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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

ia, pancreatite, tumori maligni e i risultati degli esami di laboratorio. I tassi di ipoglicemia, tumore maligno, pancreatite, dialisi e un innalzamento dell'amino-transferasi sierica sono stati simili per i gruppi alogliptin e placebo. Nel corso dello studio non sono stati riportati casi di cancro del pancreas. I gruppi alogliptin e placebo non hanno evidenziato differenze significative relativamente ai tassi degli eventi avversi seri (rispettivamente 33,6% e 35,5%, p=0,14).

Informazioni su EXAMINE
EXAMINE , uno studio clinico globale, di grandi dimensioni, randomizzato, in doppio cieco, controllato con placebo, è stato concepito per valutare la sicurezza cardiovascolare del trattamento con alogliptin in aggiunta al trattamento standard, in confronto al placebo in aggiunta al trattamento standard solamente, in pazienti affetti da diabete di tipo 2 e una sindrome coronarica acuta (ACS) recente (da 15 a 90 giorni prima della randomizzazione). Lo studio aveva un endpoint primario composito di morti per cause cardiovascolari, infarto miocardico non fatale e ictus non fatale.

Nel gruppo trattato con alogliptin, il 71,4% dei pazienti è stato trattato con 25 mg, il 25,7% con 12,5 mg, e il 2,9% con 6,25 mg di alogliptin al giorno. I dosaggi di alogliptin sono stati determinati in base alla funzionalità renale: tasso di filtrazione glomerulare stimato (eGFR) secondo la formula della "Modification in Diet in Renal Disease" > 60 ml/min, 25 mg giornalieri; < 60 ml/min ma > 30 ml/min, 12,5 mg giornalieri; e < 30 ml/min, 6,25 mg giornalieri. L'interruzione prematura del farmaco in studio è stata simile nei gruppi alogliptin e placebo (20,9% dei pazienti rispetto a 22,6%). La durata mediana dell'esposizione al farmaco in studio è stata di 533 giorni (range interquartile, 280 - 751 giorni). Al termine dello studio, la variazione media di HbA1c dal basale è stata pari a -0,33% e 0,03% rispettivamente nel gr
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SOURCE Takeda Pharmaceutical Company Limited
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