Dapagliflozin in Heart Failure with Mildly Reduced or Preserved Ejection FractionShow others and affiliations
2022 (English)In: New England Journal of Medicine, ISSN 0028-4793, E-ISSN 1533-4406, Vol. 387, no 12, p. 1089-1098Article in journal (Refereed) Published
Abstract [en]
BACKGROUND: Sodium-glucose cotransporter 2 (SGLT2) inhibitors reduce the risk of hospitalization for heart failure and cardiovascular death among patients with chronic heart failure and a left ventricular ejection fraction of 40% or less. Whether SGLT2 inhibitors are effective in patients with a higher left ventricular ejection fraction remains less certain. METHODS: We randomly assigned 6263 patients with heart failure and a left ventricular ejection fraction of more than 40% to receive dapagliflozin (at a dose of 10 mg once daily) or matching placebo, in addition to usual therapy. The primary outcome was a composite of worsening heart failure (which was defined as either an unplanned hospitalization for heart failure or an urgent visit for heart failure) or cardiovascular death, as assessed in a time-to-event analysis. RESULTS: Over a median of 2.3 years, the primary outcome occurred in 512 of 3131 patients (16.4%) in the dapagliflozin group and in 610 of 3132 patients (19.5%) in the placebo group (hazard ratio, 0.82; 95% confidence interval [CI], 0.73 to 0.92; P$<$0.001). Worsening heart failure occurred in 368 patients (11.8%) in the dapagliflozin group and in 455 patients (14.5%) in the placebo group (hazard ratio, 0.79; 95% CI, 0.69 to 0.91); cardiovascular death occurred in 231 patients (7.4%) and 261 patients (8.3%), respectively (hazard ratio, 0.88; 95% CI, 0.74 to 1.05). Total events and symptom burden were lower in the dapagliflozin group than in the placebo group. Results were similar among patients with a left ventricular ejection fraction of 60% or more and those with a left ventricular ejection fraction of less than 60%, and results were similar in prespecified subgroups, including patients with or without diabetes. The incidence of adverse events was similar in the two groups. CONCLUSIONS: Dapagliflozin reduced the combined risk of worsening heart failure or cardiovascular death among patients with heart failure and a mildly reduced or preserved ejection fraction. (Funded by AstraZeneca; DELIVER ClinicalTrials.gov number, NCT03619213.).
Place, publisher, year, edition, pages
2022. Vol. 387, no 12, p. 1089-1098
Keywords [en]
*Heart Failure/complications/drug therapy/mortality/physiopathology, *Sodium-Glucose Transporter 2 Inhibitors/adverse effects/pharmacology/therapeutic use, *Stroke Volume/drug effects, *Ventricular Function, Left/drug effects, Benzhydryl Compounds/adverse effects/therapeutic use, Diabetes Mellitus, Type 2/complications/drug therapy, Glucosides/adverse effects/therapeutic use, Humans
National Category
Cardiology and Cardiovascular Disease
Identifiers
URN: urn:nbn:se:uu:diva-512691DOI: 10.1056/NEJMoa2206286ISI: 000877574100001OAI: oai:DiVA.org:uu-512691DiVA, id: diva2:1859892
2024-05-222024-05-222025-02-10Bibliographically approved