Full results from the phase 3 EMPEROR-Preserved trial showed that treatment with empagliflozin demonstrated significant risk reduction of cardiovascular death or hospitalization for heart failure in adults with heart failure and preserved ejection fraction (HFpEF).
The randomized, double-blind trial (ClinicalTrials.gov Identifier: NCT03057951) compared the efficacy and safety of empagliflozin with placebo in 5988 adults with heart failure and preserved ejection fraction, with and without diabetes. Patients were randomly assigned 1:1 to receive either empagliflozin 10mg once daily (n=2997) or placebo (n=2991), in addition to standard of care for up to 38 months. The primary endpoint of the study was the time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure.
Results showed that over a median follow-up of 26.2 months, the primary outcome event occurred in 13.8% of empagliflozin-treated patients vs 17.1% of those who received placebo, corresponding to a 21% relative risk reduction (hazard ratio 0.79; 95% CI, 0.69-0.90; P <.001). The reduction was mainly related to a lower risk of hospitalization for heart failure.
Compared with placebo, treatment with empagliflozin was associated with significantly lower risk of first and recurrent hospitalizations for heart failure (hazard ratio 0.73; 95% CI, 0.61-0.88; P <.001). Findings also showed that empagliflozin significantly slowed kidney function decline. The safety profile of empagliflozin was consistent with that observed in previous findings.
Professor Stefan Anker, EMPEROR-Preserved principal investigator and heart failure cardiologist at Charité Berlin, Germany, said: “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.”
Empagliflozin is marketed under the trade name Jardiance. In August 2021, the Food and Drug Administration approved Jardiance to reduce the risk of cardiovascular death and hospitalization for heart failure and to slow kidney function decline in adults with chronic heart failure with reduced ejection fraction, including those with and without type 2 diabetes. The approval was based on data from the phase 3 EMPEROR-Reduced trial (ClinicalTrials.gov Identifier: NCT03057977), which demonstrated that treatment with empagliflozin reduced the combined relative risk of cardiovascular death or hospitalization for heart failure by 25% compared with placebo in adults with heart failure with reduced ejection fraction.
- Landmark trial demonstrates Jardiance® (empagliflozin) is the first therapy to show statistically significant improvement in heart failure outcomes in adults with preserved ejection fraction. News release. Eli Lilly and Company. August 27, 2021. Accessed August 30, 2021. https://www.prnewswire.com/news-releases/landmark-trial-demonstrates-jardiance-empagliflozin-is-the-first-therapy-to-show-statistically-significant-improvement-in-heart-failure-outcomes-in-adults-with-preserved-ejection-fraction-301364113.html.
- Anker SD, Butler J, Filippatos G, et al. Empagliflozin in Heart Failure with a Preserved Ejection Fraction. N Engl J Med. Published online August 27, 2021. doi: 10.1056/NEJMoa2107038