{"id":1798,"date":"2023-01-31T14:12:00","date_gmt":"2023-01-31T13:12:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1798"},"modified":"2024-03-30T14:14:23","modified_gmt":"2024-03-30T13:14:23","slug":"16b-liecivo-enzalutamid-xtandi-na-liecbu-nemetastatickeho-kastracne-rezistentneho-karcinomu-prostaty-nmcrpc","status":"publish","type":"post","link":"https:\/\/niho.sk\/en\/16b-liecivo-enzalutamid-xtandi-na-liecbu-nemetastatickeho-kastracne-rezistentneho-karcinomu-prostaty-nmcrpc\/","title":{"rendered":"16B: Lie\u010divo enzalutamid (Xtandi) na lie\u010dbu nemetastatick\u00e9ho kastra\u010dne rezistentn\u00e9ho karcin\u00f3mu prostaty (nmCRPC)"},"content":{"rendered":"
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  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

    Pacienti bez metast\u00e1z v \u0161t\u00e1diu nmCRPC s\u00fa zv\u00e4\u010d\u0161a asymptomatick\u00ed. V d\u00f4sledku rastu n\u00e1doru a zv\u00e4\u010d\u0161ovania prostaty sa m\u00f4\u017eu objavi\u0165 probl\u00e9my s mo\u010den\u00edm ako nutkanie na mo\u010denie, potreba \u010dastej\u0161ieho mo\u010denia, unikaj\u00faci mo\u010d, pocit nedostato\u010dn\u00e9ho vypr\u00e1zdnenia, krv v mo\u010di alebo v ejakul\u00e1te \u010di probl\u00e9my s erekciou.<\/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 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

      Liek Xtandi s lie\u010divom enzalutamid bol registrovan\u00fd Eur\u00f3pskou liekovou agent\u00farou d\u0148a 21.6.2013. Roz\u0161\u00edrenie indik\u00e1cie na pacientov s vysokorizikov\u00fdm nmCRPC t\u00fdkaj\u00face sa tohto hodnotenia bolo schv\u00e1len\u00e9 20.9.2018.<\/p>\n\n\n\n

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

        Pod\u013ea vyjadrenia odborn\u00edka, ktor\u00e9ho NIHO oslovilo, v s\u00fa\u010dasnosti sa v klinickej praxi pou\u017e\u00edvaj\u00fa v hodnotenej indik\u00e1cii intervencie apalutamid a darolutamid.<\/p>\n\n\n\n

        Odborn\u00edk o\u010dak\u00e1va ve\u013emi m\u00e1lo pacientov v indik\u00e1cii nmCRPC, okrem toho po\u010det pacientov progres\u00edvne kles\u00e1 v s\u00favislosti s pokrokmi v zobrazovac\u00edch vy\u0161etreniach. Nepredpoklad\u00e1, \u017ee existuj\u00fa podskupiny pacientov, pre ktor\u00fdch by bolo lie\u010divo viac alebo menej efekt\u00edvne alebo vhodn\u00e9.<\/p>\n\n\n\n

        Odborn\u00edk sa vyjadril, \u017ee by malo by\u0165 na Slovensku na lie\u010dbu nmCRPC plne hraden\u00e9 aspo\u0148 jedno z lie\u010div Enzalutamid <\/strong>\/ Apalutamid \/ Darolutamid. NIHO medzi\u010dasom vydalo hodnotenie lieku Nubeqa (Darolutamid) v rovnakej indik\u00e1cii.<\/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 hraden\u00e1 lie\u010dba dospel\u00fdch pacientov s nmCRPC v kombin\u00e1cii s androg\u00e9n depriva\u010dnou terapiou (chirurgickou \/ farmakologickou kastr\u00e1ciou), u ktor\u00fdch je vysok\u00e9 riziko vzniku metastatick\u00e9ho ochorenia. Lie\u010dba je hraden\u00e1 do \u010dasu, kedy d\u00f4jde k r\u00e1diografick\u00e9mu roz\u0161\u00edreniu ochorenia alebo do rozvoja neprijate\u013enej toxicity. Hraden\u00e1 lie\u010dba podlieha predch\u00e1dzaj\u00facemu s\u00fahlasu zdravotnej pois\u0165ovne.<\/p>\n\n\n\n

          NIHO odpor\u00fa\u010da nevyhovie\u0165 <\/strong>\u017eiadosti o kategorizovanie lieku Xtandi, pokia\u013e dr\u017eite\u013e registr\u00e1cie neposkytne z\u013eavu vo v\u00fd\u0161ke, ktor\u00fa navrhuje NIHO, aby:<\/p>\n\n\n\n

            \n
          • boli splnen\u00e9 krit\u00e9ri\u00e1 n\u00e1kladovej efekt\u00edvnosti pod\u013ea \u00a77 z\u00e1kona 363\/2011 Z.z..<\/li>\n\n\n\n
          • bola zoh\u013eadnen\u00e1 stredn\u00e1 neistota, \u017ee krit\u00e9ria n\u00e1kladovej efekt\u00edvnosti nebud\u00fa splnen\u00e9 ani pri navrhnutej z\u013eavnenej v\u00fd\u0161ke \u00fahrady<\/li>\n<\/ul>","protected":false},"excerpt":{"rendered":"

            NIHO odpor\u00fa\u010da nevyhovie\u0165 \u017eiadosti o kategorizovanie lieku Xtandi, pokia\u013e dr\u017eite\u013e registr\u00e1cie neposkytne z\u013eavu vo v\u00fd\u0161ke, ktor\u00fa navrhuje NIHO…<\/p>","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-1798","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\/1798","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=1798"}],"version-history":[{"count":0,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/1798\/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=1798"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1798"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1798"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}