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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

4 inhibitor sono concepiti per rallentare l'inattivazione degli ormoni incretinici GLP-1 e GIP. Di conseguenza, una maggiore quantità di incretine attive permette al pancreas di secernere l'insulina in modo dipendente dal glucosio, contribuendo così i al controllo dei livelli di glucosio nel sangue. Nell' aprile 2010 è stata approvata dal Ministero della Sanità, del Lavoro e del Welfare giapponese una richiesta per nuovo farmaco (NDA) presentata per NESINA (alogliptin), per il trattamento del diabete di tipo 2, e la terapia è disponibile con lo stesso marchio in Giappone. Nel gennaio 2013 NESINA (alogliptin) è stato approvato dalla FDA degli Stati Uniti come terapia a dosaggio libero e anche in combinazione fissa (FDC) con il pioglitazone (OSENI) e la metformina HCl (KAZANO) per il trattamento del diabete di tipo 2 negli adulti, quale aggiunta alla dieta e all'esercizio fisico. Alogliptin in monoterapia è attualmente approvato in compresse con dosaggi da 6,25 mg, 12,5 mg, e 25 mg. Per i pazienti con insufficienza renale moderata(creatinina clearance [CrCl] > 30 fino a < 60 mL/min), il dosaggio di alogliptin è di 12,5 mg una volta al giorno, mentre per i pazienti con insufficienza renale grave (CrCl > 15 a < 30 mL/min) e per i pazienti con malattia renale allo stadio terminale (ESRD) (CrCl < 15 mL/min o che necessitano di emodialisi), il dosaggio di alogliptin è di 6,25 mg una volta al giorno.

Alogliptin non è attualmente autorizzato o disponibile in Europa. VIPIDIA (alogliptin), VIPDOMET (alogliptin e metformina FDC) e INCRESYNC (alogliptin e pioglitazone FDC) sono attualmente in attesa dell'autorizzazione finale della European Medicines Agency (EMA – Agenzia Europea per i Medicinali), dopo avere ricevuto pareri positivi all'uso da parte del Committee for Medicinal Products for Human Use (CHMP – Comitato per i P
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SOURCE Takeda Pharmaceutical Company Limited
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