Boehringer Ingelheim and Lilly initiate first ever study to assess empagliflozin in people hospitalised for acute heart failure who have been stabilised

EMPULSE is a superiority study that will assess the clinical benefit, safety and tolerability of 10 mg daily empagliflozin in acute heart failure[1]
News Source: Boehringer Ingelheim International GmbH
2019-11-13 10:00
INGELHEIM, GERMANY & INDIANAPOLIS, US--(Business Wire/Korea Newswire) November 13, 2019 -- Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) today announced the initiation of EMPULSE, the sixth Phase III study in the empagliflozin heart failure programme. The study will assess whether in-hospital administration of empagliflozin 10 mg daily improves heart failure outcomes when initiated in people hospitalised for any type of acute heart failure event once they have been stabilised. The study will include participants both with and without type 2 diabetes.

Heart failure is the leading cause of hospitalisation in Europe and the US, and half of people with heart failure are expected to die within five years of diagnosis.[2,3] However, outcomes for patients after they have been hospitalised for heart failure are poor, with a 15 percent mortality and 30 percent readmission rate within 60 to 90 days of discharge from hospital.[4] Initiating treatment in hospital is one of the best predictors of long-term improved prognosis and patient treatment adherence.[5] The EMPULSE study aims to understand whether empagliflozin has the potential to improve outcomes in this population.

“Acute decompensated heart failure is one of the fastest-growing diseases in the world and a leading cause of hospital admissions worldwide with high short term mortality and rehospitalisation. Unlike chronic heart failure, there is no established therapy available that improves clinical outcomes in acute heart failure,” said Adriaan Voors, Professor of Cardiology, University Medical Center Groningen, Netherlands. “The beneficial effects of SGLT2 inhibitors, as seen in three large randomised trials in type 2 diabetes patients, are thought to be at least partly explained by the diuretic/natriuretic effects of SGLT2 inhibitors. The EMPULSE study will investigate whether empagliflozin, due to its mode of action, can alleviate symptoms associated with heart failure and improve outcomes after discharge from the hospital.”

The primary outcome of the study will be net clinical benefit, a composite of all-cause mortality, number of heart failure events (including hospitalisations, urgent heart failure visits and unplanned patient visits), time to first heart failure event and change from baseline in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS), an instrument for measuring disease-specific quality of life in heart failure.[1]

“We are particularly delighted to announce the addition of EMPULSE as the first-ever study to assess the effects of empagliflozin in people who have been hospitalised for acute heart failure,” said Mohamed Eid, M.D., M.P.H., M.H.A., Vice President, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc. "The study aims to address an unmet need and is an important addition to our broad and comprehensive heart failure programme.”

EMPULSE is part of the empagliflozin heart failure programme, which also consists of the EMPEROR-Reduced and EMPEROR-Preserved, EMPERIAL-Preserved and EMPERIAL-Reduced, and EMPA-VISION studies. These studies are investigating the effects of empagliflozin on heart failure-related outcomes and functional capacity in more than 9,500 adults with heart failure, including those with and without diabetes.[6,7,8,9,10]

About EMPULSE (NCT04157751)

The EMPULSE study is a multicentre, randomised, double-blind, 90-day superiority study to evaluate the effect on clinical benefit, safety and tolerability of once-daily oral EMPagliflozin 10 mg compared to placebo, initiated in patients hospitalised for acUte heart faiLure (de novo or decompensated chronic HF) who have been StabilisEd (EMPULSE).

· Primary endpoint: Net clinical benefit, a composite of all-cause mortality, number of heart failure events (including hospitalisations for heart failure, urgent heart failure visits and unplanned outpatient visits), time to first heart failure event and change from baseline in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS) after 90 days of treatment.

· Anticipated number of patients: approximately 500.

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.[11] It is a widespread condition affecting 60 million people worldwide and expected to increase as the population ages.[12] Heart failure is highly prevalent in people with diabetes;[13] however, approximately half of all people with heart failure do not have diabetes.[2,14]

Symptoms of heart failure include difficulty breathing, swelling - most commonly in feet, legs and ankles - and fatigue, among others.[15] 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.[16] This is, in part, due to the 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.[17] Additionally, heart failure represents the most common cause of hospitalisation among individuals aged 65 years and over in the US and Europe.[2]

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.[18,19,20]

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.[21]

Please click on the following link for ‘Notes to Editors’ and ‘References’: https://www.boehringer-ingelheim.com/press-release/empulse

View source version on businesswire.com: https://www.businesswire.com/news/home/20191112005650/en/
Media Contact: Boehringer Ingelheim   Stefanie Dölz   Product Communication Manager   +49 (6132) 77-172209       Lilly Diabetes   Stephan Thalen   Global Business Communications   +1 (317) 276 8304  
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