Dapagliflozin in Heart Failure with Mildly Reduced or Preserved Ejection Fraction
Open accessAbstract
BACKGROUND: Sodium-glucose cotransporter 2 (SGLT2) inhibitors reduce the risk of hospitalization for heart failure and cardiovascular death among patients with chronic heart failure and a left ventricular ejection fraction of 40% or less. Whether SGLT2 inhibitors are effective in patients with a higher left ventricular ejection fraction remains less certain. METHODS: We randomly assigned 6263 patients with heart failure and a left ventricular ejection fraction of more than 40% to receive dapagliflozin (at a dose of 10 mg once daily) or matching placebo, in addition to usual therapy. The primary outcome was a composite of worsening heart failure (which was defined as either an unplanned hospitalization for heart failure or an urgent visit for heart failure) or cardiovascular death, as assessed in a time-to-event analysis. RESULTS: Over a median of 2.3 years, the primary outcome occurred in 512 of 3131 patients (16.4%) in the dapagliflozin group and in 610 of 3132 patients (19.5%) in the placebo group (hazard ratio, 0.82; 95% confidence interval [CI], 0.73 to 0.92; P<0.001). Worsening heart failure occurred in 368 patients (11.8%) in the dapagliflozin group and in 455 patients (14.5%) in the placebo group (hazard ratio, 0.79; 95% CI, 0.69 to 0.91); cardiovascular death occurred in 231 patients (7.4%) and 261 patients (8.3%), respectively (hazard ratio, 0.88; 95% CI, 0.74 to 1.05). Total events and symptom burden were lower in the dapagliflozin group than in the placebo group. Results were similar among patients with a left ventricular ejection fraction of 60% or more and those with a left ventricular ejection fraction of less than 60%, and results were similar in prespecified subgroups, including patients with or without diabetes. The incidence of adverse events was similar in the two groups. CONCLUSIONS: Dapagliflozin reduced the combined risk of worsening heart failure or cardiovascular death among patients with heart failure and a mildly reduced or preserved ejection fraction. (Funded by AstraZeneca; DELIVER ClinicalTrials.gov number, NCT03619213.).
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Risk of diabetic ketoacidosis is increased in persons using SGLT2 inhibitors, especially those treated with insulin (particularly with recent insulin dose reduction) and/or those with acute illness and prolonged fasting.
“Risk of DKA is increased in persons using SGLT2is, especially in those being treated with insulin (especially if there has been a recent reduction in their insulin dose) and/or those with acute illnesses and prolonged fasting.1049,1050”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [1049]
The Efficacy section’s safety table reports two diabetic ketoacidosis cases among dapagliflozin recipients and none among placebo recipients in this heart-failure trial. It does not establish an increased risk across SGLT2 inhibitors generally or identify insulin treatment, recent insulin-dose reduction, acute illness, or prolonged fasting as risk factors; searches for those terms found no supporting passage. (LLM, conf=0.83)
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 [302]
The Results and Efficacy sections report fewer heart-failure hospitalizations and a lower symptom burden with dapagliflozin; the Results say effects were similar in patients with and without diabetes. However, the trial enrolled people who already had heart failure, so it does not establish reduced incidence of new heart failure. It studied ejection fractions above 40%, not the full reduced-ejection-fraction range. Page numbers were not available in our copy. (LLM, conf=0.88)
Experimental — accuracy not yet measuredIn the DELIVER trial, dapagliflozin showed a similar benefit for heart failure outcomes in people with mildly reduced or preserved ejection fraction.
“A similar benefit for heart failure outcomes was seen in the Dapagliflozin Evaluation to Improve the Lives of Patients with Preserved Ejection Fraction Heart Failure (DELIVER) trial for dapagliflozin in people with mildly reduced or preserved ejection fraction (302).”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [302]
In the DELIVER trial, dapagliflozin showed a similar benefit for heart failure outcomes in people with mildly reduced or preserved ejection fraction.
“A similar benefit for heart failure outcomes was seen in the Dapagliflozin Evaluation to Improve the Lives of Patients with Preserved Ejection Fraction Heart Failure (DELIVER) trial for dapagliflozin in people with mildly reduced or preserved ejection fraction (290).”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [290]
In the PARAGON-HF trial, sacubitril/valsartan compared with valsartan reduced the likelihood of the primary composite outcome of cardiovascular death and total heart failure hospitalization by 22% in those with an LVEF below or equal to the median of 57%.
“Sacubitril/valsartan, compared with valsartan, reduced the likelihood of the primary composite outcome of CV death and total HF hospitalization by 22% in those with an LVEF below or equal to the median of 57%.534”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [534]
Several large randomized controlled trials failed to achieve statistical significance for effects on primary outcomes in patients with HFpEF, including PEP-CHF, CHARM-Preserved, I-PRESERVE, TOPCAT, DIG Ancillary Trial, and PARAGON-HF.
“Over the past decade, several large RCTs failed to achieve statistical significance with regard to effects on the primary outcomes in patients with HFpEF including: PEP-CHF (perindopril), CHARM-Preserved (candesartan), I-PRESERVE (irbesartan), TOPCAT (spironolactone), DIG Ancillary Trial (digoxin), and PARAGON-HF (sacubitril/valsartan). 477,[534][535][536][537][538]”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [534]
DELIVER recruited 6263 patients with heart failure with mildly reduced or preserved (>40%) ejection fraction including 3109 patients without diabetes.
“DELIVER recruited 6263 patients with heart failure with mildly reduced or preserved (>40%) ejection fraction including 3109 patients without 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.
“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.”
Since 2021, two placebo-controlled SGLT2 inhibitor trials (EMPA-KIDNEY and DELIVER) have studied a large number of people without diabetes.
“Since 2021, two placebo-controlled SGLT2 inhibitor trials (EMPA-KIDNEY and DELIVER) have studied a large number of people without diabetes.”
In DELIVER, results were consistent regardless of the presence of type 2 diabetes.
“Approximately 44% of patients randomized to either dapaglifl ozin or placebo had type 2 diabetes, and results were consistent regardless of the presence of type 2 diabetes.”
From 10. Cardiovascular Disease and Risk Management: <i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [199]
In DELIVER, dapagliflozin reduced the primary composite of worsening heart failure or cardiovascular death by 18% compared with placebo (HR 0.82).
“The primary outcome of a composite of worsening heart failure, de fi ned as hospitalization or urgent visit for heart failure, or cardiovascular death was reduced by 18% in patients treated with dapagli fl ozin compared with placebo (HR 0.82 [95% CI 0.73 -0.92]; P < 0.001).”
From 10. Cardiovascular Disease and Risk Management: <i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [199]
Over the past decade, medications effective in heart failure with reduced ejection fraction have been evaluated in large-scale trials in patients with heart failure with mildly reduced ejection fraction and patients with heart failure with preserved ejection fraction.
“Over the past decade, the use of medications that have been demonstrated to be effective in patients with HF with reduced ejection fraction (angiotensin receptor neprilysin inhibitors, mineralocorticoid receptor antagonists, and sodium-glucose cotransporter 2 [SGLT2] inhibitors) has been evaluated in large-scale trials in patients with HF and mildly reduced ejection fraction and patients with HFpE”
From Effects of Tirzepatide on the Clinical Trajectory of Patients With Heart Failure, Preserved Ejection Fraction, and Obesity (2025) · cites this paper as [5]
The median NT-proBNP in SUMMIT was significantly lower than in the STEP-HFpEF program (median ≈470 pg/mL) and substantially lower than in other large-scale outcome trials in HFpEF (median 900-1400 pg/mL).
“This level was significantly lower than that in the STEP-HFpEF program (median, ≈470 pg/mL)36 and substantially lower than in other large-scale outcome trials in HFpEF (median 900–1400 pg/mL).3–6”
From Effects of Tirzepatide on the Clinical Trajectory of Patients With Heart Failure, Preserved Ejection Fraction, and Obesity (2025) · cites this paper as [5]
In EMPEROR-Preserved and DELIVER, SGLT2 inhibition reduced the risk of cardiovascular death and worsening HF events by 18% to 21% and improved KCCQ-CSS by 1.5 to 2.3 points, with odds ratios for threshold improvements in KCCQ-CSS of 1.1 to 1.2.
“In the EMPEROR-Preserved trial (Empagliflozin Outcome Trial in Patients With Chronic Heart Failure With Preserved Ejection Fraction) and DELIVER trial (Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure), SGLT2 inhibition reduced the risk of cardiovascular death and worsening HF events by 18% to 21%4,5 and improved KCCQ-CSS by 1.5 to 2.3 points”
From Effects of Tirzepatide on the Clinical Trajectory of Patients With Heart Failure, Preserved Ejection Fraction, and Obesity (2025) · cites this paper as [5]
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- Authors
- Solomon, S. D., McMurray, J. J. V., Claggett, B., de Boer, R. A., DeMets, D., Hernandez, A. F., Inzucchi, S. E., Kosiborod, M. N., Lam, C. S. P., Martinez, F., Shah, S. J., Desai, A. S., Jhund, P. S., Belohlavek, J., Chiang, C.-E., Borleffs, C. J. W., Comin-Colet, J., Dobreanu, D., Drozdz, J., Fang, J. C., Alcocer-Gamba, M. A., Al Habeeb, W., Han, Y., Cabrera Honorio, J. W., Janssens, S. P., Katova, T., Kitakaze, M., Merkely, B., O’Meara, E., Saraiva, J. F. K., Tereshchenko, S. N., Thierer, J., Vaduganathan, M., Vardeny, O., Verma, S., Pham, V. N., Wilderäng, U., Zaozerska, N., Bachus, E., Lindholm, D., Petersson, M., & Langkilde, A. M.
- Affiliations
- Brigham and Women's Hospital (US)
- From the Cardiovascular Division, Brigham and Women’s Hospital, Harvard Medical School, Boston (S.D.S., B.C., A.S.D., M.V.); the British Heart Foundation Glasgow Cardiovascular Research Centre, School of Cardiovascular and Metabolic Health, University of Glasgow, Glasgow, Scotland, United Kingdom (J.J.V.M., P.S.J.); the Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen (R.A.B., C.S.P.L.), and Haga Teaching Hospital, the Hague (C.J.W.B.) — both in the Netherlands; the University of Wisconsin, Madison (D. DeMets); Duke University Medical Center, Durham, NC (A.F.H.); Yale School of Medicine, New Haven, CT (S.E.I.); Saint Luke’s Mid America Heart Institute, University of Missouri, Kansas City, Kansas City (M.N.K.); National Heart Center Singapore and Duke–National University of Singapore, Singapore (C.S.P.L.); National University of Cordoba, Cordoba (F.M.), and Jefe de Unidad de Insuficiencia Cardíaca, Centro de Educación Médica e Investigaciones Clínicas Norbert...
- Northwestern University (US)
- Semmelweis University (HU)
- ORCID
- Solomon, Scott D.
- McMurray, John J.V.
- Claggett, Brian
- de Boer, Rudolf A.
- DeMets, David
- Hernandez, Adrian F.
- Inzucchi, Silvio E.
- Kosiborod, Mikhail N.
- Lam, Carolyn S.P.
- Shah, Sanjiv J.
- Desai, Akshay S.
- Jhund, Pardeep S.
- Chiang, Chern-En
- Dobreanu, Dan
- Fang, James C.
- Alcocer-Gamba, Marco Antonio
- Han, Yaling
- Janssens, Stefan P.
- Kitakaze, Masafumi
- Merkely, Béla
- O’Meara, Eileen
- Tereshchenko, Sergey N.
- Thierer, Jorge
- Vaduganathan, Muthiah
- Vardeny, Orly
- Verma, Subodh
- Pham, Vinh Nguyen
- Wilderäng, Ulrica
- Bachus, Erasmus
- Lindholm, Daniel
- Petersson, Magnus
- Langkilde, Anna Maria
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2022-09-22
- Volume
- 387
- Issue
- 12
- Pages
- 1089-1098
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W4293354639
- Cited by
- 2,884
- References
- 15
- Citations by year
- 2026: 635 · 2025: 716 · 2024: 714 · 2023: 673 · 2022: 139 · 2021: 2 · 2012: 1
- FWCI
- 390.50
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- New England Journal of Medicine (publishedVersion, other-oa)
- PubMed (publishedVersion)
- ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (submittedVersion, cc-by-sa)
- Lirias (KU Leuven) (submittedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion, other-oa)
- Funders
- AstraZeneca
- 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, preserved ejection fraction, mildly reduced ejection fraction, heart failure hospitalization, cardiovascular mortality, left ventricular ejection fraction
- MeSH terms
- Sodium-Glucose Transporter 2 Inhibitors, Benzhydryl Compounds, Diabetes Mellitus, Type 2, Glucosides, Heart Failure, Humans, Stroke Volume, Ventricular Function, Left
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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