{"id":1775,"date":"2023-07-07T13:39:00","date_gmt":"2023-07-07T11:39:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1775"},"modified":"2024-03-23T13:47:42","modified_gmt":"2024-03-23T12:47:42","slug":"10-liecivo-esketamin-spravato-v-kombinacii-s-ssri-alebo-snri-na-liecbu-dospelych-pacientov-s-depresivnou-poruchou-rezistentnou-na-liecbu-ktori-pocas-sucasnej-stredne-tazkej-az-tazkej-depresivnej-e","status":"publish","type":"post","link":"https:\/\/www.niho.sk\/en\/10-liecivo-esketamin-spravato-v-kombinacii-s-ssri-alebo-snri-na-liecbu-dospelych-pacientov-s-depresivnou-poruchou-rezistentnou-na-liecbu-ktori-pocas-sucasnej-stredne-tazkej-az-tazkej-depresivnej-e\/","title":{"rendered":"10: Lie\u010divo esketam\u00edn (Spravato) v kombin\u00e1cii s SSRI alebo SNRI na lie\u010dbu dospel\u00fdch pacientov s depres\u00edvnou poruchou rezistentnou na lie\u010dbu, ktor\u00ed po\u010das s\u00fa\u010dasnej stredne \u0165a\u017ekej a\u017e \u0165a\u017ekej depres\u00edvnej epiz\u00f3dy neodpovedali na najmenej dve r\u00f4zne lie\u010dby antidepres\u00edvami"},"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

    Sympt\u00f3mami depresie s\u00fa vo v\u0161eobecnosti pocity sm\u00fatku, pr\u00e1zdnoty a bezn\u00e1deje, iritovate\u013enos\u0165, strata z\u00e1ujmu o predt\u00fdm ob\u013e\u00faben\u00e9 aj be\u017en\u00e9 aktivity, poruchy sp\u00e1nku, nedostatok energie, zn\u00ed\u017een\u00e1 alebo naopak zv\u00fd\u0161en\u00e1 chu\u0165 do jedla, zhor\u0161en\u00e9 kognit\u00edvne schopnosti, pocity viny a hanby, samovra\u017eedn\u00e9 tendencie a nevysvetlite\u013en\u00e9 fyzick\u00e9 probl\u00e9my (napr. bolesti). Jednozna\u010dn\u00e9 d\u00f4vody vzniku depresie nie s\u00fa zn\u00e1me. Je sp\u00f4soben\u00e1 kombin\u00e1ciou genetick\u00fdch, biologick\u00fdch, psychologick\u00fdch, soci\u00e1lnych a environment\u00e1lnych faktorov.<\/p>\n\n\n\n

    Depres\u00edvna porucha sa pova\u017euje za rezistentn\u00fa, ak pacientom zlyhali aspo\u0148 dve predch\u00e1dzaj\u00face lie\u010dby antidepres\u00edvami. Rezistentn\u00e1 depres\u00edvna porucha predstavuje v\u00fdrazn\u00fa z\u00e1\u0165a\u017e pre pacientov a ich bl\u00edzkych. Pacienti \u010dasto vy\u017eaduj\u00fa pomoc okolia, ochorenie obmedzuje ka\u017edodenn\u00e9 fungovanie pacienta, zn\u00ed\u017eenie pracovnej produktivity. Ochorenie je spojen\u00e9 s rizikom samovra\u017edy, rizikom zhor\u0161enia \u010di dokonca vzniku z\u00e1va\u017en\u00fdch telesn\u00fdch ochoren\u00ed (napr. srdcovo-cievnych). U pacientov, ktor\u00fdm zlyhalo viacero lie\u010dob je ni\u017e\u0161ia \u0161anca, \u017ee \u010fal\u0161ia lie\u010dba zaberie.  Cie\u013eom lie\u010dby by malo by\u0165 dosiahnutie stavu bez pr\u00edznakov ochorenia.<\/p>\n\n\n\n

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

      Esketam\u00edn je antidepres\u00edvum s r\u00fdchlym n\u00e1stupom \u00fa\u010dinku (do 24 hod\u00edn). U\u017e\u00edva sa v kombin\u00e1ci\u00ed s \u010fal\u0161\u00edmi \u0161pecifick\u00fdmi antidepres\u00edvami. Forma podania esketam\u00ednu je nosn\u00fd sprej pod doh\u013eadom lek\u00e1ra v ambulancii. <\/p>\n\n\n\n

      Spravato bol registrovan\u00fd Eur\u00f3pskou liekovou agent\u00farou v decembri roku 2019.<\/p>\n\n\n\n

        \n
      1. Ako sa na esketam\u00edn pozeraj\u00fa odborn\u00edci? <\/strong><\/li>\n<\/ol>\n\n\n\n

        Zast\u00fapen\u00ed odborn\u00edci v stanovisku po\u017eaduj\u00fa, aby bolo lie\u010divo na Slovensku dostupn\u00e9. Odborn\u00edk, ktor\u00e9ho NIHO oslovil, predpoklad\u00e1 v\u00fdznamn\u00fd klinick\u00fd pr\u00ednos lie\u010diva pre pacientov s rezistentnou depres\u00edvnou poruchou, pri ktorej preva\u017euje zn\u00ed\u017eenie energie, motiv\u00e1cie, celkovo zn\u00ed\u017een\u00e9 fungovanie, a podstatne zlep\u0161en\u00fa kvalitu \u017eivota.<\/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 (Janssen – Cilag International N.V.) navrhuje, aby bola hraden\u00e1 lie\u010dba Spravatom na lie\u010dbu dospel\u00fdch pacientov s depres\u00edvnou poruchou rezistentnou na lie\u010dbu, ktor\u00ed po\u010das s\u00fa\u010dasnej stredne \u0165a\u017ekej a\u017e \u0165a\u017ekej depres\u00edvnej epiz\u00f3dy neodpovedali tri r\u00f4zne lie\u010dby antidepres\u00edvami samostatne alebo v kombin\u00e1cii s \u010fal\u0161\u00edm antidepres\u00edvami alebo v kombin\u00e1ci\u00ed s in\u00fdmi lie\u010divami. Dr\u017eite\u013e registr\u00e1cie p\u00f4vodne navrhol hradenie lie\u010dby pacientom, ktor\u00ed neodpovedali na dve r\u00f4zne lie\u010dby antidepres\u00edvami. Na \u017eiados\u0165 NIHO v\u0161ak tento n\u00e1vrh upravil.<\/p>\n\n\n\n

          V r\u00e1mci hodnotenej \u017eiadosti dr\u017eite\u013e registr\u00e1cie navrhuje \u00fahradu za aplik\u00e1tor lieku Spravato s obsahom 28 mg \u00fa\u010dinnej l\u00e1tky nosov\u00e1 roztokov\u00e1 aerodisperzia vo v\u00fd\u0161ke 222,64 eur.<\/p>\n\n\n\n

          NIHO odpor\u00fa\u010da nevyhovie\u0165 <\/strong>\u017eiadosti o kategorizovanie lieku Spravato, pokia\u013e:<\/p>\n\n\n\n

            \n
          1. ned\u00f4jde k \u00faprave podmienok hradenia na z\u00e1klade odpor\u00fa\u010dan\u00ed NIHO:\n
              \n
            • lie\u010dba by bola poskytovan\u00e1 iba pacientom vo veku 18 \u2013 64 rokov bez psychotick\u00fdch pr\u00edznakov <\/li>\n<\/ul>\n<\/li>\n\n\n\n
            • a z\u00e1rove\u0148 dr\u017eite\u013e registr\u00e1cie neposkytne z\u013eavu vo v\u00fd\u0161ke, ktor\u00fa navrhuje NIHO, aby:\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 ve\u013ek\u00e1 neistota v\u00fdsledkov hodnotenia klinick\u00e9ho pr\u00ednosu a n\u00e1kladovej efekt\u00edvnosti<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n\n\n\n

                NIHO tie\u017e odpor\u00fa\u010da prehodnoti\u0165 klinick\u00fd pr\u00ednos a n\u00e1kladov\u00fa efektivitu po 2 rokoch po pr\u00edpadnej kategoriz\u00e1ci\u00ed na z\u00e1klade aktualizovan\u00fdch d\u00e1t predlo\u017een\u00fdch dr\u017eite\u013eom registr\u00e1cie.<\/p>","protected":false},"excerpt":{"rendered":"

                NIHO odpor\u00fa\u010da nevyhovie\u0165 \u017eiadosti o kategorizovanie lieku Spravato, pokia\u013e…<\/p>","protected":false},"author":3,"featured_media":1776,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[30,31],"class_list":["post-1775","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-esketamin","tag-spravato"],"_links":{"self":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1775","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=1775"}],"version-history":[{"count":0,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1775\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media\/1776"}],"wp:attachment":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media?parent=1775"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1775"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1775"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}