Empagliflozin. Results of the EMPA-REG OUTCOME trial. A breakthrough in treatment of type 2 diabetes?

Abstract

Cardiovascular (CV) complications are the main health challenge among type 2 diabetic patients. They may cause premature death, disability and reduce the quality of life. Administering a multifactorial intervention aimed at controlling glycaemia, lipaemia and arterial blood pressure allows to reduce the risk of their occurrence. FDA ruled that all newly introduced hypoglycaemic agents must undergo tests for CV safety. The EMPAREG OUTCOME trial was conducted on a group of type 2 diabetic patients at high CV risk. It showed that including empagliflozin in the standard therapy reduces the risk of primary outcome (death from CV causes, non-fatal myocardial infarction or non-fatal stroke) by 14% and all-cause mortality by 32%. The causes of this effect of empagliflozin — an inhibitor of SGLT2, which is an enzyme present only in renal proximal tubules — are unclear. Reduction in insulin resistance and in oxidative stress, changes in lipid levels, reduction in uric acid levels, in albuminuria, in blood pressure and reduction in sympathetic activity are all named as potential mechanisms underlying the  rotective effect of empagliflozin.

Results of the EMPA-REG OUTCOME trial are a breakthrough in the treatment of diabetes, and if other SGLT2 inhibitors are found to have similar effects, a fundamental change in therapy recommendations for this patient population may be made.