The US Food and Drug Administration (FDA) approved a new indication for Jardiance (empagliflozin) tablets to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease.

Jardiance is the first type 2 diabetes treatment approved with this additional indication and the only oral type 2 diabetes medicine shown in a clinical trial to provide a life-saving cardiovascular benefit. Jardiance is marketed by Boehringer Ingelheim and Eli Lilly and Company.

"As the only diabetes treatment approved by the FDA to reduce the risk of cardiovascular death, Jardiance represents a tremendous step forward in our efforts to reduce the impact of heart disease among adults with type 2 diabetes and cardiovascular disease," said Paul Fonteyne, president and CEO, Boehringer Ingelheim Pharmaceuticals, Inc. "This approval is another example of our commitment to the discovery and development of treatment options for adults with type 2 diabetes. We believe that Jardiance is an important treatment option for this patient population."

Jardiance is not for people with type 1 diabetes or people with diabetic ketoacidosis (increased ketones in the blood or urine).

The approval is based on breakthrough evidence from the landmark EMPA-REG OUTCOME trial, which investigated the effects of Jardiance compared with placebo when added to standard of care type 2 diabetes and cardiovascular medicines in adults with type 2 diabetes and established cardiovascular disease. In the trial, Jardiance significantly reduced the risk of the combined primary endpoint of cardiovascular death, non-fatal heart attack or non-fatal stroke by 14 per cent versus placebo (HR 0.86, 95% CI: 0.74-0.99); absolute risk reduction was 1.6 per cent for Jardiance versus placebo. This primary finding was driven by a significant 38 per cent reduction in the risk of cardiovascular death (HR 0.62, 95% CI: 0.49-0.77); absolute risk reduction was 2.2 per cent for patients taking Jardiance versus placebo. There was no change in the risk of non-fatal heart attack (HR 0.87, 95% CI: 0.70-1.09) or non-fatal stroke (HR 1.24, 95% CI: 0.92-1.67). The cardiovascular benefits of Jardiance were consistent among patient subgroups.

Adults with type 2 diabetes should not take Jardiance if they have severe kidney problems or are on dialysis, or if they are allergic to empagliflozin or any ingredient in Jardiance. Jardiance can cause dehydration and low blood pressure. Jardiance can also cause increased ketones in the blood (ketoacidosis), serious urinary tract infection, acute kidney injury and impairment in renal function, low blood glucose when used with insulin or insulin secretagogues (e.g., sulfonylurea, a medication used to treat type 2 diabetes), vaginal yeast infections and yeast infections of the penis, and increased cholesterol.

"People with diabetes are two to four times more likely to develop cardiovascular disease than people without diabetes. The new indication for empagliflozin enables physicians for the first time to provide adults with type 2 diabetes with a diabetes medication that can reduce their risk of dying from cardiovascular disease," said Christopher P. Cannon, M.D., Cardiovascular Division, Brigham and Women's Hospital and professor of medicine, Harvard Medical School. "It also gives physicians an opportunity to speak with and educate people with type 2 diabetes about their increased risk for cardiovascular disease and to help them understand this serious complication of their condition."

"Despite significant medical advances, approximately two out of three people with type 2 diabetes still die from cardiovascular disease. The Boehringer Ingelheim and Lilly diabetes alliance is proud to bring a groundbreaking innovation to millions of adults with type 2 diabetes and established cardiovascular disease," said Enrique Conterno, senior vice president and president, Lilly Diabetes. "As part of our ongoing commitment to people with type 2 diabetes, we are also expanding our efforts to educate the public on the link between cardiovascular disease and type 2 diabetes."

In 2014, Jardiance was approved by the FDA as an adjunct to diet and exercise to improve glycemic control, or blood glucose levels, in adults with type 2 diabetes.

EMPA-REG OUTCOME was a long-term, multicenter, randomized, double-blind, placebo-controlled trial of more than 7,000 patients, from 42 countries, with type 2 diabetes and established cardiovascular 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 glucose-lowering agents and cardiovascular drugs (including for blood pressure and cholesterol). The primary endpoint was defined as time to first occurrence of cardiovascular death, non-fatal heart attack or non-fatal stroke.

Given the critical connection between diabetes and cardiovascular disease, Boehringer Ingelheim and Eli Lilly and Company are committed to providing a wide range of diabetes therapies along with programs and support to raise awareness, understanding and action toward reducing the impact of cardiovascular disease in people with type 2 diabetes.