{"id":1196,"date":"2023-11-05T00:07:10","date_gmt":"2023-11-05T00:07:10","guid":{"rendered":"https:\/\/accord-prostata.se\/hcp\/?page_id=1196"},"modified":"2025-02-20T15:42:59","modified_gmt":"2025-02-20T15:42:59","slug":"kliniska-data","status":"publish","type":"page","link":"https:\/\/accord-prostata.se\/hcp\/kliniska-data\/","title":{"rendered":"Clinical data"},"content":{"rendered":"\n<div class=\"wp-block-custom-blocks-container block-container block-container--full-width block-container--align-middle  has-none-background-color\"><div class=\"block-container--background-image\" style=\"background-image:url(https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2023\/06\/green-background.webp);opacity:1\"><\/div>\n<div class=\"wp-block-columns has-2-columns\">\n<div class=\"wp-block-column\">\n<h1 class=\"wp-block-heading has-white-color has-text-color\" id=\"kliniska-data\"><strong>Kliniska data<\/strong><\/h1>\n<\/div>\n\n\n\n<div class=\"wp-block-column\">\n\n<div class=\"responsive-image--container\">\n  <img decoding=\"async\" src=\"https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2023\/11\/image-tie.png\" \n       class=\"responsive-image\" \n       alt=\"\" \n       loading=\"lazy\"       srcset=\"https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2023\/11\/image-tie-480x259.png 480w, \n               https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2023\/11\/image-tie-960x518.png 782w, \n               https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2023\/11\/image-tie-960x518.png 1366w, \n               https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2023\/11\/image-tie.png 2048w, \n               https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2023\/11\/image-tie.png 2500w\"\n       sizes=\"(max-width: 2500px) 100vw, 2500px\">\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-custom-blocks-container block-container block-container--full-width block-container--align-top  block-container--spacer-top block-container--spacer-bottom has-none-background-color clinical-data\">\n<div class=\"wp-block-columns has-1-columns\">\n<div class=\"wp-block-column\">\n<h2 class=\"wp-block-heading\" id=\"hero-studiedesign\"><strong>HERO studiedesign<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">HERO-studien var en internationell, randomiserad, \u00f6ppen, fas 3 studie som unders\u00f6kte effekt och s\u00e4kerhet av ORGOVYX<sup>\u00ae<\/sup> j\u00e4mf\u00f6rt med leuprorelin hos m\u00e4n med hormonk\u00e4nslig avancerad prostatacancer.<sup>1<\/sup><\/p>\n\n\n\n<div class=\"wp-block-custom-blocks-accordion block-accordion--group\">\n<div class=\"block-accordion--group---menu block-tab--group---menu block-all--group---button\">\n    <div class=\"block-accordion--group---menu----symbol\"><\/div>\n  <button type=\"button\" class=\"block-accordion--group---menu----heading block-tab--group---menu----heading\">Deltagande patienter<\/button>\n<\/div>\n\n\n<div class=\"wp-block-column block-accordion--group---content  block-all--group---content\">\n<p class=\"wp-block-paragraph\">Patienter var l\u00e4mpliga om de var \u226518 \u00e5r, hade histologiskt eller cytologiskt bekr\u00e4ftat adenokarcinom i prostatan som kr\u00e4vde kontinuerlig ADT i minst ett \u00e5r.<sup>1<\/sup><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Deltagande patienter hade en av f\u00f6ljande tre kliniska sitiationer:<sup>1<\/sup><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>biokemiska tecken (PSA) eller kliniska tecken p\u00e5 \u00e5terfall efter en lokal, prim\u00e4r&nbsp;intervention&nbsp;i botande syfte, var inte aktuella f\u00f6r \u201dr\u00e4ddande kirurgi\u201d (50,2 %)<\/li>\n\n\n\n<li>hade nyligen f\u00e5tt diagnosen androgenk\u00e4nslig metastaserad sjukdom (22,7 %)<\/li>\n\n\n\n<li>hade en framskriden lokal sjukdom som sannolikt inte skulle kunna botas genom prim\u00e4r&nbsp;intervention&nbsp;med vare sig&nbsp;kirurgi&nbsp;eller str\u00e5lning (27,1 %)<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Patienter med allvarliga kardiovaskul\u00e4ra h\u00e4ndelser inom 6 m\u00e5nader innan studien p\u00e5b\u00f6rjades exkluderades.<sup>1<\/sup><\/p>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-custom-blocks-accordion block-accordion--group\">\n<div class=\"block-accordion--group---menu block-tab--group---menu block-all--group---button\">\n    <div class=\"block-accordion--group---menu----symbol\"><\/div>\n  <button type=\"button\" class=\"block-accordion--group---menu----heading block-tab--group---menu----heading\">Dosering<\/button>\n<\/div>\n\n\n<div class=\"wp-block-column block-accordion--group---content  block-all--group---content\">\n<p class=\"wp-block-paragraph\">Patienterna randomiserades, i f\u00f6rh\u00e5llandet 2:1, till att f\u00e5 antingen ORGOVYX<sup>\u00ae<\/sup> (120 mg en g\u00e5ng dagligen efter en peroral eng\u00e5ngsdos p\u00e5 360 mg) eller leuprorelin (22,5 mg* som injektion var 3:e m\u00e5nad) under 48 veckor.<sup>1<\/sup><\/p>\n\n\n\n<p class=\"has-small-print-font-size wp-block-paragraph\">*11,25 mg i Japan och Taiwan.<\/p>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-custom-blocks-accordion block-accordion--group\">\n<div class=\"block-accordion--group---menu block-tab--group---menu block-all--group---button\">\n    <div class=\"block-accordion--group---menu----symbol\"><\/div>\n  <button type=\"button\" class=\"block-accordion--group---menu----heading block-tab--group---menu----heading\">Effektm\u00e5tt<\/button>\n<\/div>\n\n\n<div class=\"wp-block-column block-accordion--group---content  block-all--group---content\">\n<p class=\"wp-block-paragraph\"><strong>Prim\u00e4rt effektm\u00e5tt<\/strong><br>Ih\u00e5llande kastrationsfrekvens, definierad som den kumulativa sannolikheten f\u00f6r testosteronsuppression till &lt;50 ng\/dl under mottagandet av studiebehandling fr\u00e5n dag 29 till 48 veckor.<sup>1<\/sup><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Viktiga sekund\u00e4ra effektm\u00e5tt<\/strong><br>Icke-underl\u00e4gsenhet av ORGOVYX<sup>\u00ae<\/sup> j\u00e4mf\u00f6rt med leuprorelin med avseende p\u00e5 ih\u00e5llande kastrationsfrekvens och kraftfull kastrationsfrekvens (definierad som den kumulativa sannolikheten f\u00f6r testosteronsuppression till &lt;20 ng\/dL) p\u00e5 dag 15.<sup>1<\/sup><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Explorativa effektm\u00e5tt<\/strong><br>Testosteron\u00e5terh\u00e4mtning till minst 280 ng\/dL vid 90 dagar analyserades i explorativa syften utan formell testning.<sup>2<\/sup><\/p>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-custom-blocks-accordion block-accordion--group\">\n<div class=\"block-accordion--group---menu block-tab--group---menu block-all--group---button\">\n    <div class=\"block-accordion--group---menu----symbol\"><\/div>\n  <button type=\"button\" class=\"block-accordion--group---menu----heading block-tab--group---menu----heading\">Unders\u00f6kningar<\/button>\n<\/div>\n\n\n<div class=\"wp-block-column block-accordion--group---content  block-all--group---content\">\n<p class=\"wp-block-paragraph\">Effekt- och s\u00e4kerhetsanalyserna utf\u00f6rdes p\u00e5 alla randomiserade patienter som fick minst en dos av pr\u00f6vningsbehandlingen.<sup>1<\/sup><\/p>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-custom-blocks-accordion block-accordion--group\">\n<div class=\"block-accordion--group---menu block-tab--group---menu block-all--group---button\">\n    <div class=\"block-accordion--group---menu----symbol\"><\/div>\n  <button type=\"button\" class=\"block-accordion--group---menu----heading block-tab--group---menu----heading\">Schematisk studiedesign<\/button>\n<\/div>\n\n\n<div class=\"wp-block-column block-accordion--group---content  block-all--group---content accord-image\">\n\n<div class=\"responsive-image--container responsive-image--bottom-gap responsive-image--margin-left-right\">\n  <img decoding=\"async\" src=\"https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2024\/11\/Study_design_schematic_1_SE.png\" \n       class=\"responsive-image\" \n       alt=\"\" \n       loading=\"lazy\"       srcset=\"https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2024\/11\/Study_design_schematic_1_SE-480x306.png 480w, \n               https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2024\/11\/Study_design_schematic_1_SE-960x612.png 782w, \n               https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2024\/11\/Study_design_schematic_1_SE-960x612.png 1366w, \n               https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2024\/11\/Study_design_schematic_1_SE.png 2048w, \n               https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2024\/11\/Study_design_schematic_1_SE.png 2500w\"\n       sizes=\"(max-width: 2500px) 100vw, 2500px\">\n<\/div>\n\n\n<p class=\"has-small-print-font-size wp-block-paragraph\">Anpassad fr\u00e5n Shore, <em>et al.<\/em> 2020.<sup>1,2<\/sup><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-custom-blocks-container block-container block-container--full-width block-container--align-top  has-indigo-background-color\">\n<div class=\"wp-block-columns has-1-columns\">\n<div class=\"wp-block-column\">\n<h3 class=\"wp-block-heading has-text-align-center has-white-color has-text-color\" id=\"orgovyx-uppnadde-bibehallen-testosteronsuppression-till-50-ng-dl-jamforbar-med-leuprorelin1\">ORGOVYX<sup>\u00ae<\/sup> uppn\u00e5dde bibeh\u00e5llen testosteronsuppression till &lt;50 ng\/dl, j\u00e4mf\u00f6rbar med leuprorelin<sup>1<\/sup><\/h3>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-custom-blocks-container block-container block-container--full-width block-container--align-top  block-container--spacer-top block-container--spacer-bottom has-none-background-color clinical-data\">\n<div class=\"wp-block-columns has-1-columns\">\n<div class=\"wp-block-column\">\n<h2 class=\"wp-block-heading\" id=\"primart-effektmatt\"><strong>Prim\u00e4rt effektm\u00e5tt<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Studien uppn\u00e5dde sitt prim\u00e4ra effektm\u00e5tt:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Bibeh\u00e5llen testosteronsuppression under kastrationsniv\u00e5er (&lt;50 ng\/dl) fr\u00e5n dag 29 till och med vecka 48 uppn\u00e5ddes hos 96,7 % av patienterna som fick ORGOVYX<sup>\u00ae<\/sup> (95 % KI, 94,9\u201397,9), j\u00e4mf\u00f6rt med 88,8 % (95 % KI, 84,6\u201391,8) av patienterna som fick leuprorelin<sup>1<\/sup><\/li>\n\n\n\n<li>Skillnaden mellan grupperna p\u00e5 7,9 % (95 % KI, 4,1\u201311,8) visade non-inferiority f\u00f6r ORGOVYX<sup>\u00ae<\/sup> j\u00e4mf\u00f6rt med leuprorelin (den nedre gr\u00e4nsen f\u00f6r 95 % KI f\u00f6r skillnaden mellan grupperna var st\u00f6rre \u00e4n den f\u00f6rspecificerade icke-underl\u00e4gsenhetsmarginalen p\u00e5 \u221210 %)<sup>1<\/sup><\/li>\n\n\n\n<li>Den nedre gr\u00e4nsen f\u00f6r det 95-procentiga konfidensintervallet f\u00f6r skillnaden mellan grupperna var \u00f6ver noll, vilket visade \u00f6verl\u00e4gsenheten** f\u00f6r ORGOVYX<sup>\u00ae<\/sup> \u00f6ver leuprorelin (p&lt;0,001)<sup>1<\/sup><\/li>\n<\/ul>\n\n\n\n\n<div class=\"responsive-image--container responsive-image--bottom-gap responsive-image--margin-left-right\">\n  <img decoding=\"async\" src=\"https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2024\/11\/Sustained-testosterone-suppression-rate-graph-SE.png\" \n       class=\"responsive-image\" \n       alt=\"\" \n       loading=\"lazy\"       srcset=\"https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2024\/11\/Sustained-testosterone-suppression-rate-graph-SE-480x138.png 480w, \n               https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2024\/11\/Sustained-testosterone-suppression-rate-graph-SE-960x276.png 782w, \n               https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2024\/11\/Sustained-testosterone-suppression-rate-graph-SE-960x276.png 1366w, \n               https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2024\/11\/Sustained-testosterone-suppression-rate-graph-SE-2048x590.png 2048w, \n               https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2024\/11\/Sustained-testosterone-suppression-rate-graph-SE.png 2500w\"\n       sizes=\"(max-width: 2500px) 100vw, 2500px\">\n<\/div>\n\n\n<p class=\"has-small-print-font-size wp-block-paragraph\">Anpassad fr\u00e5n: Shore, <em>et al.<\/em> 2020<sup>1<\/sup><br>KI, konfidensintervall.<\/p>\n\n\n\n<p class=\"has-small-print-font-size wp-block-paragraph\">**\u00d6verl\u00e4gsenhet var inte specificerad i f\u00f6rv\u00e4g. Analysen utf\u00f6rdes post-hoc.<br><sup>\u2020<\/sup>Kaplan-Meier-uppskattningar inom varje grupp.<\/p>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-custom-blocks-container block-container block-container--full-width block-container--align-top  has-indigo-background-color\">\n<div class=\"wp-block-columns has-1-columns\">\n<div class=\"wp-block-column\">\n<h3 class=\"wp-block-heading has-text-align-center has-white-color has-text-color\" id=\"orgovyx-erbjuder-snabb-utan-flare-ihallande-testosteronsuppression1\">ORGOVYX<sup>\u00ae<\/sup> erbjuder snabb utan &#8220;flare&#8221;, ih\u00e5llande testosteronsuppression<sup>1<\/sup><\/h3>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-custom-blocks-container block-container block-container--full-width block-container--align-top  block-container--spacer-top block-container--spacer-bottom has-none-background-color clinical-data\">\n<div class=\"wp-block-columns has-1-columns\">\n<div class=\"wp-block-column\">\n<h2 class=\"wp-block-heading\" id=\"sekundara-effektmatt\">Sekund\u00e4ra effektm\u00e5tt<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Genomsnittlig testosteronniv\u00e5 bland alla patienter<\/strong><\/p>\n\n\n\n\n<div class=\"responsive-image--container responsive-image--bottom-gap responsive-image--margin-left-right\">\n  <img decoding=\"async\" src=\"https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2024\/10\/Mean_testosterone_level_graph.png\" \n       class=\"responsive-image\" \n       alt=\"\" \n       loading=\"lazy\"       srcset=\"https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2024\/10\/Mean_testosterone_level_graph-480x238.png 480w, \n               https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2024\/10\/Mean_testosterone_level_graph-960x477.png 782w, \n               https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2024\/10\/Mean_testosterone_level_graph-960x477.png 1366w, \n               https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2024\/10\/Mean_testosterone_level_graph-2048x1017.png 2048w, \n               https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2024\/10\/Mean_testosterone_level_graph.png 2500w\"\n       sizes=\"(max-width: 2500px) 100vw, 2500px\">\n<\/div>\n\n\n<p class=\"has-small-print-font-size wp-block-paragraph\">Anpassad fr\u00e5n: Shore, <em>et al<\/em>. 2020<sup>1<\/sup><\/p>\n\n\n\n<div class=\"wp-block-custom-blocks-accordion block-accordion--group\">\n<div class=\"block-accordion--group---menu block-tab--group---menu block-all--group---button\">\n    <div class=\"block-accordion--group---menu----symbol\"><\/div>\n  <button type=\"button\" class=\"block-accordion--group---menu----heading block-tab--group---menu----heading\">Snabb: ORGOVYX<sup>\u00ae<\/sup> hj\u00e4lper dig att uppn\u00e5 snabb testosteronsuppression dag 4<\/button>\n<\/div>\n\n\n<div class=\"wp-block-column block-accordion--group---content  block-all--group---content\">\n<p class=\"wp-block-paragraph\">Kastreringsniv\u00e5er<sup>\u2021<\/sup> av testosteron uppn\u00e5ddes av 56 % av patienterna som tog ORGOVYX<sup>\u00ae<\/sup> vid dag 4 j\u00e4mf\u00f6rt med 0 % av patienterna som tog leuprorelin (p&lt;0,0001). Dessutom uppn\u00e5dde 98,7 % av patienterna som tog ORGOVYX<sup>\u00ae<\/sup> kastratniv\u00e5er<sup>\u2021<\/sup> av testosteron vid dag 15, j\u00e4mf\u00f6rt med 12,1 % av patienterna som tog leuprorelin (p&lt;0,0001).<sup>1<\/sup><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">P\u00e5 dag 15 uppn\u00e5ddes testosteronsuppression till kraftfulla kastratniv\u00e5er p\u00e5 &lt;20 ng\/dl av 78,4 % av patienterna som tog ORGOVYX<sup>\u00ae<\/sup>, j\u00e4mf\u00f6rt med 1,0 % av patienterna som tog leuprorelin (p&lt;0,0001).<sup>1<\/sup><\/p>\n\n\n\n<p class=\"has-small-print-font-size wp-block-paragraph\"><sup>\u2021<\/sup>Niv\u00e5erna av kastrattestosteron definierades som &lt;50 ng\/dl.<\/p>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-custom-blocks-accordion block-accordion--group\">\n<div class=\"block-accordion--group---menu block-tab--group---menu block-all--group---button\">\n    <div class=\"block-accordion--group---menu----symbol\"><\/div>\n  <button type=\"button\" class=\"block-accordion--group---menu----heading block-tab--group---menu----heading\">Ingen &#8220;flare&#8221;: Uppn\u00e5 kontroll av testosteron utan &#8220;flare&#8221; med ORGOVYX<sup>\u00ae<\/sup>, vilket eliminerar risken f\u00f6r ett kliniskt skov och behovet av antiandrogenterapi<\/button>\n<\/div>\n\n\n<div class=\"wp-block-column block-accordion--group---content  block-all--group---content\">\n<p class=\"wp-block-paragraph\">Behandling med ORGOVYX<sup>\u00ae<\/sup> \u00e4r inte f\u00f6rknippad med initial \u00f6kning av testosteron (eller potentiellt symtomatiskt skov), som observeras i samband med initiering av behandling med en LHRH-agonist.<sup>1,3<\/sup><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-custom-blocks-container block-container block-container--full-width block-container--align-top  has-none-background-color\">\n<div class=\"wp-block-columns has-1-columns\">\n<div class=\"wp-block-column\"><\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-custom-blocks-container block-container block-container--full-width block-container--align-middle  has-indigo-background-color\">\n<div class=\"wp-block-columns has-2-columns\">\n<div class=\"wp-block-column\">\n<h3 class=\"wp-block-heading has-white-color has-text-color\" id=\"orgovyx-uppfyllde-alla-andra-viktiga-sekundara-effektmatt12\">ORGOVYX<sup>\u00ae<\/sup> uppfyllde alla andra viktiga sekund\u00e4ra effektm\u00e5tt<sup>1,2<\/sup><\/h3>\n<\/div>\n\n\n\n<div class=\"wp-block-column\">\n\n<div class=\"responsive-image--container\">\n  <img decoding=\"async\" src=\"https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2023\/11\/Image.png\" \n       class=\"responsive-image\" \n       alt=\"\" \n       loading=\"lazy\"       srcset=\"https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2023\/11\/Image-480x193.png 480w, \n               https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2023\/11\/Image.png 782w, \n               https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2023\/11\/Image.png 1366w, \n               https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2023\/11\/Image.png 2048w, \n               https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2023\/11\/Image.png 2500w\"\n       sizes=\"(max-width: 2500px) 100vw, 2500px\">\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-custom-blocks-container block-container block-container--full-width block-container--align-top  block-container--spacer-top block-container--spacer-bottom has-none-background-color clinical-data\">\n<div class=\"wp-block-columns has-1-columns\">\n<div class=\"wp-block-column\">\n<h2 class=\"wp-block-heading\" id=\"andra-sekundara-effektmatt12\"><strong>Andra sekund\u00e4ra effektm\u00e5tt<sup>1,2<\/sup><\/strong><\/h2>\n\n\n\n\n<div class=\"responsive-image--container responsive-image--bottom-gap responsive-image--margin-left-right\">\n  <img decoding=\"async\" src=\"https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2024\/11\/Other-secondary-endpoints-table-SE.png\" \n       class=\"responsive-image\" \n       alt=\"\" \n       loading=\"lazy\"       srcset=\"https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2024\/11\/Other-secondary-endpoints-table-SE-480x237.png 480w, \n               https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2024\/11\/Other-secondary-endpoints-table-SE-960x473.png 782w, \n               https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2024\/11\/Other-secondary-endpoints-table-SE-960x473.png 1366w, \n               https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2024\/11\/Other-secondary-endpoints-table-SE-2048x1010.png 2048w, \n               https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2024\/11\/Other-secondary-endpoints-table-SE.png 2500w\"\n       sizes=\"(max-width: 2500px) 100vw, 2500px\">\n<\/div>\n\n\n<p class=\"has-small-print-font-size wp-block-paragraph\">IE\/L, internationella enheter per liter.<br><sup>\u00b6<\/sup>Ett PSA-svar definierades som en minskning med \u226550 % av PSA-niv\u00e5n.<br><\/p>\n\n\n\n<p class=\"has-small-print-font-size wp-block-paragraph\">Anpassad fr\u00e5n Shore, <em>et al.<\/em> 2020 &amp; ORGOVYX<sup>\u00ae<\/sup> SPC.<sup>1,2<\/sup><\/p>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-custom-blocks-container block-container block-container--full-width block-container--align-top  has-indigo-background-color\">\n<div class=\"wp-block-columns has-1-columns\">\n<div class=\"wp-block-column\">\n<h3 class=\"wp-block-heading has-text-align-center has-white-color has-text-color\" id=\"orgovyx-ger-snabb-testosteronaterhamtning-vid-utsattning-jamfort-med-leuprorelin1\">ORGOVYX<sup>\u00ae<\/sup> ger snabb testosteron\u00e5terh\u00e4mtning vid uts\u00e4ttning j\u00e4mf\u00f6rt med leuprorelin<sup>1<\/sup><\/h3>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-custom-blocks-container block-container block-container--full-width block-container--align-top  block-container--spacer-top block-container--spacer-bottom has-none-background-color clinical-data\">\n<div class=\"wp-block-columns has-1-columns\">\n<div class=\"wp-block-column\">\n<h2 class=\"wp-block-heading\" id=\"explorativa-effektmatt\"><strong>Explorativa effektm\u00e5tt<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Genomsnittliga testosteronniv\u00e5er 90 dagar efter avslutad behandling i subgruppen som \u00e5terh\u00e4mtade testosteronniv\u00e5er (n=184) var 288,4 ng\/dl i ORGOVYX-gruppen<sup>\u00ae<\/sup> och 58,6 ng\/dl i leuprorelingruppen.<sup>1<\/sup><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Andelen patienter med testosteron\u00e5terh\u00e4mtning till minst 280 ng\/dl (den nedre gr\u00e4nsen f\u00f6r det normala intervallet) efter 90 dagar var <strong>54 %<\/strong> i ORGOVYX-gruppen<sup>\u00ae<\/sup> och <strong>3 %<\/strong> i leuprorelingruppen (nominellt p=0,002).<sup>1<\/sup><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Genomsnittlig testosteronniv\u00e5 i subgruppen som f\u00f6ljdes f\u00f6r testosteron\u00e5terh\u00e4mtning<\/strong><\/p>\n\n\n\n\n<div class=\"responsive-image--container responsive-image--bottom-gap responsive-image--margin-left-right\">\n  <img decoding=\"async\" src=\"https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2024\/10\/Mean_testosterone_level_graph_2.png\" \n       class=\"responsive-image\" \n       alt=\"\" \n       loading=\"lazy\"       srcset=\"https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2024\/10\/Mean_testosterone_level_graph_2-480x251.png 480w, \n               https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2024\/10\/Mean_testosterone_level_graph_2-960x502.png 782w, \n               https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2024\/10\/Mean_testosterone_level_graph_2-960x502.png 1366w, \n               https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2024\/10\/Mean_testosterone_level_graph_2-2048x1070.png 2048w, \n               https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2024\/10\/Mean_testosterone_level_graph_2.png 2500w\"\n       sizes=\"(max-width: 2500px) 100vw, 2500px\">\n<\/div>\n\n\n<p class=\"has-small-print-font-size wp-block-paragraph\">Anpassad fr\u00e5n: Shore, <em>et al.<\/em> 2020<sup>1<\/sup><\/p>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-custom-blocks-container block-container block-container--full-width block-container--align-top  has-indigo-background-color\">\n<div class=\"wp-block-columns has-1-columns\">\n<div class=\"wp-block-column\">\n<h3 class=\"wp-block-heading has-text-align-center has-white-color has-text-color\" id=\"den-totala-incidensen-av-biverkningar-var-jamforbar-mellan-orgovyx-och-leuprorelin\">Den totala incidensen av biverkningar var j\u00e4mf\u00f6rbar mellan ORGOVYX<sup>\u00ae<\/sup> och leuprorelin<\/h3>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-custom-blocks-container block-container block-container--full-width block-container--align-top  block-container--spacer-top block-container--spacer-bottom has-none-background-color clinical-data\">\n<div class=\"wp-block-columns has-1-columns\">\n<div class=\"wp-block-column\">\n<h2 class=\"wp-block-heading\" id=\"orgovyx-biverkningar\"><strong>ORGOVYX<sup>\u00ae<\/sup> Biverkningar<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">De vanligaste observerade biverkningarna under behandling med ORGOVYX<sup>\u00ae<\/sup> (\u226510 % incidens) inkluderar:<sup>3<\/sup><\/p>\n\n\n\n\n<div class=\"responsive-image--container responsive-image--bottom-gap responsive-image--margin-left-right\">\n  <img decoding=\"async\" src=\"https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2025\/02\/Adverse-events-icons-desktop-SE.png\" \n       class=\"responsive-image\" \n       alt=\"\" \n       loading=\"lazy\"       srcset=\"https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2025\/02\/Adverse-events-icons-mobile-SE-480x432.png 480w, \n               https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2025\/02\/Adverse-events-icons-mobile-SE-960x863.png 782w, \n               https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2025\/02\/Adverse-events-icons-mobile-SE-960x863.png 1366w, \n               https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2025\/02\/Adverse-events-icons-desktop-SE-2048x418.png 2048w, \n               https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2025\/02\/Adverse-events-icons-desktop-SE.png 2500w\"\n       sizes=\"(max-width: 2500px) 100vw, 2500px\">\n<\/div>\n\n\n<p class=\"wp-block-paragraph\"><strong>Ytterligare s\u00e4kerhetsinformation<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Milda, \u00f6verg\u00e5ende \u00f6kningar av alaninaminotransferas och aspartataminotransferas har observerats men \u00e5tf\u00f6ljdes inte av n\u00e5gon \u00f6kning av bilirubin och var inte heller f\u00f6rknippade med kliniska symtom.<sup>3<\/sup><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Hemoglobinkoncentrationen minskade med 10 g\/l under upp till 1 \u00e5rs behandling med ORGOVYX.<sup>\u00ae<\/sup> En markant s\u00e4nkning av hemoglobin (\u2264105 g\/l) observerades hos 4,8 % av patienterna efter behandling med ORGOVYX,<sup>\u00ae<\/sup> med s\u00e4nkningar till grad 3\/4 hos 0,5 % av patienterna.<sup>3<\/sup><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Se <a href=\"https:\/\/www.fass.se\/LIF\/product?userType=0&amp;nplId=20210308000013&amp;docType=6\">produktresum\u00e9n<\/a> f\u00f6r en fullst\u00e4ndig lista \u00f6ver biverkningar.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"allvarliga-hjartbiverkningar-som-utvarderades-under-hero-studien\"><strong>Allvarliga hj\u00e4rtbiverkningar som utv\u00e4rderades under HERO-studien<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">I en f\u00f6rspecificerad s\u00e4kerhetsanalys definierades allvarliga kardiovaskul\u00e4ra h\u00e4ndelser (MACE) som icke-fatal hj\u00e4rtinfarkt, icke-fatal stroke och d\u00f6d oavsett orsak.<sup>1<\/sup><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Efter 48 veckors behandling var incidensen av MACE 2,9 % (exakt 95 % KI, 1,7 \u2013 4,5) i ORGOVYX-gruppen<sup>\u00ae<\/sup> och 6,2 % (exakt 95 % KI, 3,8 \u2013 9,5) i leuprorelingruppen.<sup>1<\/sup><\/p>\n\n\n\n\n<div class=\"responsive-image--container responsive-image--bottom-gap responsive-image--margin-left-right\">\n  <img decoding=\"async\" src=\"https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2024\/11\/Hero-study-table-SE.png\" \n       class=\"responsive-image\" \n       alt=\"\" \n       loading=\"lazy\"       srcset=\"https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2024\/11\/Hero-study-table-SE-480x97.png 480w, \n               https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2024\/11\/Hero-study-table-SE-960x194.png 782w, \n               https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2024\/11\/Hero-study-table-SE-960x194.png 1366w, \n               https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2024\/11\/Hero-study-table-SE-2048x414.png 2048w, \n               https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2024\/11\/Hero-study-table-SE.png 2500w\"\n       sizes=\"(max-width: 2500px) 100vw, 2500px\">\n<\/div>\n\n\n<p class=\"has-small-print-font-size wp-block-paragraph\">\u00a7Analys utf\u00f6rd post-hoc.<\/p>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-custom-blocks-container block-container block-container--full-width block-container--align-top  block-container--spacer-bottom has-pine-background-color\">\n<div class=\"wp-block-columns has-1-columns\">\n<div class=\"wp-block-column\">\n<h3 class=\"wp-block-heading has-white-color has-text-color\" id=\"upptack-hur-orgovyx-kan-hjalpa-till-att-tillgodose-behoven-hos-patienter-med-avancerad-hormonkanslig-prostatacancer\">Uppt\u00e4ck hur ORGOVYX<sup>\u00ae<\/sup> kan hj\u00e4lpa till att tillgodose behoven hos patienter med avancerad hormonk\u00e4nslig prostatacancer<\/h3>\n\n\n\n<div class=\"button-container button-container--left-align\">\n              <a class=\"custom-button custom-button--primary\" href=\"https:\/\/accord-prostata.se\/hcp\/medicinska-behov\/\" target=\"_self\">\n                                                                        <span>Ta reda p\u00e5 mer<\/span>\n                                  <\/a>\n          <\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-custom-blocks-container block-container block-container--full-width block-container--align-top  block-container--spacer-top has-ocean-background-color\">\n<div class=\"wp-block-columns has-2-columns\">\n<div class=\"wp-block-column references\">\n<h5 class=\"wp-block-heading has-white-color has-text-color\" id=\"referenser\"><strong>Referenser<\/strong><\/h5>\n\n\n\n<ol class=\"wp-block-list has-white-color has-text-color\">\n<li>Shore ND, <em>et al. N Engl J Med<\/em>. 2020;382(4):2187\u20132196.<\/li>\n\n\n\n<li>Shore ND, <em>et al. N Engl J Med<\/em>. 2020;382(4):2187\u20132196. Supplementary Appendix.<\/li>\n\n\n\n<li>ORGOVYX<sup>\u00ae<\/sup> Produktresum\u00e9.<\/li>\n<\/ol>\n<\/div>\n\n\n\n<div class=\"wp-block-column\">\n<h5 class=\"wp-block-heading has-white-color has-text-color\" id=\"akronymer\"><strong>Akronymer<\/strong><\/h5>\n\n\n\n<p class=\"has-white-color has-text-color wp-block-paragraph\"><strong>ADT<\/strong>, androgen deprivationsterapi.<br><strong>LHRH<\/strong>, luteiniserande hormonfris\u00e4ttande hormon.<br><strong>MACE<\/strong>, major adverse cardiovascular events.<br><strong>PSA<\/strong>, prostataspecifikt antigen.<\/p>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-custom-blocks-container block-container block-container--full-width block-container--align-top  has-ocean-background-color\">\n<div class=\"wp-block-columns has-1-columns\">\n<div class=\"wp-block-column\">\n<div class=\"adverse-event-reporting--container\">\n  <div class=\"adverse-event-reporting--container---box\">\n    <p><span style=\"color:black\">\u25bc<\/span> Detta l\u00e4kemedel \u00e4r f\u00f6rem\u00e5l f\u00f6r ut\u00f6kad \u00f6vervakning. F\u00f6r fullst\u00e4ndig SPC Orgovyx klicka <a href=\"https:\/\/www.fass.se\/LIF\/product?userType=0&amp;nplId=20210308000013&amp;docType=6\">h\u00e4r<\/a>.<\/p>\n  <\/div>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-custom-blocks-container block-container block-container--full-width block-container--align-top  block-container--spacer-bottom has-ocean-background-color\">\n<div class=\"wp-block-columns has-1-columns\">\n<div class=\"wp-block-column\">\n<p class=\"has-text-align-right has-white-color has-text-color has-small-print-font-size wp-block-paragraph\">SE-Onc-Org-01428 | Senast uppdaterad november 2024<\/p>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-1196","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- 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