SGLT2 inhibitors in patients with heart failure with reduced ejection fraction: A meta-analysis of the EMPEROR-Reduced and DAPA-HF trials
Open accessAbstract
BACKGROUND: Both DAPA-HF (assessing dapagliflozin) and EMPEROR-Reduced (assessing empagliflozin) trials showed that sodium-glucose co-transporter-2 (SGLT2) inhibition reduced the combined risk of cardiovascular death or hospitalisation for heart failure in patients with heart failure with reduced ejection fraction (HFrEF) with or without diabetes. However, neither trial was powered to assess effects on cardiovascular death or all-cause death or to characterise effects in clinically important subgroups. Using study-level published data from DAPA-HF and patient-level data from EMPEROR-Reduced, we aimed to estimate the effect of SGLT2 inhibition on fatal and non-fatal heart failure events and renal outcomes in all randomly assigned patients with HFrEF and in relevant subgroups from DAPA-HF and EMPEROR-Reduced trials. METHODS: We did a prespecified meta-analysis of the two single large-scale trials assessing the effects of SGLT2 inhibitors on cardiovascular outcomes in patients with HFrEF with or without diabetes: DAPA-HF (assessing dapagliflozin) and EMPEROR-Reduced (assessing empagliflozin). The primary endpoint was time to all-cause death. Additionally, we assessed the effects of treatment in prespecified subgroups on the combined risk of cardiovascular death or hospitalisation for heart failure. These subgroups were based on type 2 diabetes status, age, sex, angiotensin receptor neprilysin inhibitor (ARNI) treatment, New York Heart Association (NYHA) functional class, race, history of hospitalisation for heart failure, estimated glomerular filtration rate (eGFR), body-mass index, and region (post-hoc). We used hazard ratios (HRs) derived from Cox proportional hazard models for time-to-first event endpoints and Cochran's Q test for treatment interactions; the analysis of recurrent events was based on rate ratios derived from the Lin-Wei-Yang-Ying model. FINDINGS: Among 8474 patients combined from both trials, the estimated treatment effect was a 13% reduction in all-cause death (pooled HR 0·87, 95% CI 0·77-0·98; p=0·018) and 14% reduction in cardiovascular death (0·86, 0·76-0·98; p=0·027). SGLT2 inhibition was accompanied by a 26% relative reduction in the combined risk of cardiovascular death or first hospitalisation for heart failure (0·74, 0·68-0·82; p<0·0001), and by a 25% decrease in the composite of recurrent hospitalisations for heart failure or cardiovascular death (0·75, 0·68-0·84; p<0·0001). The risk of the composite renal endpoint was also reduced (0·62, 0·43-0·90; p=0·013). All tests for heterogeneity of effect size between trials were not significant. The pooled treatment effects showed consistent benefits for subgroups based on age, sex, diabetes, treatment with an ARNI and baseline eGFR, but suggested treatment-by-subgroup interactions for subgroups based on NYHA functional class and race. INTERPRETATION: The effects of empagliflozin and dapagliflozin on hospitalisations for heart failure were consistent in the two independent trials and suggest that these agents also improve renal outcomes and reduce all-cause and cardiovascular death in patients with HFrEF. FUNDING: Boehringer Ingelheim.
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A meta-analysis of DAPA-HF and EMPEROR-Reduced revealed a composite outcome on first hospitalization for heart failure or cardiovascular death of HR 0.72 (95% CI 0.62-0.82) for an eGFR ≥60 ml/min per 1.73 m2.
“a composite outcome on fi rst hospitalization for heart failure or cardiovascular death of HR: 0.72 (95% CI: 0.62 -0.82) for an eGFR $ 60 ml/min per 1.73 m 2”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [108]
The Outcomes and subgroups section defines an eGFR subgroup at 60 ml/min/1.73 m², and Pooled effects in subgroups says the meta-analysis assessed first heart-failure hospitalization or cardiovascular death by eGFR. Our copy does not state HR 0.72 (95% CI 0.62–0.82) for the ≥60 subgroup; it reports an overall HR of 0.74 (95% CI 0.68–0.82) in Methods. No page numbers are available in our copy. (LLM, conf=0.82)
Experimental — accuracy not yet measuredIn the same meta-analysis of DAPA-HF and EMPEROR-Reduced, the composite outcome on first hospitalization for heart failure or cardiovascular death was HR 0.77 (95% CI 0.68-0.88) for eGFR <60 ml/min per 1.73 m2.
“and HR: 0.77 (95% CI: 0.68 -0.88) for eGFR < 60 ml/min per 1.73 m 2”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [108]
The Outcomes and subgroups section (page unavailable) defines an eGFR-below-60 subgroup, and Pooled effects in subgroups (page unavailable) says the analysis assessed first heart-failure hospitalisation or cardiovascular death by eGFR. Our copy does not give HR 0.77 or its 95% CI of 0.68–0.88 for that subgroup; it refers to Figure 2 without providing those values in the available text. (LLM, conf=0.82)
Experimental — accuracy not yet measuredAs shown in a meta-analysis by Zannad and colleagues, the results of DAPA-HF and EMPEROR-Reduced show that SGLT2 inhibitor reduces morbidity and mortality in patients with symptomatic HFrEF, whether type 2 diabetes is present or not.
“Taken together, as shown in a meta-analysis by Zannad and colleagues, the results of these 2 landmark trials show that SGLT2 inhibitor reduces morbidity and mortality in patients with symptomatic HFrEF, whether type 2 diabetes is present or not.44”
From CCS/CHFS Heart Failure Guidelines Update: Defining a New Pharmacologic Standard of Care for Heart Failure With Reduced Ejection Fraction (2021) · cites this paper as [44]
The same meta-analysis of DAPA-HF and EMPEROR-Reduced reported a composite kidney outcome HR of 0.62 (95% CI 0.43-0.90) (P=0.013).
“a composite kidney outcome HR: 0.62; 95% CI: 0.43 -0.90 ( P ¼ 0.013) was also reported.”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [108]
Heart failure risk is two to four times greater in people with diabetes than in those without diabetes.
“The risk of HF is 2- to 4-fold higher in persons with DM compared with those without DM.647”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [647]
The Introduction and Discussion address heart-failure hospitalisation and SGLT2-inhibitor treatment effects, including in patients with and without diabetes. They do not report that people with diabetes have a two- to fourfold higher risk of developing heart failure than people without diabetes; searches for that comparison found no supporting passage in our copy. (LLM, conf=0.77)
Experimental — accuracy not yet measured
In the original publication and in a meta-analysis of the DAPA-HF and EMPEROR-Reduced trials, a somewhat lesser benefit was noted in patients with ejection fraction of 31% to 40% and in patients with class III symptoms.
“In our original publication and in a meta-analysis of the DAPA-HF and EMPEROR-Reduced trials, we noted a somewhat lesser benefit in patients with ejection fraction of 31% to 40% and in patients with class III symptoms.”
From Effect of Empagliflozin on the Clinical Stability of Patients With Heart Failure and a Reduced Ejection Fraction: The EMPEROR-Reduced Trial (2021) · cites this paper as [26]
There is good evidence to support the use of SGLT2 inhibitors as a foundational therapy to prevent cardiovascular death or hospitalisation for heart failure in patients with heart failure, irrespective of ejection fraction or history of previous diabetes.
“There is good evidence to support the use of SGLT2 inhibitors as a foundational therapy to prevent cardiovascular death or hospitalisation for heart failure in patients with heart failure, irrespective of ejection fraction or history of previous diabetes.1, 2, 3, 4, 5”
Large placebo-controlled trials have shown that SGLT2 inhibitors reduce the risk of cardiovascular disease, and particularly hospitalisation for heart failure, in patients with type 2 diabetes at high risk of atherosclerotic cardiovascular disease, heart failure, or chronic kidney disease.
“Large placebo-controlled trials have shown that sodium glucose co-transporter-2 (SGLT2) inhibitors reduce the risk of cardiovascular disease, and particularly hospitalisation for heart failure, in patients with type 2 diabetes at high risk of atherosclerotic cardiovascular disease, heart failure, or chronic kidney disease.”
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- Authors
- Zannad, F., Ferreira, J. P., Pocock, S. J., Anker, S. D., Butler, J., Filippatos, G., Brueckmann, M., Ofstad, A. P., Pfarr, E., Jamal, W., & Packer, M.
- Affiliations
- Inserm (FR)
- London School of Hygiene & Tropical Medicine (GB)
- German Centre for Cardiovascular Research (DE)
- University of Mississippi Medical Center (US)
- National and Kapodistrian University of Athens (GR)
- Boehringer Ingelheim (Germany) (DE)
- Boehringer Ingelheim (Norway) (NO)
- Baylor University (US)
- Corresponding author
- Zannad, Faiez
- ORCID
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2020-09
- Volume
- 396
- Issue
- 10254
- Pages
- 819-829
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- OpenAlex
- W3082758064
- Cited by
- 1,408
- References
- 17
- Citations by year
- 2026: 136 · 2025: 165 · 2024: 225 · 2023: 226 · 2022: 309 · 2021: 294 · 2020: 51
- FWCI
- 37.43
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- The Lancet (acceptedVersion, other-oa)
- PubMed (publishedVersion)
- HAL (submittedVersion, cc-by-nc)
- Funders
- Boehringer Ingelheim
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Failure Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiovascular Function and Risk Factors
- Keywords
- SGLT2 inhibitors, heart failure with reduced ejection fraction, dapagliflozin, empagliflozin, all-cause mortality, cardiovascular mortality, heart failure hospitalization, renal outcomes, type 2 diabetes, subgroup analysis, treatment interaction, DAPA-HF, EMPEROR-Reduced, estimated glomerular filtration rate
- MeSH terms
- Sodium-Glucose Transporter 2 Inhibitors, Aged, Benzhydryl Compounds, Cause of Death, Clinical Trials as Topic, Death, Diabetes Mellitus, Type 2, Drug Therapy, Combination, Female, Glomerular Filtration Rate, Glucosides, Heart Failure, Hospitalization, Humans, Male, Middle Aged, Stroke Volume, Neprilysin, Body Mass Index, Case-Control Studies, Angiotensin Receptor Antagonists, Patient Outcome Assessment
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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