While many have speculated about the effect of SGLT2 inhibitors in HFpEF for years, EMPEROR-Preserved provides the first evidence from a phase 3 RCT of the safety and efficacy of empagliflozin for use in patients with heart failure across the spectrum of ejection fraction.
The EMPEROR-Preserved trial has met its primary endpoint, demonstrating empagliflozin (Jardiance) use was associated with a significant reduction in risk of a composite of cardiovascular death or hospitalization for heart failure in adults with heart failure with preserved ejection fraction (HFpEF), according to a statement from Boehringer Ingelheim and Eli Lilly and Company.
Scheduled to be presented at the European Society of Cardiology meeting, the phase 3 trial, combined with data from EMPEROR-Reduced, demonstrate the safety and efficacy of empagliflozin for use in patients with heart failure across the spectrum of ejection fraction.
"We look forward to presenting the EMPEROR-Preserved results at ESC 2021, which should offer a significant breakthrough in cardiovascular medicine and a new hope for people with HFpEF, which is an increasingly prevalent public health issue. HFpEF has long been the most challenging form of heart failure to treat," said Professor Stefan Anker, heart failure cardiologist at Charita Berlin, Germany, and EMPEROR-Preserved principal investigator. "Building on previous results from the EMPA-REG OUTCOME trial, and the EMPEROR-Reduced trial in heart failure with reduced ejection fraction, the EMPEROR-Preserved findings demonstrate that empagliflozin reduces cardiovascular death or hospitalization for heart failure and has the potential to transform the care of people living with heart failure."
Announced in a statement on July 6, the results of EMPEROR-Preserved have been among the most anticipated trial results in recent memory due to the results of EMPEROR-Reduced, DAPA-HF, and SOLOIST-WHF. EMPEROR-Preserved was launched back in 2017 and, ultimately enrolled, 5988 patients with and without diabetes for inclusion in the phase 3 trial.
These patients were randomized 1:1 to empagliflozin 10 mg once-daily or placebo therapy. The primary endpoint of the trial was time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure over a follow-up period lasting up to 38 months.
"Jardiance was the first SGLT2 inhibitor to reduce cardiovascular death for people with type 2 diabetes and cardiovascular disease, and we have now reached another important milestone, this time in heart failure," added Jeff Emrick, MD, PhD, vice president, Product Development, Lilly, in the aforementioned statement. "The EMPEROR-Preserved results offer promise in a type of heart failure that until now has traditionally been very challenging to treat effectively. The EMPEROR heart failure studies are part of our EMPOWER clinical trial program exploring the effect of Jardiance across a spectrum of cardio-renal-metabolic diseases, aiming to significantly improve outcomes in these highly prevalent conditions that impact many people's lives."