02 September 2021 | News
Landmark trial demonstrates empagliflozin is the first therapy to show statistically significant improvement in heart failure outcomes in adults with preserved ejection fraction
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Full results from the landmark EMPEROR-Preserved Phase III trial demonstrated that empagliflozin showed an impressive 21 percent relative risk reduction for the composite primary endpoint of cardiovascular death or hospitalization for heart failure in adults with heart failure with preserved ejection fraction (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. The results were presented at the European Society of Cardiology (ESC) Congress 20212 and published in The New England Journal of Medicine.
Key secondary endpoint analyses from the trial showed that empagliflozin also reduced the relative risk of first and recurrent hospitalizations for heart failure by 27 percent 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.”
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.
Waheed Jamal, M.D., Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim said, “The risk of death in people with heart failure rises with each hospital admission and with kidney function decline. The landmark EMPEROR-Preserved trial shows that empagliflozin brings significant benefit, which is incredibly exciting and welcome news for both the medical and patient communities.”
"Heart failure patients with preserved ejection fraction have been living without any proven treatment and with poor prognoses for a long time. Now the outcome of the EMPEROR-Preserved trial brings immense hope and will positively affect the quality of their lives. Effective management of heart failure and related co-morbidities will ultimately help to reduce hospitalization and enhance survival rates.” said Professor Dr Joerg Kreuzer, Head of Medicine, Boehringer Ingelheim (Southeast Asia & South Korea)".