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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

uppo trattato con alogliptin e in quello trattato con placebo, e la differenza delle medie least square di HbA1c tra alogliptin e placebo è stata di -0,36% (95% CI, -0,43, -0,28, p<0.001). Nell'analisi dei componenti dell'endpoint primario le hazard ratio erano coerenti con i risultati globali. Le hazard ratio per morte per tutte le cause e per morte per cause cardiovascolari erano coerenti con l'endpoint primario composito.

Takeda ha condotto lo studio globale EXAMINE in conformità con quanto previsto dalla Guida 2008 della Food and Drug Administration (FDA) degli Stati Uniti (US), dal titolo "Guidance for Industry: Diabetes Mellitus - Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes", per tutti i nuovi trattamenti per il diabete di tipo 2. Trattandosi di uno studio globale, i risultati di EXAMINE saranno condivisi con le agenzie regolatorie una volta completate tutte le analisi, come appropriato.

Informazioni sul diabete di tipo 2
Il diabete di tipo 2 è la forma più comune di diabete che interessa milioni di persone in tutto il mondo. Il diabete di tipo 2 è una condizione cronica e progressiva e i pazienti devono lavorare insieme a professionisti della sanità per gestire e monitorare la loro patologia. In aggiunta alla dieta e all'esercizio fisico, i pazienti devono spesso assumere uno o più medicinali che li aiutino a controllare i livelli di glucosio nel sangue. Secondo la International Diabetes Federation, la spesa sanitaria mondiale per il diabete (sia di tipo 1 che di tipo 2) è stata stimata maggiore di 471 miliardi di dollari USA nel 2012. Entro il 2030, si prevede che questa cifra supererà i 595 miliardi di dollari US.

Informazioni su Alogliptin
Alogliptin è un inibitore del dipeptidil peptidasi-4 (DPP-4i) per il trattamento del diabete di tipo 2 negli adulti, in aggiunta alla dieta e all'esercizio fisico. I DPP-
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SOURCE Takeda Pharmaceutical Company Limited
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