Effect of dapagliflozin according to baseline systolic blood pressure in the Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure trial (DAPA-HF)
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Aims: Concern about hypotension often leads to withholding of beneficial therapy in patients with heart failure and reduced ejection fraction (HFrEF). We evaluated the efficacy and safety of dapagliflozin, which lowers systolic blood pressure (SBP),according to baseline SBP in Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure trial (DAPA-HF). Methods and results: Key inclusion criteria were: New York Heart Association Class II−IV, left ventricular ejection fraction ≤ 40%, elevated N-terminal pro-B-type natriuretic peptide level, and SBP ≥95 mmHg. The primary outcome was a composite of worsening heart failure or cardiovascular death. The efficacy and safety of dapagliflozin were examined using SBP as both a categorical and continuous variable. A total of 1205 patients had a baseline SBP <110 mmHg; 981 ≥ 110 < 120; 1149 ≥ 120 < 130; and 1409 ≥ 130 mmHg. The placebo-corrected reduction in SBP from baseline to 2 weeks with dapagliflozin was −2.54 (−3.33 to −1.76) mmHg (P < 0.001), with a smaller between-treatment difference in patients in the lowest compared to highest SBP category. Patients in the lowest SBP category had a much higher rate (per 100 person-years) of the primary outcome [20.6, 95% confidence interval (95% CI) 17.6–24.2] than those in the highest SBP category (13.8, 11.7–16.4). The benefit and safety of dapagliflozin was consistent across the range of SBP; hazard ratio (95% CI) in each SBP group, lowest to highest: 0.76 (0.60–0.97), 0.76 (0.57–1.02), 0.81 (0.61–1.08), and 0.67 (0.51–0.87), P interaction = 0.78. Study drug discontinuation did not differ between dapagliflozin and placebo across the SBP categories examined. Conclusion: Dapagliflozin had a small effect on SBP in patients with HFrEF and was superior to placebo in improving outcomes, and well tolerated, across the range of SBP included in DAPA-HF. Clinical Trial Registration: ClinicalTrials.gov NCT03036124.
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Similar modest changes in natriuretic peptides and systolic blood pressure were reported with dapagliflozin in patients with heart failure and a reduced ejection fraction in 2 trials.
“Similar modest changes in natriuretic peptides and systolic blood pressure were reported with dapagliflozin in patients with heart failure and a reduced ejection fraction in 2 trials.”
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 [31]
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- Authors
- Serenelli, M., Böhm, M., Inzucchi, S. E., Køber, L., Kosiborod, M. N., Martinez, F. A., Ponikowski, P., Sabatine, M. S., Solomon, S. D., DeMets, D. L., Bengtsson, O., Sjöstrand, M., Langkilde, A. M., Anand, I. S., Chiang, C.-E., Chopra, V. K., de Boer, R. A., Diez, M., Dukát, A., Ge, J., Howlett, J. G., Katova, T., Kitakaze, M., Ljungman, C. E. A., Verma, S., Docherty, K. F., Jhund, P. S., & McMurray, J. J. V.
- Affiliations
- British Heart Foundation (GB)
- Universitätsklinikum des Saarlandes (DE)
- Yale University (US)
- Copenhagen University Hospital (DK)
- University of Missouri–Kansas City (US)
- National University of Cordoba , Cordoba, Argentina
- Wroclaw Medical University (PL)
- Brigham and Women's Hospital (US)
- University of Wisconsin–Madison (US)
- AstraZeneca (Sweden) (SE)
- University of Minnesota (US)
- Taipei Veterans General Hospital (TW)
- Max Super Speciality Hospital (IN)
- Department of Cardiology, University Medical Center and University of Groningen , Groningen, Netherlands
- Division of Cardiology, Institute Cardiovascular de Buenos Aires , Buenos Aires, Argentina
- Comenius University Bratislava (SK)
- Fudan University (CN)
- University of Calgary (CA)
- National Heart Hospital (BG)
- National Cerebral and Cardiovascular Center (JP)
- Department of Molecular and Clinical Medicine and Cardiology, Sahlgrenska Academy , Gothenburg, Sweden
- St. Michael's Hospital (CA)
- Corresponding author
- McMurray, John J V
- ORCID
- Serenelli, Matteo
- Böhm, Michael
- Inzucchi, Silvio E
- Køber, Lars
- Kosiborod, Mikhail N
- Ponikowski, Piotr
- Sabatine, Marc S
- Solomon, Scott D
- DeMets, David L
- Bengtsson, Olof
- Sjöstrand, Mikaela
- Langkilde, Anna Maria
- Anand, Inder S
- Chiang, Chern-En
- Chopra, Vijay K
- de Boer, Rudolf A
- Diez, Mirta
- Ge, Junbo
- Howlett, Jonathan G
- Kitakaze, Masafumi
- Ljungman, Charlotta E A
- Verma, Subodh
- Docherty, Kieran F
- Jhund, Pardeep S
- McMurray, John J V
- Venue
- European Heart Journal
- Publisher
- Oxford University Press (OUP)
- Published
- 2020-08-21
- Volume
- 41
- Issue
- 36
- Pages
- 3402-3418
- ISSN
- 0195-668X (ISSN-L)
- 1522-9645
- PMC
- PMC7550197
- OpenAlex
- W3039701622
- Cited by
- 138
- References
- 24
- Citations by year
- 2026: 10 · 2025: 11 · 2024: 18 · 2023: 17 · 2022: 43 · 2021: 33 · 2020: 6
- FWCI
- 15.31
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- European Heart Journal (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)
- Institutional Research Information System University of Ferrara (University of Ferrara) (submittedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion, cc-by)
- Funders
- AstraZeneca
- British Heart Foundation Centre of Research Excellence (RE/18/6/34217)
- 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 › Blood Pressure and Hypertension Studies
- Keywords
- heart failure with reduced ejection fraction, systolic blood pressure, baseline blood pressure, SGLT2 inhibitors, hypotension, worsening heart failure, cardiovascular mortality, subgroup analysis, drug discontinuation, DAPA-HF trial, SGLT2 inhibitor safety
- MeSH terms
- Benzhydryl Compounds, Blood Pressure, Glucosides, Heart Failure, Humans, Stroke Volume, Ventricular Function, Left
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