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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

AMSTERDAM, Niederlande, und OSAKA, Japan, 11. September 2013 /PRNewswire/ -- Takeda Pharmaceutical Company Limited (Takeda) gab heute die Ergebnisse der Studie zur kardiovaskulären Sicherheit EXAMINE bekannt. EXAMINE steht für EXamination of CArdiovascular OutcoMes: AlogliptIN vs. Standard of CarE (Vergleich des kardiovaskulären Outcomes – Alogliptin vs. Standardtherapie). Die Studie wurde bei Patienten mit Typ 2 Diabetes, die bereits ein akutes Koronarsyndrom hinter sich hatten, durchgeführt, die auf Basis einer Standardtherapie entweder Alogliptin oder Placebo erhielten. Es konnte gezeigt werden, dass das Risiko für ein kardiovaskuläres Ereignis in beiden Gruppen vergleichbar war. Damit konnte die Anforderung der „Non-Inferiority" („Nicht-Unterlegenheit") für Alogliptin erfüllt werden. Der primäre Endpunkt der Nichtinferiorität gegenüber Placebo auf Basis der Standardtherapie bei einer Patientenpopulation mit Diabetes Typ 2 und erhöhtem Risiko für ein kardiovaskuläres Ereignis wurde erreicht. Diese im New England Journal of Medicine (NEJM) veröffentlichten und auf dem ESC Congress 2013 vorgestellten Daten belegen, dass Alogliptin das kardiovaskuläre Risiko von Patienten mit Diabetes Typ 2, bei denen aufgrund eines kurz zuvor aufgetretenen akuten Koronarsyndroms (ACS) ein hohes Risiko für ein schwerwiegendes kardiovaskuläres Ereignis (major adverse cardiovascular event,  MACE) besteht, nicht erhöht. Der primäre Endpunkt bestand aus folgenden Komponenten: kardiovaskulär bedingter Tod, nicht tödlicher Herzinfarkt, nicht tödlicher Schlaganfall. Der primäre Endpunkt trat in der Alogliptin und in der Placebo-Gruppe mit ähnlicher Häufigkeit auf: bei 11,3 % der Patienten der Alogliptin-Gruppe bzw. bei 11,8 % der Patienten der Placebogruppe
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SOURCE Takeda Pharmaceutical Company Limited
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