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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

12,5 mg bzw. 25 mg zugelassen. Bei Patienten mit einer moderaten Einschränkung der Nierenfunktion (Creatinin-Clearance [CrCl] > 30 bis < 50 ml/min) beträgt die Dosis Alogliptin einmalig 12,5 mg pro Tag, und bei Patienten mit schwerer Einschränkung der Nierenfunktion (CrCl > 15 bis < 30 ml/min) und solchen mit Nierenerkrankungen im Endstadium (ESRD) (CrCl < 15 ml/min oder mit Hämodialysebedarf) beträgt die Dosis Alogliptin einmalig 6,25 mg pro Tag.

Alogliptin ist in Europa derzeit noch nicht zugelassen. VIPIDIA (Alogliptin), VIPDOMET (Alogliptin und Metformin FDC) sowie INCRESYNC (Alogliptin und Pioglitazon FDC) werden gegenwärtig von der Europäischen Arzneimittel-Agentur (EMA) geprüft und wurden vom Committee for Medicinal Products for Human Use (CHMP) im Juli 2013 positiv bewertet. Alogliptin wurde auch zur Anwendung in China, Mexiko und Südkorea zugelassen, obgleich die Therapie auf diesen Märkten noch nicht erhältlich ist.

Die Wirksamkeit von Alogliptin wurde als Ergänzung zu Diät und Bewegung sowie als Zusatztherapie für andere Antidiabetika untersucht, darunter Metformin, Pioglitazon, Insulin und Sulfonylharnstoffe. In diesen Studien wurde Alogliptin als 25-mg-Tablette einmal täglich eingenommen und zeigte eine klinisch und statistisch signifikante Reduzierung des HbA1c mit einem guten Verträglichkeitsprofil und einer geringen Hypoglykämie-Rate im Vergleich zur aktiven Kontrolle oder Placebo. Studienergebnisse legten nahe, dass Alogliptin bei gemeinsamer Verabreichung mit Metformin oder Pioglitazon in einer jeweiligen Therapie mit freier Dosierung zu einer wesentlichen Verbesserung der Blutzuckerkontrolle führte.

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Takeda ist in Osaka, Japan, ansässig und ist ein weltweit agierendes Unternehmen mit Schwerpunkt
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