EMPEROR-Reduced: what the trial showed
In 3,730 patients with heart failure and an ejection fraction of 40% or less, empagliflozin 10 mg daily reduced cardiovascular death or heart failure hospitalisation from 24.7% to 19.4% over a median of 16 months, and slowed the decline in kidney function.
Main cited publication: Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure. New England Journal of Medicine, 2020. PMID 32865377. Results are summarized from the cited trial report and any companion publications listed below.
At a glance
| Design | Randomised, double-blind, placebo-controlled, event-driven |
|---|---|
| Population | 3,730 adults with NYHA class II to IV heart failure and an ejection fraction of 40% or less, on recommended therapy, with or without diabetes |
| Intervention | Empagliflozin 10 mg once daily |
| Comparator | Placebo |
| Follow-up | Median 16 months |
| Registration | NCT03057977 |
| Funding | Boehringer Ingelheim and Eli Lilly |
Primary outcome
Composite of cardiovascular death or hospitalisation for worsening heart failure.
| Empagliflozin 10 mg once daily | Placebo | Effect |
|---|---|---|
| 19.4% (361 of 1,863) | 24.7% (462 of 1,867) | Hazard ratio 0.75 (95% CI 0.65 to 0.86), P<0.001 |
Key findings
- The total number of heart failure hospitalisations was lower with empagliflozin (HR 0.70, 95% CI 0.58 to 0.85).
- The annual rate of eGFR decline was slower with empagliflozin (-0.55 versus -2.28 ml/min/1.73 m2 per year), and serious renal outcomes were less frequent.
- The benefit on the primary outcome was consistent with and without diabetes, mirroring DAPA-HF and confirming a class effect for SGLT2 inhibition in HFrEF.
- Unlike DAPA-HF, the primary publication does not report a significant reduction in cardiovascular death on its own.
Harms and safety
- Uncomplicated genital tract infection was reported more frequently with empagliflozin.
- No signal of excess volume depletion, hypoglycaemia, or ketoacidosis is reported in the abstract.
Limitations
- The population had a lower mean ejection fraction and higher baseline risk than DAPA-HF, which helps explain the absolute effect sizes but limits direct comparison.
- Median follow-up of 16 months; durability beyond that period is inferred from other studies.
- Industry funded and placebo controlled.
Where it sits in guidelines
Together with DAPA-HF, this trial underpins the class I recommendation for SGLT2 inhibitors in HFrEF in the 2021 ESC heart failure guideline. A prespecified meta-analysis of the two trials (Lancet 2020) is cited for the pooled effect on cardiovascular death and hospitalisation.
CliniAtlas answers that use this trial
Written for healthcare professionals as an orientation to the primary publication, not as a substitute for reading it. For literature search, education, and professional evidence review only. Not for diagnosis, treatment selection, triage, monitoring, prognosis, or patient-specific clinical decision-making.