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“Combattere la fibrillazione atriale nel mondo reale”. Terminato in Europa l’arruolamento di ETNA-AF Europe, il registro real life europeo su Edoxaban

Contributo importante dell’Italia, con 3.353 pazienti arruolati in 192 centri, su un totale di 13.333 pazienti provenienti da 1.450 centri distribuiti in 12 Paesi con un follow up fino a 4 anni

Roma, 12 febbraio 2018 - Con la chiusura dell'arruolamento in Italia, è terminato ieri in Europa l'arruolamento del registro di ETNA-AF Europe (Edoxaban Treatment in routiNe clinical prActice - Atrial Fibrillation), uno dei due studi sviluppati da Daiichi Sankyo per raccogliere ulteriori dati sulla sicurezza del mondo reale e la pratica clinica del trattamento con LIXIANA® (edoxaban). Questo inibitore orale, selettivo del fattore Xa in monosomministrazione giornaliera, viene utilizzato per la prevenzione dell'ictus e dell'embolismo sistemico in pazienti adulti con FANV che presentano uno o più fattori di rischio, quali insufficienza cardiaca congestizia, ipertensione, età uguale o superiore a 75 anni, diabete mellito e precedenti di ictus o attacchi ischemici transitori. Inoltre LIXIANA® può essere utilizzato nei pazienti adulti per il trattamento e la prevenzione delle recidive di trombosi venosa profonda ed embolia polmonare, che è oggetto di studio del secondo registro ETNA-VTE Europe. Su un totale di 13.333 pazienti europei arruolati in 1.450 centri distribuiti in 12 Paesi, l'Italia darà un contributo decisivo, con 3.353 pazienti arruolati in 192 centri, seconda solo alla Germania (5290 pazienti in 366 centri).

Il registro ETNA-AF Europe è condotto su pazienti che già ricevono il trattamento LIXIANA in monosomministrazione giornaliera per la prevenzione dell'ictus nella fibrillazione atriale non valvolare, e verranno seguiti con un follow up fino a 4 anni. Oltre ai dati su efficacia e sicurezza del farmaco, il registro raccoglierà feedback basati su altri importanti parametri tra cui l'aderenza dei pazienti al trattamento, al fine di creare una guida completa al miglior uso di questa molecola.

L'approvazione dell'anticoagulante orale diretto di Daiichi Sankyo è stata frutto dei risultati di ENGAGE AF-TIMI 48, un trial già disegnato con tutti i criteri necessari a riflettere la pratica clinica quotidiana e a combattere la fibrillazione atriale nel mondo reale. L'obiettivo primario dello studio ETNA-AF-Europe è ora quello di raccogliere dati real life sulla sicurezza di edoxaban riguardo gli eventi emorragici, inclusi emorragie intracraniche, eventi avversi correlati all'uso del farmaco, e la mortalità per qualunque causa . Saranno, inoltre, effettuate analisi di sottogruppi in popolazioni specifiche di pazienti, come soggetti che presentano compromissione epatica o renale. Gli obiettivi secondari dello studio, infine includono la valutazione degli effetti di LIXIANA® su eventi clinici rilevanti quali ictus, eventi embolici sistemici, eventi cardiovascolari maggiori e ospedalizzazione a seguito di problemi cardiovascolari.

 

Contatti

Dr.ssa Elisa Porchetti
Daiichi Sankyo Italia
Communication & Product PR Manager
Phone +39 06 85255202
elisa.porchetti@daiichi-sankyo.it