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The European Commission has approved an update to the label of SGLT2 inhibitor empagliflozin (Jardiance) to include a change to the indication statement, meaning it is now indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus (T2DM) as an adjunct to diet and exercise.
Empagliflozin is the only oral diabetes treatment shown to reduce the risk of CV death in a dedicated CV outcome trial to date. This follows the results of the EMPA-REG OUTCOME trial, which showed that empagliflozin reduced the risk of CV death by 38% 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% 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.
Dr Georg van Husen, Corporate Senior Vice President, Head of the Therapeutic Area CardioMetabolism, 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 Jardiance label. This makes Jardiance the only diabetes drug which use is not restricted to just lowering blood glucose.
“That means that Jardiance 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.”
Enrique Conterno, Senior Vice President and President, Lilly Diabetes, said: “This is very good news for the type 2 diabetes community.
“This approval from the European Commission, along with approvals from other regulatory authorities around the world, marks a significant step towards making a positive difference to the lives of people with type 2 diabetes and established cardiovascular disease.”
Toe amputation risk
However, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has recently issued a warning regarding the diabetes medicine canagliflozin, and other medicines in the same class – including empagliflozin – saying they may contribute to the risk of toe amputation.
The PRAC warns that an increase in cases of lower limb amputation, mostly affecting the toes, has been observed in patients taking the type 2 diabetes medicine canagliflozin compared with those taking placebo, in two ongoing clinical trials involving patients at high risk of heart problems.
An increased risk has not been seen in studies with other medicines in the same class, dapagliflozin and empagliflozin. However, for these medicines, data available to date are limited and the risk may also apply to these other medicines, the PRAC warned.
On the basis of the available data, the PRAC recommends that a warning on the risk of lower limb amputation, mostly affecting the toes, should be included in the prescribing information for canagliflozin, empagliflozin and dapagliflozin, highlighting to healthcare professionals and patients the importance of routine preventative foot care.