New data presented at the American Heart Association Scientific Sessions 2016 showed that Jardiance (empagliflozin) tablets consistently reduced the risk for cardiovascular death, regardless of the type of cardiovascular disease at baseline, compared with placebo when added to standard of care in adults with type 2 diabetes and established cardiovascular disease.
The findings are part of the landmark EMPA-REG OUTCOME trial, which is the first trial of a diabetes medication to show a reduction in cardiovascular death in adults with type 2 diabetes and established cardiovascular disease. This study is supported by Boehringer Ingelheim and Eli Lilly and Company.
"Cardiovascular disease is two to four times more common in people with type 2 diabetes and is an umbrella term consisting of several different vascular outcomes, including heart attack, heart failure, peripheral vascular disease and stroke," said lead investigator of the trial Bernard Zinman, M.D., director, Diabetes Centre, Mount Sinai Hospital, Toronto; senior scientist, Lunenfeld Tanenbaum Research Institute, and professor of medicine, University of Toronto. "Since approximately two out of three deaths in people with type 2 diabetes in the US are attributed to cardiovascular causes, we need diabetes therapies that help reduce this complication in individuals who have an underlying cardiovascular issue."
For this post hoc analysis, trial participants were grouped based on type of cardiovascular disease at baseline, which included history of heart attack, stroke, heart failure, atrial fibrillation and existing peripheral artery disease. Lower rates of cardiovascular death were seen in the Jardiance group independent of cardiovascular disease type. Observed adverse events were consistent with the known safety profile of Jardiance.
"Jardiance is the only oral type 2 diabetes medicine shown in a clinical trial to reduce the risk of cardiovascular death," said Professor Hans-Juergen Woerle, global vice president medicine, Metabolism, Boehringer Ingelheim. "These results provide further evidence and reinforce the strength of the EMPA-REG OUTCOME data demonstrating a reduction in risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease."
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.
Over a median of 3.1 years, Jardiance significantly reduced the risk of cardiovascular death, non-fatal heart attack or non-fatal stroke by 14 percent versus placebo. Risk of cardiovascular death was reduced by 38 percent, with no significant difference in the risk of non-fatal heart attack or non-fatal stroke.
The overall safety profile of Jardiance in the EMPA-REG OUTCOME trial was consistent with that of previous trials.
Approximately 29 million Americans and an estimated 415 million people worldwide have diabetes, and nearly 28 percent of Americans with diabetes—totaling 8 million people—are undiagnosed. In the US, approximately 12 percent of those aged 20 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 US. 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 68 percent of deaths in people with type 2 diabetes in the US are caused by cardiovascular disease. In the US, health care costs for managing cardiovascular conditions in patients with diabetes totaled more than $23 billion in 2012.
Having diabetes 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 can shorten a person's lifespan by as much as 12 years compared with someone without these conditions.