New analyses of the landmark EMPA-REG OUTCOME trial showed that Jardiance (empagliflozin) tablets reduced the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease, independent of blood sugar control at the start of the study. A reduction in cardiovascular death was also seen when Jardiance was added to common first and second-line diabetes medications, such as metformin or sulfonylurea.
"Now that we have a new option for reducing the risk of cardiovascular death among adults with type 2 diabetes, we are striving to better understand if there are differences in how adults with type 2 diabetes can benefit," said Silvio Inzucchi, M.D., professor of medicine, Yale School of Medicine, who presented the data today. "These new analyses of the EMPA-REG OUTCOME trial showed empagliflozin was effective in reducing the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease, no matter what the blood sugar levels at the start of the study were or if empagliflozin was added to commonly used oral blood sugar lowering treatments."
In all four blood sugar level groups at study start (A1C levels of <7.0 percent, 7.0 percent to <8.0 percent, 8.0 percent to <9.0 percent and ≥9.0 percent), patients receiving Jardiance demonstrated a reduction in the risk of cardiovascular death compared with placebo. This was consistent with the risk reduction seen in the overall trial population and seen irrespective of whether blood sugar control was improved following introduction of the study treatment (as measured by a decrease in A1C level of ≥ 0.5 percent at week 12).
Additional post-hoc analyses showed that when Jardiance was added to metformin or sulfonylurea, the reduction of cardiovascular death compared with placebo was consistent with the overall trial population. These analyses also showed the proportion of patients with hypoglycemic side effects were similar between the placebo and Jardiance groups in the EMPA-REG OUTCOME trial.
Jardiance is the first and only oral type 2 diabetes medicine approved to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease. The landmark EMPA-REG OUTCOME trial demonstrated that Jardiance reduced the risk of cardiovascular death by 38 percent versus placebo in people with type 2 diabetes and established cardiovascular disease when added to standard of care (including glucose-lowering agents and cardiovascular drugs). The overall safety profile of Jardiance in EMPA-REG OUTCOME was consistent with that of previous studies of Jardiance and current label information.
"Cardiovascular disease remains the leading cause of death in people with type 2 diabetes and contributes significantly to the burden of diabetes care," said David Kendall, M.D., distinguished medical fellow, Lilly Diabetes. "The results presented at EASD add further evidence of the benefit Jardiance can provide to adults with type 2 diabetes with different background blood sugar control."
Approximately 30 million Americans and an estimated 415 million people worldwide have diabetes, and nearly 24 percent of Americans with diabetes—or more than 7 million people—are undiagnosed. In the U.S., approximately nine percent of those aged 18 and older have diabetes. Type 2 diabetes is the most common type, accounting for an estimated 90 to 95 percent of all diagnosed adult diabetes cases in the U.S. Diabetes is a chronic condition that occurs when the body does not properly produce or use the hormone insulin.
Due to the complications associated with diabetes, such as high blood sugar, high blood pressure and obesity, cardiovascular disease is a major complication and the leading cause of death associated with diabetes. People with diabetes are two to four times more likely to develop cardiovascular disease than people without diabetes. Approximately 50 percent of deaths in people with type 2 diabetes worldwide and approximately two-thirds of deaths in people with type 2 diabetes in the U.S. are caused by cardiovascular disease. In the U.S., healthcare costs for managing cardiovascular conditions in patients with diabetes totaled more than $23 billion in 2012.
Having a history of diabetes at age 60 can shorten a person's lifespan by as much as six years compared with someone without diabetes. And having both diabetes and a history of heart attack or stroke at age 60 can shorten a person's lifespan by as much as 12 years compared with someone without these conditions.