{"id":1925,"date":"2023-11-10T16:24:00","date_gmt":"2023-11-10T15:24:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1925"},"modified":"2024-04-10T16:26:07","modified_gmt":"2024-04-10T14:26:07","slug":"44-liecivo-darolutamid-nubeqa-na-liecbu-metastatickeho-hormonalne-citliveho-karcinomu-prostaty-v-kombinacii-s-adt-a-docetaxelom-u-dospelych-muzov","status":"publish","type":"post","link":"https:\/\/www.niho.sk\/en\/44-liecivo-darolutamid-nubeqa-na-liecbu-metastatickeho-hormonalne-citliveho-karcinomu-prostaty-v-kombinacii-s-adt-a-docetaxelom-u-dospelych-muzov\/","title":{"rendered":"44: Lie\u010divo darolutamid (Nubeqa) na lie\u010dbu metastatick\u00e9ho, hormon\u00e1lne citliv\u00e9ho karcin\u00f3mu prostaty v kombin\u00e1cii s ADT a docetaxelom u dospel\u00fdch mu\u017eov"},"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

    Metastatick\u00fd, hormon\u00e1lne senzit\u00edvny karcin\u00f3m prostaty (mHSPC) patr\u00ed medzi n\u00e1dorov\u00e9 ochorenia, ktor\u00e9 postihuje naj\u010dastej\u0161ie pacientov v star\u0161om veku. S progresiou ochorenia mu\u017ei poci\u0165uj\u00fa sympt\u00f3my pod\u013ea v\u00fdskytu ich metast\u00e1z. Ochorenie ich rob\u00ed slab\u0161\u00edmi, pacienti maj\u00fa \u010dasto nerie\u0161ite\u013en\u00fa chorobnos\u0165, m\u00f4\u017eu preto vy\u017eadova\u0165 urgentn\u00fa starostlivos\u0165 a m\u00f4\u017eu by\u0165 n\u00e1chylnej\u0161\u00ed na zlomeniny alebo infekcie. Niektor\u00fdm sa m\u00f4\u017ee vyvin\u00fa\u0165 v\u00fdznamn\u00e1 boles\u0165. Metast\u00e1zy v mozgu ved\u00fa k v\u00fdznamn\u00fdm a znepokojuj\u00facim neurologick\u00fdm deficitom. Neistota z bud\u00facnosti m\u00e1 dopad na psychiku a kvalitu \u017eivota pacientov. Ochorenie m\u00e1 \u010dasto v\u00fdrazn\u00fd dopad na bl\u00edzkych pacienta, ke\u010f\u017ee vznik\u00e1 potreba pom\u00e1ha\u0165 so starostlivos\u0165ou o pacienta a jeho dom\u00e1cnos\u0165. Diagn\u00f3za sp\u00f4sobuje u rod\u00edn strach a \u00fazkos\u0165.<\/p>\n\n\n\n

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

      NUBEQA obsahuje lie\u010divo darolutamid. Pou\u017e\u00edva sa na lie\u010dbu dospel\u00fdch mu\u017eov s rakovinou prostaty, ktor\u00e1: <\/p>\n\n\n\n

        \n
      • sa neroz\u0161\u00edrila do ostatn\u00fdch \u010dast\u00ed tela a u\u017e nereaguje na medikament\u00f3znu alebo chirurgick\u00fa lie\u010dbu, ktor\u00e1 zni\u017euje hladinu testoster\u00f3nu (druh rakoviny naz\u00fdvan\u00fd aj nemetastatick\u00fd kastra\u010dne rezistentn\u00fd karcin\u00f3m prostaty),\u00a0<\/li>\n\n\n\n
      • sa roz\u0161\u00edrila do ostatn\u00fdch \u010dast\u00ed tela a reaguje na medikament\u00f3znu alebo chirurgick\u00fa lie\u010dbu zni\u017euj\u00facu hladinu testoster\u00f3nu (druh rakoviny naz\u00fdvan\u00fd aj metastatick\u00fd, hormon\u00e1lne citliv\u00fd karcin\u00f3m prostaty).\u00a0<\/li>\n<\/ul>\n\n\n\n

        NUBEQA blokuje aktivitu mu\u017esk\u00fdch pohlavn\u00fdch horm\u00f3nov naz\u00fdvan\u00fdch androg\u00e9ny, ako napr\u00edklad testoster\u00f3n. Blokovan\u00edm t\u00fdchto horm\u00f3nov zastavuje darolutamid rast a delenie rakovinov\u00fdch buniek prostaty.<\/p>\n\n\n\n

        Nubeqa bol registrovan\u00fd v Eur\u00f3pskej liekovej agent\u00fare pre hodnoten\u00fa indik\u00e1ciu vo febru\u00e1ri 2023.<\/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 (Bayer AG (DEU))  podal \u017eiados\u0165 o zaradenie lie\u010diva darolutamid (Nubeqa) na lie\u010dbu metastatick\u00e9ho, hormon\u00e1lne citliv\u00e9ho karcin\u00f3mu prostaty v kombin\u00e1cii s ADT a docetaxelom u dospel\u00fdch mu\u017eov.<\/p>\n\n\n\n

          NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Nubeqa v predmetnej indik\u00e1ci\u00ed, pokia\u013e dr\u017eite\u013e registr\u00e1cie uprav\u00ed po\u017eadovan\u00fa v\u00fd\u0161ku \u00fahrady tak, aby sp\u013a\u0148ala krit\u00e9ri\u00e1 n\u00e1kladovej efekt\u00edvnosti.<\/p>\n\n\n\n

          Z\u00e1rove\u0148, aj pri uvedenej \u00fahrade je pr\u00edtomn\u00e1 vysok\u00e1 miera neistoty, \u017ee krit\u00e9ri\u00e1 n\u00e1kladovej efekt\u00edvnosti nebud\u00fa v klinickej praxi splnen\u00e9. NIHO preto odpor\u00fa\u010da po\u017eadova\u0165 od dr\u017eite\u013ea registr\u00e1cie adekv\u00e1tnu dodato\u010dn\u00fa z\u013eavu, ktor\u00e1 zn\u00ed\u017ei t\u00fato neistotu.<\/p>\n\n\n\n

          NIHO odpor\u00fa\u010da aj zv\u00e1\u017ei\u0165 doplnenie indika\u010dn\u00e9ho obmedzenia.<\/p>","protected":false},"excerpt":{"rendered":"

          NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Nubeqa v predmetnej indik\u00e1ci\u00ed, pokia\u013e dr\u017eite\u013e registr\u00e1cie…<\/p>","protected":false},"author":3,"featured_media":1745,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[22,23],"class_list":["post-1925","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-darolutamid","tag-nubeqa"],"_links":{"self":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1925","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=1925"}],"version-history":[{"count":0,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1925\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media\/1745"}],"wp:attachment":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media?parent=1925"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1925"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1925"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}