Boehringer Ingelheim and Eli Lilly and Company announced findings from two new analyses of the landmark EMPA-REG OUTCOME trial, presented at the 78th American Diabetes Association (ADA) Scientific Sessions. Results include a post-hoc analysis demonstrating consistent effects for Jardiance versus placebo on renal outcomes in patients with established cardiovascular (CV) disease and type 2 diabetes, irrespective of control of certain CV risk factors.
“Previous EMPA-REG OUTCOME data suggested that Jardiance may reduce the risk of new or worsening kidney disease in adults with cardiovascular disease and type 2 diabetes, which is the number one cause of kidney failure in the U.S.,” said Thomas Seck, M.D., vice president of Clinical Development and Medical Affairs – Primary Care, Boehringer Ingelheim Pharmaceuticals, Inc. “In this analysis, the reduced risk of kidney disease progression seen with Jardiance was present whether or not patients had control of common cardiovascular risk factors, such as cholesterol and blood pressure.”
This new post-hoc analysis of the EMPA-REG OUTCOME trial showed Jardiance consistently reduced the risk of new or worsening kidney disease versus placebo irrespective of control of blood pressure, low-density lipoprotein (LDL) cholesterol or A1C levels, individually or combined. Control of these measures was defined as systolic blood pressure below 90 mmHg, LDL cholesterol under 100 mg/dL and A1C levels below 7.5 percent.
In a separate presentation, the effect of Jardiance versus placebo on CV outcomes was examined in a post-hoc analysis of sub-groups of EMPA-REG OUTCOME defined by CV risk at trial start—low, intermediate, high, and highest risk (per the 10-point TIMI Risk Score for Secondary Prevention). The findings demonstrated consistent reductions in the risk of CV death with Jardiance compared with placebo independent of CV risk group. Similar consistency in the effects of Jardiance among CV risk groups was seen for reduced risk for hospitalization for heart failure and for the combination of hospitalization for heart failure or CV death.
“Identifying ways to reduce serious outcomes such as heart failure is critical for adults with type 2 diabetes and cardiovascular disease, irrespective of their degree of cardiovascular risk,” said Jeff Emmick, M.D., Ph.D., vice president, Product Development, Lilly Diabetes. “We are encouraged by the consistent reductions in cardiovascular death and hospitalization for heart failure with Jardiance seen across the spectrum of risk in this patient population. We look forward to our continued study of Jardiance in cardiometabolic areas of high unmet need, particularly our planned trials in chronic kidney disease and chronic heart failure in adults both with and without diabetes.”
(Source: Eli Lilly and Company)
Filed Under: Drug Discovery