Interim analysis from EMPRI

• This analysis on effectiveness also shows      empagliflozin was associated with a similar risk of non-fatal      atherosclerotic cardiovascular events compared with DPP-4 inhibitors or      GLP-1 receptor agonists¹

• A second analysis on healthcare resource      utilisation shows empagliflozin was associated with a reduced risk in      all-cause hospitalisations compared with DPP-4 inhibitors²

INGELHEIM, Germany and INDIANAPOLIS, US -- (BUSINESS WIRE) --

A new interim analysis of three-year data from the EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) real-world study on effectiveness shows that empagliflozin was associated with a decreased risk of hospitalisation for heart failure and a similar risk of non-fatal atherosclerotic cardiovascular events compared with DPP-4 inhibitors and GLP-1 receptor agonists.¹ The interim analysis included 190,000 adults in the US with type 2 diabetes with and without cardiovascular disease. The results were shared today on behalf of Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) at the American Heart Association^® Scientific Sessions 2019 in Philadelphia, US.

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“Heart failure is the most common cause of hospitalisation among individuals aged 65 years and over in Europe and the US. It is therefore encouraging to see that, in addition to the clinical trial setting, empagliflozin has been seen to reduce the risk of heart failure hospitalisation in people with type 2 diabetes in routine clinical practice,” said Waheed Jamal, MD, Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim. “On top of this, as one in three people with type 2 diabetes has cardiovascular disease, it is encouraging to see similar results on risk of non-fatal atherosclerotic cardiovascular events with empagliflozin and other type 2 diabetes medications that have also previously shown favourable results for this endpoint.”

In this new interim analysis, empagliflozin was associated with a reduction in risk of hospitalisation for heart failure of 41 percent compared with DPP-4 inhibitors and of 17 percent compared with GLP-1 receptor agonists.¹ Risk for non-fatal atherosclerotic cardiovascular events – defined as non-fatal heart attack or stroke, hospitalisation for unstable angina or coronary revascularisation – was similar for those treated with empagliflozin (14.6 events per 1,000 patient-years) compared with DPP-4 inhibitors (17.6 events per 1,000 patient-years). The risk was also similar for those treated with empagliflozin (14.2 events per 1,000 patient-years) compared with GLP-1 receptor agonists (14.8 events per 1,000 patient-years).¹

In a second interim analysis of EMPRISE, which included more than 45,000 patients, empagliflozin was associated with a significant reduction in all-cause hospitalisations, emergency department visits and physician’s office visits compared with DPP-4 inhibitors.²

Results from the EMPRISE real-world study in routine clinical care complement data from the landmark EMPA-REG OUTCOME^® trial, in which empagliflozin showed a 35 percent relative risk reduction in hospitalisation for heart failure compared with placebo in adults with type 2 diabetes and established cardiovascular disease. The EMPA-REG OUTCOME^® trial also showed a 38 percent relative risk reduction in cardiovascular death in those taking empagliflozin versus placebo in the same population.³

“We are pleased to see the three-year data for EMPRISE continues to complement findings from the EMPA-REG OUTCOME trial,” said Sherry Martin, MD, Vice President, Global Medical Affairs, Lilly. “These new real-world findings are just one part of a broad and comprehensive clinical development programme, including a large heart failure programme, that explores how empagliflozin can improve patient health outcomes and potentially fill treatment gaps for people with cardiorenal metabolic conditions.”

The effects of empagliflozin on heart failure-related outcomes and functional capacity in people with heart failure are being evaluated in the empagliflozin heart failure programme. The programme, which includes more than 9,500 adults with heart failure, including those with and without diabetes, consists of the EMPEROR-Reduced, EMPEROR-Preserved, EMPERIAL-Reduced, EMPERIAL-Preserved, EMPULSE and EMPA-VISION studies.^4,5,6,7,8,9

About EMPRISE^1,10,11
EMPRISE was initiated in 2016 to complement the EMPA-REG OUTCOME^® trial results by providing data on the comparative effectiveness, safety, healthcare resource utilisation and costs in routine clinical care compared with DPP-4 inhibitors in people with type 2 diabetes with and without cardiovascular disease. In addition, a sub-group analysis has provided data on the effectiveness of empagliflozin compared with GLP-1 receptor agonists.

The study will assess the first five years of empagliflozin use in the US between 2014 and 2019. Data analyses includes planned interim analyses (based on 12-month data updates) and a final analysis. More than 200,000 people with type 2 diabetes are projected to participate in the EMPRISE trial by its completion. From 2019, additional EMPRISE studies, including 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)³
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 medication for the treatment of hypertension and hypercholesteremia). 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 Heart Failure
Heart failure is a progressive, debilitating and potentially fatal condition that occurs when the heart cannot supply adequate circulation to meet the body’s demands for oxygenated blood or, to do so, requires increased blood volume leading to fluid accumulation (congestion) in the lungs and peripheral tissues.¹² It is a widespread condition, affecting 60 million people worldwide, and expected to increase as the population ages.¹³ Heart failure is highly prevalent in people with diabetes; however, approximately half of all people with heart failure do not have diabetes.^14,15

Symptoms of heart failure include difficulty with breathing, swelling – most commonly in feet, legs and ankles – and fatigue, among others.¹⁶ People with heart failure experience a substantial reduction in quality of life, approximately 76 percent of whom find it difficult to carry out usual activities.¹⁷ This is, in part, due to limitation of physical activity.

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.¹⁸ Additionally, heart failure represents the most common cause of hospitalisation among individuals aged 65 years and over in the US and Europe.¹⁴

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.^19,20,21

Inhibition of SGLT2 with empagliflozin in people with type 2 diabetes and high blood sugar levels prevents sugar being re-absorbed by the kidneys, leading to the excretion of excess sugar in the urine. In addition, initiation of empagliflozin also prevents salt being re-absorbed, leading to increased excretion of salt from the body and reducing 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.²²