Pooled analysis of DAPA-HF and DELIVER

The pooled analysis of the phase 3 DAPA-HF and DELIVER trials found that dapagliflozin improved cardiovascular outcomes for patients with heart failure (HF) across the entire spectrum of ejection fraction (EF) measurements.

The pre-specified meta-analysis from 2 randomised phase 3 trials interrogating the efficacy of the SGLT2 inhibitor dapagliflozin (10 mg once daily) versus placebo in HF, DAPA-HF (EF <40%, NCT03036124) and DELIVER (EF >40%, NCT03619213), was presented by Prof. Pardeep Jhund (University of Glasgow, UK) and simultaneously published in the journal Nature Medicine [1–4].

Collectively, the average age of participants (n=11,007) was 69 years, 35% were women, and there was a median follow-up of 1.8 years. The survival data were strong; dapagliflozin reduced the risk of death from cardiovascular causes by 14% (HR 0.86; 95% CI 0.76–0.97; P=0.01), death from any cause by 10% (HR 0.90; 95% CI 0.82–0.99; P=0.03), total hospital admissions for HF by 29% (RR 0.71; 95% CI 0.65–0.78; P<0.001), and major adverse cardiovascular events by 10%, the latter with only borderline statistical significance (HR 0.90; 95% CI 0.81–1.00; P=0.045). In subgroup analyses, it was evident that the baseline ejection fraction (EF) of the participants did not significantly alter any of the individual or composite outcomes.

Using the data from this pooled analysis, the number of patients with HF who needed to be treated (NNT) for a median of 22 months to prevent 1 death from cardiovascular causes was 68 (95% CI 39–281). This analysis supports a recommendation that treatment with dapagliflozin can be initiated in patients with a clinical diagnosis of HF and no contraindications, even if a measurement of EF is awaited.

Prof. Jhund concluded: “Our findings confirm that all patients with HF, regardless of EF, may benefit from dapagliflozin in addition to any other HF therapy they are receiving.”

1. McMurray JJV, et al. N Engl J Med. 2019 Nov 21;381(21):1995–2008.
2. Solomon S, et al. DELIVER – Dapagliflozin in Heart Failure with Mildly Reduced and Preserved Ejection Fraction. Hot Line Session 4, ESC Congress 2022, Barcelona, Spain, 26–29 August.
3. Jhund P, et al. Pooled analysis of DAPA-HF and DELIVER. Hot Line Session 4, ESC Congress 2022, Barcelona, Spain, 26–29 August.
4. Jhund PS, et al. Nat Med. 2022. doi: 10.1038/s41591-022-01971-4.

Posted on 27 October, 202226 October, 2022