Epidemiological studies showed a clear relation between an insufficient glycaemic control and development of macrovascular
complications, which was proved in clinically randomised studies. The relation between the glycaemic compensation
and development of microvascular diseases is less persuasive. While epidemiological studies found out a certain
dependence of incidence of cardiovascular diseases on a glycaemic compensation, until now randomised studies
have brought controversial results. While in the majority of studies no benefit of better glycaemic control with the use
of almost all antidiabetic drugs, some studies showed even higher cardiovascular mortality, which might have been related
to side effects of some drugs.
Present recommendations for the treatment of diabetes are related to metformin effects, which led to lowering of cardiovascular
and overall mortality in diabetes type 2 patients compared with a standard regimen based on this diet. EMPA-
REG OUTCOME is the first published study with a sodium glucose cotransporter 2 inhibitor. In this study the impact
of empagliflozin added to previous standard antidiabetic, antihypertensive, hypolipidemic and antiaggregation treatment
was tested in patients with diabetes 2 with a coexisting cardiovascular disease. When compared with placebo,
empagliflozin treatment led to a significant lowering of total and cardiovascular mortality, as well as hospitalisation
for heart failure by more than one third. This effect was related neither to lowered glycaemia and body weight, nor blood
pressure. So the treatment with empagliflozin is the first intervention based on evidence in patients with type 2 diabetes
and a coexisting cardiovascular disease, even the mechanism of a favourable effect has not been explained, yet.