{"id":5390,"date":"2014-11-24T15:23:08","date_gmt":"2014-11-24T20:23:08","guid":{"rendered":"https:\/\/themedicalxchange.com\/2014\/11\/24\/congres-scientifique-de-lamerican-heart-associat-4\/"},"modified":"2021-08-24T16:40:16","modified_gmt":"2021-08-24T20:40:16","slug":"congres-scientifique-de-lamerican-heart-associat-4","status":"publish","type":"post","link":"https:\/\/themedicalxchange.com\/fr\/2014\/11\/24\/congres-scientifique-de-lamerican-heart-associat-4\/","title":{"rendered":"Progr\u00e8s de la mise au point d\u2019un agent neutralisant les effets des nouveaux anticoagulants \u00e0 prise orale"},"content":{"rendered":"<p>Les nouveaux anticoagulants \u00e0 prise orale sont destin\u00e9s \u00e0 remplacer \u00e9ventuellement la warfarine utilis\u00e9e pour r\u00e9duire le risque d\u2019AVC et d\u2019embolie g\u00e9n\u00e9rale chez les patients atteints de fibrillation auriculaire non valvulaire et dans le traitement de la thromboembolie veineuse ou art\u00e9rielle. Contrairement \u00e0 la warfarine, ces nouveaux anticoagulants n\u2019exigent pas une surveillance syst\u00e9matique du patient au moyen d\u2019analyses sanguines. Ils peuvent \u00eatre administr\u00e9s \u00e0 doses fixes et ne provoquent pas d\u2019interactions majeures avec d\u2019autres m\u00e9dicaments ou des aliments. En plus de leur commodit\u00e9, leur efficacit\u00e9 est \u00e9quivalente, voire plus grande que celle de la warfarine et leurs taux d\u2019h\u00e9morragie sont comparables et m\u00eame plus bas. Cela dit, leur emploi est limit\u00e9 en raison de l\u2019absence d\u2019antidote permettant de neutraliser leur effet anticoagulant chez les patients aux prises avec une h\u00e9morragie grave ou devant subir une intervention chirurgicale d\u2019urgence.<\/p>\n<h2>\u00c9tude ANNEXA-A<\/h2>\n<p>Le D<sup>r<\/sup>\u00a0Mark Crowther, de l\u2019universit\u00e9 McMaster, de Hamilton, en Ontario, a pr\u00e9sent\u00e9 des donn\u00e9es prometteuses issues d\u2019un essai clinique portant sur un agent neutralisant les effets de l\u2019apixaban, un nouvel inhibiteur du facteur Xa (fXa) pour administration par voie orale. \u00ab\u00a0L\u2019andexanet alfa (andexanet) est un analogue du facteur Xa humain, modifi\u00e9 et obtenu par recombinaison, qui agit comme leurre pour contrer les anti-Xa circulants, d\u2019o\u00f9 son effet neutralisant sur l\u2019action anticoagulante des inhibiteurs du fXa\u00a0\u00bb, a expliqu\u00e9 le D<sup>r<\/sup>\u00a0Crowther. Des \u00e9tudes de Phase\u00a0II de validation de principe ont d\u00e9montr\u00e9 que l\u2019andexanet neutralise nettement et rapidement l\u2019activit\u00e9 anticoagulante de l\u2019apixaban \u00e0 5\u00a0mg administr\u00e9 par voie orale. L\u2019\u00e9tude ANNEXA-A constitue l\u2019\u00e9tape suivante de la mise au point de cet agent dirig\u00e9 contre l\u2019apixaban. Lors de la premi\u00e8re partie de cette \u00e9tude, 33\u00a0sujets (\u00e2ge moyen\u00a0: 59\u00a0ans) ont pris de l\u2019apixaban par voie orale \u00e0 raison de 5\u00a0mg 2\u00a0fois par jour pendant 4\u00a0jours. Ils ont ensuite \u00e9t\u00e9 r\u00e9partis au hasard selon un rapport de 3 pour 1 (3:1) de mani\u00e8re \u00e0 recevoir par perfusion i.v. un seul bolus de 400\u00a0mg d\u2019andexanet ou un placebo administr\u00e9s le 4<sup>e<\/sup>\u00a0jour, 3\u00a0heures apr\u00e8s la derni\u00e8re dose d\u2019apixaban (C<sub>max<\/sub> approximative de l\u2019apixaban). \u00ab\u00a0Juste avant la perfusion de l\u2019andexanet, la coagulation des patients \u00e9tait tr\u00e8s nettement inhib\u00e9e et imm\u00e9diatement apr\u00e8s, elle \u00e9tait presque revenue \u00e0 la normale, a affirm\u00e9 le D<sup>r<\/sup>\u00a0Crowther. Nous savons que la demi-vie de ce produit est courte, de sorte qu\u2019une heure plus tard, l\u2019effet anticoagulant commen\u00e7ait \u00e0 se manifester de nouveau et qu\u2019au bout de 3\u00a0heures, l\u2019effet de l\u2019anti-fXa \u00e9tait de la m\u00eame ampleur que si les patients n\u2019avaient pas re\u00e7u l\u2019agent neutralisant.\u00a0\u00bb L\u2019inhibition de la coagulation a \u00e9t\u00e9 neutralis\u00e9e dans une proportion d\u2019au moins 90\u00a0% chez tous les patients ayant re\u00e7u l\u2019andexanet, la variation de l\u2019activit\u00e9 anti-fXa s\u2019\u00e9tant chiffr\u00e9e \u00e0 94\u00a0% entre les valeurs enregistr\u00e9es au d\u00e9but de l\u2019\u00e9tude et le nadir, le param\u00e8tre d\u2019\u00e9valuation principal de l\u2019\u00e9tude (<em>p\u00a0<\/em>&lt;\u00a00,0001) <a href=\"javascript:void(0)\" class=\"show-image\" data-index=\"0\">(Figure\u00a01)<\/a>. Les r\u00e9sultats obtenus pour les param\u00e8tres d\u2019\u00e9valuation secondaires ont \u00e9galement \u00e9t\u00e9 concluants. En faisaient partie la variation entre les valeurs de r\u00e9f\u00e9rence obtenues au d\u00e9but de l\u2019\u00e9tude et le nadir enregistr\u00e9s pour la concentration d\u2019apixaban circulant sous forme libre, et entre les valeurs de r\u00e9f\u00e9rence obtenues au d\u00e9but de l\u2019\u00e9tude et le point culminant pour la production de thrombine (<em>p\u00a0<\/em>&lt;\u00a00,0001 pour les deux), ainsi que le retour de la production de thrombine \u00e0 la valeur mesur\u00e9e au d\u00e9but de l\u2019\u00e9tude chez 100\u00a0% des sujets trait\u00e9s par l\u2019andexanet (la production de thrombine n\u2019a subi aucun effet rebond une fois l\u2019andexanet et\/ou l\u2019apixaban \u00e9limin\u00e9s de l\u2019organisme). La prolongation du temps de coagulation activ\u00e9e par l\u2019apixaban (ACT) a \u00e9t\u00e9 corrig\u00e9e en fonction des valeurs de r\u00e9f\u00e9rences obtenues au d\u00e9but de l\u2019\u00e9tude. Tous les sujets ont particip\u00e9 \u00e0 l\u2019\u00e9tude jusqu\u2019\u00e0 la fin. Comme ce fut le cas pendant les \u00e9tudes r\u00e9alis\u00e9es ant\u00e9rieurement, aucun effet ind\u00e9sirable grave n\u2019a \u00e9t\u00e9 signal\u00e9. \u00ab\u00a0Aucun incident de nature thrombotique n\u2019a \u00e9t\u00e9 observ\u00e9 pendant cette \u00e9tude ni dans aucune des autres qui l\u2019ont pr\u00e9c\u00e9d\u00e9e\u00a0\u00bb, a confirm\u00e9 le D<sup>r\u00a0<\/sup>Crowther. Aucun anticorps dirig\u00e9 contre les facteurs\u00a0X ou Xa n\u2019a \u00e9t\u00e9 d\u00e9cel\u00e9. La deuxi\u00e8me partie de l\u2019\u00e9tude ANNEXA-A portera sur l\u2019administration de 400\u00a0mg d\u2019andexanet sous forme de bolus, suivie de la perfusion de ce m\u00e9dicament ou d\u2019un placebo pendant 2\u00a0heures \u00e0 raison de 4\u00a0mg\/min. Elle vise \u00e0 d\u00e9montrer qu\u2019il est possible de prolonger l\u2019effet neutralisant de l\u2019andexanet apr\u00e8s son administration en bolus au moyen d\u2019une perfusion en continu de cet agent. Le D<sup>r\u00a0<\/sup>Crowther a \u00e9galement annonc\u00e9 qu\u2019une \u00e9tude de confirmation sera r\u00e9alis\u00e9e \u00e0 partir de la fin de 2014 ou au d\u00e9but de 2015 chez des patients en h\u00e9morragie. Donnant son avis sur cette \u00e9tude dans le cadre du congr\u00e8s de l\u2019AHA, la D<sup>re\u00a0<\/sup>Linda Shore-Lesserson, de l\u2019\u00c9cole de m\u00e9decine Hofstra North Shore-LIJ, de Hempstead, New York, a insist\u00e9 sur l\u2019importance de pouvoir disposer de tels agents neutralisants pendant les interventions chirurgicales. \u00ab\u00a0Ces agents sont l\u00e0 pour rester \u2013 nous ne reviendrons pas en arri\u00e8re\u00a0\u00bb, a-t-elle d\u00e9clar\u00e9.<\/p>\n","protected":false},"excerpt":{"rendered":"<p><b> Chicago <\/b> \u2013 Des chercheurs ont rapport\u00e9 qu\u2019un agent neutralisant dirig\u00e9 contre un nouvel anticoagulant \u00e0 prise orale aurait pratiquement normalis\u00e9 tous les param\u00e8tres de la coagulation au cours d\u2019une \u00e9tude men\u00e9e chez des adultes d\u2019\u00e2ge m\u00fbr en sant\u00e9, et ce sans aucun signe de la formation d\u2019anticorps, ce qui confirmerait les r\u00e9sultats d\u2019\u00e9tudes de validation de principe r\u00e9alis\u00e9es ant\u00e9rieurement. Ces donn\u00e9es de Phase III rendent compte de la neutralisation rapide de l\u2019activit\u00e9 anticoagulante de l\u2019apixaban par l\u2019andexanet alpha.<\/p>\n","protected":false},"author":1,"featured_media":12444,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"tags":[409,425,301,523],"class_list":["post-5390","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","tag-2014-fr","tag-aha-fr","tag-cardiologie","tag-extract-fr","area_tag-cardiologie"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Progr\u00e8s de la mise au point d\u2019un agent neutralisant les effets des nouveaux anticoagulants \u00e0 prise orale - The Medical Xchange<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/themedicalxchange.com\/fr\/2014\/11\/24\/congres-scientifique-de-lamerican-heart-associat-4\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Progr\u00e8s de la mise au point d\u2019un agent neutralisant les effets des nouveaux anticoagulants \u00e0 prise orale - The Medical Xchange\" \/>\n<meta property=\"og:description\" content=\"Chicago \u2013 Des chercheurs ont rapport\u00e9 qu\u2019un agent neutralisant dirig\u00e9 contre un nouvel anticoagulant \u00e0 prise orale aurait pratiquement normalis\u00e9 tous les param\u00e8tres de la coagulation au cours d\u2019une \u00e9tude men\u00e9e chez des adultes d\u2019\u00e2ge m\u00fbr en sant\u00e9, et ce sans aucun signe de la formation d\u2019anticorps, ce qui confirmerait les r\u00e9sultats d\u2019\u00e9tudes de validation de principe r\u00e9alis\u00e9es ant\u00e9rieurement. 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