Effects of Dapagliflozin on Symptoms, Function, and Quality of Life in Patients With Heart Failure and Reduced Ejection Fraction
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- Mikhail N. Kosiborod
- Saint Luke’s Mid America Heart Institute, University of Missouri-Kansas City (M.N.K.).
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- Pardeep S. Jhund
- British Heart Foundation Cardiovascular Research Centre, University of Glasgow, UK (P.S.J., K.F.D., M.C.P., J.J.V.M.).
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- Kieran F. Docherty
- British Heart Foundation Cardiovascular Research Centre, University of Glasgow, UK (P.S.J., K.F.D., M.C.P., J.J.V.M.).
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- Mirta Diez
- Division of Cardiology, Instituto Cardiovascular de Buenos Aires, Argentina (M.D.).
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- Mark C. Petrie
- British Heart Foundation Cardiovascular Research Centre, University of Glasgow, UK (P.S.J., K.F.D., M.C.P., J.J.V.M.).
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- Subodh Verma
- St Michael’s Hospital, University of Toronto, Canada (S.V.).
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- Jose C. Nicolau
- Instituto do Coracao (InCor), Hospital das Clínicas Faculdade de Medicina, Universidade de São Paulo, Brazil (J.C.N.).
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- Béla Merkely
- Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.).
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- Masafumi Kitakaze
- Department of Clinical Medicine and Development, National Cerebral and Cardiovascular Center, Suita Osaka, Japan (M.K.).
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- David L. DeMets
- Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison (D.L.D.).
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- Silvio E. Inzucchi
- Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.).
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- Lars Køber
- Rigshospitalet, Department of Cardiology, University of Copenhagen, Denmark (L.K.).
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- Felipe A. Martinez
- Universidad Nacional de Córdoba, Argentina (F.A.M.).
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- Piotr Ponikowski
- Center for Heart Diseases, University Hospital, Wroclaw Medical University, Poland (P.P.).
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- Marc S. Sabatine
- Division of Cardiovascular Medicine, Brigham and Women’s Hospital, Boston, MA (M.S.S., S.D.S.).
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- Scott D. Solomon
- Division of Cardiovascular Medicine, Brigham and Women’s Hospital, Boston, MA (M.S.S., S.D.S.).
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- Olof Bengtsson
- Late Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (O.B., D.L., A.N., M.S., A.M.L.).
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- Daniel Lindholm
- Late Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (O.B., D.L., A.N., M.S., A.M.L.).
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- Anna Niklasson
- Late Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (O.B., D.L., A.N., M.S., A.M.L.).
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- Mikaela Sjöstrand
- Late Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (O.B., D.L., A.N., M.S., A.M.L.).
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- Anna Maria Langkilde
- Late Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (O.B., D.L., A.N., M.S., A.M.L.).
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- John J.V. McMurray
- British Heart Foundation Cardiovascular Research Centre, University of Glasgow, UK (P.S.J., K.F.D., M.C.P., J.J.V.M.).
書誌事項
- タイトル別名
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- Results From the DAPA-HF Trial
抄録
<jats:sec> <jats:title>Background:</jats:title> <jats:p>Goals of management in patients with heart failure and reduced ejection fraction include reducing death and hospitalizations, and improving health status (symptoms, physical function, and quality of life). In the DAPA-HF trial (Dapagliflozin and Prevention of Adverse-Outcomes in Heart Failure), sodium–glucose cotransporter-2 inhibitor, dapagliflozin, reduced death and hospitalizations, and improved symptoms in patients with heart failure and reduced ejection fraction. In this analysis, we examine the effects of dapagliflozin on a broad range of health status outcomes, using the Kansas City Cardiomyopathy Questionnaire (KCCQ).</jats:p> </jats:sec> <jats:sec> <jats:title>Methods:</jats:title> <jats:p>KCCQ was evaluated at randomization, 4 and 8 months. Patients were divided by baseline KCCQ total symptom score (TSS); Cox proportional hazards models examined the effects of dapagliflozin on clinical events across these subgroups. We also evaluated the effects of dapagliflozin on KCCQ-TSS, clinical summary score, and overall summary score. Responder analyses were performed to compare proportions of dapagliflozin versus placebo-treated patients with clinically meaningful changes in KCCQ at 8 months.</jats:p> </jats:sec> <jats:sec> <jats:title>Results:</jats:title> <jats:p> A total of 4443 patients had available KCCQ at baseline (median KCCQ-TSS, 77.1 [interquartile range, 58.3–91.7]). The effects of dapagliflozin vs placebo on reducing cardiovascular death or worsening heart failure were consistent across the range of KCCQ-TSS (lowest to highest tertile: hazard ratio, 0.70 [95% CI, 0.57–0.86]; hazard ratio, 0.77 [95% CI, 0.61–0.98]; hazard ratio, 0.62 [95% CI, 0.46–0.83]; <jats:italic>P</jats:italic> for heterogeneity=0.52). Patients treated with dapagliflozin had greater improvement in mean KCCQ-TSS, clinical summary score, and overall summary score at 8 months (2.8, 2.5 and 2.3 points higher versus placebo; <jats:italic>P</jats:italic> <0.0001 for all). Fewer patients treated with dapagliflozin had a deterioration in KCCQ-TSS (odds ratio, 0.84 [95% CI, 0.78–0.90]; <jats:italic>P</jats:italic> <0.0001); and more patients had at least small, moderate, and large improvements (odds ratio, 1.15 [95% CI, 1.08–1.23]; odds ratio, 1.15 [95% CI, 1.08–1.22]; odds ratio, 1.14 [95% CI, 1.07–1.22]; number needed to treat=14, 15, and 18, respectively; <jats:italic>P</jats:italic> <0.0001 for all; results consistent for KCCQ clinical summary score and overall summary score). </jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions:</jats:title> <jats:p>Dapagliflozin reduced cardiovascular death and worsening heart failure across the range of baseline KCCQ, and improved symptoms, physical function, and quality of life in patients with heart failure and reduced ejection fraction. Furthermore, dapagliflozin increased the proportion of patients experiencing at least small, moderate, and large improvements in health status; these effects were clinically important.</jats:p> </jats:sec> <jats:sec> <jats:title>Clinical Trial Registration:</jats:title> <jats:p> URL: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://www.clinicaltrials.gov">https://www.clinicaltrials.gov</jats:ext-link> . Unique identifier: NCT03036124. </jats:p> </jats:sec>
収録刊行物
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- Circulation
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Circulation 141 (2), 90-99, 2020-01-14
Ovid Technologies (Wolters Kluwer Health)