Type 2 medicine label to include cardiovascular death reduction data
The type 2 drug Jardiance (empagliflozin) has become the first medication in the European Union to include cardiovascular death reduction data on the label.
The newly approved information has been taken from the findings from the EMPA-REG OUTCOME® trial.
The study showed the drug, which is is an oral, once daily, highly selective sodium-glucose co-transporter-2 (SGLT2) inhibitor, reduced the risk of CV death by 38 per cent when compared to placebos taken by people with type 2 diabetes.
It is the only oral diabetes treatment which has been shown to reduce the risk of CV death in a dedicated outcome trial to date.
Dr Georg van Husen, corporate senior vice president, head of the therapeutic area cardioMetabolism for 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.”
The trial also demonstrated that Jardiance® significantly reduced the risk of the primary endpoint of CV death, non-fatal heart attack or non-fatal stroke by 14 per cent versus placebo when added to standard of care in adults with type 2 and established CV disease.
Enrique Conterno, senior vice president and president of 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.”
EMPA-REG OUTCOME® was a long-term, multicentre, randomised, double-blind, placebo-controlled trial of more than 7,000 patients from 42 countries with type 2 diabetes and established CV disease.
The study assessed the effect of Jardiance® (10 mg or 25 mg once daily) added to standard of care compared with placebo added to standard of care.
Standard of care was comprised of sugar-lowering agents and CV drugs (including for blood pressure and cholesterol). The primary endpoint was defined as time to first occurrence of CV death, non-fatal heart attack or non-fatal stroke.