Therapy Areas: Cardiovascular
Real-World Evidence Study Shows Empagliflozin Reduces Risk for Hospitalisation for Heart Failure
5 November 2018 - - Initial results from EMPRISE real-world evidence study shows empagliflozin was associated with reduced risk for hospitalisation for heart failure compared with DPP-4 inhibitors in people with type 2 diabetes with and without cardiovascular disease, German drugmaker Boehringer Ingelheim said.

Empagliflozin was associated with a 44% reduction in relative risk of hospitalization for heart failure compared with commonly used dipeptidyl peptidase-4 inhibitors

Effect of empagliflozin on HHF was consistent in patients with and without established cardiovascular disease

Findings support data from the landmark EMPA-REG OUTCOME trial, in which empagliflozin reduced the relative risk of HHF by 35 % in people with type 2 diabetes and established cardiovascular disease2

Initial effectiveness results from the real-world EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) study showed empagliflozin was associated with a 44% relative risk reduction in hospitalisation for heart failure compared with dipeptidyl peptidase-4 (DPP-4) inhibitors in routine clinical practice in the US

The EMPRISE analysis of data from approximately 35,000 people with type 2 diabetes between August 2014 and September 2016 will be presented at the American Heart Association(AHA) Scientific Sessions 2018 in Chicago, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced.

These results support findings from the EMPA-REG OUTCOMEtrial, which showed a 35% relative risk reduction in HHF (a secondary endpoint) with empagliflozin, compared with placebo, when added to standard of care, in people with type 2 diabetes and established cardiovascular disease.

The full EMPRISE real-world evidence study will provide a clinical picture of empagliflozin in routine clinical care including comparative effectiveness, safety and healthcare resource utilisation and cost outcomes compared with commonly used DPP-4 inhibitors between 2014 and 2019.

Early findings from EMPRISE, which at completion will assess the first five years of empagliflozin use in the US through 2019, represent data collected between August 2014 and September 2016.

The effectiveness findings will be updated as more data are gathered. Safety data from EMPRISE are not yet available and will be presented at a future time.

EMPRISE was initiated, and is being led by academic partners from the Division of Pharmacoepidemiology at Brigham and Women's Hospital and Harvard Medical School.

The study is part of an academic collaboration between Brigham and Women's Hospital and Boehringer Ingelheim.

By study completion, EMPRISE is expected to have analysed health records of more than 200,000 people with type 2 diabetes from two commercial US healthcare providers and Medicare.

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.

As part of their efforts to help address unmet needs, Boehringer Ingelheim and Lilly have initiated two large clinical trial programs focused on improving outcomes and reducing morbidity and mortality for people with heart failure.

EMPEROR HF comprises two Phase III outcome trials investigating empagliflozin for the treatment of adults with chronic heart failure.

The trials include not only adults with type 2 diabetes who have heart failure, but also people with heart failure who do not have diabetes.

EMPERIAL comprises two Phase III studies evaluating the effect of empagliflozin on exercise ability and heart failure symptoms in people with chronic heart failure with or without type 2 diabetes.

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.

The study will assess the first five years of empagliflozin use in the US between 2014 to 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 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, USA. The study is part of an academic collaboration between Brigham and Women's Hospital and Boehringer Ingelheim.

EMPA-REG OUTCOME was a long-term, multicenter, 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.

Heart failure is a progressive, debilitating and potentially fatal condition that occurs when the heart cannot pump enough blood around the body.

Symptoms of heart failure include difficulty with breathing, swelling most commonly in feet, legs and ankles and fatigue, among others.8 Heart failure is a prevalent disease; 26m people around the world have chronic heart failure.

There is a high unmet need in the treatment of heart failure, as upto 45% of people diagnosed with heart failure will die within one year.

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

Heart failure is highly prevalent in people with diabetes, but approximately half of all people with heart failure do not have diabetes.

More than 425 m people worldwide have diabetes, of which over 212 m are estimated to be undiagnosed.

By 2045, the number of people with diabetes is expected to rise to 629 m people worldwide.

Type 2 diabetes is the most common form of diabetes, responsible for around 90 % 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, cardiovascular 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 cardiovascular disease than people without diabetes.

In 2017, diabetes caused four m deaths worldwide, with cardiovascular disease as the leading cause.

Approximately 50 % of deaths in people with type 2 diabetes worldwide are caused by cardiovascular disease.

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.

More than 50 guidelines have been updated to endorse type 2 diabetes agents with proven cardiovascular benefits since 2016, including a recent 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.

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.
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