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Tromboembolia venosa, edoxaban (LIXIANA) efficace e sicuro anche per i pazienti a più alto rischio

Edoxaban, per la prevenzione delle recidive di tromboembolia venosa (TEV), è altrettanto efficace e più sicuro del warfarin nei pazienti affetti da embolia polmonare con disfunzione ventricolare destra, e in soggetti fragili che hanno assunto il dosaggio ridotto o prolungato il trattamento fino a 12 mesi. Le sottoanalisi del trial Hokusai –VTE presentate al Congresso SIC 2016

Roma, 19 dicembre 2016 - Quella con edoxaban è una terapia anticoagulante efficace e più sicura rispetto al warfarin anche nei pazienti che presentano un'embolia polmonare con disfunzione ventricolare destra, dunque con una prognosi più sfavorevole, e in soggetti fragili che hanno assunto il dosaggio ridotto a 30 mg/die o prolungato il trattamento fino a 12 mesi. E' quanto emerge dai risultati presentati nel simposio satellite organizzato da Daiichi Sankyo durante il Congresso Italiano di Cardiologia (SIC), che sta per concludersi a Roma.

Hokusai-VTE è uno studio randomizzato, in doppio cieco, condotto su 8.292 pazienti in cui edoxaban in monosomministrazione giornaliera è stato confrontato con il warfarin per il trattamento e la prevenzione di recidive di tromboembolia venosa. Edoxaban ha dimostrato la non-inferiorità in termini di efficacia rispetto al warfarin e una riduzione significativa dei sanguinamenti maggiori e non maggiori clinicamente rilevanti.

Nel trial Hokusai-VTE è stata prespecificata un'analisi per cui nei pazienti con embolia polmonare veniva misurato il dosaggio di un marker plasmatico di disfunzione ventricolare destra, la porzione N-terminale del proBNP (NTproBNP). Il BNP è un ormone prodotto dall'atrio del cuore in risposta ad un eccessivo allungamento delle sue cellule muscolari. Le cellule muscolari degli atri cardiaci si allungano in maniera eccessiva quando queste camere si riempiono troppo di sangue; ciò che accade per esempio in presenza di embolia polmonare quando, a causa dell'ostruzione di un'arteria polmonare, si crea a monte (atrio destro) un accumulo di sangue e quindi una dilatazione della camera cardiaca. In studi precedenti, la disfunzione ventricolare destra veniva definita quando il livello del NT-proBNP era ≥500 pg/ml, e la positività di questo marker è risultata essere predittiva di un aumento del rischio di mortalità nelle prime settimane dalla diagnosi.

Questo esame di laboratorio è stato eseguito in circa il 90% dei pazienti con embolia polmonare (1484 trattati con edoxaban e 1505 trattati con warfarin) ed è risultato essere alterato con un valore ≥500 pg/ml nel 30% e nel 32% dei pazienti, rispettivamente. Nel 30% dei pazienti che presentava embolia polmonare con disfunzione ventricolare destra, quindi una patologia più severa e con un indice prognostico più sfavorevole, la recidiva di TEV nel braccio edoxaban è risultata essere la metà rispetto a quella nel braccio warfarin, con una riduzione del rischio relativo del 48%.

"La ricerca scientifica nel campo della terapia anticoagulante non ha tanto mirato a perseguire una maggiore efficacia nei confronti della cura tradizionale col Warfarin, che già dimostra notevole validità nell'ambito delle patologie tromboemboliche, quanto di ottenere un farmaco più sicuro, agevole da assumere e semplice nel dosaggio. Avere trovato nell'edoxaban questi requisiti rappresenta un punto di vantaggio, visto che proprio nei pazienti più critici, quelli sottopeso, quelli con compromessa funzione renale, quelli con peggiore prognosi di malattia, l'edoxaban ha evidenziato superiorità e evidente riduzione delle emorragie nei confronti del warfarin", ha spiegato Andrea Fontanella, Presidente Nazionale della FADOI, Direttore del Dipartimento di Medicina dell'Ospedale Fatebenefratelli di Napoli.

In quei pazienti che necessitano di una dose ridotta a causa delle loro condizioni cliniche (clearance di creatinina di 30-50 ml/minuto, peso corporeo ≤ 60 kg o in terapia con alcuni inibitori della glicoproteina P), edoxaban 30mg in monosomministrazione giornaliera (LIXIANA®), si è dimostrato altrettanto efficace e più sicuro del warfarin nella riduzione dei sanguinamenti (7,9% vs 12,8% HR=0,62; 95 % CI: 0,44-0,86; p < 0,01 per superiorità). L'analisi ha evidenziato come la dose di edoxaban di 30 mg era correlata a livelli ematici lievemente più bassi di edoxaban, mostrando tuttavia la stessa efficacia nel prevenire le recidive di TEV rispetto ai soggetti trattati con la dose piena di 60 mg.

Infine, un'ulteriore sottoanalisi ha valutato il rischio/beneficio dell'estensione del trattamento con edoxaban rispetto al warfarin fino a 12 mesi, prolungandolo oltre i 3 mesi previsti dalla terapia standard. Nei pazienti affetti da tromboembolia venosa che richiedono una estensione del trattamento per prevenirne le recidive, i risultati hanno dimostrato non solo che edoxaban è altrettanto efficace ma è anche associato a un minor numero di sanguinamenti maggiori rispetto al warfarin (0,3% vs 0,7% HR= 0,45; 95% CI: 0,22-0,92).