medwireNews: Dapagliflozin significantly reduces the risk for worsening heart failure or cardiovascular death in people who have heart failure with preserved ejection fraction (HFpEF), show the results of the DELIVER trial.
The benefits were irrespective of whether the study participants had type 2 diabetes, which was the case for 45% of them, the investigators report in The New England Journal of Medicine.
The findings therefore “extend those of the DAPA-HF trial to patients with heart failure and a left ventricular ejection fraction of more than 40% and are consistent with the overall results of the EMPEROR-Preserved trial,” they write.
The trial’s composite primary outcome was worsening HF (unplanned hospitalization or urgent visit for HF) or cardiovascular death. During a median 2.3 years of treatment, a primary outcome event occurred in 16.4% of the 3131 trial participants randomly assigned to receive dapagliflozin and in 19.5% of the 3132 given placebo.
This amounted to a significant 18% difference in favor of dapagliflozin, report Scott Solomon (Brigham and Women’s Hospital, Boston, Massachusetts, USA) and co-researchers.
People taking the sodium-glucose cotransporter (SGLT)2 inhibitor also had a significantly lower rate of total events (first and recurrent) than those taking placebo, at 11.8 versus 15.3 events per 100 person–years, and were significantly more likely to have improved on the Kansas City Cardiomyopathy Questionnaire total symptom score by month 8.
The trial participants were an average age of approximately 72 years, about 44% were women and the majority were White (71%) or Asian (20%). Their average left ventricular EF was about 54%.
The benefits of dapagliflozin were consistent across multiple subgroups, including in the approximately 18% of participants who previously had a left ventricular EF of 40% or below but in whom treatment had improved it to more than 40% by the time of trial enrollment.
This point is highlighted in an accompanying editorial by Kenneth Margulies (University of Pennsylvania, Philadelphia, USA), who says it “merits particular attention,” because people with an improved EF “represent a growing cohort” of people with HF.
“Such patients are typically excluded from clinical trials of treatments for heart failure and a preserved ejection fraction,” says Margulies.
“However, recent reviews and guidelines highlight the fact that patients with heart failure and an improved left ventricular ejection fraction have worse outcomes than patients with no history of heart failure, even when the left ventricular ejection fraction has improved to within the normal range.”
He concludes: “Building on trials that show that outcomes worsen when disease-modifying therapy is discontinued in patients with heart failure and an improved left ventricular ejection fraction, the DELIVER trial shows that the addition of an SGLT2 inhibitor provides further benefit among those with residual symptoms of heart failure.”
The DELIVER findings were also presented at the European Society of Cardiology conference in Barcelona, Spain.
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N Engl J Med 2022; doi:10.1056/NEJMoa2206286
N Engl J Med 2022; doi:10.1056/NEJMe2210177