RIDGEFIELD, Conn. and INDIANAPOLIS, June 23, 2018 — Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) today 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."
About EMPA-REG OUTCOME® (NCT01131676) 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.
Although the EMPA-REG OUTCOME trial was not designed to assess the potential mechanisms behind the effect of Jardiance on kidney outcomes, the kidney assessment was part of a pre-specified exploratory analysis plan of additional endpoints.
The overall safety profile of Jardiance was consistent with that of previous trials.
About Chronic Kidney Disease Chronic kidney disease is defined as a progressive decline of kidney function over time. About two thirds of chronic kidney disease cases are attributable to metabolic diseases such as diabetes, hypertension and obesity. Notably, chronic kidney disease is associated with increased morbidity and mortality. The majority of deaths among people with chronic kidney disease occur as a result of cardiovascular complications, often before reaching end stage renal disease. Chronic kidney disease affects approximately 15 percent of adults in the United States and treatment costs are estimated to exceed $48 billion annually. Since there are currently only few treatment options, the overarching unmet medical need for new treatment options in chronic kidney disease is evident.
About Heart Failure Heart failure is a progressive, debilitating and potentially fatal condition that occurs when the heart cannot pump enough blood around the body. Symptoms of heart failure include difficulty breathing, swelling—most commonly in feet, legs and ankles—and fatigue, among others. Heart failure is a prevalent disease; 26 million people around the world and more than 6 million people in the United Stateshave chronic heart failure. There is a high unmet need in the treatment of heart failure, as approximately 50 percent of people diagnosed with heart failure will die within five years. Additionally, heart failure represents the most common cause of hospitalization among individuals aged 65 years and over in the United States and Europe. Heart failure is highly prevalent in people with diabetes, but approximately half of all people with heart failure do not have diabetes.
What is JARDIANCE? (www.jardiance.com) JARDIANCE is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
JARDIANCE is also used to reduce the risk of cardiovascular death in adults with type 2 diabetes who have known cardiovascular disease.
JARDIANCE is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).