{"id":1944,"date":"2023-12-05T16:55:00","date_gmt":"2023-12-05T15:55:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1944"},"modified":"2024-04-10T17:01:54","modified_gmt":"2024-04-10T15:01:54","slug":"50-liecivo-kyselina-obeticholova-ocaliva-na-liecbu-primarnej-biliarnej-cholangitidy","status":"publish","type":"post","link":"https:\/\/www.niho.sk\/en\/50-liecivo-kyselina-obeticholova-ocaliva-na-liecbu-primarnej-biliarnej-cholangitidy\/","title":{"rendered":"50: Lie\u010divo kyselina obeticholov\u00e1 (Ocaliva) na lie\u010dbu prim\u00e1rnej bili\u00e1rnej cholangit\u00eddy"},"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

    Prim\u00e1rna bili\u00e1rna cholangit\u00edda (PBC) je chronick\u00e9 zriedkav\u00e9 autoimunitn\u00e9 ochorenie pe\u010dene, ktor\u00e9 m\u00f4\u017ee vies\u0165 k cirh\u00f3ze pe\u010dene, zlyhaniu pe\u010dene a smrti, alebo k transplant\u00e1cii pe\u010dene. Pr\u00edznaky ochorenia ako pruritus, \u00fanava a sicca syndr\u00f3m v\u00fdznamne vpl\u00fdvaj\u00fa na kvalitu \u017eivota pacientov. Cie\u013eom lie\u010dby je zabr\u00e1nenie progresie ochorenia do kone\u010dn\u00fdch \u0161t\u00e1di\u00ed a zmiernenie pr\u00edznakov. V prvej l\u00ednii s\u00fa pacienti lie\u010den\u00ed UDCA (Ursodeoxycholic acid – kyselina ursodeoxycholov\u00e1), \u010das\u0165 pacientov v\u0161ak na t\u00fato lie\u010dbu neodpoved\u00e1 alebo lie\u010dbu UDCA netoleruje.<\/p>\n\n\n\n

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

      Ocaliva obsahuje \u00fa\u010dinn\u00fa l\u00e1tku kyselinu obeticholov\u00fa (agonistu farnezoidov\u00e9ho X receptora), ktor\u00e1 pom\u00e1ha zlep\u0161i\u0165 funkciu pe\u010dene zn\u00ed\u017een\u00edm tvorby a hromadenia \u017el\u010de v pe\u010deni a tie\u017e zn\u00ed\u017een\u00edm z\u00e1palu.<\/p>\n\n\n\n

      Ocaliva bol registrovan\u00fd na pou\u017eitie v Eur\u00f3pskej \u00fanii pre hodnoten\u00fa indik\u00e1ciu v decembri 2016.<\/p>\n\n\n\n

        \n
      1. Ako sa na hodnoten\u00e9 lie\u010divo pozeraj\u00fa odborn\u00edci?\u00a0<\/strong><\/li>\n<\/ol>\n\n\n\n

        Pre pacientov s PBC, ktor\u00ed netoleruj\u00fa lie\u010dbu UDCA alebo nedosahuj\u00fa dostato\u010dn\u00fa klinick\u00fa odpove\u010f na lie\u010dbu UDCA, neexistuje moment\u00e1lne \u017eiadna druh\u00e1 l\u00ednia lie\u010dby. Pre lek\u00e1rov je preto implement\u00e1cia Ocaliva roz\u0161\u00edren\u00edm terapeutick\u00fdch mo\u017enost\u00ed.<\/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 (ADVANZ PHARMA Limited (IRL)) podal \u017eiados\u0165 o zaradenie lie\u010diva kyselina obeticholov\u00e1 (Ocaliva) na lie\u010dbu prim\u00e1rnej bili\u00e1rnej cholangit\u00eddy.<\/p>\n\n\n\n

          NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Ocaliva v predmetnej indik\u00e1ci\u00ed, nako\u013eko sp\u013a\u0148a krit\u00e9ri\u00e1 n\u00e1kladovej efekt\u00edvnosti.<\/p>\n\n\n\n

          V\u00fdsledok hodnotenia n\u00e1kladovej efekt\u00edvnosti je pri po\u017eadovanej \u00fahrade spojen\u00fd so strednou mierou neistoty, \u017ee v klinickej praxi nebud\u00fa splnen\u00e9 krit\u00e9ri\u00e1 n\u00e1kladovej efekt\u00edvnosti. 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 z\u00e1rove\u0148 odpor\u00fa\u010da zv\u00e1\u017ei\u0165 \u00fapravu indika\u010dn\u00e9ho obmedzenia.<\/p>","protected":false},"excerpt":{"rendered":"

          NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Ocaliva v predmetnej indik\u00e1ci\u00ed, nako\u013eko…<\/p>","protected":false},"author":3,"featured_media":1945,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[133,132],"class_list":["post-1944","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-kyselina-obeticholova","tag-ocaliva"],"_links":{"self":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1944","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=1944"}],"version-history":[{"count":0,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1944\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media\/1945"}],"wp:attachment":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media?parent=1944"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1944"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1944"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}