- Empagliflozin significantly reduced the risk of cardiovascular death or hospitalization for heart failure versus placebo in the EMPEROR-Reduced heart failure trial. The study evaluated adults with heart failure with reduced ejection fraction
- Treatment of heart failure is an important unmet need with over half of those diagnosed dying within five years1
- The EMPEROR-Reduced trial included 32 study sites across Canada
"Heart failure is on the rise and is a major cause of death, disability and cost to Canadians. New therapies to treat heart failure are urgently required," said Dr.
An estimated 600,000 Canadians are living with heart failure, and the risk of death in people with heart failure rises with each hospital admission.2,3 Heart failure with reduced ejection fraction occurs when the heart muscle does not contract effectively, and less blood is pumped out to the body compared to a normally functioning heart.4 Symptoms associated with heart failure, such as breathlessness and fatigue, can impact quality of life.2
"One in five people can expect to develop heart failure in their lifetime, so it is very encouraging to see these positive results from the EMPEROR-Reduced trial demonstrating that empagliflozin improves heart failure outcomes," said
Full results from the EMPEROR-Reduced trial will be presented in a hot line session at the
Additionally, a second study, the EMPEROR-Preserved trial is exploring the effect of empagliflozin on cardiovascular death or hospitalization in adults with heart failure with preserved ejection fraction – an area with no approved treatment options.5,6 EMPEROR-Preserved results are expected in 2021.
The EMPEROR trials are part of the EMPOWER clinical program, one of the broadest and most comprehensive of any SGLT2 inhibitor, exploring the impact of empagliflozin on the lives of people across the spectrum of cardio-renal-metabolic conditions.
"These results build upon the already established cardiovascular benefits of empagliflozin in adults living with type 2 diabetes and cardiovascular disease," said
About the EMPEROR Heart Failure Studies6,7
The EMPEROR (EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure) chronic heart failure studies are two Phase III, randomized, double-blind trials investigating once-daily empagliflozin compared with placebo in adults with chronic heart failure with preserved or reduced ejection fraction*, both with and without diabetes, who are receiving current standard of care:
- EMPEROR-Reduced [NCT03057977]: will investigate the safety and efficacy of empagliflozin in patients with chronic heart failure with reduced ejection fraction (HFrEF)
- Primary endpoint: time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure
- Number of patients: 3,730
- Completion: 2020
- EMPEROR-Preserved [NCT03057951]: will investigate the safety and efficacy of empagliflozin in patients with chronic heart failure with preserved ejection fraction (HFpEF).
- Primary endpoint: time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure [Time Frame: up to 38 months]
- Anticipated number of patients: approx. 5,990
- Estimated completion: 2021
*Ejection fraction is a measurement of the percentage of blood the left ventricle pumps out with each contraction. When the heart relaxes, the ventricle refills with blood.
HFrEF occurs when the heart muscle does not contract effectively, and less blood is pumped out to the body compared with a normally functioning heart.
HFpEF occurs when the heart muscle contracts normally but the ventricle does not fill with enough blood, so less blood can enter the heart compared with a normally functioning heart.
About the EMPOWER program
The Alliance has developed the EMPOWER program to explore the impact of empagliflozin on major clinical cardiovascular and renal outcomes in a spectrum of cardio-renal-metabolic conditions. Cardio-renal-metabolic conditions are the leading cause of mortality worldwide and account for up to 20 million deaths annually.8 Through the EMPOWER program, Boehringer Ingelheim and
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.9 An estimated 600,000 Canadians are living with heart failure.2 Worldwide 60 million people are affected and the prevalence is expected to increase as the population ages.10 Heart failure is highly prevalent in people with diabetes11 however, approximately half of all people with heart failure do not have diabetes.10,12
The empagliflozin heart failure program was initiated based on data from the EMPA-REG OUTCOME® trial, which assessed the effect of empagliflozin added to standard of care compared with placebo added to standard of care.13
About Cardio-Renal-Metabolic Conditions
Boehringer Ingelheim and
The cardiovascular, renal and metabolic systems are interconnected, and share many of the same risk factors and pathological pathways along the disease continuum. Dysfunction in one system may accelerate the onset of others, resulting in progression of interconnected diseases such as type 2 diabetes, cardiovascular disease, heart failure, and kidney disease, which in turn leads to an increased risk of cardiovascular death. Conversely, improving the health of one system can lead to positive effects throughout the others.14,15
Through our research and treatments, our goal is to support people's health, restoring the balance between the interconnected cardio-renal-metabolic systems and reducing their risk of serious complications. As part of our commitment to those whose health is jeopardized by cardio-renal-metabolic conditions, we will continue embracing a multidisciplinary approach towards care and focusing our resources on filling treatment gaps.
About Empagliflozin
Empagliflozin 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 its label in several countries.16,17
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.18
About Boehringer Ingelheim and
In
About
Making new and better medicines for humans and animals is at the heart of what we do. Our mission is to create breakthrough therapies that change lives. Since its founding in 1885, Boehringer Ingelheim is independent and family-owned. We have the freedom to pursue our long-term vision, looking ahead to identify the health challenges of the future and targeting those areas of need where we can do the most good.
As a world-leading, research-driven pharmaceutical company, more than 51,000 employees create value through innovation daily for our three business areas: Human Pharma,
We realize more scientific opportunities by embracing the power of partnership and diversity of experts across the life-science community. By working together, we accelerate the delivery of the next medical breakthrough that will transform the lives of patients now, and in generations to come.
The Canadian headquarters of Boehringer Ingelheim was established in 1972 in
More information about Boehringer Ingelheim can be found at www.boehringer-ingelheim.ca or in our annual report: http://annualreport.boehringer-ingelheim.com.
About
For our perspective on issues in healthcare and innovation, follow us on twitter @LillyPadCA.
References
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1 | Ponikowski P, Anker SD, AlHabib KF. Heart Failure: preventing disease and death worldwide. ESC Heart Fail. 2014;1(1):4–25. |
2 | |
3 | Solomon S, Dobson J, Pocock S, et al. Influence of Nonfatal Hospitalization for Heart Failure on Subsequent Mortality in Patients with Chronic Heart Failure. Circulation. 2007;116(13):1482–7. |
4 | |
5 | ClinicalTrials.gov. EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved). Available at: https://clinicaltrials.gov/ct2/show/NCT03057951. Accessed |
6 | Harper A, Patel H, |
7 | ClinicalTrials.gov. EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction (EMPEROR-Reduced). Available at: https://clinicaltrials.gov/ct2/show/NCT03057977. Accessed |
8 | GBD 2015 Mortality and Causes of Death Collaborators. Global, regional, and national life expectancy, all-cause mortality, and cause-specific mortality for 249 causes of death, 1980–2015: A systematic analysis for the Global Burden of Disease Study 2015. The |
9 | |
10 | GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. |
11 | Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA guideline for the management of heart failure: a report of the |
12 | Suskin N, McKelvie RS, Burns RJ, et al. Glucose and insulin abnormalities relate to functional capacity in patients with congestive heart failure. |
13 | Zinman B, Wanner C, Lachin JM, et al. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015;373:2117–28. |
14 | Ronco, |
15 | |
16 | Product Monograph Jardiance®. Canada. Available at: https://www.boehringer-ingelheim.ca/sites/ca/files/documents/jardiancepmen.pdf. Accessed: July2020. |
17 | European Summary of Product Characteristics Jardiance®, approved |
18 | Vallon V and Thompson SC. Targeting renal glucose reabsorption to treat hyperglycaemia: the pleiotropic effects of SGLT2 inhibition. Diabetologia. 2017;60(2):215–25. |
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