L\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA), via son Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP), a publi\u00e9 le 5 octobre 2026 un document de cadrage pr\u00e9parant la r\u00e9vision de la ligne directrice sur l\u2019investigation clinique des m\u00e9dicaments utilis\u00e9s dans le traitement de l\u2019hypertension art\u00e9rielle (r\u00e9f\u00e9rence EMA\/CHMP\/29947\/2013\/Rev.4). Ce futur texte remplacera la ligne directrice actuellement en vigueur. Le projet a \u00e9t\u00e9 approuv\u00e9 par le groupe de travail cardiovasculaire (Cardiovascular Working Party) le 24 septembre 2026, puis adopt\u00e9 par le CHMP pour \u00eatre soumis \u00e0 consultation publique. La consultation est ouverte du 19 octobre 2026 au 31 janvier 2027, les contributions devant \u00eatre transmises via un formulaire EUSurvey.<\/p>\n
Le document rappelle que l\u2019hypertension art\u00e9rielle est le principal facteur de risque modifiable de morbidit\u00e9 et de mortalit\u00e9 globales et cardiovasculaires. Il souligne la complexit\u00e9 de la physiopathologie de l\u2019hypertension, impliquant facteurs environnementaux et comportementaux, facteurs g\u00e9n\u00e9tiques, r\u00e9seaux hormonaux et plusieurs syst\u00e8mes d\u2019organes (r\u00e9nal, cardiovasculaire, syst\u00e8me nerveux central). Il est indiqu\u00e9 que la majorit\u00e9 des patients pr\u00e9sentent une hypertension essentielle, environ 10 % ayant une hypertension secondaire d\u2019\u00e9tiologie identifiable. En l\u2019absence de traitement suffisant, l\u2019hypertension art\u00e9rielle conduit \u00e0 des atteintes d\u2019organes subcliniques (c\u0153ur, cerveau, reins, yeux, art\u00e8res de gros et moyen calibre, microcirculation), \u00e9voluant vers des maladies cardiovasculaires, c\u00e9r\u00e9brovasculaires et r\u00e9nales.<\/p>\n
Le texte se r\u00e9f\u00e8re aux lignes directrices 2024 de la Soci\u00e9t\u00e9 europ\u00e9enne de cardiologie (ESC), qui maintiennent la d\u00e9finition de l\u2019hypertension comme une pression art\u00e9rielle de consultation \u2265 140 mmHg pour la systolique ou \u2265 90 mmHg pour la diastolique, mais introduisent une nouvelle cat\u00e9gorie de pression art\u00e9rielle dite \u00ab \u00e9lev\u00e9e \u00bb. Les patients pr\u00e9sentant des valeurs de pression art\u00e9rielle sup\u00e9rieures \u00e0 130\/80 mmHg doivent \u00eatre trait\u00e9s par m\u00e9dicaments antihypertenseurs s\u2019ils pr\u00e9sentent un risque cardiovasculaire accru. Il est indiqu\u00e9 qu\u2019une r\u00e9duction de la pression art\u00e9rielle systolique de 10 mmHg est associ\u00e9e \u00e0 une diminution estim\u00e9e d\u2019environ 20 % du risque cardiovasculaire. Le texte mentionne \u00e9galement l\u2019importance de mesures non m\u00e9dicamenteuses, parmi lesquelles la r\u00e9duction des apports en sel, l\u2019augmentation des apports en potassium et l\u2019accroissement de l\u2019activit\u00e9 physique.<\/p>\n
Les principaux acteurs impliqu\u00e9s sont l\u2019EMA (agence de l\u2019Union europ\u00e9enne charg\u00e9e de l\u2019\u00e9valuation scientifique des m\u00e9dicaments), le CHMP (en charge des m\u00e9dicaments \u00e0 usage humain), ainsi que le groupe de travail cardiovasculaire, qui a \u00e9labor\u00e9 le concept de r\u00e9vision. La Soci\u00e9t\u00e9 europ\u00e9enne de cardiologie est cit\u00e9e comme source des d\u00e9finitions et cat\u00e9gories de pression art\u00e9rielle utilis\u00e9es. Les autorit\u00e9s nationales et autres parties prenantes sont invit\u00e9es \u00e0 participer \u00e0 la consultation, ce qui peut \u00eatre pertinent pour les administrations fran\u00e7aises en mati\u00e8re de suivi des normes europ\u00e9ennes encadrant le d\u00e9veloppement clinique des m\u00e9dicaments antihypertenseurs et, indirectement, des strat\u00e9gies de pr\u00e9vention et de r\u00e9duction du risque cardiovasculaire. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" L\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA), via son Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP), a publi\u00e9 le 5 octobre 2026 un document de cadrage pr\u00e9parant la r\u00e9vision de la ligne […]<\/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-21412","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\/21412","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=21412"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21412\/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=21412"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21412"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21412"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}