{"id":1764,"date":"2022-11-08T13:12:00","date_gmt":"2022-11-08T12:12:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1764"},"modified":"2024-03-23T13:22:01","modified_gmt":"2024-03-23T12:22:01","slug":"7-liecivo-inklisiran-leqvio-na-liecbu-primarnej-hypercholesterolemie-alebo-zmiesanej-dyslipidemie-v-sekundarnej-prevencii-kardiovaskularnych-udalosti","status":"publish","type":"post","link":"https:\/\/www.niho.sk\/en\/7-liecivo-inklisiran-leqvio-na-liecbu-primarnej-hypercholesterolemie-alebo-zmiesanej-dyslipidemie-v-sekundarnej-prevencii-kardiovaskularnych-udalosti\/","title":{"rendered":"7: Lie\u010divo inklisiran (Leqvio) na lie\u010dbu prim\u00e1rnej hypercholesterol\u00e9mie alebo zmie\u0161anej dyslipid\u00e9mie v sekund\u00e1rnej prevencii kardiovaskul\u00e1rnych udalost\u00ed"},"content":{"rendered":"

1.<\/strong> O ak\u00fd liek sa jedn\u00e1?<\/strong><\/p>\n\n\n\n

Inklisiran je kyselina, ktor\u00e1 p\u00f4sob\u00ed v pe\u010deni ako blok\u00e1tor produkcie \u0161pecifickej bielkoviny \u201cPCSK9\u201d. V\u010faka tomu je pe\u010de\u0148 schopn\u00e1 absorbova\u0165 viac LDL-cholesterolu, \u010d\u00edm zni\u017euje jeho hladinu v krvi. Inklisiran sa zvy\u010dajne u\u017e\u00edva v kombin\u00e1cii so stat\u00ednmi alebo inou lie\u010dbou na zn\u00ed\u017eenie LDL-cholesterolu.<\/p>\n\n\n\n

Inklisiran sa pod\u00e1va ako podko\u017en\u00e1 injekcia, na za\u010diatku lie\u010dby, n\u00e1sledne po 3 mesiacoch, potom ka\u017ed\u00fdch 6 mesiacov. Injekciu m\u00e1 pod\u00e1va\u0165 odborn\u00fd zdravotn\u00fd person\u00e1l.<\/p>\n\n\n\n

Liek Leqvio (inklisiran) bol registrovan\u00fd v Eur\u00f3pskej liekovej agent\u00fare d\u0148a 9.12.2020.<\/p>\n\n\n\n

2. \u010co je z\u00e1\u0165a\u017e ochorenia pre pacienta? Ako je z\u00e1sadn\u00e9?<\/strong><\/p>\n\n\n\n

Vysok\u00e9 hladiny LDL-cholesterolu s\u00fa jednou z hlavn\u00fdch pr\u00ed\u010din ateroskler\u00f3zy, ktor\u00e1 vedie k vzniku aterosklerotick\u00fdch kardiovaskul\u00e1rnych ochoren\u00ed, medzi ktor\u00e9 patria napr\u00edklad infarkt myokardu, cievna mozgov\u00e1 pr\u00edhoda alebo nestabiln\u00e1 angina pectoris. Z\u00e1\u0165a\u017e kardiovaskul\u00e1rnymi ochoreniami je na Slovensku ve\u013emi vysok\u00e1, s\u00fa naj\u010dastej\u0161ou pr\u00ed\u010dinou \u00famrt\u00ed u mu\u017eov aj \u017eien. Ischemick\u00e1 choroba srdca, ktor\u00e1 je d\u00f4sledkom ateroskler\u00f3zy, v roku 2019 sp\u00f4sobila 24 % \u00famrt\u00ed u mu\u017eov a 30 % \u00famrt\u00ed u \u017eien.<\/p>\n\n\n\n

Poruchy metabolizmu tukov sa naz\u00fdvaj\u00fa dyslipid\u00e9mie. Prim\u00e1rne dyslipid\u00e9mie s\u00fa geneticky podmienen\u00e9 ochorenia, av\u0161ak okrem genetick\u00fdch faktorov ovplyv\u0148uje hladiny tukov aj \u017eivotospr\u00e1va (faj\u010denie, alkohol, di\u00e9ta) a pr\u00edtomnos\u0165 in\u00fdch ochoren\u00ed.<\/p>\n\n\n\n

3. Ako sa na inklisiran pozeraj\u00fa odborn\u00edci?<\/strong><\/p>\n\n\n\n

Farmakologick\u00e1 lie\u010dba prvej vo\u013eby s\u00fa pod\u013ea v\u0161etk\u00fdch osloven\u00fdch odborn\u00edkov stat\u00edny, pr\u00edpadne ich kombin\u00e1cia s ezetimibom. Odborn\u00edci sa vyjadrili, \u017ee na Slovensku s\u00fa\u010dasn\u00e1 lie\u010dba zv\u00fd\u0161en\u00e9ho LDL-cholesterolu nie je v s\u00falade s najnov\u0161\u00edmi medzin\u00e1rodn\u00fdmi odpor\u00fa\u010daniami, najm\u00e4 pri sekund\u00e1rnej prevencii u pacientov po prekonan\u00ed kardiovaskul\u00e1rnej pr\u00edhody. Probl\u00e9mom pod\u013ea odborn\u00edkov je aj zbyto\u010dn\u00e1 administrat\u00edvna z\u00e1\u0165a\u017e spojen\u00e1 so s\u00fa\u010dasn\u00fdmi mo\u017enos\u0165ami lie\u010dby, ktor\u00fa vytv\u00e1raj\u00fa komplikovan\u00e9 indika\u010dn\u00e9 obmedzenia (podmienky pre \u00fahradu lieku), najm\u00e4 pri modernej biologickej lie\u010dbe.<\/p>\n\n\n\n

Odborn\u00edci o\u010dak\u00e1vaj\u00fa, \u017ee pri inklisirane sa u pacientov zlep\u0161\u00ed dodr\u017eiavanie lie\u010debn\u00e9ho re\u017eimu v porovnan\u00ed s ostatn\u00fdmi mo\u017enos\u0165ami lie\u010dby, ke\u010f\u017ee sa pod\u00e1va menej \u010dasto.<\/p>\n\n\n\n

4. \u010co hodnotilo NIHO a ak\u00fd je v\u00fdsledok?<\/strong><\/p>\n\n\n\n

Dr\u017eite\u013e registr\u00e1cie (farmaceutick\u00e1 spolo\u010dnos\u0165) navrhuje hradi\u0165 lie\u010dbu inklisiran u pacientov s hypercholesterol\u00e9miou alebo zmie\u0161anou dyslipid\u00e9miou a z\u00e1rove\u0148 ve\u013emi vysok\u00fdm rizikom kardiovaskul\u00e1rnej pr\u00edhody, ktor\u00ed maj\u00fa potvrden\u00e9 aterosklerotick\u00e9 kardiovaskul\u00e1rne ochorenie. Navrhovanou podmienkou je aj pretrv\u00e1vaj\u00faca hladina LDL-cholesterolu \u2265 2,6 mmol\/l po lieb\u010de stat\u00ednmi, resp. inej lie\u010dbe a dodr\u017eiavanie podmienok \u017eivotospr\u00e1vy.<\/p>\n\n\n\n

NIHO odpor\u00fa\u010da nevyhovie\u0165 \u017eiadosti o kategorizovanie lieku Leqvio v predmetnej indik\u00e1ci\u00ed, pokia\u013e nepr\u00edde k zmene indika\u010dn\u00e9ho obmedzenia pod\u013ea n\u00e1vrhu NIHO a z\u00e1rove\u0148 dr\u017eite\u013e registr\u00e1cie neposkytne z\u013eavu vo\u010di ofici\u00e1lnej \u00fahrade.<\/p>","protected":false},"excerpt":{"rendered":"

NIHO odpor\u00fa\u010da nevyhovie\u0165 \u017eiadosti o kategorizovanie lieku Leqvio v predmetnej indik\u00e1ci\u00ed, pokia\u013e nepr\u00edde k zmene indika\u010dn\u00e9ho obmedzenia pod\u013ea n\u00e1vrhu NIHO a z\u00e1rove\u0148 dr\u017eite\u013e registr\u00e1cie neposkytne z\u013eavu vo\u010di ofici\u00e1lnej \u00fahrade.<\/p>","protected":false},"author":3,"featured_media":1765,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[24,25],"class_list":["post-1764","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-inklisiran","tag-leqvio"],"_links":{"self":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1764","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=1764"}],"version-history":[{"count":0,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1764\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media\/1765"}],"wp:attachment":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media?parent=1764"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1764"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1764"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}