Efficacy and safety of dapagliflozin according to aetiology in heart failure with reduced ejection fraction: insights from the DAPA-HF trial.

Autor: Butt JH; Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark., Nicolau JC; Instituto do Coracao (InCor), Hospital das Clínicas Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil., Verma S; Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto, Canada., Docherty KF; BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, UK., Petrie MC; BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, UK., Inzucchi SE; Section of Endocrinology, Yale School of Medicine, New Haven, CT, USA., Schou M; Department of Cardiology, Herlev-Gentofte University Hospital, Herlev, Denmark., Kosiborod MN; Saint Luke's Mid America Heart Institute, University of Missouri, Kansas City; The George Institute for Global Health, University of New South Wales, Sydney, Australia., Langkilde AM; Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden., Martinez FA; Universidad Nacional de Córdoba, Córdoba, Argentina., Ponikowski P; Center for Heart Diseases, University Hospital, Wroclaw Medical University, Wroclaw, Poland., Sabatine MS; TIMI Study Group, Brigham and Women's Hospital, Boston, MA, USA., Sjöstrand M; Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden., Solomon SD; Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA, USA., Bengtsson O; Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden., Jhund PS; BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, UK., McMurray JJV; BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, UK., Køber L; Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Jazyk: angličtina
Zdroj: European journal of heart failure [Eur J Heart Fail] 2021 Apr; Vol. 23 (4), pp. 601-613. Date of Electronic Publication: 2021 Mar 10.
DOI: 10.1002/ejhf.2124
Abstrakt: Aims: We examined the efficacy and safety of dapagliflozin, compared with placebo, according to aetiology in patients with heart failure (HF) with reduced ejection fraction (HFrEF) enrolled in the Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure trial (DAPA-HF).
Methods and Results: Aetiology was investigator-reported and categorized as ischaemic or non-ischaemic. The primary outcome was the composite of an episode of worsening HF or cardiovascular death. A total of 4744 patients were randomized in DAPA-HF, of whom 2674 (56.4%) patients had an ischaemic aetiology. Participants with an ischaemic aetiology had a higher risk of cardiovascular mortality [hazard ratio (HR) 1.35, 95% confidence interval (CI) 1.13-1.63], but lower risk of HF hospitalization (HR 0.83, 95% CI 0.70-0.98) than non-ischaemic patients. Compared with placebo, dapagliflozin reduced the risk of worsening HF or cardiovascular death to a similar extent in both patients with ischaemic and non-ischaemic aetiology (HR 0.77, 95% CI 0.65-0.92, and HR 0.71, 95% CI 0.58-0.87, respectively; P for interaction = 0.55). Consistent benefits were observed for the components of the primary outcome and all-cause mortality. Dapagliflozin, as compared with placebo, increased the proportion of patients with an improvement of Kansas City Cardiomyopathy Questionnaire total symptom score (KCCQ-TSS) of ≥5 points (P for interaction = 0.32) and decreased the proportion with a deterioration in KCCQ-TSS of ≥5 points (P for interaction = 0.76), irrespective of aetiology. Study drug discontinuation and serious adverse events were similar according to treatment groups, irrespective of aetiology.
Conclusions: Dapagliflozin reduced the risk of worsening HF and death, and improved symptoms, similarly in patients with ischaemic and non-ischaemic aetiology. In addition, dapagliflozin was safe and well-tolerated, irrespective of aetiology.
(© 2021 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)
Databáze: MEDLINE
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