Clinical trials for evaluating cardiovascular safety of sglt-2-inhibitor drugs in patients with type 2 diabetes [Cardiovascularis biztonságossági vizsgálatok SGLT-2-gátló antidiabetikumokkal 2-es típusú diabetesben]
Jermendy G.,Bajcsy Zsilinszky Korhaz |
Jermendy G.,Hospital Bajcsy Zsilinszky
Lege Artis Medicinae | Year: 2016
SGLT-2-inihibitors are considered as a new class among oral antidiabetic drugs. The first derivatives of this class became available in the last couple of years in Hungary. According to the requirements from regulatory bodies, randomized, controlled clinical trials have been initiated in order to evaluate the cardiovascular safety of nearly all new antidiabetic drugs in patients with type 2 diabetes. Among SGLT-2-inhibitors, only one trial with empagliflozine has been completed so far. Based on the endpoints of the EMPA-REG OUTCOME trial a significant decrease in different cardiovascular events and total mortality was observed in type 2 diabetic patients with elevated cardiovascular risk. The exact pathomechanism of this beneficial effect has not been clearly understood. Currently, the position statements and scientific guidelines clearly describe the place of SGLT-2-inhibitor drugs in the treatment algorithm; the beneficial effect of empagliflozine on cardiovascular events should seriously be considered when making therapeutic decision. Together with the results of ongoing studies with SGLT-2-inhibitors (dapagliflozine: DECLARE, canagliflozine: CANVAS), these data will provide a more robust evidence about the cardiovascular safety of this new class of oral antidiabetic drugs.