Étude de la saxagliptine sur la survenue d'événements cardiovasculaires chez des patients diabétiques de type 2 (Étude SAVOR-TIMI 53) : les résultats

Several studies on cardiovascular outcomes are currently conducted to verify the absence of deleterious effects of new treatments for diabetes at the request of regulatory authorities (FDA, EMA). Limited animal and human data have suggested that those acting on the incretin axis may have a cardiovascular protective effect independent of blood glucose control. From these arguments and positive meta-analyzes on clinical trials development, the Saxagliptin assessment of vascular outcomes recorded in patients with diabetes mellitus-thrombolysis in myocardial infarction (SAVOR-TIMI 53) study included more than 16,000 patients with type 2 diabetes (T2D) mainly in secondary cardiovascular prevention, to assess a cardioprotective effect of saxaglipitine (a DPP-4 inhibitor [iDPP-1]) compared to placebo. The study was conducted over 2.1 years and demonstrated the safety of the molecule both for cardiovascular events or pancreatitis risk. However, it was not observed any cardiovascular protective effects. Patients having a congestive heart failure at baseline were more hospitalized in the group receiving saxagliptin. There is no explanation for this unexpected result. Similar results were reported with another iDPP-4, alogliptin, in an outcome study conducted in immediate post-myocardial infarction in T2D patients.