IN-BOEHRINGER-INGELHEIM

Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced initial results from the EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) real-world evidence study that show that empagliflozin is associated with a 22 percent relative risk reduction in all-cause hospitalisations, compared to DPP-4 inhibitors, within a mean follow-up of 5.4 months.¹ Among those admitted to hospital, people treated with empagliflozin were discharged earlier compared to those treated with DPP-4 inhibitors (17,539 matched pairs in each treatment group).¹

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Results also show that empagliflozin is associated with significantly fewer recurrent emergency department visits and physician’s office visits compared to DPP-4 inhibitors.¹ These initial results, observed during the first two years of the EMPRISE real-world evidence study evaluating US-only data, were presented at the Academy of Managed Care Pharmacy (AMCP) Annual Meeting 2019 in San Diego, US.

Initial EMPRISE results support data from the landmark EMPA-REG OUTCOME^® trial, which showed a relative risk reduction of 11 percent in all-cause hospitalisations with empagliflozin in people with type 2 diabetes and established cardiovascular disease.³

“People with diabetes are more likely to be admitted to hospital from any cause than those without the condition, experiencing longer and more costly hospital stays. This can have a substantial impact on healthcare resources,” said Dr Mehdi Najafzadeh, PhD, MSc, MA, of the Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital and Instructor in Medicine, Harvard Medical School and study co-investigator. “Initial results from the EMPRISE real-world study show that empagliflozin is associated with a relative risk reduction in hospitalisations and with a shorter length of hospital stay for people with type 2 diabetes.”

Initial effectiveness and safety data from EMPRISE were also recently presented at the American College of Cardiology’s 68^th Annual Scientific Session & Expo in New Orleans, US (ACC.19). Results show that empagliflozin was associated with a 42 percent relative risk reduction in hospitalisation for heart failure* or all-cause mortality compared to DPP-4 inhibitors, and was not associated with a statistically significant increased risk of bone fracture or lower leg amputation compared to DPP-4 inhibitors.² These results support the findings from the EMPA-REG OUTCOME^® trial, which showed that empagliflozin reduced the relative risk of hospitalisation for heart failure or cardiovascular death in people with type 2 diabetes and established cardiovascular disease by 34 percent, with no imbalance with bone fractures or lower leg amputation.⁴

*Broad definition of hospitalisation for heart failure, defined as a discharge diagnosis of heart failure in any position.

About EMPRISE (NCT03363464, EUPAS20677) ⁵
EMPRISE was initiated in 2016 to complement the EMPA-REG OUTCOME^® trial results and provide a comprehensive clinical picture of empagliflozin in routine care. By study completion, EMPRISE will provide insights into the comparative effectiveness, safety, healthcare resource utilisation and costs of empagliflozin, compared with DPP-4 inhibitors, in people with type 2 diabetes with and without cardiovascular disease in routine clinical care.

The study will assess the first five years of empagliflozin use in the US between 2014 and 2019. Over 200,000 people with type 2 diabetes from two commercial US healthcare providers and Medicare are projected to be included by study completion. From 2019, additional EMPRISE studies including analyses of data from Asia and Europe will provide insights from different regions of the world with an international perspective on the use of empagliflozin in routine clinical care.

The EMPRISE study was initiated, and is being led, by academic partners from the Division of Pharmacoepidemiology at Brigham and Women’s Hospital and Harvard Medical School, Boston, US. The study is part of an academic collaboration between Brigham and Women’s Hospital and Boehringer Ingelheim.

About EMPA-REG OUTCOME ^® (NCT01131676) ⁴
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.

The study assessed the effect of empagliflozin (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.

The overall safety profile of empagliflozin was consistent with that of previous trials.

About Diabetes and Cardiovascular Disease
More than 425 million people worldwide have diabetes, of which over 212 million are estimated to be undiagnosed.⁶  By 2045, the number of people with diabetes is expected to rise to 629 million people worldwide.⁶ Type 2 diabetes is the most common form of diabetes, responsible for around 90 percent of diabetes cases in high-income countries.⁶ Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin_. ⁶

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.^7,8 People with diabetes are two to four times more likely to develop cardiovascular disease than people without diabetes.⁸ In 2017, diabetes caused four million deaths worldwide, with cardiovascular disease as the leading cause.⁶ Approximately 50 percent of deaths in people with type 2 diabetes worldwide are caused by cardiovascular disease.^9,10

Having a history of diabetes at age 60 can shorten a person’s life span by as much as six years compared with someone without diabetes. And having both diabetes and a history of heart attack or stroke by age 60 can shorten a person’s life span by as much as 12 years compared with someone without these conditions.¹¹

More than 60 guidelines have been updated to endorse type 2 diabetes agents with proven cardiovascular benefits since 2016, including a Consensus Report initiated by the American Diabetes Association^® and European Association for the Study of Diabetes, recommending that, in patients with type 2 diabetes and established atherosclerotic cardiovascular disease, SGLT2 inhibitors (such as empagliflozin) or GLP1 receptor agonists with proven cardiovascular benefits are recommended as part of glycaemic management.^12,13

About Empagliflozin
Empagliflozin (marketed as Jardiance^® ) is an oral, once daily, highly selective sodium glucose cotransporter 2 (SGLT2) inhibitor and the first type 2 diabetes medicine to include cardiovascular death risk reduction data in the label in several countries.^14,15,16

Inhibition of SGLT2 with empagliflozin in people with type 2 diabetes and high blood sugar levels leads to excretion of excess sugar in the urine. In addition, initiation of empagliflozin increases excretion of salt from the body and reduces the fluid load of the body’s blood vessel system (i.e. intravascular volume). Empagliflozin induces changes to the sugar, salt and water metabolism in the body that may contribute to the reductions in cardiovascular death observed in the EMPA-REG OUTCOME^® trial.

Please click on the following link for ‘Notes to Editors’ and ‘References’:  http://www.boehringer-ingelheim.com/EMPRISE-real-world-study-results

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Contact:

Dr Petra Kienle Product Communication Manager Boehringer Ingelheim Email: press@boehringer-ingelheim.com Phone: +49 (6132) 77 143877 Stephan Thalen Global Business Communications Lilly Diabetes Email: stephan.thalen@lilly.com Phone: +1 317 903 5640