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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- Matteo Serenelli
- British Heart Foundation Cardiovascular Research Centre, University of Glasgow , 126 University Place, Glasgow G12 8TA, UK
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- Michael Böhm
- Klinik für Innere Medizin III, Universität des Saarlandes, Universitätsklinikum des Saarlandes , Homburg/Saar, Germany
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- Silvio E Inzucchi
- Section of Endocrinology, Yale University School of Medicine , New Haven, CT, USA
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- Lars Køber
- Department of Cardiology, Rigshospitalet Copenhagen University Hospital , Copenhagen, Denmark
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- Mikhail N Kosiborod
- Saint Luke’s Mid America Heart Institute and University of Missouri-Kansas City , Kansas City, MO, USA
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- Felipe A Martinez
- National University of Cordoba , Cordoba, Argentina
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- Piotr Ponikowski
- Department of Heart Diseases, Wroclaw Medical University , Wroclaw, Poland
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- Marc S Sabatine
- Cardiovascular Division, Brigham and Women’s Hospital , Boston, MA, USA
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- Scott D Solomon
- Cardiovascular Division, Brigham and Women’s Hospital , Boston, MA, USA
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- David L DeMets
- Department of Biostatistics & Medical Informatics, University of Wisconsin , Madison, WI, USA
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- Olof Bengtsson
- AstraZeneca R&D , Gothenburg, Sweden
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- Mikaela Sjöstrand
- AstraZeneca R&D , Gothenburg, Sweden
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- Anna Maria Langkilde
- AstraZeneca R&D , Gothenburg, Sweden
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- Inder S Anand
- Department of Cardiology, University of Minnesota , Minneaspolis, MN, USA
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- Chern-En Chiang
- General Clinical Research Center and Division of Cardiology, Taipei Veterans General Hospital and National Yang-Ming University , Taipei, Taiwan
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- Vijay K Chopra
- Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi , India
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- Rudolf A de Boer
- Department of Cardiology, University Medical Center and University of Groningen , Groningen, Netherlands
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- Mirta Diez
- Division of Cardiology, Institute Cardiovascular de Buenos Aires , Buenos Aires, Argentina
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- Andrej Dukát
- Department of Internal Medicine, Comenius University in Bratislava , Bratislava, Slovakia
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- Junbo Ge
- Department of Cardiology, Shanghai Institute of Cardiovascular Disease and Zhongshan Hospital Fudan University , Shanghai, China
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- Jonathan G Howlett
- Cardiac Sciences and Medicine , University of Calgary, Calgary, AB, Canada
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- Tzvetana Katova
- Clinic of Cardiology, National Cardiology Hospital , Sofia, Bulgaria
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- Masafumi Kitakaze
- Cardiovascular Division of Medicine, National Cerebral and Cardiovascular Center , Osaka, Japan
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- Charlotta E A Ljungman
- Department of Molecular and Clinical Medicine and Cardiology, Sahlgrenska Academy , Gothenburg, Sweden
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- Subodh Verma
- Division of Cardiac Surgery, St Michael’s Hospital, University of Toronto , ON, Canada
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- Kieran F Docherty
- British Heart Foundation Cardiovascular Research Centre, University of Glasgow , 126 University Place, Glasgow G12 8TA, UK
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- Pardeep S Jhund
- British Heart Foundation Cardiovascular Research Centre, University of Glasgow , 126 University Place, Glasgow G12 8TA, UK
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- John J V McMurray
- British Heart Foundation Cardiovascular Research Centre, University of Glasgow , 126 University Place, Glasgow G12 8TA, UK
説明
<jats:title>Abstract</jats:title> <jats:sec> <jats:title>Aims</jats:title> <jats:p>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).</jats:p> </jats:sec> <jats:sec> <jats:title>Methods and results</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusion</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Clinical Trial Registration:</jats:title> <jats:p>ClinicalTrials.gov NCT03036124.</jats:p> <jats:p /> </jats:sec>
収録刊行物
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- European Heart Journal
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European Heart Journal 41 (36), 3402-3418, 2020-08-21
Oxford University Press (OUP)