It should be highlighted, though, that ACCORD and VADT patients were older, with longstanding diabetes, and a great prevalence of macrovascular disease; in subjects with these characteristics (which are similar to those of the VHCVR group in our study), strictly pursuing near normal glucose levels with insulin could increase the frequency of hypoglycaemic events, a strong risk factor for CV acute complications and sudden death. Here, INS is linked to diabetes mellitus.