Symposium 2: What have CVOT taught us about microvascular impact in T2DM?

Abstract

In the last years of the 20th century, efforts were concentrated on demonstrating whether bringing blood glucose levels as close as possible to normal was associated with a reduction in complications of diabetes (DM), trying to avoid endothelial damage of glucotoxicity. First results showed benefits at microvascular level, but not in macrovascular complications. In 2008, FDA demanded that randomised placebo-controlled CVOTs had to be done to demonstrate cardiovascular (CV) safety before approval of new drugs for DM. Clinical trials with DPP4 inhibitors showed CV safety and some kidney benefits.

But everything changes after the publication of the EMPA REG OUTCOME, where empagliflozin demonstrated a significant reduction in the primary trial objective, without changes in the risk of acute heart attack or stroke, recognized by this time as the main cause of death in T2DM, and a significant reduction in the risk of hospitalization for heart failure and surprising renal benefits.