article115

DELIVER

Clinical Question

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%?

Bottom Line

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.

Major Points

Guidelines

Design

- 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

Population

- 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

Interventions

- Randomly assigned to dapagliflozin 10 mg once daily or matching placebo, along with their usual therapy

Outcomes

- 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

Criticisms

- 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.

Funding

- Supported by AstraZeneca.