# EMPEROR-Reduced: what the trial showed

Canonical page: https://cliniatlas.com/trials/emperor-reduced/

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. https://pubmed.ncbi.nlm.nih.gov/32865377/

## 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: 19.4% (361 of 1,863)
- Placebo: 24.7% (462 of 1,867)
- Effect: 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

- https://cliniatlas.com/evidence/sglt2-inhibitors-heart-failure-reduced-ejection-fraction/

Ask about this trial against live sources (free, no sign-in): https://cliniatlas.com/?q=What%20did%20the%20EMPEROR-Reduced%20trial%20show%20and%20how%20should%20it%20be%20interpreted%3F

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