Abstract

Abstract BACKGROUND AND AIMS In patients with type 2 diabetes, inhibitors of sodium–glucose cotransporter 2 (SGLT2) reduce the risk of a first hospitalization for heart failure, possibly through glucose-independent mechanisms. More data are needed regarding the effects of SGLT2 inhibitors in patients with established heart failure and a reduced ejection fraction, regardless of the presence or absence of type 2 diabetes. METHOD A multicenter prospective cohort study, where 225 patients with heart failure (III and IV by NYHA) and an ejection fraction of 45% or less to receive either dapagliflozin (10 mg once daily) or placebo, in addition to basic therapy. The primary outcome was a composite of worsening heart failure (hospitalization or an urgent visit resulting in intravenous therapy for heart failure) or cardiovascular death. RESULTS After 12 months, the primary outcome occurred in 17 of 111 patients (15.31%) in the dapagliflozin group and in 24 of 114 patients (21.05%) in the placebo group {HR 0.74 [95% confidence interval (CI), 0.65–0.85]; P < 0.001}. A first worsening heart failure event occurred in 10 patients (9.0%) in the dapagliflozin group and in 16 patients (14.0%) in the placebo group [HR 0.70 (95% CI 0.59–0.85)]. Death from cardiovascular reasons occurred in six patients (5.4%) in the dapagliflozin group and in 11 patients (9.6%) in the placebo group [HR 0.80 (95% CI 0.69–0.95)]; 12 patients (10.8%) and 15 patients (13.1%), respectively, died from other causes [HR 0.83 (95% CI 0.71–0.96)]. Findings in patients with diabetes were not significantly pronounced than in patients without diabetes. The frequency of adverse events related to volume depletion, renal dysfunction and hypo/hyperglycemia did not differ between treatment groups. CONCLUSION Among patients with heart failure and a reduced ejection fraction, the risk of worsening heart failure or death from cardiovascular events was lower among those who received dapagliflozin than among those who received placebo, regardless of the presence or absence of diabetes.

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