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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

e del glucosio nei pazienti diabete ad elevato rischio di patologie cardiovascolari," ha dichiarato William B. White, MD, FASH, FAHA, FACP, ricercatore principale dello studio EXAMINE. "Considerato il concetto su cui è stato costruito lo studio EXAMINE e la popolazione a elevato rischio valutata, questi risultati forniscono importanti informazioni ai medici che curano pazienti diabetici affetti da malattia coronarica."

Lo studio globale EXAMINE costituisce una valutazione importante poiché prende in esame la sicurezza cardiovascolare in pazienti di cui è noto l'elevato rischio di malattie cardiovascolari (CVD), causa principale di condizioni patologiche e mortalità nella popolazione di pazienti affetti da diabete di tipo 2. EXAMINE, uno studio clinico globale, di grandi dimensioni, randomizzato, in doppio cieco, controllato verso placebo, è stato concepito per valutare la sicurezza cardiovascolare del trattamento con alogliptin in aggiunta alla terapia standard, rispetto al placebo in aggiunta alla sola terapia standard, in pazienti affetti da diabete di tipo 2 e con un ACS (sindrome coronarica acuta) recente.

Nel corso dello studio EXAMINE, i pazienti sono stati assegnati a random al gruppo che sarebbe stato trattato con alogliptin o a quello che sarebbe stato trattato con placebo in aggiunta ai medicinali normalmente previsti per il trattamento del diabete e delle malattie cardiovascolari. 5.380 pazienti sono stati assegnati a random e sono stati seguiti per un tempo mediano di 18 mesi e per un tempo massimo di 40 mesi. Il tasso di interruzioni anticipate del trattamento in studio è stato simile nel gruppo trattato con alogliptin e in quello trattato con il placebo. I pazienti sono stati curati secondo livelli elevati di standard terapeutico del diabete di tipo 2 e dei fattori di rischio cardiovascolari.

"Il disegno dello studio EXAMINE e soprattutto i risultati rilevati per la sicure
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SOURCE Takeda Pharmaceutical Company Limited
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