License extension for empagliflozin in type 2 diabetes
For the first time the European Commission has approved the use of a diabetes treatment for its effect on both blood sugar and cardiovascular events. Empagliflozin (Jardiance®) product information now includes data on the reduction of risk of cardiovascular death in patients with type 2 diabetes and established cardiovascular disease in addition to data on the improvement of blood sugar control.
The cardiovascular data incorporated into the updated label for the drug are from the EMPA-REG OUTCOME trial which showed that empagliflozin reduces the risk of cardiovascular death by 38% vs placebo in patients with type 2 diabetes and established cardiovascular disease when added to standard of care.
Dr Georg van Husen from the manufacturers Boehringer Ingelheim said, ““One in two people with type 2 diabetes die of cardiovascular disease. The European Commission now reflects the importance of reducing cardiovascular death in these patients by extending the empagliflozin label. This makes it the only diabetes drug where use is not restricted to just lowering blood glucose. That means that it enables physicians to provide their type 2 diabetes patient with established cardiovascular disease with a diabetes medication that can offer a life-saving cardiovascular benefit.”
The EMPA-REG OUTCOME trial also demonstrated that empagliflozin significantly reduced the risk of the primary endpoint of cardiovascular death, non-fatal heart attack or non-fatal stroke by 14% vs placebo when added to standard of care in adults with type 2 diabetes and established cardiovascular disease. There were no statistically significant differences in the risk of non-fatal heart attack or non-fatal stroke.
Empagliflozin summary of product characteristics at www.medicines.org.uk/emc/medicine/28973