INGELHEIM, Germany & INDIANAPOLIS, US - Monday, June 13th 2016 [ME NewsWire]
In a separate analysis, Jardiance® also reduced risk for CV events consistently in groups divided by LDL cholesterol level
Results from sub-analyses of the landmark EMPA-REG OUTCOME® trial presented at the American Diabetes Association 76th Scientific Sessions®
(BUSINESS WIRE)-- New analyses showed risk reductions were consistent across age groups for cardiovascular (CV) outcomes, including CV death, with Jardiance® (empagliflozin) compared with placebo when added to standard of care in adults with type 2 diabetes (T2D) and established CV disease. These data, which were presented at the American Diabetes Association (ADA) 76th Scientific Sessions® in New Orleans, are from the Boehringer Ingelheim and Eli Lilly and Company EMPA-REG OUTCOME® trial.
“As people with type 2 diabetes age, their risk for cardiovascular events increases,” said lead investigator of the trial Dr Bernard Zinman, Director, Diabetes Centre, Mount Sinai Hospital; Senior Scientist, Lunenfeld Tanenbaum Research Institute, and Professor of Medicine, University of Toronto, Canada. “These sub-analyses suggest that empagliflozin is associated with reducing cardiovascular events regardless of age when starting treatment. These data provide additional information about the EMPA-REG OUTCOME trial.”
Data presented at the ADA Scientific Sessions® examined the effect of treatment with Jardiance® by age in the EMPA-REG OUTCOME® trial. Trial participants were grouped based on their age at baseline: under 65 years, from 65 to 74, and 75 years and older. Consistent reduction in the risk of CV death was seen independent of age groups. Further analysis demonstrated similar consistency by age group in reducing risk for hospitalisation for heart failure, as well as for the combination of hospitalisation for heart failure or CV death. Adverse events were consistent with the known safety profile of Jardiance®.
Furthermore, the reduction in risk for CV events did not differ among sub-groups of people in the EMPA-REG OUTCOME® trial based on their LDL (“bad”) cholesterol levels at baseline (<70 mg/dL; 70-<85 mg/dL; 85-<100 mg/dL; 100-115 mg/dL; and >115 mg/dL). The risk reduction with Jardiance® was consistent across the LDL sub-groups (indicated by a lack of statistical interaction by sub-group) for the combination of CV death, non-fatal heart attack or non-fatal stroke, as well as for the individual outcomes of CV death, hospitalisation for heart failure and death from any cause.
“These analyses from the landmark EMPA-REG OUTCOME trial further demonstrate that Jardiance reduced the risk of cardiovascular death and hospitalisation for heart failure in people with type 2 diabetes,” said Professor Hans-Juergen Woerle, Global Vice President Medicine, Boehringer Ingelheim. “Through our ongoing research, the Boehringer Ingelheim and Eli Lilly and Company Diabetes Alliance is proud to continue to advance the understanding of how to improve the management of cardiovascular risk in this population.”
Additional insight into the EMPA-REG OUTCOME® findings will be presented at an ADA Scientific Sessions® symposium on Tuesday 14 June at 08:00 CDT.
About the EMPA-REG OUTCOME® Trial
EMPA-REG OUTCOME® was a long-term, multicentre, randomised, double-blind, placebo-controlled trial of more than 7,000 patients from 42 countries with type 2 diabetes and established cardiovascular (CV) 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 CV drugs (including for blood pressure and cholesterol). The primary endpoint was defined as time to first occurrence of CV death, non-fatal heart attack or non-fatal stroke.
Over a median of 3.1 years, Jardiance® significantly reduced the risk of CV death, non-fatal heart attack or non-fatal stroke by 14 percent versus placebo. Risk of CV 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.
About Diabetes and Cardiovascular Disease
More than 415 million people worldwide have diabetes, of which 193 million are estimated to be undiagnosed. By 2040, the number of people with diabetes is expected to rise to 642 million people worldwide. Type 2 diabetes is the most common form of diabetes, responsible for up to 91 percent of diabetes cases in high-income countries. Diabetes is a chronic condition that occurs when the body either 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, CV 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 CV disease than people without diabetes. In 2015, diabetes caused 5 million deaths worldwide, with CV disease as the leading cause. Approximately 50 percent of deaths in people with type 2 diabetes worldwide are caused by CV disease.
Jardiance® (empagliflozin) is an oral, once daily, highly selective sodium glucose co-transporter 2 (SGLT2) inhibitor approved for use in Europe, the United States and other markets around the world for the treatment of adults with type 2 diabetes.
Jardiance® works by blocking the reabsorption of glucose (blood sugar) by the kidney, leading to urinary glucose excretion, and lowering blood glucose levels in people with type 2 diabetes. SGLT2 inhibition targets glucose directly and works independently of β-cell function and the insulin pathway.
Jardiance® is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).
This press release is issued from Boehringer Ingelheim Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where Boehringer Ingelheim and Eli Lilly and Company do business.
Please click on the link below for ‘Notes to Editors’ and ‘References’:
Boehringer Ingelheim GmbH
Dr Ralph Warsinsky
Executive Director Media & PR
Phone: +49 6132 77 7051
Phone: +1 (317) 478 5423