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Lo studio EXAMINE della Takeda sulla sicurezza cardiovascolare di alogliptin in aggiunta alla terapia standard ha soddisfatto l'endpoint primario di non inferiorità rispetto al placebo dimostrando che non si verifica nessun incremento del rischio ca
Date:9/17/2013

zza, lo rendono uno studio informativo unico per il trattamento del diabete in alcuni dei pazienti a più alto rischio," ha dichiarato Ajay Ahuja, MD, Vice Presidente, Global Medical Affairs, Takeda. "Nel corso degli ultimi 20 anni, Takeda ha costruito fondamenta solide e mantenuto una elevata attenzione sul diabete. EXAMINE rafforza il nostro impegno scientifico costante sia su alogliptin che nei riguardi della comunità diabetica."

L'endpoint principale secondario di sicurezza è stato costituito da quello composito primario con l'aggiunta del ricovero per angina instabile che ha richiesto una rivascolarizzazione coronarica entro 24 dal ricovero in ospedale. Le valutazioni dell'endpoint secondario composito costituito dalla morte per cause cardiovascolari, infarto del miocardio non fatale, ictus non fatale e angina instabile con rivascolarizzazione urgente, non hanno evidenziato differenze nei tassi di comparsa degli eventi tra alogliptin e placebo (12,7% rispetto al 13,4%; hazard ratio 0,95; limite superiore dell' intervallo di confidenza unilaterale ripetuto, 1,14).

Gli altri endpoint secondari comprendevano la morte per sole cause cardiovascolari e la morte per tutte le cause. La morte per cause cardiovascolari si è verificata in 112 pazienti trattati con alogliptin (4,1%) e in 130 pazienti trattati con placebo (4,9%) per una hazard ratio di 0,85 (limiti di confidenza 95% [CL] dal 0,66 a 1,10, p=0,21). La mortalità per tutte le cause (morti per tutte le cause) si è verificata in 153 pazienti trattati con alogliptin (5,7%) e in 173 pazienti trattati con placebo (6,5%) per una hazard ratio di 0,88 (95% CL da 0,71 a 1,09, p=0,23). Complessivamente, i tassi di morte per tutte le cause e di morte per cause cardiovascolari non hanno evidenziato differenze statisticamente significative tra i gruppi alogliptin e placebo.

Gli endpoint di sicurezza aggiuntivi comprendevano angioedema, ipoglicem
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SOURCE Takeda Pharmaceutical Company Limited
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