{"id":1795,"date":"2023-01-31T14:12:00","date_gmt":"2023-01-31T13:12:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1795"},"modified":"2024-03-30T14:14:46","modified_gmt":"2024-03-30T13:14:46","slug":"16a-liecivo-enzalutamid-xtandi-v-liecbe-dospelych-muzov-s-metastatickym-hormonalne-citlivym-karcinomom-prostaty-mhspc-v-kombinacii-s-androgennou-deprivacnou-terapiou","status":"publish","type":"post","link":"https:\/\/niho.sk\/en\/16a-liecivo-enzalutamid-xtandi-v-liecbe-dospelych-muzov-s-metastatickym-hormonalne-citlivym-karcinomom-prostaty-mhspc-v-kombinacii-s-androgennou-deprivacnou-terapiou\/","title":{"rendered":"16A: Lie\u010divo enzalutamid (Xtandi) v lie\u010dbe dospel\u00fdch mu\u017eov s metastatick\u00fdm, hormon\u00e1lne citliv\u00fdm karcin\u00f3mom prostaty (mHSPC) v kombin\u00e1cii s androg\u00e9nnou depriva\u010dnou terapiou"},"content":{"rendered":"
    \n
  1. Ak\u00e1 je z\u00e1\u0165a\u017e ochorenia pre pacienta? Ako z\u00e1sadn\u00e9 je ochorenie?<\/strong><\/li>\n<\/ol>\n\n\n\n

    Rakovina prostaty je po rakovine ko\u017ee celosvetovo najroz\u0161\u00edrenej\u0161\u00edm druhom rakoviny postihuj\u00facej mu\u017esk\u00fa popul\u00e1ciu. Ochorenie sa prejavuje najsk\u00f4r zv\u00e4\u010d\u0161en\u00edm prostaty, sp\u00f4sobuj\u00facim v\u00fdrazn\u00fd diskomfort pacienta pri mo\u010den\u00ed, krvou v mo\u010di a neschopnos\u0165ou vymo\u010di\u0165 sa. Pri objaven\u00ed metast\u00e1z maj\u00fa pacienti naj\u010dastej\u0161ie bolesti kost\u00ed, n\u00e1chylnos\u0165 na ich zlomeniny a doch\u00e1dza ku kompresii in\u00fdch org\u00e1nov a ku strate hmotnosti.<\/p>\n\n\n\n

    N\u00e1dory prostaty vznikaj\u00fa spont\u00e1nne a nie je u nich zn\u00e1my jasn\u00fd rizikov\u00fd faktor. Rakovina prostaty je u pacientov, ktor\u00ed maj\u00fa menej ako 40 rokov sk\u00f4r vz\u00e1cna, av\u0161ak riziko sa v\u00fdrazne zvy\u0161uje po 50. roku \u017eivota. Z mo\u017en\u00fdch rizikov\u00fdch faktorov je uv\u00e1dzan\u00e1 vysok\u00e1 konzum\u00e1cia tukov a v\u00e1pnika (z mlie\u010dnych produktov), n\u00edzka pohybov\u00e1 aktivita, nedostatok vitam\u00ednov v strave, faj\u010denie, prekonan\u00fd z\u00e1pal prostaty a vazekt\u00f3mia.<\/p>\n\n\n\n

      \n
    1. O ak\u00fd liek ide?<\/strong><\/li>\n<\/ol>\n\n\n\n

      Lie\u010dba enzalutamidom m\u00e1 spoma\u013eova\u0165 rast buniek rakoviny prostaty a t\u00fdm vyvola\u0165 \u00fastup a eventu\u00e1lne z\u00e1nik n\u00e1doru.<\/p>\n\n\n\n

      Odpor\u00fa\u010dan\u00e1 d\u00e1vka je 160 mg enzalutamidu (\u0161tyri 40 mg filmom obalen\u00e9 tablety) podan\u00e1 \u00fastne jedenkr\u00e1t denne.<\/p>\n\n\n\n

      Enzalutamid bol prv\u00fdkr\u00e1t registrovan\u00fd Eur\u00f3pskou liekovou agent\u00farou d\u0148a 21.6.2013. Hodnoten\u00e1 indik\u00e1cia bola pridan\u00e1 25.2.2021.<\/p>\n\n\n\n

        \n
      1. Ako sa na enzalutamid pozeraj\u00fa odborn\u00edci? <\/strong><\/li>\n<\/ol>\n\n\n\n

        Odborn\u00edci sa vyjadrili, \u017ee z odpor\u00fa\u010dan\u00fdch lie\u010dob s\u00fa v s\u00fa\u010dasnosti dostupn\u00e9 (v zmysle \u00fahrady zdravotn\u00fdmi pois\u0165ov\u0148ami) apalutamid pre v\u0161etk\u00fdch pacientov a abirater\u00f3n, resp. docetaxel pre \u010das\u0165 pacientov. V\u0161etky lie\u010div\u00e1 sa pou\u017e\u00edvaj\u00fa v kombin\u00e1cii s androg\u00e9nnou depriva\u010dnou terapiou (chirurgickou\/farmakologickou kastr\u00e1ciou). Odborn\u00edci pova\u017euj\u00fa za najvhodnej\u0161ie porovna\u0165 enzalutamid s apalutamidom, pr\u00edpadne s docetaxelom a apalutamidom.<\/p>\n\n\n\n

        Odborn\u00edci uv\u00e1dzaj\u00fa, \u017ee celkov\u00fd po\u010det pacientov s t\u00fdmto typom rakoviny v SR mo\u017eno odhadn\u00fa\u0165 na 390 a vzh\u013eadom na dostupnos\u0165 in\u00fdch lie\u010div mo\u017eno po\u010det pacientov indikovan\u00fdch na lie\u010dbu hodnoten\u00fdm lie\u010divom v uvedenej indik\u00e1cii odhadn\u00fa\u0165 na nie viac ako 100 ro\u010dne.<\/p>\n\n\n\n

          \n
        1. \u010co hodnotilo NIHO a ak\u00fd je v\u00fdsledok?<\/strong><\/li>\n<\/ol>\n\n\n\n

          Dr\u017eite\u013e registr\u00e1cie (Astellas Pharma Europe) navrhuje, aby bola lie\u010dba hraden\u00e1 pre dospel\u00fdch mu\u017eov s metastatick\u00fdm, hormon\u00e1lne citliv\u00fdm karcin\u00f3mom prostaty (mHSPC) v kombin\u00e1cii s androg\u00e9nnou depriva\u010dnou terapiou. Lie\u010dba je hraden\u00e1 do \u010dasu, kedy d\u00f4jde ku klinickej progresii ochorenia.<\/p>\n\n\n\n

          NIHO odpor\u00fa\u010da nevyhovie\u0165 <\/strong>\u017eiadosti o kategorizovanie lieku Xtandi, nako\u013eko dr\u017eite\u013e registr\u00e1cie: <\/p>\n\n\n\n

            \n
          1. nepreuk\u00e1zal efekt\u00edvnos\u0165 lie\u010diva enzalutamid vo\u010di v\u0161etk\u00fdm relevantn\u00fdm porovnate\u013en\u00fdm lie\u010div\u00e1m a <\/li>\n\n\n\n
          2. nepreuk\u00e1zal v\u00fdznamn\u00fd pr\u00ednos vo\u010di porovn\u00e1van\u00fdm lie\u010div\u00e1m v najd\u00f4le\u017eitej\u0161\u00edch ukazovate\u013eoch.<\/li>\n<\/ol>\n\n\n\n

            Napriek v\u00fdzve zo strany Ministerstva zdravotn\u00edctva, dr\u017eite\u013e registr\u00e1cie nedodal porovnanie so v\u0161etk\u00fdmi porovnate\u013en\u00fdmi lie\u010divami.<\/p>","protected":false},"excerpt":{"rendered":"

            Rakovina prostaty je po rakovine ko\u017ee celosvetovo najroz\u0161\u00edrenej\u0161\u00edm druhom rakoviny postihuj\u00facej mu\u017esk\u00fa popul\u00e1ciu. Ochorenie sa prejavuje najsk\u00f4r zv\u00e4\u010d\u0161en\u00edm prostaty, sp\u00f4sobuj\u00facim v\u00fdrazn\u00fd diskomfort pacienta pri mo\u010den\u00ed, krvou v mo\u010di a neschopnos\u0165ou vymo\u010di\u0165 sa. Pri objaven\u00ed metast\u00e1z maj\u00fa pacienti naj\u010dastej\u0161ie bolesti kost\u00ed, n\u00e1chylnos\u0165 na ich zlomeniny a doch\u00e1dza ku kompresii in\u00fdch org\u00e1nov a ku strate hmotnosti. N\u00e1dory […]<\/p>\n","protected":false},"author":3,"featured_media":1796,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[64,65],"class_list":["post-1795","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-enzalutamid","tag-xtandi"],"_links":{"self":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/1795","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/comments?post=1795"}],"version-history":[{"count":0,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/1795\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media\/1796"}],"wp:attachment":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media?parent=1795"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1795"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1795"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}