First T2DM medicine in EU to receive expansion of indication to lower CV deathNews - Feb. 13, 2017
The European Commission has approved an update to the SGLT2 inhibitor empagliflozin label to include a change to the indication statement. Empagliflozin is now indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus (T2DM) as an adjunct to diet and exercise. The approved product information now includes data on the reduction of risk of cardiovascular (CV) death in patients with T2D and established CV disease in addition to data on the improvement of blood sugar control. Empagliflozin is the only oral diabetes treatment shown to reduce the risk of CV death in a dedicated CV outcome trial to date.
The updated EU label now includes results from the EMPA-REG OUTCOME® trial, which showed that empagliflozin reduced the risk of CV death by 38 percent versus placebo in patients with T2DM and established CV disease when added to standard of care. The trial also demonstrated that empagliflozin significantly reduced the risk of the primary endpoint of CV death, non-fatal heart attack or non-fatal stroke by 14 percent versus placebo when added to standard of care in adults with T2D and established CV disease. There were no statistically significant differences in the risk of non-fatal heart attack or non-fatal stroke.
Empagliflozin is an oral, once daily, highly selective sodium-glucose co-transporter-2 (SGLT2) inhibitor for the treatment of adults with type 2 diabetes.
Inhibition of SGLT2 with empagliflozin in patients with T2D and high blood sugar levels leads to excretion of excess sugar in the urine. In addition, initiation of empagliflozin increases excretion of salt from the body (i.e. sodium) and reduces the fluid load of the body’s blood vessel system (i.e. intravascular volume). Excretion of sugar, salt and water after the initiation of treatment with empagliflozin may therefore contribute to the improvement in cardiovascular outcomes.
The change to the existing indication approved by the European Commission is as follows:
Empagliflozin is indicated for the treatment of adults with insufficiently controlled T2DM as an adjunct to diet and exercise:
- as monotherapy when metformin is considered inappropriate due to intolerance
- in addition to other medicinal products for the treatment of diabetes
For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.