Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction
Open accessAbstract
BACKGROUND: In patients with type 2 diabetes, inhibitors of sodium-glucose cotransporter 2 (SGLT2) reduce the risk of a first hospitalization for heart failure, possibly through glucose-independent mechanisms. More data are needed regarding the effects of SGLT2 inhibitors in patients with established heart failure and a reduced ejection fraction, regardless of the presence or absence of type 2 diabetes. METHODS: In this phase 3, placebo-controlled trial, we randomly assigned 4744 patients with New York Heart Association class II, III, or IV heart failure and an ejection fraction of 40% or less to receive either dapagliflozin (at a dose of 10 mg once daily) or placebo, in addition to recommended therapy. The primary outcome was a composite of worsening heart failure (hospitalization or an urgent visit resulting in intravenous therapy for heart failure) or cardiovascular death. RESULTS: Over a median of 18.2 months, the primary outcome occurred in 386 of 2373 patients (16.3%) in the dapagliflozin group and in 502 of 2371 patients (21.2%) in the placebo group (hazard ratio, 0.74; 95% confidence interval [CI], 0.65 to 0.85; P<0.001). A first worsening heart failure event occurred in 237 patients (10.0%) in the dapagliflozin group and in 326 patients (13.7%) in the placebo group (hazard ratio, 0.70; 95% CI, 0.59 to 0.83). Death from cardiovascular causes occurred in 227 patients (9.6%) in the dapagliflozin group and in 273 patients (11.5%) in the placebo group (hazard ratio, 0.82; 95% CI, 0.69 to 0.98); 276 patients (11.6%) and 329 patients (13.9%), respectively, died from any cause (hazard ratio, 0.83; 95% CI, 0.71 to 0.97). Findings in patients with diabetes were similar to those in patients without diabetes. The frequency of adverse events related to volume depletion, renal dysfunction, and hypoglycemia did not differ between treatment groups. CONCLUSIONS: Among patients with heart failure and a reduced ejection fraction, the risk of worsening heart failure or death from cardiovascular causes was lower among those who received dapagliflozin than among those who received placebo, regardless of the presence or absence of diabetes. (Funded by AstraZeneca; DAPA-HF ClinicalTrials.gov number, NCT03036124.).
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In DAPA-HF, 55% of patients did not have diabetes at baseline, and the effect of dapagliflozin was similar at any hemoglobin A1c level.
“Importantly, 55% of patients in this trial did not have diabetes at baseline, and the effect of dapagliflozin was similar at any hemoglobin A1c level.40”
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 [40]
The Discussion (p. 8) states that 55% of patients did not have type 2 diabetes and that dapagliflozin was as effective in those patients as in patients with diabetes. The Outcomes section (p. 6) likewise reports a generally consistent effect across prespecified subgroups, including patients without diabetes. Our copy does not establish that the effect was similar at every hemoglobin A1c level; comparing diabetes status does not establish that more specific claim. (LLM, conf=0.86)
Experimental — accuracy not yet measuredIn DAPA-HF, the secondary outcome of worsening kidney function occurred in 1.2% of the dapagliflozin arm and 1.6% of the placebo arm (HR 0.71; 95% CI 0.44-1.16), which was not statistically significant (P=0.17).
“the secondary outcome of worsening kidney function (de fi ned as a sustained $ 50% reduction in eGFR, kidney failure, or death from kidney causes) occurred in 1.2% of the dapagli fl ozin arm and 1.6% of the placebo arm (HR: 0.71; 95% CI: 0.44 -1.16), which was not statistically signi fi cant ( P ¼ 0.17).”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [100]
The Outcomes section (p. 4) defines the renal composite as a sustained eGFR decline of at least 50%, end-stage renal disease, or renal death. The Outcomes results (p. 6) say its incidence did not differ between groups, supporting the claim of no statistically significant difference. The passages available from our copy do not establish the stated percentages, hazard ratio, confidence interval, or P value. (LLM, conf=0.82)
Experimental — accuracy not yet measuredIn the DAPA-HF trial, major hypoglycemia, lower-limb amputation, and fracture occurred infrequently and incidences were similar between the 2 treatment groups.
“In the DAPA-HF trial, major hypoglycemia, lower-limb amputation, and fracture occurred infrequently and the incidences were similar between the 2 treatment groups.”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [100]
The Discussion (p. 13) says major hypoglycemia was rare, and the Results (p. 2) say hypoglycemia-related adverse events did not differ between groups. The Outcomes section (p. 4) lists fractures and amputations among the prespecified safety analyses, but the passages found do not establish that those events were infrequent or had similar incidences between groups. (LLM, conf=0.82)
Experimental — accuracy not yet measuredSGLT2 inhibitors reduce the incidence of heart failure and improve heart failure-related outcomes, including hospitalization for heart failure and heart failure-related symptoms, in people with diabetes with preserved or reduced ejection fraction.
“SGLT2 inhibitors reduce the incidence of heart failure and improve heart failurerelated outcomes, including hospitalization for heart failure and heart failure-related symptoms, in people with diabetes with preserved or reduced ejection fraction (250,(255)(256)(257)(298)(299)(300)(301)(302)(303)(304)(305)(306).”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [299]
The Background (p. 2) says SGLT2 inhibitors reduce the risk of a first heart-failure hospitalization in people with type 2 diabetes. The Discussion (p. 8) reports fewer heart-failure hospitalizations and symptoms with dapagliflozin, but this trial enrolled patients with reduced ejection fraction, not preserved ejection fraction; its results therefore do not support that part of the claim. (LLM, conf=0.90)
Experimental — accuracy not yet measuredThe lower risk of heart-failure hospitalization or cardiovascular death with dapagliflozin is consistent with the DECLARE-TIMI 58 and DAPA-HF trials.
“The lower risk of hospitalization for heart failure or death from cardiovascular causes in the dapagliflozin group than in the placebo group is consistent with the results of two previous trials of dapagliflozin, the DECLARE-TIMI 58 (Dapagliflozin Effect on Cardiovascular Events-Thrombolysis in Myocardial Infarction 58) and DAPA-HF (Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure”
From Dapagliflozin in Patients with Chronic Kidney Disease (2020) · cites this paper as [18]
SGLT2 inhibition is known to benefit patients with heart failure and a reduced ejection fraction.
“SGLT2 inhibition is also known to benefit patients with heart failure and a reduced ejection fraction.471”
From Glucagon-like peptide-1 receptor: mechanisms and advances in therapy (2024) · cites this paper as [471]
In the DAPA-HF trial, over a median 18-month follow-up of 4744 patients with HFrEF, treatment with dapagliflozin significantly reduced the composite primary end point of time to first worsening of HF or death from CV causes (HR, 0.74 [95% CI 0.65-0.85]; P < 0.001), as well as HHF (HR, 0.70 [95% CI 0.59-0.83]) and CV death (HR, 0.82 [95% CI 0.69-0.98]).
“Over a median 18-month follow-up of 4744 patients with HFrEF, treatment with dapagliflozin significantly reduced the composite primary end point of time to first worsening of HF or death from CV causes (hazard ratio [HR], 0.74 [95% CI 0.65-0.85]; P < 0.001), as well as HHF (HR, 0.70 [95% CI 0.59 - 0.83]) and CV death (HR, 0.82 [95% CI 0.69 - 0.98]).”
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 [40]
SGLT2 inhibitor treatment was safe with no excess in hypovolemia, hypoglycemia, or renal side effects compared with placebo.
“SGLT2 inhibitor treatment was safe with no excess in hypovolemia, hypoglycemia, or renal side effects compared with placebo.”
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 [40]
In DAPA-HF, the primary outcome was similarly reduced for individuals with or without diabetes, with no effect of heterogeneity by diabetes status.
“The primary outcome was similarly reduced for individuals with or without diabetes, with no effect of heterogeneity by diabetes status.”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [100]
In DAPA-HF, the primary outcome was similar among those with an eGFR ≥60 ml/min per 1.73 m2 (HR 0.76; 95% CI 0.63-0.92) or <60 ml/min per 1.73 m2 (HR 0.72; 95% CI 0.59-0.86).
“The primary outcome was also similar among those with an eGFR $ 60 ml/min per 1.73 m 2 (HR: 0.76; 95% CI: 0.63 -0.92) or < 60 ml/min per 1.73 m 2 (HR: 0.72; 95% CI: 0.59 -0.86).”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [100]
In DAPA-HF, over a median of 18.2 months, the primary outcome of cardiovascular death, heart failure hospitalization, or urgent heart failure visit occurred in 16.3% of the dapagliflozin group and 21.2% of the placebo group (HR 0.74; 95% CI 0.65-0.85).
“the primary outcome of cardiovascular death, heart failure hospitalization, or urgent heart failure visit occurred in 16.3% of the dapagli fl ozin group and 21.2% of the placebo group (HR: 0.74; 95% CI: 0.65 -0.85).”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [100]
SGLT2i have been studied among patients without T2D who have CKD in the DAPA-CKD trial (and the soon-to-be-published EMPA-KIDNEY trial) or who have heart failure (in the DAPA-HF, EMPEROR-Reduced, and EMPEROR-Preserved trials) and did not confer any increased risk of severe hypoglycemia or diabetic ketoacidosis among individuals without T2D.
“However, notably, SGLT2i have been studied among patients without T2D who have CKD in the DAPA-CKD trial (and the soonto-be-published EMPA-KIDNEY trial) or who have heart failure (in the DAPA-HF, EMPEROR-Reduced, and EMPEROR-Preserved trials) and did not confer any increased risk of severe hypoglycemia or diabetic ketoacidosis among individuals without T2D.”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [100]
In the DAPA-HF trial, the effect of dapagliflozin on the primary outcome was consistent regardless of the presence or absence of type 2 diabetes.
“The effect of dapagliflozin on the primary outcome was consistent regardless of the presence or absence of type 2 diabetes (299).”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [299]
In the DAPA-HF trial, dapagliflozin treatment had a lower risk of first worsening heart failure event (HR 0.70 [95% CI 0.59-0.83]) compared with placebo.
“lower risk of first worsening heart failure event (HR 0.70 [95% CI 0.59-0.83]),”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [299]
In the DAPA-HF trial, dapagliflozin treatment had a lower risk of the primary outcome of worsening heart failure or cardiovascular death (HR 0.74 [95% CI 0.65-0.85]) compared with placebo.
“Dapagliflozin treatment had a lower risk of the primary outcome (HR 0.74 [95% CI 0.65-0.85]),”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [299]
The effect of dapagliflozin on the primary outcome in DAPA-HF was consistent regardless of the presence or absence of type 2 diabetes.
“The effect of dapagliflozin on the primary outcome was consistent regardless of the presence or absence of type 2 diabetes (287).”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [287]
In DAPA-HF, dapagliflozin treatment had a lower risk of the primary composite outcome of worsening heart failure or cardiovascular death (HR 0.74 [95% CI 0.65-0.85]), lower risk of first worsening heart failure event (HR 0.70 [95% CI 0.59-0.83]), and lower risk of cardiovascular death (HR 0.82 [95% CI 0.69-0.98]) compared with placebo in individuals with NYHA class II-IV heart failure and ejection
“Dapagliflozin treatment had a lower risk of the primary outcome (HR 0.74 [95% CI 0.65–0.85]), lower risk of first worsening heart failure event (HR 0.70 [95% CI 0.59–0.83]), and lower risk of cardiovascular death (HR 0.82 [95% CI 0.69–0.98]) compared with placebo.”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [287]
SGLT2 inhibitors have been shown to reduce the risk of hospitalizations for heart failure in 8 large-scale trials, including those focused on type 2 diabetes, heart failure with reduced ejection fraction, and chronic kidney disease.
“Sodium-glucose cotransporter 2 (SGLT2) inhibitors have been shown to reduce the risk of hospitalizations for heart failure in 8 large-scale trials, including those that focused on type 2 diabetes, heart failure with a reduced ejection fraction, and chronic kidney disease.1–8”
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 [6]
Rates of worsening heart failure or cardiovascular death are lower among patients with heart failure who are treated with dapagliflozin and empagliflozin regardless of diabetes diagnosis.
“Rates of worsening heart failure or cardiovascular death are lower among patients with heart failure who are treated with dapagliflozin and empagliflozin regardless of diabetes diagnosis.7,8”
From Association of race/ethnicity, gender, and socioeconomic status with sodium-glucose cotransporter 2 inhibitor use among patients with diabetes in the US (2021) · cites this paper as [7]
SGLT-2i has special potency such as reducing blood glucose, reducing oxidative stress, losing weight, reducing uric acid, controlling blood pressure and improving renal ultrafiltration and hypoxia.
“As for the morbidity, renal outcome and HHF, it was clear that SGLT-2i had more significant impact than finerenone, which might be explained by the special potency of SGLT-2i such as reducing blood glucose, reducing oxidative stress, losing weight, reducing uric acid, controlling blood pressure and improving renal ultrafiltration and hypoxia [65, 71–79].”
In DAPA-HF, dapagliflozin reduced the risk for worsening heart failure or cardiovascular death irrespective of diabetes status.
“In DAPA-HF, dapagliflozin reduced the risk for worsening HF or CVD death irrespective of diabetes status (58).”
From SGLT2 inhibition for CKD and cardiovascular disease in type 2 diabetes: report of a scientific workshop sponsored by the National Kidney Foundation (2021) · cites this paper as [58]
Rates of heart failure hospitalization have been improved in recent trials of people with type 2 diabetes, most of whom also had ASCVD, using SGLT2 inhibitors.
“Rates of heart failure hospitalization have been improved in recent trials including people with type 2 diabetes, most of whom also had ASCVD, with sodium -glucose cotransporter 2 (SGLT2) inhibitors (8 -11).”
From 10. Cardiovascular Disease and Risk Management: <i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [11]
In DAPA-HF, dapagliflozin reduced the primary composite of worsening heart failure or cardiovascular death compared with placebo (HR 0.74).
“Over a median of 18.2 months, the group assigned to dapagli fl ozin treatment had a lower risk of the primary outcome (HR 0.74 [95% CI 0.65 -0.85]), lower risk of fi rst worsening heart failure event (HR 0.70 [95% CI 0.59 -0.83]), and lower risk of cardiovascular death (HR 0.82 [95% CI 0.69 -0.98]) compared with placebo.”
From 10. Cardiovascular Disease and Risk Management: <i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [11]
In DAPA-HF, the effect of dapagliflozin on the primary outcome was consistent regardless of the presence or absence of type 2 diabetes.
“The effect of dapagli fl ozin on the primary outcome was consistent regardless of the presence or absence of type 2 diabetes (11).”
From 10. Cardiovascular Disease and Risk Management: <i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [11]
In DAPA-HF, dapagliflozin reduced the risk of first worsening heart failure event compared with placebo (HR 0.70).
“Over a median of 18.2 months, the group assigned to dapagli fl ozin treatment had a lower risk of the primary outcome (HR 0.74 [95% CI 0.65 -0.85]), lower risk of fi rst worsening heart failure event (HR 0.70 [95% CI 0.59 -0.83]), and lower risk of cardiovascular death (HR 0.82 [95% CI 0.69 -0.98]) compared with placebo.”
From 10. Cardiovascular Disease and Risk Management: <i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [11]
In DAPA-HF, dapagliflozin reduced the risk of cardiovascular death compared with placebo (HR 0.82).
“Over a median of 18.2 months, the group assigned to dapagli fl ozin treatment had a lower risk of the primary outcome (HR 0.74 [95% CI 0.65 -0.85]), lower risk of fi rst worsening heart failure event (HR 0.70 [95% CI 0.59 -0.83]), and lower risk of cardiovascular death (HR 0.82 [95% CI 0.69 -0.98]) compared with placebo.”
From 10. Cardiovascular Disease and Risk Management: <i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [11]
In the DAPA-HF trial, dapagliflozin reduced the incidence of the primary composite outcome of cardiovascular death or worsening heart failure in patients with HFrEF with and without type 2 diabetes.
“In the DAPA-HF trial (Dapagliflozin and Prevention of Adverse-outcomes in Heart Failure), the SGLT2 inhibitor dapagliflozin reduced the incidence of the primary composite outcome of cardiovascular death or worsening heart failure (HF) in patients who had HFrEF with and without type 2 diabetes.”
From Efficacy of Dapagliflozin on Renal Function and Outcomes in Patients With Heart Failure With Reduced Ejection Fraction: Results of DAPA-HF (2021) · cites this paper as [9]
The DAPA-HF trial randomly assigned patients with HFrEF with and without type 2 diabetes in a double-blind, placebo-controlled, event-driven trial.
“The DAPA-HF trial randomly assigned patients with HFrEF with and without type 2 diabetes in a double-blind, placebo-controlled, event-driven trial.”
From Efficacy of Dapagliflozin on Renal Function and Outcomes in Patients With Heart Failure With Reduced Ejection Fraction: Results of DAPA-HF (2021) · cites this paper as [9]
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Pop‐Busui, R., Januzzi, J. L., Bruemmer, D., Butalia, S., Green, J. B., Horton, W. B., Knight, C. M., Levi, M., Rasouli, N., & Richardson, C. R. (2022) · Diabetes Care · doi:10.2337/dci22-0014 · Cited by 424 · see citing works
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Self-citation
- Authors
- McMurray, J. J. V., Solomon, S. D., Inzucchi, S. E., Køber, L., Kosiborod, M. N., Martinez, F. A., Ponikowski, P., Sabatine, M. S., Anand, I. S., Bělohlávek, J., Böhm, M., Chiang, C.-E., Chopra, V. K., de Boer, R. A., Desai, A. S., Diez, M., Drozdz, J., Dukát, A., Ge, J., Howlett, J. G., Katova, T., Kitakaze, M., Ljungman, C. E. A., Merkely, B., Nicolau, J. C., O’Meara, E., Petrie, M. C., Vinh, P. N., Schou, M., Tereshchenko, S., Verma, S., Held, C., DeMets, D. L., Docherty, K. F., Jhund, P. S., Bengtsson, O., Sjöstrand, M., & Langkilde, A.-M.
- Affiliations
- Brigham and Women's Hospital (US)
- From the BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (J.J.V.M., M.C.P., K.F.D., P.S.J.); the Cardiovascular Division (S.D.S., A.S.D.) and the TIMI Study Group, Brigham and Women’s Hospital and Harvard Medical School (M.S.S.) — all in Boston; Section of Endocrinology, Yale University School of Medicine, New Haven, CT (S.E.I.); Rigshospitalet Copenhagen University Hospital (L.K.) and the Department of Cardiology, Gentofte University Hospital (M. Schou),...
- Semmelweis University (HU)
- Uppsala University (SE)
- ORCID
- McMurray, John J.V.
- Solomon, Scott D.
- Inzucchi, Silvio E.
- Køber, Lars
- Kosiborod, Mikhail N.
- Ponikowski, Piotr
- Sabatine, Marc S.
- Anand, Inder S.
- Bělohlávek, Jan
- Böhm, Michael
- Chiang, Chern-En
- Chopra, Vijay K.
- Desai, Akshay S.
- Ge, Junbo
- Howlett, Jonathan G.
- Kitakaze, Masafumi
- Ljungman, Charlotta E.A.
- Merkely, Béla
- O’Meara, Eileen
- Petrie, Mark C.
- Schou, Morten
- Tereshchenko, Sergey
- Verma, Subodh
- Held, Claes
- DeMets, David L.
- Docherty, Kieran F.
- Jhund, Pardeep S.
- Bengtsson, Olof
- Sjöstrand, Mikaela
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2019-11-21
- Volume
- 381
- Issue
- 21
- Pages
- 1995-2008
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2974260792
- Semantic Scholar
- 43e5c9ff37bb98a622e70cb01c55e23a60782d69
- Cited by
- 7,140
- References
- 21
- Citations by year
- 2026: 842 · 2025: 955 · 2024: 979 · 2023: 1060 · 2022: 1138 · 2021: 1152 · 2020: 904 · 2019: 89 · 2018: 3 · 2017: 2 · 2014: 1 · 2013: 1 · 2012: 1
- FWCI
- 593.03
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- New England Journal of Medicine (publishedVersion, other-oa)
- PubMed (publishedVersion)
- Research at the University of Copenhagen (University of Copenhagen) (publishedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (publishedVersion, other-oa)
- ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (acceptedVersion, cc-by-sa)
- Research Bank (Australian Catholic University) (submittedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion, other-oa)
- Funders
- AstraZeneca Plc
- 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
- dapagliflozin, SGLT2 inhibitors, heart failure with reduced ejection fraction, type 2 diabetes, cardiovascular mortality, heart failure hospitalization, hypovolemia, renal dysfunction, hypoglycemia, SGLT2 inhibition, heart failure prognosis, adverse events, glucose monitoring, heart failure with preserved ejection fraction
- MeSH terms
- Sodium-Glucose Transporter 2 Inhibitors, Aged, Benzhydryl Compounds, Cardiovascular Agents, Cardiovascular Diseases, Combined Modality Therapy, Diabetes Mellitus, Type 2, Drug Therapy, Combination, Female, Glucosides, Heart Failure, Glycated Hemoglobin, Hospitalization, Humans, Male, Middle Aged, Stroke Volume, Ventricular Dysfunction, Left, Kaplan-Meier Estimate
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