- Results from an analysis of the landmark EMPA-REG OUTCOME® trial were presented at the American Heart Association Scientific Sessions 2016
INGELHEIM, Germany and INDIANAPOLIS, IN, USA I November 14, 2016 I New data presented at the American Heart Association Scientific Sessions 2016 showed that Jardiance® (empagliflozin) 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.1 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 (NYSE: LLY).
“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 Dr Bernard Zinman, Director, Diabetes Centre, Mount Sinai Hospital, Toronto; Senior Scientist, Lunenfeld Tanenbaum Research Institute, and Professor of Medicine, University of Toronto, Canada. “Since approximately 50 percent of deaths in people with type 2 diabetes worldwide 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®.1,2
“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.”
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 disease.3
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.3
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.3
The safety profile of Jardiance® in the EMPA-REG OUTCOME® trial was consistent with that of previous trials. The overall incidence of adverse events was similar to placebo.3
About Diabetes and Cardiovascular Disease
More than 415 million people worldwide have diabetes, of which 193 million are estimated to be undiagnosed.4 By 2040, the number of people with diabetes is expected to rise to 642 million people worldwide.4 Type 2 diabetes is the most common form of diabetes, responsible for up to 91 percent of diabetes cases in high-income countries.4 Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.4
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.5,6 People with diabetes are two to four times more likely to develop cardiovascular disease than people without diabetes.5 In 2015, diabetes caused 5 million deaths worldwide,4 with cardiovascular disease as the leading cause.5 Approximately 50 percent of deaths in people with type 2 diabetes worldwide are caused by cardiovascular disease.7,8
About Jardiance®
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).
Intended audiences
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.
Boehringer Ingelheim and Eli Lilly and Company
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in diabetes that centres on compounds representing several of the largest diabetes treatment classes. This alliance leverages the strengths of two of the world’s leading pharmaceutical companies. By joining forces, the companies demonstrate commitment in the care of patients with diabetes and stand together to focus on patient needs. Find out more about the alliance at www.boehringer-ingelheim.com or www.lilly.com (link is external).
About Boehringer Ingelheim
Boehringer Ingelheim is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally through 145 affiliates and a total of some 47,500 employees. The focus of the family-owned company, founded in 1885, is on researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.
Social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects through, for example, the initiative “Making More Health” while also caring for employees. Respect, equal opportunity and reconciling career and family form the foundation of mutual cooperation. The company also focuses on environmental protection and sustainability in everything it does.
In 2015, Boehringer Ingelheim achieved net sales of about 14.8 billion euros. R&D expenditure corresponds to 20.3 per cent of net sales.
For more information please visit www.boehringer-ingelheim.com.
About Lilly Diabetes
Lilly has been a global leader in diabetes care since 1923, when we introduced the world’s first commercial insulin. Today we are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research and collaboration, a wide range of therapies and a continued determination to provide real solutions—from medicines to support programmes and more—we strive to make life better for all those affected by diabetes around the world. For more information, visit www.lillydiabetes.com (link is external).
About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com (link is external) and newsroom.lilly.com/social-channels (link is external).
References
1. Zinman B. et al. Consistent Effect of Empagliflozin on Cardiovascular Death in Subgroups by Type of Cardiovascular Disease: Results from EMPA-REG OUTCOME. Poster No. 16903. Presented at the American Heart Association (AHA) Scientific Sessions®. November 12 – 14, New Orleans, Louisiana.
2. Jardiance® (empagliflozin) tablets. EMA Summary of Product Characteristics. Approval 22 May 2014. Available from: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002677/WC500168592.pdf. (Last accessed: October 2016).
3. Zinman B, et al. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med 2015;373:2117–28.
4. International Diabetes Federation. IDF Diabetes Atlas, 7th edition. Brussels, Belgium 2015. Available from: www.diabetesatlas.org/ (Last accessed: June 2016).
5. World Heart Federation. Cardiovascular Disease Risk Factors. Available from: http://www.world-heart-federation.org/cardiovascular-health/cardiovascular-disease-risk-factors/diabetes/ (Last accessed: June 2016).
6. World Health Organisation. Diabetes: fact sheet no. 312. Available from: www.who.int/mediacentre/factsheets/fs312/en/# (Last accessed: June 2016).
7. Nwaneri C, Cooper H, Bowen-Jones D. Mortality in type 2 diabetes mellitus: magnitude of the evidence from a systematic review and meta-analysis. The British Journal of Diabetes & Vascular Disease. 2013;13(4):192-207.
8. Morrish, N.J., et al. Mortality and causes of death in the WHO Multinational Study of Vascular Disease in Diabetes. Diabetologia. 2001;44 Suppl 2:S14-21.
SOURCE: Boehringer Ingelheim
