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Ictus e fibrillazione atriale non valvolare, Edoxaban arriva anche in Europa con l’approvazione di Lixiana® in Svizzera

Con il nome commerciale di Lixiana®, la Svizzera è il primo paese europeo ad approvare l’anticoagulante orale edoxaban per la prevenzione dell’ictus e dell’embolismo sistemico in pazienti adulti affetti da fibrillazione atriale non valvolare, per la prevenzione del tromboembolismo venoso e infine per il trattamento del tromboembolismo venoso a seguito di un precedente trattamento di 5 giorni a base di eparina frazionata o non frazionata.

Roma 22 aprile 2015 - Dopo Giappone e Stati Uniti, arriva anche in Europa edoxaban, il nuovo anticoagulante orale in monosomministrazione giornaliera che inibisce in modo specifico, reversibile e diretto il fattore Xa, un importante fattore della cascata della coagulazione. L'autorità regolatoria svizzera Swissmedic, ha infatti approvato l'uso di Lixiana® per la prevenzione dell'ictus e dell'embolismo sistemico (ES) in pazienti adulti con fibrillazione atriale non valvolare (FANV). L'autorizzazione si estende inoltre al trattamento del tromboembolismo venoso (TEV), inclusi la trombosi venosa profonda (TVP) e l'embolia polmonare (EP) in seguito a precedente trattamento a base di eparina frazionata o non frazionata per 5 giorni, così come alla prevenzione delle recidive di TEV. La dose raccomandata di Lixiana è di 60 mg in monosomministrazione giornaliera, con dose ridotta a 30 mg in pazienti con rischio moderato o severo di insufficienza renale (clearance della creatinina 30-50 mL/min), peso corporeo uguale o inferiore a 60 kg, o uso concomitante di inibitori della glicoproteina P (ciclosporina, dronedarone, eritromicina, ketoconazolo, chinidina o verapamil).

La fibrillazione atriale è la più comune forma di aritmia cardiaca, ed è associata a una significativa morbilità e mortalità. Più di 6 milioni sono le diagnosi in Europa e questa cifra è destinata almeno a raddoppiare nei prossimi 50 anni. 1 ictus su 5 è causato da fibrillazione atriale, e solo in Svizzera sono 80.000 le persone che ne soffrono ma la prevalenza potrebbe aumentare di un terzo se si considerassero i pazienti asintomatici che restano non diagnosticati.

Il tromboembolismo venoso è un serio problema di salute in Europa, con più di un milione di eventi o decessi ogni anno in Francia, Germania, Italia, Spagna, Svezia e Regno Unito.

L'approvazione della Swissmedic è basata sui risultati pubblicati sul New England Journal of Medicine degli studi di fase III ENGAGE AF-TIMI 48 e Hokusai-VTE, i più ampi e lunghi trial singoli comparativi per un anticoagulante orale, che hanno coinvolto rispettivamente 21.105 e 8.292 pazienti affetti da FANV o TEV acuta. I due studi clinici hanno valutato edoxaban in monosomministrazione giornaliera per il trattamento e la prevenzione delle recidive di TEV nei pazienti con TVP e/o EP, e per la prevenzione di ictus ed embolia sistemica in pazienti con fibrillazione atriale non valvolare.

"L'approvazione di Lixiana in Svizzera è un passo significativo di edoxaban verso l'Europa, e dimostra ancora una volta l'apprezzamento per l'impegno di Daiichi Sankyo di rispondere, con nuove opzioni di trattamento, ai bisogni non ancora soddisfatti dei pazienti affetti da malattie cardiovascolari,", dichiara Glenn Gormley, capo del dipartimento globale di Ricerca e Sviluppo Daiichi Sankyo.