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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

AMSTERDAM, Paesi Bassi e OSAKA, Giappone, 17 settembre 2013 /PRNewswire/ -- Takeda Pharmaceutical Company Limited (Takeda) ha annunciato oggi i risultati di EXAMINE (EXamination of CArdiovascular OutcoMes: AlogliptIN vs. Standard of CarE in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome) studio di outcome sulla sicurezza cardiovascolare, mostrando come l'endpoint primario di non-inferiorità di alogliptin rispetto al placebo in aggiunta alla normale terapia standard sia stato soddisfatto con l'assenza di incremento del rischio cardiovascolare in una popolazione di pazienti con diabete di tipo 2 a elevato rischio di eventi cardiovascolari. Questi dati, pubblicati nel New England Journal of Medicine (NEJM) e presentati anche al congresso ESC 2013, dimostrano che alogliptin non aumenta il rischio cardiovascolare nei pazienti affetti da diabete di tipo 2 che presentano un elevato rischio di eventi avversi cardiaci maggiori (MACE) a causa di una recente sindrome coronarica acuta (ACS). L'obiettivo principale dello studio era valutare la non inferiorità di alogliptin rispetto al placebo, nel rischio cardiovascolare basato su un endpoint primario composito di morte per cause cardiovascolari, infarto non fatale del miocardio e ictus non fatale. L'endpoint primario ha fatto registrare tassi simili nel gruppo trattato con alogliptin e in quello trattato con placebo (rispettivamente nell'11,3% dei pazienti rispetto all'11,8% dei pazienti nel corso di un periodo di follow-up mediano di 18 mesi; hazard ratio, 0,96; limite superiore dell' intervallo di confidenza unilaterale ripetuto [CI], 1,16). Alogliptin è un inibitore del dipeptidil peptidasi-4 (DPP-4i) per il trattamento del diabete di tipo 2 negli adulti, utilizzato per migliorare il controllo glicemico in aggiunta a dieta ed esercizio fisico.

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SOURCE Takeda Pharmaceutical Company Limited
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