Giapreza est un m\u00e9dicament indiqu\u00e9 chez l\u2019adulte en \u00e9tat de choc avec hypotension art\u00e9rielle s\u00e9v\u00e8re, lorsque les autres traitements visant \u00e0 augmenter la pression art\u00e9rielle se sont r\u00e9v\u00e9l\u00e9s insuffisants. Il contient de l\u2019angiotensine II, substance active identique \u00e0 une hormone endog\u00e8ne qui augmente la pression art\u00e9rielle par vasoconstriction et par lib\u00e9ration d\u2019aldost\u00e9rone, ce qui accro\u00eet le volume sanguin circulant. Le traitement est r\u00e9serv\u00e9 \u00e0 l\u2019h\u00f4pital, sous la responsabilit\u00e9 d\u2019un m\u00e9decin exp\u00e9riment\u00e9 dans la prise en charge du choc, et administr\u00e9 en perfusion intraveineuse continue, avec un ajustement posologique en fonction du poids et de la pression art\u00e9rielle du patient.<\/p>\n
L\u2019efficacit\u00e9 de Giapreza a \u00e9t\u00e9 d\u00e9montr\u00e9e dans une \u00e9tude principale portant sur 344 patients en \u00e9tat de choc. Apr\u00e8s 3 heures de traitement, 70 % des patients recevant Giapreza en plus du traitement standard ont atteint une pression art\u00e9rielle moyenne sup\u00e9rieure \u00e0 75 mmHg ou une augmentation d\u2019au moins 10 mmHg, contre 23 % des patients recevant un placebo en plus du traitement standard. Cette augmentation de la pression art\u00e9rielle est consid\u00e9r\u00e9e comme de nature \u00e0 pr\u00e9venir des l\u00e9sions d\u2019organes et \u00e0 r\u00e9duire la mortalit\u00e9 li\u00e9e au choc, m\u00eame si ces effets cliniques ultimes restent \u00e0 documenter davantage.<\/p>\n
Les effets ind\u00e9sirables les plus fr\u00e9quents, touchant plus d\u2019un patient sur dix, sont des \u00e9v\u00e9nements thromboemboliques (complications li\u00e9es \u00e0 des caillots sanguins) et des \u00e9pisodes d\u2019hypertension transitoire. Selon l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA), le profil de s\u00e9curit\u00e9 de Giapreza est comparable \u00e0 celui des traitements standard et les effets ind\u00e9sirables sont jug\u00e9s g\u00e9rables. Sur cette base, l\u2019EMA a conclu que le rapport b\u00e9n\u00e9fice\/risque de Giapreza est favorable et a accord\u00e9 une autorisation de mise sur le march\u00e9 valable dans l\u2019ensemble de l\u2019Union europ\u00e9enne le 23 ao\u00fbt 2019.<\/p>\n
L\u2019EMA impose un suivi renforc\u00e9 : le titulaire de l\u2019autorisation doit r\u00e9aliser une \u00e9tude compl\u00e9mentaire afin d\u2019\u00e9valuer plus pr\u00e9cis\u00e9ment l\u2019efficacit\u00e9 et la s\u00e9curit\u00e9 de Giapreza, notamment son impact sur la pr\u00e9vention des l\u00e9sions d\u2019organes et la survie des patients. Des recommandations et pr\u00e9cautions d\u2019utilisation destin\u00e9es aux professionnels de sant\u00e9 et aux patients figurent dans le r\u00e9sum\u00e9 des caract\u00e9ristiques du produit et la notice. Les donn\u00e9es de pharmacovigilance sont r\u00e9guli\u00e8rement actualis\u00e9es, les effets ind\u00e9sirables \u00e9tant analys\u00e9s de fa\u00e7on continue afin de prendre, le cas \u00e9ch\u00e9ant, les mesures n\u00e9cessaires de protection des patients. Les derni\u00e8res modifications de l\u2019information produit rel\u00e8vent d\u2019une proc\u00e9dure r\u00e9f\u00e9renc\u00e9e T\/003119 en septembre 2024. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Giapreza est un m\u00e9dicament indiqu\u00e9 chez l\u2019adulte en \u00e9tat de choc avec hypotension art\u00e9rielle s\u00e9v\u00e8re, lorsque les autres traitements visant \u00e0 augmenter la pression art\u00e9rielle se sont r\u00e9v\u00e9l\u00e9s insuffisants. Il […]<\/p>\n","protected":false},"author":1,"featured_media":17698,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[7],"tags":[257,227,226],"class_list":["post-20451","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicaments-et-produits-de-sante","tag-ema","tag-ia","tag-sources-etrangeres"],"_links":{"self":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/20451","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=20451"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/20451\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/media\/17698"}],"wp:attachment":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=20451"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=20451"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=20451"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}