"Dapagliflozin in Heart Failure with Preserved Ejection Fraction (DELIVER)".The New England Journal of Medicine. 2022.
Links to original sources: Wiki Journal Post Full Journal Article
Does dapagliflozin reduce the composite risk of worsening heart failure or cardiovascular death among patients with heart failure and a left ventricular ejection fraction of more than 40%?
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.
SGLT2 inhibitors have demonstrated benefits in patients with chronic heart failure and a reduced ejection fraction, but evidence for their effectiveness in individuals with a mildly reduced or preserved ejection fraction was less defined before the DELIVER trial. This trial revealed that dapagliflozin also provided benefits to this patient group, thus supporting the broader use of SGLT2 inhibitors across the heart failure spectrum.
At the time the trial was published, recent guidelines had classified SGLT2 inhibitors as a class IIA, level B recommendation for treatment of heart failure with mildly reduced or preserved ejection fraction. Results from the DELIVER trial may contribute to future updates in clinical guidelines for the management of these patients.
- Phase 3, international, multicenter, parallel-group, event-driven, randomized, placebo-controlled trial - N=6,263 patients with heart failure and ejection fraction >40% - Intervention: Dapagliflozin 10 mg once daily (n=3,131) - Placebo plus usual therapy (n=3,132) - Median follow-up: 2.3 years
- Patients aged ≥40 years with heart failure and left ventricular ejection fraction of more than 40% - Included patients with stabilized heart failure, with or without type 2 diabetes mellitus
- Randomly assigned to dapagliflozin 10 mg once daily or matching placebo, along with their usual therapy
- Primary: Composite of worsening heart failure or cardiovascular death - Secondary: Total number of heart failure events and cardiovascular deaths; change in total symptom score on the Kansas City Cardiomyopathy Questionnaire; cardiovascular death; death from any cause - Safety: Incidence of adverse events
- Specific inclusion and exclusion criteria may limit generalizability. - Less than 5% of enrolled patients were Black, and while proportional on a regional basis, it is unclear how these findings may apply globally. - Owing to the COVID-19 pandemic, completion of the 8-month symptom assessment was limited.
- Supported by AstraZeneca.
- Full trial details and protocol information are available in the New England Journal of Medicine, published August 27, 2022.