Effect of Dapagliflozin on Outpatient Worsening of Patients With Heart Failure and Reduced Ejection Fraction: A Prespecified Analysis of DAPA-HF
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Background: In the DAPA-HF trial (Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure), dapagliflozin, added to guideline-recommended therapies, reduced the risk of mortality and heart failure (HF) hospitalization. We examined the frequency and significance of episodes of outpatient HF worsening, requiring the augmentation of oral therapy, and the effects of dapagliflozin on these additional events. Methods: Patients in New York Heart Association functional class II to IV, with a left ventricular ejection fraction ≤40% and elevation of NT-proBNP (N-terminal pro-B-type natriuretic peptide), were eligible. The primary outcome was the composite of an episode of worsening HF (HF hospitalization or an urgent HF visit requiring intravenous therapy) or cardiovascular death, whichever occurred first. An additional prespecified exploratory outcome was the primary outcome plus worsening HF symptoms/signs leading to the initiation of new, or the augmentation of existing, oral treatment. Results: Overall, 36% more patients experienced the expanded, in comparison with the primary, composite outcome. In the placebo group, 684 of 2371 (28.8%) patients and, in the dapagliflozin group, 527 of 2373 (22.2%) participants experienced the expanded outcome (hazard ratio, 0.73 [95% CI, 0.65–0.82]; P <0.0001). Each component of the composite was reduced significantly by dapagliflozin. Over the median follow-up of 18.2 months, the number of patients needed to treat with dapagliflozin to prevent 1 experiencing an episode of fatal or nonfatal worsening was 16. Among the 4744 randomly assigned patients, the first episode of worsening was outpatient augmentation of treatment in 407 participants (8.6%), an urgent HF visit with intravenous therapy in 20 (0.4%), HF hospitalization in 489 (10.3%), and cardiovascular death in 295 (6.2%). The adjusted risk of death from any cause (in comparison with no event) after an outpatient worsening was hazard ratio, 2.67 (95% CI, 2.03–3.52); after an urgent HF visit, the adjusted risk of death was hazard ratio, 3.00 (95% CI, 1.39–6.48); and after a HF hospitalization, the adjusted risk of death was hazard ratio, 6.21 (95% CI, 5.07–7.62). Conclusion: In DAPA-HF, outpatient episodes of HF worsening were common, were of prognostic importance, and were reduced by dapagliflozin. Registration: URL: https://www.clinicaltrials.gov ; Unique Identifier: NCT03036124.
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Several treatments that reduce the risk of hospitalizations for heart failure in patients with heart failure and a reduced ejection fraction also favorably impact outpatient metrics of clinical instability.
“Several treatments that reduce the risk of hospitalizations for heart failure in patients with heart failure and a reduced ejection fraction also favorably impact outpatient metrics of clinical instability.21–23”
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 [23]
A similar risk reduction in urgent outpatient worsening heart failure events was seen with dapagliflozin in a large-scale trial in patients with heart failure and a reduced ejection fraction (DAPA-HF).
“A similar risk reduction in urgent outpatient worsening heart failure events was also seen with dapagliflozin in a large-scale trial in patients with heart failure and a reduced ejection fraction (DAPA-HF [Dapagliflozin on Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure]).”
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 [23]
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“Regarding the former, there is accumulating evidence that even outpatient oral intensification of diuretic therapy is associated with an increased risk of morbidity and mortality.(28) These results suggest that the biological changes associated with the progression of disease should be considered instead of the locati…”
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“Shakoor and colleagues 4 showed in four representative HF cohorts (nearly equivalent prevalence of ischaemic heart disease and female sex) that while mean LVEF was similar in the CHF and WHF groups (mean LVEF 37% vs. 38%), the WHF group had five-fold higher pooled mortality rates than CHF.”
BackgroundMethodResultInfluentialExpanded Definition of Worsening Heart Failure
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Effect of Dapagliflozin on Exercise Capacity and Cardiovascular Risk in Patients with Heart Failure
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BackgroundSodium-Glucose Cotransporter-2 Inhibitors: Heart Failure and Renal Protection Indications
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- Authors
- Docherty, K. F., Jhund, P. S., Anand, I., Bengtsson, O., Böhm, M., de Boer, R. A., DeMets, D. L., Desai, A. S., Drozdz, J., Howlett, J., Inzucchi, S. E., Johanson, P., Katova, T., Køber, L., Kosiborod, M. N., Langkilde, A. M., Lindholm, D., Martinez, F. A., Merkely, B., Nicolau, J. C., O’Meara, E., Ponikowski, P., Sabatine, M. S., Sjöstrand, M., Solomon, S. D., Tereshchenko, S., Verma, S., & McMurray, J. J. V.
- Affiliations
- British Heart Foundation (GB)
- University of Minnesota (US)
- AstraZeneca (Sweden) (SE)
- Universitätsklinikum des Saarlandes (DE)
- Department of Cardiology, University Medical Center Groningen, University of Groningen, The Netherlands (R.A.d.B.).
- University of Wisconsin–Madison (US)
- Brigham and Women's Hospital (US)
- Department of Cardiology, Medical University of Lodz, Poland (J.D.).
- University of Calgary (CA)
- Yale University (US)
- National Heart Hospital (BG)
- Copenhagen University Hospital (DK)
- UNSW Sydney (AU)
- Universidad Nacional de Córdoba, Argentina (F.A.M.).
- Semmelweis University (HU)
- Instituto do Coracao (InCor), Hospital das Clínicas Faculdade de Medicina, Universidade de São Paulo, Brazil (J.C.N.).
- Montreal Heart Institute (CA)
- Wroclaw Medical University (PL)
- National Medical Research Center of Cardiology (RU)
- St. Michael's Hospital (CA)
- Corresponding author
- McMurray, John J.V.
- ORCID
- Docherty, Kieran F.
- Jhund, Pardeep S.
- Anand, Inder
- Bengtsson, Olof
- Böhm, Michael
- DeMets, David L.
- Desai, Akshay S.
- Howlett, Jonathan
- Inzucchi, Silvio E.
- Johanson, Per
- Køber, Lars
- Kosiborod, Mikhail N.
- Langkilde, Anna Maria
- Lindholm, Daniel
- Merkely, Béla
- Nicolau, Jose C.
- O’Meara, Eileen
- Ponikowski, Piotr
- Sabatine, Marc S.
- Sjöstrand, Mikaela
- Solomon, Scott D.
- Tereshchenko, Sergey
- Verma, Subodh
- McMurray, John J.V.
- Venue
- Circulation
- Published
- 2020-10-27
- Volume
- 142
- Issue
- 17
- Pages
- 1623-1632
- ISSN
- 0009-7322 (ISSN-L)
- 1524-4539
- PMC
- PMC7580857
- OpenAlex
- W3083153332
- Cited by
- 95
- References
- 21
- Citations by year
- 2026: 12 · 2025: 21 · 2024: 11 · 2023: 16 · 2022: 11 · 2021: 20 · 2020: 4
- FWCI
- 7.89
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by
- Locations
- Circulation (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Research at the University of Copenhagen (University of Copenhagen) (publishedVersion, cc-by)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (publishedVersion, cc-by)
- ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (acceptedVersion, cc-by-sa)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion, cc-by)
- Funders
- Amgen
- Bristol-Myers Squibb
- Eli Lilly and Company
- Pfizer
- AstraZeneca
- GlaxoSmithKline
- Sanofi
- Brigham and Women's Hospital
- Yale University
- Alnylam Pharmaceuticals
- University of Missouri
- University of Minnesota
- Alere
- Boston Scientific Corporation
- University of Missouri-Kansas City
- Regeneron Pharmaceuticals
- Universidad Nacional de Córdoba
- Intarcia Therapeutics
- Amarin Corporation
- Cytokinetics
- Zafgen
- Saint Luke's Health System
- British Heart Foundation (RE/18/6/34217)
- University of Glasgow
- Deutsche Forschungsgemeinschaft
- Rijksuniversiteit Groningen
- University of New South Wales
- Semmelweis Egyetem
- Gentofte Hospital
- Daiichi-Sankyo
- University of Toronto
- Eisai
- Novo Nordisk
- Universitair Medisch Centrum Groningen
- Universität des Saarlandes
- Universidade de São Paulo
- Uniwersytet Łódzki
- Vifor Pharma
- Uniwersytet Medyczny im. Piastów Slaskich we Wroclawiu
- Servier
- Institut de Cardiologie de Montréal
- Cumming School of Medicine, University of Calgary
- American Regent
- National Institute of Diabetes and Digestive and Kidney Diseases (P30DK045735)
- 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 › Heart rate and cardiovascular health
- Keywords
- dapagliflozin, heart failure with reduced ejection fraction, heart failure hospitalization, intravenous therapy, cardiovascular mortality, NT-proBNP, SGLT2 inhibitors, DAPA-HF trial, augmentation therapy, number needed to treat, heart failure with preserved ejection fraction
- MeSH terms
- Sodium-Glucose Transporter 2 Inhibitors, Aged, Benzhydryl Compounds, Double-Blind Method, Glucosides, Heart Failure, Humans, Outpatients, Prospective Studies, Stroke Volume
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