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EXAMINE-Studie zur kardiovaskulären Sicherheit von Alogliptin erreicht primären Endpunkt: keine Erhöhung des kardiovaskulären Risikos bei Risikopatienten mit Typ-2 Diabetes
Date:9/11/2013

rapie versus der Placebobehandlung zusätzlich zur Standardtherapie bei Patienten mit Diabetes Typ 2 und einem erst kurz vorher aufgetretenen akuten Koronarsyndrom (innerhalb von 15 bis 90 Tagen vor der Randomisierung). Die Studie hatte als primären kombinierten Endpunkt kardiovaskulären Tod, nicht tödlichen Herzinfarkt und nicht tödlichen Schlaganfall.

In der Alogliptin-Gruppe erhielten 71,4 % der Patienten 25 mg, 25,7 % 12,5 mg und 2,9 % 6,25 mg täglich. Die Alogliptin-Dosierungen wurden entsprechend der Nierenfunktion angepasst: geschätzte glomeruläre Filtrationsrate (gGFR) durch die MDRD-Formel (Modification in Diet in Renal Disease) > 60 ml/min, 25 mg täglich; < 60 ml/min und  > 30 ml/min, 12,5 mg täglich; und < 30 ml/min, 6,25 mg täglich. Das Studienpräparat wurde in beiden Gruppen ähnlich häufig vorzeitig abgesetzt. (20,9 % bzw. 22,6 % der Patienten). Die mittlere Expositionsdauer betrug 533 Tage (Quartilsabstand 280 bis 751 Tage). Zum Ende der Studie betrug die mittlere Veränderung des HbA1c versus dem Ausgangspunkt 0,33% bzw. 0,03% in der Alogliptin- und der Placebogruppe, und der Mittelwert der Differenz der HbA1c-Werte zwischen Alogliptin und Placebo betrug -0,36% (95 % KI, -0,43, -0.28, p<0,001). Die Ergebnisse der einzelnen Komponenten des primären Endpunktes stimmten mit dessen Gesamtauswertung überein. Dies traf auch für die Gesamtmortalität und den kardiovaskulären Tod zu. Die Unterschiede waren jeweils nicht signifikant.

Takeda führte die globale EXAMINE-Studie gemäß den Leitlinien der US-amerikanischen Food and Drug Administration (FDA) von 2008 („Guidance for Industry: Diabetes Mellitus – Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes) durch. Die EXAMINE-Ergebnisse werden nach Abschluss aller Analysen ordnung
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SOURCE Takeda Pharmaceutical Company Limited
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