In a landmark trial developed by Boehringer Ingelheim and Lilly Alliance, treatment with empagliflozin showed significant improvement in heart failure outcomes in adults with preserved ejection fraction.
According to the American Heart Association, heart failure is a progressive, debilitating, and potentially fatal condition that happens when the heart cannot supply enough circulation to meet the body’s demands for oxygenated blood. Globally, more than 60 million people have heart failure and approximately half of them have heart failure with preserved ejection fraction (HFpEF), which is also known as diastolic heart failure. HFpEF has been described as the single largest unmet need in cardiovascular medicine based on prevalence, poor outcomes, and the absence of clinically proven therapies to date.
Within Singapore alone, heart failure is a significant public health issue affecting 4.5 per cent of the population, and a five-year survival rate for patients with heart failure is only at 32 per cent. Heart failure is also the most common cardiac-related cause of hospitalisation in the country and there has been a rise of about 40 per cent of heart failure admissions over the last decade.
Singaporeans are more likely to develop heart failure due to prevalent risk factors such as insufficient physical activity, smoking, obesity, diabetes mellitus, and hypertension. Risk factors such as type 2 diabetes and chronic kidney disease, which commonly present concurrently with heart failure, also result in a higher risk of mortality for patients with heart failure.
Published in The New England Journal of Medicine, the landmark EMPEROR-Preserved Phase III trial demonstrated that empagliflozin showed an impressive 21 per cent relative risk reduction for the composite primary endpoint of cardiovascular death or hospitalisation for heart failure in adults with HFpEF compared with placebo. The benefit was independent of ejection fraction or diabetes status, establishing empagliflozin as the first and only treatment to significantly improve outcomes for the full spectrum of heart failure patients.
Key secondary endpoint analyses from the trial showed that empagliflozin also reduced the relative risk of first and recurrent hospitalisations for heart failure by 27 per cent and significantly slowed kidney function decline.
“For people with heart failure with preserved ejection fraction, the reality is that so far there are no clinically proven treatments we can offer that would make a significant impact on their condition,” said Professor Stefan Anker, EMPEROR-Preserved Principal Investigator and Heart Failure Cardiologist at Charité Berlin, Germany. “This data brings hope for millions of patients suffering from heart failure with preserved ejection fraction. The primary endpoint was similarly improved in all subgroups of patients, in men and women, with and without diabetes, and regardless of their ejection fraction and kidney function level. This underlines the breadth of empagliflozin’s efficacy and its potential overall impact.”
The EMPEROR-Preserved trial included 5,988 people with heart failure. Of these, 4,005 had a left ventricular ejection fraction (LVEF) of 50 per cent or above and 1,983 had an LVEF below 50 per cent. Trial participants were randomly assigned to empagliflozin or placebo once daily. The overall safety data were consistent with previous findings, confirming the well-established safety profile of empagliflozin.
“Patients are always at the heart of what we do. Heart failure patients with preserved ejection fraction have been living without any proven treatment and with poor prognosis for a long time. Now the outcome of the EMPEROR-Preserved trial brings immense hope and will positively affect the quality of their lives,” said Professor Dr. Joerg Kreuzer, Head of Medicine, Boehringer Ingelheim (Southeast Asia & South Korea). “Effective management of heart failure and related co-morbidities will ultimately help to reduce hospitalization and enhance survival rates.”
From this trial, empagliflozin is expected to bring significant benefits to both the medical and patient communities. Empagliflozin is currently indicated for the treatment of adults with insufficiently controlled type 2 diabetes. Boehringer Ingelheim plans for global regulatory submissions in HFpEF in 2021. Research is ongoing regarding the effects of empagliflozin on hospitalisation for heart failure and mortality in post-myocardial infarction (heart attack) patients with a high risk of heart failure. Empagliflozin is also currently being investigated in chronic kidney disease.
Source: Boehringer Ingelheim