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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

ären Endpunktes zuzüglich Hospitalisierung infolge instabiler Angina Pectoris, die eine koronare Revaskularisierung innerhalb von 24 Stunden nach Einweisung erforderte. Eine Prüfung des sekundären kombinierten Endpunkts zeigte bei Alogliptin und Placebo keine Unterschiede (12,7 % bzw. 13,4 %; Risikoverhältnis 0,95; obere Grenze des Konfidenzintervalls ( KI) 1,14).

Andere sekundäre Endpunkte waren alle kardiovaskulären Todesfälle und Gesamtmortalität (alle Todesfälle, gleich welcher Ursache). Der KV-Tod trat bei 112 mit Alogliptin behandelten Patienten (4,1 %) und 130 mit Placebo behandelten Patienten (4,9 %) bei einem Risikoverhältnis von 0,85 ein (95 % Konfidenzintervall von 0,66 bis 1,10, p=0,21). Insgesamt verstarben 153 der mit Alogliptin behandelten Patienten (5,7%) und 173 der mit Placebo behandelten Patienten (6,5%) bei einem Risikoverhältnis von 0,88 ein (95 % Konfidenzintervall von 0,71 bis 1,09, p=0,23). Das zeigt, dass die Ereignisraten sich statistisch nicht voneinander unterschieden. Darüber hinaus wurden das Auftreten von Angioödemen, Hypoglykämien, Pankreatitiden, Tumorerkrankungen sowie Laborergebnisse untersucht. Die Anzahl von Hypoglykämien,  verschiedenen Tumorerkrankungen, Pankreatitiden, Fällen von Dialysepflichtigkeit und erhöhten Serum-Aminotransferasewerten waren bei der Alogliptin- und der Placebogruppe ähnlich. Während der Studie wurde kein Fall von Pankreaskarzinom berichtet. Die Alogliptin- und die Placebogruppe wichen hinsichtlich des Anteils schwerwiegender unerwünschter Ereignisse nicht signifikant voneinander ab (33,6 % bzw. 35,5 %, p=0,14).

Informationen zu EXAMINE
EXAMINE war eine globale randomisierte, Placebo kontrollierte klinische Doppelblindstudie. Ihr Ziel war die Bewertung der kardiovaskulären Sicherheit der Behandlung mit Alogliptin zusätzlich zur Standardthe
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SOURCE Takeda Pharmaceutical Company Limited
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