{"id":1874,"date":"2023-05-22T17:39:00","date_gmt":"2023-05-22T15:39:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1874"},"modified":"2024-03-30T17:43:55","modified_gmt":"2024-03-30T16:43:55","slug":"32-liecivo-rimegepant-vydura-na-akutnu-liecbu-migreny-u-dospelych","status":"publish","type":"post","link":"https:\/\/www.niho.sk\/en\/32-liecivo-rimegepant-vydura-na-akutnu-liecbu-migreny-u-dospelych\/","title":{"rendered":"32: Lie\u010divo rimegepant (Vydura) na ak\u00fatnu lie\u010dbu migr\u00e9ny u dospely\u0301ch"},"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

    Migr\u00e9na je \u010dast\u00e9 chronick\u00e9 neurologick\u00e9 ochorenie, ktor\u00e9 sa prejavuje ako z\u00e1va\u017en\u00e1, vysoko zneschop\u0148uj\u00faca boles\u0165 hlavy. Charakteristick\u00e9 s\u00fa pre \u0148u ataky jednostrannej, preva\u017ene pulzuj\u00facej bolesti, ktor\u00e9 bez lie\u010dby trvaj\u00fa 4 \u2013 72 hod\u00edn. Pod\u013ea odhadov \u0148ou celosvetovo trp\u00ed viac ako 1,1 miliardy \u013eud\u00ed, pri\u010dom odhadovan\u00e1 prevalencia po\u010das jedn\u00e9ho roka je na \u00farovni 15 % v\u0161eobecnej popul\u00e1cie. Migr\u00e9na m\u00e1 negat\u00edvny dopad na vykon\u00e1vanie be\u017en\u00fdch \u010dinnost\u00ed a je spojen\u00e1 so signifikantne vy\u0161\u0161ou mierou absentizmu, prezentizmu, vyu\u017e\u00edvania zdravotn\u00edckych zdrojov a s celkovo ni\u017e\u0161ou HRQoL (z angl. Health-related quality of life, kvalita \u017eivota s\u00favisiaca so zdrav\u00edm).<\/p>\n\n\n\n

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

      VYDURA obsahuje \u00fa\u010dinn\u00fa l\u00e1tku rimegepant, ktor\u00e1 v organizme blokuje aktivitu l\u00e1tky naz\u00fdvanej peptid s\u00favisiaci s g\u00e9nom kalciton\u00ednu (calcitonin gene-related peptide CGRP). \u013dudia s migr\u00e9nou m\u00f4\u017eu ma\u0165 zv\u00fd\u0161en\u00e9 hladiny CGRP. Rimegepant sa via\u017ee na receptor pre CGRP, \u010d\u00edm tie\u017e zni\u017euje schopnos\u0165 CGRP viaza\u0165 sa na receptor. To zni\u017euje aktivitu CGRP a m\u00e1 dva \u00fa\u010dinky: <\/p>\n\n\n\n

        \n
      1. m\u00f4\u017ee zastavi\u0165 akt\u00edvny migren\u00f3zny z\u00e1chvat a <\/li>\n\n\n\n
      2. pri prevent\u00edvnom u\u017e\u00edvan\u00ed m\u00f4\u017ee zn\u00ed\u017ei\u0165 po\u010det vyskytuj\u00facich sa z\u00e1chvatov migr\u00e9ny. <\/li>\n<\/ol>\n\n\n\n

        VYDURA sa pou\u017e\u00edva na lie\u010dbu a prevenciu z\u00e1chvatov migr\u00e9ny u dospel\u00fdch.<\/p>\n\n\n\n

        Lieku Vydura (rimegepant) EMA (Eur\u00f3pska liekova agent\u00fara) udelila povolenie na uvedenie na trh 25.4.2022.<\/p>\n\n\n\n

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

          Nepredpoklad\u00e1me, \u017ee by sa u lek\u00e1rov, ktor\u00ed pracuj\u00fa s pacientami trpiacimi migr\u00e9nou, aktu\u00e1lne prejavovala frustr\u00e1cia zo zaost\u00e1vania za najlep\u0161\u00edm medzin\u00e1rodn\u00fdm \u0161tandardom, ke\u010f\u017ee rimegepant zatia\u013e nie je be\u017ene pou\u017e\u00edvan\u00fd ani v in\u00fdch eur\u00f3pskych krajin\u00e1ch. Kategorizovanie rimegepantu v\u0161ak m\u00f4\u017ee vyvola\u0165 zv\u00fd\u0161en\u00fd z\u00e1ujem zo strany pacientov o jeho predp\u00edsanie aj v pr\u00edpade, kedy nesp\u013a\u0148aj\u00fa indika\u010dn\u00e9 obmedzenie, \u010do by mohlo pre lek\u00e1rov predstavova\u0165 v\u00fdzvu vo vz\u0165ahu k profesion\u00e1lnej etike. Predpoklad\u00e1me, \u017ee pri liekoch s indika\u010dn\u00fdm obmedzen\u00edm je kladen\u00fd vy\u0161\u0161\u00ed d\u00f4raz na komunik\u00e1ciu lek\u00e1ra s pacientom oh\u013eadom dostupn\u00fdch lie\u010debn\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 (Pfizer Europe MA EEIG) podal \u017eiados\u0165 o zaradenie lie\u010diva rimegepant (Vydura) na ak\u00fatnu lie\u010dbu migr\u00e9ny u dospel\u00fdch.<\/p>\n\n\n\n

            NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Vydura 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 a z\u00e1rove\u0148 bude upraven\u00e9 indika\u010dn\u00e9 obmedzenie pod\u013ea n\u00e1vrhu NIHO.<\/p>\n\n\n\n

            V\u00fdsledok hodnotenia n\u00e1kladovej efekt\u00edvnosti je aj pri uvedenej \u00fahrade spojen\u00fd s vysokou mierou neistoty, \u017ee v klinickej praxi nebud\u00fa splnen\u00e9 krit\u00e9ri\u00e1 n\u00e1kladovej efekt\u00edvnosti. Preto NIHO odpor\u00fa\u010da po\u017eadova\u0165 od dr\u017eite\u013ea registr\u00e1cie adekv\u00e1tnu dodato\u010dn\u00fa z\u013eavu, ktorou by sa t\u00e1to neistota kompenzovala.<\/p>","protected":false},"excerpt":{"rendered":"

            NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Vydura v predmetnej indik\u00e1ci\u00ed, pokia\u013e dr\u017eite\u013e registr\u00e1cie uprav\u00ed po\u017eadovan\u00fa v\u00fd\u0161ku \u00fahrady tak, aby …<\/p>","protected":false},"author":3,"featured_media":1875,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[102,101],"class_list":["post-1874","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-rimegepant","tag-vydura"],"_links":{"self":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1874","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=1874"}],"version-history":[{"count":0,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1874\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media\/1875"}],"wp:attachment":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media?parent=1874"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1874"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1874"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}