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Hintergrund Die amerikanische FDA („U.S. Food and Drug Administration“) fordert seit 2008 für neue Antidiabetika die Durchführung kardiovaskulärer Sicherheitsstudien. Kardiale Sicherheit ist demzufolge eine Conditio sine qua non. Dieser Forderung haben wir die großen kardiovaskulären Phase-4-Endpunktstudien („cardiovascular outcome trials“, CVOT) zu verdanken, die für die neueren Antidiabetika, DPP-4-Inhibitoren...
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