wp-block-paragraph\">NIHO odpor\u00fa\u010da zv\u00e1\u017ei\u0165 doplnenie indika\u010dn\u00e9ho obmedzenia o vetu:\u00a0\u201e\u00da\u010dinnos\u0165 lie\u010dby sa vyhodnocuje ka\u017ed\u00fdch 6 mesiacov; lie\u010dba je ukon\u010den\u00e1, pokia\u013e z nej pacient na z\u00e1klade vyhodnotenia o\u0161etruj\u00faceho lek\u00e1ra \u010falej neprofituje (napr. v zmysle zn\u00ed\u017eenia frekvencie alebo intenzity z\u00e1chvatov oproti hodnot\u00e1m pred lie\u010dbou).\u201c<\/p>","protected":false},"excerpt":{"rendered":"<p>NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Epidyolex v predmetnej indik\u00e1ci\u00ed&#8230;<\/p>","protected":false},"author":3,"featured_media":1900,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[109,110],"class_list":["post-1899","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-epidyolex","tag-kanabidiol"],"_links":{"self":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1899","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/comments?post=1899"}],"version-history":[{"count":0,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1899\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media\/1900"}],"wp:attachment":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media?parent=1899"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1899"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1899"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}