Jardiance® reduced risk of kidney disease progression in adults with type 2 diabetes and established cardiovascular (CV) disease independent of control of conventional CV risk factors
Jardiance® reduced risk of kidney disease progression in adults with type 2 diabetes and established cardiovascular (CV) disease independent of control of conventional CV risk factors - In separate analysis, Jardiance (empagliflozin) reduced risk of CV death or hospitalization for heart failure in adults with CV disease and type 2 diabetes, irrespective of their CV risk at study start |
[23-June-2018] |
RIDGEFIELD, Conn. and INDIANAPOLIS, June 23, 2018 /PRNewswire/ -- 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) 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 About Heart Failure What is JARDIANCE? (www.jardiance.com) 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). IMPORTANT SAFETY INFORMATION What is the most important information I should know about JARDIANCE? JARDIANCE can cause serious side effects, including:
Who should not take JARDIANCE? Do not take JARDIANCE if you are allergic to empagliflozin or any of the ingredients in JARDIANCE. Do not take JARDIANCE if you have severe kidney problems or are on dialysis. What should I tell my doctor before using JARDIANCE? Tell your doctor if you:
Tell your doctor about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take water pills (diuretics) or medicines that can lower your blood sugar such as insulin. What are other possible side effects of JARDIANCE?
If you have any of these symptoms, stop taking JARDIANCE and contact your doctor or go to the nearest emergency room right away.
The most common side effects of JARDIANCE include urinary tract infections, and yeast infections in females. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. For more information, please see full Prescribing Information and Patient Information. CL-JAR-100002 12.19.17 Boehringer Ingelheim and Eli Lilly and Company About Boehringer Ingelheim Boehringer Ingelheim is one of the world's top 20 pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with approximately 50,000 employees. Since its founding in 1885, the company has remained family-owned and today creates value through innovation for three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and their families. Our employees create and engage in programs that strengthen our communities. Please visit www.boehringer-ingelheim.us/csr to learn more about how we make more health through our Corporate Social Responsibility initiatives. In 2017, Boehringer Ingelheim achieved net sales of about $20.4 billion (18.1 billion euros). R&D expenditure corresponds to approximately $3.4 billion (three billion euros), or 17.0 percent of its net sales. For more information please visit www.boehringer-ingelheim.us, or follow us on Twitter @BoehringerUS. About Lilly Diabetes About Eli Lilly and Company
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Jardiance and reflects Lilly's current belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with the results to date or that Jardiance will receive additional regulatory approvals. For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. Jardiance® and EMPA-REG OUTCOME® are registered trademarks of Boehringer Ingelheim.
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